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Nalamachu, MD, Srinivas R., Neha Parikh, Larry Dillaha, MD i Richard Rauck, MD. "Lack of correlation between the effective dose of fentanyl sublingual spray for breakthrough cancer pain and the around-the-clock opioid dose". Journal of Opioid Management 10, nr 4 (1.07.2014): 247. http://dx.doi.org/10.5055/jom.2014.0212.
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Objective: To examine the relationship between the dose of fentanyl sublingual spray needed to control breakthrough cancer pain (BTCP) and the dose of around-the-clock (ATC) opioid used to control background pain.Design: Analysis was based on the open-label, dose-titration phase (up to 26 days) of a randomized, double-blind, placebo-controlled trial.Patients: Opioid-tolerant cancer patients (aged ≥18 years) with chronic pain of ≤moderate severity in the 24 hours before screening while receiving stable doses of scheduled ATC opioid therapy for ≥1 week and 1 to 4 episodes of BTCP per day.Interventions: Fentanyl sublingual spray was initiated at 100 μg. Dose titration proceeded until a dose was reached that provided adequate pain relief for two consecutive BTCP episodes without intolerable adverse effects (AEs).Results: Overall, 98/130 (75.4 percent) patients completed the dose-titration phase and achieved pain relief, and 73.5 percent of those who completed the titration period attained an effective dose of ≥600 μg (median effective dose, 800 μg). No clinically relevant correlation was found between effective doses of fentanyl sublingual spray for the treatment of BTCP and the ATC opioid doses used to control persistent pain (Spearman rank correlation [rs ] = 0.351, n = 98). Sixty percent of patients reported ≥1 AE during the dose-titration phase. The most common AEs considered related to study treatment were nausea (6.2 percent), somnolence (4.6 percent), dizziness (3.8 percent), and vomiting (3.8 percent).Conclusions: These findings highlight the importance of titrating the dose of fentanyl sublingual spray to optimize dosing for individual patients.
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Bond, T. Christopher, Jaime Rubin, Steven X. Wang i Alex Yang. "More Frequent Hemoglobin Measurements and More Frequent Epoetin Alfa Titrations Are Both Associated with Increased Epoetin Alfa Dose but Not More Time in Target Hemoglobin Range",. Blood 118, nr 21 (18.11.2011): 4194. http://dx.doi.org/10.1182/blood.v118.21.4194.4194.
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Abstract Abstract 4194 For the past 20 years, management of hemoglobin (Hb) level via erythropoiesis-stimulating agents (ESAs), such as epoetin alfa (EPO) has been the norm in the care of end-stage renal disease (ESRD) patients. Recently, questions about patient safety and new economic bundling rules have brought renewed focus on appropriate Hb targets and how they relate to the use of EPO. Important issues related to Hb control are the frequency of Hb measurements, Hb value, the frequency of changes in EPO dose (titrations), and total EPO dose. Current practice aims to achieve greater control of Hb by more frequent measurement and finer EPO dose titrations. No studies have definitively shown that levels of titration and measurement frequency lead to better clinical outcomes or more efficient use of EPO. One large retrospective analysis found increasing Hb measurements and EPO dose titration frequency decreased patient variability around the facility-level Hb mean (Khan et al, 2011). However, a second study found that frequent titrations have been shown to be the most important driver of Hb cycling—potentially dangerous large fluctuations in Hb levels (Fishbane and Berns, 2005). The issue remains controversial. We conducted a retrospective database analysis in order to quantify the frequency of Hb dose titrations and measurements, and to evaluate their relationship to ESA dose and the ability to keep patients within a Hb range of 10–12 g/dL. Data from prevalent (≥ 120 days), adult (>18 years old) hemodialysis patients dialyzing at DaVita dialysis clinics ≥ 3 times per week between January 1, 2009 and December 31, 2010 were included. For every session, patients' stable dosing periods were defined as any series of at least 3 doses during which the dose did not change more than 10% from first dose in the series. Dose holds were defined as ≥ 3 consecutive sessions with 0 EPO dose. An EPO dose of 0 lasting <3 consecutive sessions was ignored when identifying stable periods and holds. Doses not categorized as part of a stable period or a dose hold were considered transition periods. A dose titration was defined as a difference of > 10% between any of the following: the mean dose of 2 consecutive stable periods; the mean dose of stable period and next/previous dose in transition period; and 2 consecutive doses within a transition period. Transitions involving a dose hold were counted as 1 titration if the patient then returned to a dose within 10% of the mean of the prior period; or 2 titrations otherwise. Similar rules were developed for the minority of patients who received EPO once or twice per week. Correlations among measures (titrations/patient-month and Hb measurements/patient-month with mean monthly EPO dose and time with Hb in range) were assessed using Pearson product-moment correlation and linear regression (adjusted for racial composition, percentage of dialysis vascular access types, percentage with comorbidities, and mean age, vintage, and BMI) at the physician and the facility levels. Time in range was defined as total patient time in range/total patient-time. Facility level analyses were weighted by facility load (minimum of 300 patient-months) and are reported here. Information from 81,464 patients at 1,336 facilities was assessed. The mean number of titrations was 13.6 ± 2.83 (mean ± SD) per patient per year and the mean number of Hb measurements was 36.3 ± 8.24 per patient per year. The mean percent of patient-time in range among these facilities was 57.1% ± 5.8%. At the facility level, after adjustment for case mix factors (mean age, vintage, and BMI at facility, access types, and racial composition) the annual number of dose titrations per patient and Hb measurements per patient were not associated with the percent of patient-months within a 10–12 g/dL Hb range (p=0.12 and p=0.47; respectively). An analysis of ESA utilization showed that an increase of 1 titration per patient at the facility level was associated with an extra 18,000 U (p<0.001) per patient. In this retrospective study of >80,000 US dialysis patients over 2 years, neither increased Hb measurements nor increased EPO titrations were associated with improving patient-time in Hb range. However, increased EPO titrations were associated with significantly increased EPO utilization. Although these associations do not demonstrate causality (or the direction of potential causality), they do underscore the need to assess titration practices. Disclosures: Bond: DaVita Clinical Research: Employment; Affymax Inc: Research presented in this study was paid for by Affymax. Rubin:DaVita Clinical Research: Employment; Affymax: The research presented in this abstract was paid for by Affymax. Wang:DaVita Clinical Research: Employment; Affymax: The research presented in this abstract was paid for by Affymax. Yang:Affymax: Employment.
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MASSEY, J. A., i P. ABRAMS. "Dose Titration in Clinical Trials". British Journal of Urology 58, nr 2-4 (kwiecień 1986): 125–28. http://dx.doi.org/10.1111/j.1464-410x.1986.tb09010.x.
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Papangkorn, Kongnara, Kiran Vangara, Benjamin J. Bruno, Kilyoung Kim, Nachiappan Chidambaram, Anthony DelConte, Mahesh Patel i in. "Efficacy and Safety of TLANDO, A Novel Oral Easy to Prescribe and Use TRT Option". Journal of the Endocrine Society 5, Supplement_1 (1.05.2021): A486. http://dx.doi.org/10.1210/jendso/bvab048.994.
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Abstract Most widely used testosterone replacement therapy (TRT) products can be inconvenient and cumbersome topical and invasive injectable requiring dose adjustments to attain efficacy. In a pivotal study, a recently approved oral TRT only 26% of patients did not require any dose adjustment. Typically, patients start on a sub-therapeutic dose with gradual dose increases to attain efficacy resulting in additional visit(s) to clinic and pharmacy. Physician research data (N=402) suggested it typically takes 3-6 months of titrations to reach an efficacious dose for majority of patients, a significant barrier in effecting a switch without a period of “efficacy gap”. The requirement of additional visit(s) presents significant challenges for new and current patients desiring to start and to switch to a convenient TRT option, especially in the current COVID-19 pandemic. Recent reports suggest increase of disease severity/mortality in men with low testosterone is possibly due to underlying co-morbidities commonly associated with male hypogonadism. There remains a need for an effective, safe, and easy to use and prescribe product that does not require dose titration. TLANDO is a “triglyceride-free” oral single strength TRT with single dose designed to lymphatically deliver effective and safe levels of testosterone regardless of meal fat content. Moreover, dose titration is prone to some inherent titration decision errors and requires understanding of often complex titration rules. The objective is to assess whether TLANDO, an oral TRT without requiring dose titration, safely restores effective testosterone (T) levels in hypogonadal men. An open-label, single-arm, multicenter study (NCT03242590) was performed with TLANDO in hypogonadal males (N=95). Subjects received orally 225 mg twice a day testosterone undecanoate (TU) for 24 days without dose adjustment. Efficacy was evaluated by % of subjects who achieved daily T Cavg within the eugonadal range. Using 450mg daily dose without dose adjustment, 80% of subjects (95% CI of 72% to 88%) achieved a T Cavg in the normal range and safely restored with mean T Cavg of 476±184 ng/dL post steady state. T restoration was comparable to other non-oral TRT products. TLANDO was well tolerated with no deaths, no drug-related severe AEs, and no hepatic AEs. In conclusion, effective T restoration using TLANDO, an easy to use and prescribe oral TRT option, was confirmed. Minimal AEs were reported with no hepatic AEs. Upon approval, TLANDO will be the first convenient TRT option without requiring dose adjustments; therefore, enabling selection of an efficacious dose from the start of therapy. TLANDO is well suited for new or existing TRT patients desiring a convenient oral option.
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Lin, Rongbo, Jinfeng Zhu, Shuitu Feng, Sunzhi Lin, Jianqian Fu, Yongzhi Yao, Lixia Hong i in. "Patient controlled analgesia (PCA) versus non-PCA intravenous hydromorphone titration for severe cancer pain: A randomized, controlled, multicenter, phase III trial, HMORCT09-1." Journal of Clinical Oncology 37, nr 15_suppl (20.05.2019): TPS11635. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.tps11635.
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TPS11635 Background: The opioid dose for an individual with cancer pain to provide adequate relief of pain with an acceptable degree of side effects is variable. Opioid titration is a process to obtain the tailored dose. Conventional titration is administered by a clinician or nurse. PCA is that patients control cancer pain by self-administration of intravenous opioids using programmable pump. The aim of our study is to evaluate the efficacy of PCA titration versus conventional titration intravenously for severe cancer pain (10-point numerical rating scale, NRS ≥ 7). Injectable Hydromorphone was selected as pharmaceutical analgesics, which works as well as morphine and oxycodone and had similar side effects. Methods: This is currently enrolling patients (n=230) with severe cancer pain during previous 24 hours. Patients are randomized 1:1 and stratified by opioid intolerance or opioid tolerance into PCA or non-PCA titration. PCA titration using programmable pump: bolus hydromorphone at 0.5mg (for opioid intolerance) or hydromorphone dose equivalent to 10% to 20% of the total opioid taken in the previous 24 hours with a lockout time 15 minutes (for opioid tolerance) was administered by the patients educated. No basal infusion was set in the pump. Non-PCA titration administered by a nurse or clinician: Initial hydromorphone doses were same with PCA titration. Reassess pain at 15 minutes. Increased dose of hydromorphone by 50%-100% if pain unchanged or increased, or repeat same dose if pain decreased to NRS 4-6, or continue at current effective dose as needed over initial 24 hours. The primary endpoint is the time needed to successful titration was defined the time from the first dose of hydromorphone after randomization to achieve satisfied pain control. The satisfied pain control was defined NRS pain score ≤ 3 at rest in at least 2 consecutive assessment (15 minutes interval). The time needed to successful titration was extended to achieve satisfied pain control again if NRS pain score ≥ 7 after satisfied pain control within 24 hours. The failure of successful titration was defined that satisfied pain control does not achieve within 24 hours. Secondary endpoints include the percentage of patients titrated successfully, the mean NRS pain score of 24 hours, the total dose of hydromorphone titrated, and adverse events. Clinical trial information: NCT03375515.
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Norris, David C. "Dose Titration Algorithm Tuning (DTAT) should supersede the Maximum Tolerated Dose (MTD) concept in oncology dose-finding trials". F1000Research 6 (7.02.2017): 112. http://dx.doi.org/10.12688/f1000research.10624.1.
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Background. Absent adaptive, individualized dose-finding in early-phase oncology trials, subsequent ‘confirmatory’ Phase III trials risk suboptimal dosing, with resulting loss of statistical power and reduced probability of technical success for the investigational drug. While progress has been made toward explicitly adaptive dose-finding and quantitative modeling of dose-response relationships, most such work continues to be organized around a concept of ‘the’ maximum tolerated dose (MTD). The purpose of this paper is to demonstrate concretely how the aim of early-phase trials might be conceived of, not as ‘dose-finding’, but as dosing algorithm-finding. Methods. A Phase I dosing study is simulated, for a notional cytotoxic chemotherapy drug, with neutropenia constituting the critical dose-limiting toxicity. The drug’s population pharmacokinetics and myelosuppression dynamics are simulated using published parameter estimates for docetaxel. The amenability of this model to linearization is explored empirically. The properties of a simple dose titration algorithm targeting neutrophil nadir of 500 cells/mm3 using a Newton-Raphson heuristic are explored through simulation in 25 simulated study subjects. Results. Individual-level myelosuppression dynamics in the simulation model approximately linearize under simple transformations of neutrophil concentration and drug dose. The simulated dose titration exhibits largely satisfactory convergence, with great variance in individualized optimal dosing. Some titration courses exhibit overshooting. Conclusions. The large inter-individual variability in simulated optimal dosing underscores the need to replace ‘the’ MTD with an individualized concept of MTDi . To illustrate this principle, the simplest possible dose titration algorithm capable of realizing such a concept is demonstrated. Qualitative phenomena observed in this demonstration support discussion of the notion of tuning such algorithms. The individual-level linearization of myelosuppression dynamics demonstrated for the simulation model used here suggest that a titration algorithm specified in the more general terms of the linear Kalman filter will be worth exploring.
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Yeh, Yu-Chen, Joseph C. Cappelleri, Xiaocong L. Marston i Ahmed Shelbaya. "Effects of dose titration on adherence and treatment duration of pregabalin among patients with neuropathic pain: A MarketScan database study". PLOS ONE 16, nr 1 (20.01.2021): e0242467. http://dx.doi.org/10.1371/journal.pone.0242467.
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Objective To examine pregabalin dose titration and its impact on treatment adherence and duration in patients with neuropathic pain (NeP). Methods MarketScan database (2009–2014) was used to extract a cohort of incident adult pregabalin users with NeP who had at least 12 months of follow-up data. Any dose augmentation within 45 days following the first pregabalin claim was defined as dose titration. Adherence (measured by medication possession ratio/MPR) and persistence (measured as the duration of continuous treatment) were compared between the cohorts with and without dose titration. Logistic regressions and Cox proportional hazards models were used to identify the factors associated with adherence (MPR ≥ 0.8) and predictors of time to discontinuation. Results Among the 5,186 patients in the analysis, only 18% of patients had dose titration. Patients who had dose titration were approximately 2.6 times as likely to be adherent (MPR ≥ 0.8) (odds ratio = 2.59, P < 0.001) than those who did not have dose titration. Kaplan-Meier analysis shows that the time to discontinuation or switch was significantly longer among patients who had dose titration (4.99 vs. 4.04 months, P = 0.009). Conclusions Dose titration was associated with improved treatment adherence and persistence among NeP patients receiving pregabalin. The findings will provide valuable evidence to increase physician awareness of dose recommendations in the prescribing information and to educate patients on the importance of titration and adherence.
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Santosh Kumar, Rada, i R. Venkata Sandhya. "Titration Design: An Important Key in Drug Dose Determination". Journal of Drug Delivery and Therapeutics 9, nr 4-s (29.08.2019): 826–28. http://dx.doi.org/10.22270/jddt.v9i4-s.3374.
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Drug titration is the process of adjusting the dose of a medicine for the maximum benefits without adverse effects. To determine the optimum dose range the clinical trials are carried out and it is divided into two types of study design. The parallel type study design and titration type study design. The titration studies provide the information about the cumulative effects of the drug. Titration designs are mainly used in dose determining especially in insulin, anticonvulsants, anti-depressants, and sedatives. In the analysis of titration design, the phase I, II, III clinical trials are carried out to determine the dose-response relationship, safety and efficacy of the drug.
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Anis, Mursalin M., i Natasha Pollak. "Treatment of Palatal Myoclonus with Botulinum Toxin Injection". Case Reports in Otolaryngology 2013 (2013): 1–3. http://dx.doi.org/10.1155/2013/231505.
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Palatal myoclonus is a rare cause of pulsatile tinnitus in patients presenting to the otolaryngology office. Rhythmic involuntary contractions of the palatal muscles produce the pulsatile tinnitus in these patients. Treatment of this benign but distressing condition with anxiolytics, anticonvulsants, and surgery has been largely unsuccessful. A few investigators have obtained promising results with botulinum toxin injection into the palatal muscles. We present a patient with palatal myoclonus who failed conservative treatment with anxiolytics. Unilateral injection of botulinum toxin into her tensor veli palatini muscle under electromyographic guidance resolved pulsatile tinnitus in her ipsilateral ear and unmasked pulsatile tinnitus in the contralateral ear. A novel method of following transient postinjection symptoms using a diary is presented in this study. Botulinum toxin dose must be titrated to achieve optimal results in each individual patient, analogous to titrations done for spasmodic dysphonia. Knowledge of the temporal onset of postinjection side effects and symptomatic relief may aid physicians in dose titration and surveillance. We present suggestions on titrating the botulinum toxin dose to optimal levels. A review of the literature on the use of botulinum toxin for palatal myoclonus and some common complications are discussed.
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Tomita, Yoshihiko, Hirotsugu Uemura, Mototsugu Oya, Nobuo Shinohara, Tomonori Habuchi, Yosuke Fujii, Yoichi Kamei, Yoshiko Umeyama, A. H. Bair i Brian I. Rini. "Patients with metastatic renal cell carcinoma who have benefit from axitinib dose titration: Analysis from a randomized, double-blind, axitinib dose titration phase II study." Journal of Clinical Oncology 35, nr 6_suppl (20.02.2017): 438. http://dx.doi.org/10.1200/jco.2017.35.6_suppl.438.
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438 Background: Axitinib is a potent, selective inhibitor of VEGF receptors. In a randomized, double-blind, phase II study in patients with metastatic renal cell carcinoma, median overall survival (OS) was 42.7 months who underwent axitinib titration versus (vs.) 30.4 months in placebo titration (hazard ratio [HR]: 0.785; 95% confidence interval: 0.485, 1.272). OS Kaplan-Meier curves for two arms appeared to cross over at approximately 24 months and thus we investigated baseline characteristics associated with OS benefit from axitinib titration. Methods: Patients received axitinib 5 mg twice daily (BID) for 28 days. Patients who met the dose titration criteria were randomized 1:1 to axitinib titration or placebo titration. Patients who did not meet the dose titration criteria continued axitinib 5 mg BID. Baseline characteristics were compared between patients with OS ≥ 24 and < 24 months who were randomized to axitinib titration and subsequently, multivariate analysis for baseline characteristics was conducted to investigate effect of interaction with axitinib titration. Results: Fifty-six patients underwent axitinib titration with 53 evaluable for this analysis. Thirty-three patients had an OS ≥ 24 months and had significantly fewer metastatic sites (≤2, ≥3: 52/48% vs. 10/90%), compared to the 20 patients with OS < 24 months. In addition, a lower percentage of patients with OS ≥ 24 months had lymph node metastasis (45 vs. 75%), liver metastasis (15 vs. 45%), duration from diagnosis to treatment <1 year (36 vs. 85%), and baseline hemoglobin (Hb) < LLN (lower limit of normal) (33 vs. 75%), compared to the patients with OS < 24 months. In multivariate analysis in total of 112 patients who were randomized to axitinib or placebo titration, duration from diagnosis and baseline Hb were significantly associated with favorable OS with axitinib titration (p<0.1). Conclusions: Duration from diagnosis and baseline Hb are associated with favorable OS with axitinib titration. Clinical trial information: NCT00835978.
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Chung, Ka Fai, i Susan Joyce Wong. "Stimulus dose titration for electroconvulsive therapy". Psychiatry and Clinical Neurosciences 55, nr 2 (kwiecień 2001): 105–10. http://dx.doi.org/10.1046/j.1440-1819.2001.00795.x.
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Bastiampillai, Tarun, Jessica Dalwood, Rohan Dhillon i Prashant Tibrewal. "Why not rapid clozapine dose titration?" Asian Journal of Psychiatry 26 (kwiecień 2017): 13. http://dx.doi.org/10.1016/j.ajp.2016.12.010.
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Jensen, Rikke Beck, Ajay Thankamony, Susan M. O'Connell, Jeremy Kirk, Malcolm Donaldson, Sten-A. Ivarsson, Olle Söder i in. "A randomised controlled trial evaluating IGF1 titration in contrast to current GH dosing strategies in children born small for gestational age: the North European Small-for-Gestational-Age Study". European Journal of Endocrinology 171, nr 4 (październik 2014): 509–18. http://dx.doi.org/10.1530/eje-14-0419.
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BackgroundShort children born small for gestational age (SGA) are treated with a GH dose based on body size, but treatment may lead to high levels of IGF1. The objective was to evaluate IGF1 titration of GH dose in contrast to current dosing strategies.MethodsIn the North European Small-for-Gestational-Age Study (NESGAS), 92 short pre-pubertal children born SGA were randomised after 1 year of high-dose GH treatment (67 μg/kg per day) to three different regimens: high dose (67 μg/kg per day), low dose (35 μg/kg per day) or IGF1 titration.ResultsThe average dose during the second year of the randomised trial did not differ between the IGF1 titration group (38 μg/kg per day,s.d.0.019) and the low-dose group (35 μg/kg per day,s.d.0.002;P=0.46), but there was a wide variation in the IGF1 titration group (range 10–80 μg/kg per day). The IGF1 titration group had significantly lower height gain (0.17 SDS,s.d.0.18) during the second year of the randomised trial compared with the high-dose group (0.46 SDS,s.d.0.25), but not significantly lower than the low-dose group (0.23 SDS,s.d.0.15;P=0.17). The IGF1 titration group had lower IGF1 levels after 2 years of the trial (mean 1.16,s.d.1.24) compared with both the low-dose (mean 1.76,s.d.1.48) and the high-dose (mean 2.97,s.d.1.63) groups.ConclusionIGF1 titration of GH dose in SGA children proved less effective than current dosing strategies. IGF1 titration resulted in physiological IGF1 levels with a wide range of GH dose and a poorer growth response, which indicates the role of IGF1 resistance and highlights the heterogeneity of short SGA children.
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Xu, Xu Steven, Min Yuan i Partha Nandy. "Analysis of dose-response in flexible dose titration clinical studies". Pharmaceutical Statistics 11, nr 4 (11.03.2012): 280–86. http://dx.doi.org/10.1002/pst.1498.
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Rosenman, Stephen J. "Electroconvulsive therapy stimulus titration: Not all it seems". Australian & New Zealand Journal of Psychiatry 52, nr 5 (5.12.2017): 410–14. http://dx.doi.org/10.1177/0004867417743793.
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Objective: To examine the provenance and implications of seizure threshold titration in electroconvulsive therapy. Background: Titration of seizure threshold has become a virtual standard for electroconvulsive therapy. It is justified as individualisation and optimisation of the balance between efficacy and unwanted effects. Result: Present day threshold estimation is significantly different from the 1960 studies of Cronholm and Ottosson that are its usual justification. The present form of threshold estimation is unstable and too uncertain for valid optimisation or individualisation of dose. Threshold stimulation (lowest dose that produces a seizure) has proven therapeutically ineffective, and the multiples applied to threshold to attain efficacy have never been properly investigated or standardised. The therapeutic outcomes of threshold estimation (or its multiples) have not been separated from simple dose effects. Threshold estimation does not optimise dose due to its own uncertainties and the different short-term and long-term cognitive and memory effects. Potential harms of titration have not been examined. Conclusion: Seizure threshold titration in electroconvulsive therapy is not a proven technique of dose optimisation. It is widely held and practiced; its benefit and harmlessness assumed but unproven. It is a prematurely settled answer to an unsettled question that discourages further enquiry. It is an example of how practices, assumed scientific, enter medicine by obscure paths.
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Rini, Brian I., Viktor Gruenwald, Mayer N. Fishman, Bohuslav Melichar, Takeshi Ueda, A. H. Bair, Ying Chen i in. "Axitinib with or without dose titration for first-line metastatic renal cell carcinoma (mRCC): Unblinded results from a randomized phase II study." Journal of Clinical Oncology 31, nr 6_suppl (20.02.2013): LBA349. http://dx.doi.org/10.1200/jco.2013.31.6_suppl.lba349.
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LBA349 Background: Patients receiving the 5-mg twice daily (BID) axitinib starting dose exhibit variable drug exposure; prior pharmacokinetic analyses indicate higher exposure is associated with better outcomes in mRCC. Dose titration based on individual tolerability may optimize exposure and improve efficacy. Methods: Patients (N=213) with treatment-naïve mRCC received axitinib 5 mg BID for a 4-week lead-in period. Then, patients with 2 consecutive weeks of blood pressure ≤150/90 mmHg, no axitinib-related toxicities >grade 2, no dose reductions, and ≤2 antihypertensive medications were randomized (double-blind) to axitinib 5 mg BID + dose titration to 10 mg BID maximum with axitinib or placebo. Those not eligible for randomization continued axitinib 5 mg BID or lower. Primary endpoint was objective response rate (ORR) in randomized arms. Progression-free survival (PFS), overall survival, and safety were secondary endpoints. Assuming response rate under the null hypothesis is 0.15, this study had ≥80% power (1-sided type I error 10%) to detect a ≥25% absolute improvement in ORR with active vs placebo titration. Results: In all, 56 patients each were randomized to active and placebo titration arms, 91 were not randomized, and 10 withdrew during the lead-in period. As of Oct 12, 2012, ORR (95% confidence interval [CI]) was 54% (40–67) in the active titration arm vs 34% (22–48) in the placebo titration arm (1-sided P=0.019), and 59% (49–70) in the non-randomized arm. Median PFS (95% CI) from first dose was 14.5 mo (9.2–24.5) in the active titration arm vs 15.7 mo (8.3–19.4) in the placebo titration arm (hazard ratio favored active titration, 0.85; 95% CI, 0.54–1.35; 1-sided P=0.244), and 16.6 mo (11.2–22.5) in the non-randomized arm. Most frequent all-grade, all-causality adverse events in active titration, placebo titration, and non-randomized arms, respectively, were diarrhea (61% vs 63% vs 63%), hypertension (61% vs 43% vs 82%), and fatigue (45% vs 46% vs 54%). Conclusions: Axitinib is effective and well tolerated in first-line mRCC with prolonged median PFS in all treatment arms compared to historical controls. Axitinib dose titration significantly improved ORR vs placebo. Clinical trial information: NCT00835978.
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Legrand, S. B., B. Estfan, D. Walsh, M. P. Davis i R. L. Lagman. "Parenteral opioid dose titration and ventilatory function". Journal of Clinical Oncology 22, nr 14_suppl (15.07.2004): 8005. http://dx.doi.org/10.1200/jco.2004.22.90140.8005.
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Legrand, S. B., B. Estfan, D. Walsh, M. P. Davis i R. L. Lagman. "Parenteral opioid dose titration and ventilatory function". Journal of Clinical Oncology 22, nr 14_suppl (15.07.2004): 8005. http://dx.doi.org/10.1200/jco.2004.22.14_suppl.8005.
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Chang, Yeu-Jhy, Shan-Jin Ryu i Tsong-Hai Lee. "Dose Titration to Reduce Dipyridamole-Related Headache". Cerebrovascular Diseases 22, nr 4 (2006): 258–62. http://dx.doi.org/10.1159/000094013.
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Buti, Sebastiano, i Camillo Porta. "Axitinib dose titration: what's the limiting factor?" Lancet Oncology 14, nr 12 (listopad 2013): 1152–54. http://dx.doi.org/10.1016/s1470-2045(13)70489-3.
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Kellner, Charles H., George Petrides, Kevin O'Connor i Rafik Istafanous. "To Restimulate or Not in Dose Titration". Journal of ECT 23, nr 4 (grudzień 2007): 293–94. http://dx.doi.org/10.1097/yct.0b013e318141f982.
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Scott, Allan I. F. "To Restimulate or Not in Dose Titration". Journal of ECT 24, nr 4 (grudzień 2008): 294. http://dx.doi.org/10.1097/yct.0b013e31816fe9ba.
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Saunders, J., N. Willmott, A. Palasz i R. J. Mapletoft. "Dose titration of Folltropin in the cow". Theriogenology 33, nr 1 (styczeń 1990): 319. http://dx.doi.org/10.1016/0093-691x(90)90743-d.
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Laidlaw, J., P. Bentham, G. Khan, V. Staples, A. Dhariwal, B. Coope, E. Day, C. Fear, C. Marley i J. Stemman. "A comparison of stimulus dosing methods for electroconvulsive therapy". Psychiatric Bulletin 24, nr 5 (maj 2000): 184–87. http://dx.doi.org/10.1192/pb.24.5.184.
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Aims and MethodsA prospective study comparing initial electroconvulsive therapy treatment doses determined by empirical dose titration with estimates derived from two simple dose prediction methods and a fixed-dose regimen (275 mC).ResultsThirty-three patients had seizure thresholds between 25 mC and 403 mC. The dose titration method led to a mean initial treatment dose of 195 mC that was intermediate between those predicted by the age method (275 mC) and the half-age method (137 mC). Estimates were within acceptable limits in 33% of cases for the age method, 64% for the half-age method and 40% for the fixed-dose method.Clinical ImplicationsEither dose prediction or dose titration methods may be more appropriate in different clinical situations. The half-age method appears to be a more accurate predictor of optimum initial treatment dose.
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Norris, David C. "Dose Titration Algorithm Tuning (DTAT) should supersede ‘the’ Maximum Tolerated Dose (MTD) in oncology dose-finding trials". F1000Research 6 (30.03.2017): 112. http://dx.doi.org/10.12688/f1000research.10624.2.
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Background. Absent adaptive, individualized dose-finding in early-phase oncology trials, subsequent ‘confirmatory’ Phase III trials risk suboptimal dosing, with resulting loss of statistical power and reduced probability of technical success for the investigational therapy. While progress has been made toward explicitly adaptive dose-finding and quantitative modeling of dose-response relationships, most such work continues to be organized around a concept of ‘the’ maximum tolerated dose (MTD). The purpose of this paper is to demonstrate concretely how the aim of early-phase trials might be conceived, not as ‘dose-finding’, but as dose titration algorithm (DTA)-finding. Methods. A Phase I dosing study is simulated, for a notional cytotoxic chemotherapy drug, with neutropenia constituting the critical dose-limiting toxicity. The drug’s population pharmacokinetics and myelosuppression dynamics are simulated using published parameter estimates for docetaxel. The amenability of this model to linearization is explored empirically. The properties of a simple DTA targeting neutrophil nadir of 500 cells/mm 3 using a Newton-Raphson heuristic are explored through simulation in 25 simulated study subjects. Results. Individual-level myelosuppression dynamics in the simulation model approximately linearize under simple transformations of neutrophil concentration and drug dose. The simulated dose titration exhibits largely satisfactory convergence, with great variance in individualized optimal dosing. Some titration courses exhibit overshooting. Conclusions. The large inter-individual variability in simulated optimal dosing underscores the need to replace ‘the’ MTD with an individualized concept of MTDi . To illustrate this principle, the simplest possible DTA capable of realizing such a concept is demonstrated. Qualitative phenomena observed in this demonstration support discussion of the notion of tuning such algorithms. Although here illustrated specifically in relation to cytotoxic chemotherapy, the DTAT principle appears similarly applicable to Phase I studies of cancer immunotherapy and molecularly targeted agents.
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Norris, David C. "Dose Titration Algorithm Tuning (DTAT) should supersede ‘the’ Maximum Tolerated Dose (MTD) in oncology dose-finding trials". F1000Research 6 (17.07.2017): 112. http://dx.doi.org/10.12688/f1000research.10624.3.
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Background. Absent adaptive, individualized dose-finding in early-phase oncology trials, subsequent ‘confirmatory’ Phase III trials risk suboptimal dosing, with resulting loss of statistical power and reduced probability of technical success for the investigational therapy. While progress has been made toward explicitly adaptive dose-finding and quantitative modeling of dose-response relationships, most such work continues to be organized around a concept of ‘the’ maximum tolerated dose (MTD). The purpose of this paper is to demonstrate concretely how the aim of early-phase trials might be conceived, not as ‘dose-finding’, but as dose titration algorithm (DTA)-finding. Methods. A Phase I dosing study is simulated, for a notional cytotoxic chemotherapy drug, with neutropenia constituting the critical dose-limiting toxicity. The drug’s population pharmacokinetics and myelosuppression dynamics are simulated using published parameter estimates for docetaxel. The amenability of this model to linearization is explored empirically. The properties of a simple DTA targeting neutrophil nadir of 500 cells/mm 3 using a Newton-Raphson heuristic are explored through simulation in 25 simulated study subjects. Results. Individual-level myelosuppression dynamics in the simulation model approximately linearize under simple transformations of neutrophil concentration and drug dose. The simulated dose titration exhibits largely satisfactory convergence, with great variance in individualized optimal dosing. Some titration courses exhibit overshooting. Conclusions. The large inter-individual variability in simulated optimal dosing underscores the need to replace ‘the’ MTD with an individualized concept of MTDi . To illustrate this principle, the simplest possible DTA capable of realizing such a concept is demonstrated. Qualitative phenomena observed in this demonstration support discussion of the notion of tuning such algorithms. Although here illustrated specifically in relation to cytotoxic chemotherapy, the DTAT principle appears similarly applicable to Phase I studies of cancer immunotherapy and molecularly targeted agents.
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Wells, DNSc, RN, Nancy, Barbara Murphy, MD, Stacey Douglas, MSN, RN i Nancy Yelton, MSN, RN. "Establishing the safety and efficacy of an opioid titration protocol". Journal of Opioid Management 1, nr 1 (1.03.2005): 41. http://dx.doi.org/10.5055/jom.2005.0011.
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The primary goal of this single-group study was to determine the safety of a standard opioid titration order sheet to manage pain in ambulatory cancer patients. Secondary goals were to examine opioid toxicity and efficacy of this pain protocol.Twenty-seven patients who required fixed-dose opioids and who had uncontrolled pain were enrolled. All patients had their initial opioid dose titrated by the study physician using the opioid titration order sheet. Data were obtained by the study nurse during a weekly telephone interview and used to determine if pain was controlled. After initial titration, a trained study nurse titrated opioid doses based upon the standing order sheet. At each contact, patients were assessed for adverse effects, pain intensity, and analgesics used.Patients who completed the four-week trial (n = 17) did not differ from patients who did not complete the trial. No adverse effects were observed in 39 opioid titrations com-pleted by the study nurse. Opioid toxicities, worst pain, usual pain, and pain-related distress declined from baseline to week four. Patients who were adherent to their prescribed medications reported significantly lower pain intensity and distress (ps < 0.06).The opioid titration order sheet, used by a trained nurse, is safe to use in ambulatory cancer patients who have moderate to severe pain. Common opioid toxicities were reduced. The protocol also demonstrated initial efficacy in improving worst and usual pain and pain-related distress. Further research to establish efficacy of theprotocol is recommended.
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Tiller, John W. G., i Nicholas Ingram. "Seizure Threshold Determination for Electroconvulsive Therapy: Stimulus dose Titration Versus Age-Based Estimations". Australian & New Zealand Journal of Psychiatry 40, nr 2 (luty 2006): 188–92. http://dx.doi.org/10.1080/j.1440-1614.2006.01773.x.
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Objective: This study compared electroconvulsive therapy (ECT) seizure threshold determined by stimulus dose titration with age-based estimations. Method: Patients with major depressive disorder had their initial seizure thresholds determined by stimulus dose titration and the results compared with age-based estimations. There are no significant differences in thresholds determined by these methods. Results: Two hundred and three psychiatric patients (149 females, 54 males) had their seizure thresholds determined by stimulus dose titration. There was a significant positive correlation between seizure thresholds and age for males and females with male thresholds greater than female thresholds. Age determinations of seizure threshold would have resulted in excessive initial treatment stimuli for 30% of females and 8% of males. Ineffective stimulus doses would have been given to 2% of females and 7% of males on a full age basis and 64% using a half age strategy. Conclusions: For effective high-dose right unilateral ECT, initial seizure threshold should be determined by stimulus dose titration.
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Wilhelm, Amanda, Karen E. Anderson, Hubert H. Fernandez, Hadas Barkay, Nayla Chaijale, Alexander F. Send, Juha-Matti Savola i Mark Forrest Gordon. "Comparison of Safety and Tolerability of Deutetrabenazine During Titration and Maintenance in Patients with Tardive Dyskinesia". CNS Spectrums 26, nr 2 (kwiecień 2021): 164. http://dx.doi.org/10.1017/s1092852920002643.
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AbstractBackgroundDeutetrabenazine is approved to treat tardive dyskinesia (TD) in adults and is titrated weekly by 6 mg/day, from 12 to 48 mg/day, based on dyskinesia control and tolerability. This analysis compared the safety of deutetrabenazine during titration versus maintenance.MethodsSafety was assessed during titration versus maintenance using integrated data from two 12-week placebo-controlled studies (ARM-TD and AIM-TD) and the open-label extension study. Rates were compared for overall and serious adverse events (AEs), AEs leading to discontinuation, treatment-related AEs, common AEs (≥4%), and specific AEs (parkinsonism, suicidal ideation, akathisia, restlessness).ResultsIn titration versus maintenance, AE rates with placebo (n=130) were: overall, 43.1% vs 25.4%; serious, 4.6% vs 2.3%; leading to discontinuation, 3.1% vs 0; treatment-related, 26.9% vs 10.0%. For placebo, common AEs during titration were somnolence, headache, nausea, fatigue, and dry mouth; none occurred during maintenance. In titration versus maintenance, AE rates in fixed-dose deutetrabenazine 12–36 mg (n=216) were: overall, 33.3–38.9% vs 22.2–29.2%; serious, 2.8–6.9% vs 0–1.4%; leading to discontinuation, 2.8–5.6% vs 0; treatment-related, 8.3–16.7% vs 8.3–13.9%. For fixed-dose deutetrabenazine, common AEs during titration were headache, diarrhea, nasopharyngitis, depression, hypertension, and dry mouth; headache was the only common AE during maintenance. In titration versus maintenance, AE rates with flexible-dose deutetrabenazine (n=168) were: overall, 49.4% vs 32.7%; serious, 3.6% vs 2.4%; leading to discontinuation, 2.4% vs 0.6%. For flexible-dose deutetrabenazine, the only common AE during titration was somnolence; none occurred during maintenance. Rates of parkinsonism, suicidal ideation, akathisia, and restlessness were low and comparable in titration and maintenance.ConclusionsDeutetrabenazine was well-tolerated, with AE rates similar to placebo during both phases; AE rates were higher during titration and decreased during maintenance.FundingTeva Pharmaceutical Industries Ltd., Petach Tikva, Israel
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Suntharalingam, J., D. Hodgkins, F. H. Cafferty, R. J. Hughes i J. Pepke-Zaba. "Does rapid dose titration affect the hepatic safety profile of Bosentan?" Vascular Pharmacology 44, nr 6 (czerwiec 2006): 508–12. http://dx.doi.org/10.1016/j.vph.2006.03.004.
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Sumethkul, Kittiwan, Tasanee Kitumnuaypong, Sungchai Angthararak i Warangkana Pichaiwong. "Low-dose cyclosporine for active lupus nephritis: a dose titration approach". Clinical Rheumatology 38, nr 8 (1.04.2019): 2151–59. http://dx.doi.org/10.1007/s10067-019-04469-6.
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Wroe, SJ. "Effects of Dose Titration on Tolerability and Efficacy of Interferon Beta-1b in People with Multiple Sclerosis". Journal of International Medical Research 33, nr 3 (maj 2005): 309–18. http://dx.doi.org/10.1177/147323000503300306.
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Multiple sclerosis (MS) treatment with interferon beta is associated with well-known, easily managed adverse events, including influenza-like symptoms and injection-site reactions that decline over time. Initial dose titration has been shown to be one way of limiting these adverse events. Hence, a placebo-controlled, multicentre study of 98 patients was set up to explore whether a slower, four-stage, 4-week titration to a final dose of 250 μg subcutaneous interferon beta-1b might improve tolerability over a more rapid two-stage, 2-week titration in patients with relapsing-remitting MS. Frequency of adverse events was found to be similar between the two regimens: notably, no difference in the incidence of injection-site reactions, with a trend towards fewer influenza-like symptoms in the slow-titration group. Relative to placebo, significantly fewer patients receiving interferon beta-1b relapsed. This was more pronounced in the rapid-titration group than in the slow-titration group, showing that rapid and significant improvements in relapse rates were achieved within 90 days of starting interferon beta-1b. Although a rapid-titration regimen results in a quicker onset of clinical benefit, slow titration showed a non-significant trend towards reduced influenza-like symptoms.
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Alva Venur, Vyshak, Laura S. Wood, Paul Elson, Allison Martin, Jennifer Beach, Jorge A. Garcia i Brian I. Rini. "An alternative titration schedule of axitinib in metastatic renal cell carcinoma." Journal of Clinical Oncology 33, nr 7_suppl (1.03.2015): 444. http://dx.doi.org/10.1200/jco.2015.33.7_suppl.444.
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444 Background: Titration of axitinib for metastatic renal cell carcinoma (mRCC) is currently based on tolerance with escalation from 10 mg/day to 14 mg/day and then to 20 mg/day. However, not all patients who can be titrated upward require a higher dose for response, nor do all patients tolerate the increased dose levels. An alternative titrating strategy was employed based on radiographic response, tolerance, and using intermediate dosing levels. Methods: In this retrospective analysis of mRCC, axitinib was initiated at 10 mg/day (5 mg BID). Response was assessed with CT scans at 6 weeks after each dosing change. Patients with response by MASS criteria and acceptable toxicity (<grade 2) were continued on the same dose. If the patient had no response and <grade 2 toxicity, axitinib was increased by 2 mg/day at each reassessment (e.g., initially to 6 mg BID), to a maximum of 20 mg/day. If the patient had >grade 2 toxicity the dose was reduced by 1 mg/day. Results: Twenty-eight patients were started on axitinib as per the above titration scheme between May 2013 and June 2014. Twenty four patients had clear cell, 3 had papillary and 1 had chromophobe mRCC, and all patients had received at least one prior systemic therapy. The final dose of axitinib ranged from 2 mg/day through 20 mg/day. Eleven patients did not change from the starting dose. Ten patients (36%) underwent dose escalation whereas 7 patients required dose reduction. Overall, for the 17 patients who had their dosage adjusted, the median time to final (current) dose was 9.9 weeks (range, 6.0-23.7), and the median time within a dose was 6.6 weeks (range, 1.1-10.0). Five of 10 patients who required dose escalation ended up on doses other than 14 mg/day or 20 mg/day (three at 12 mg/day and two at 16 mg/day). Among the dose-escalated patients, two patients had grade 1 diarrhea, one each had grade 3 diarrhea, grade 2 diarrhea, grade 1 nausea, grade 2 fatigue, grade 1 hypertension and grade 1 hand foot syndrome. The objective response rate was 17% with a median PFS of 7.4 months. Conclusions: Axitinib dose titration guided by radiographic response and toxicity is a feasible strategy with acceptable overall disease control and good tolerance. A prospective study is warranted.
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Ioachimescu, Adriana Gabriela, Richard Joseph Auchus, Wenyu Huang, Joanna L. Spencer-Segal, Kevin Choong Ji Yuen, Kelley C. Dacus, William Henry Ludlam i in. "LBMON177 Dosing And Titration Of Osilodrostat In A Real-world Cohort Of US Patients With Endogenous Cushing's Disease: Analysis Of The ILLUSTRATE Study". Journal of the Endocrine Society 6, Supplement_1 (1.11.2022): A473—A474. http://dx.doi.org/10.1210/jendso/bvac150.983.
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Abstract Background Osilodrostat, a potent oral inhibitor of 11β-hydroxylase, demonstrated efficacy in normalizing urinary free cortisol (UFC) in Cushing's disease (CD) patients; however, information describing its use in clinical practice is limited. We present osilodrostat dosing and titration information from a real-world cohort of endogenous Cushing's syndrome (CS) patients, focused on CD. Methods ILLUSTRATE, a retrospective chart review study analyzed confirmed endogenous CS patients who initiated osilodrostat treatment May 1, 2020 - October 29, 2021. Forty-two adult patients with endogenous CS and a prescription for osilodrostat were included in this real-world study. We describe the experience with initial osilodrostat dose, dose titration, and persistence in the CD subset (n=34, 81%). Results In patients with CD (n=34) the mean total daily starting dose was 3.4 mg (SD 1; median 4 mg; range 1-6 mg/day). Twenty-one patients (62%) were initiated on 2 mg BID, 9 (27%) on 1 mg BID, and 1 each (3%) on 1 mg QD, 2 mg QD, 3 mg BID and 4 mg QD. In CD patients with multiple documented clinical encounters (n=26), 16 initiated at 4 mg/day, of which the dose was interrupted or down-titrated in 4 patients (25%) within 71 days of treatment initiation; 2/4 of these patients experienced hypocortisolism related symptoms and permanently discontinued. Five of the 16 patients (31%) were maintained on 4 mg/day throughout the observation period, with a mean (SD) treatment duration of 273 (median 278 days; SD 92) days. Seven of 16 patients (44%) had a dose up-titration; in 6/7 patients, initial dose increase was incremental (1-2 mg BID), and the mean (SD) time to up-titration was 78 (SD 25; median 83; range 40-108) days. In the 10 of 26 CD patients who initiated therapy at <2 mg BID, 6 (60%) did not require dose reduction or interruption, all of which had up-titration in small increments (1-2 mg/day) and/or first titration at ≥80 days. Treatment persistence for those enrolled ≥ 6 months prior to study end was 95.8%, mean (SD) duration of therapy was 339.2 (106.8) days. Osilodrostat was generally well tolerated. Symptoms related to decreased cortisol levels were reported in 10/26 patients (38%), including 3 patients with adrenal insufficiency and 7 patients with glucocorticoid withdrawal symptoms. Conclusion ILLUSTRATE captures real-world US data describing the experience of CD patients treated with osilodrostat. Importantly, one-third (11/34) of patients were initiated on a dose lower than 4 mg/day (lower than starting dose previously used in clinical trials). Of 16 patients initiated at 4 mg/day, 4 (25%) required interruption or down-titration and 5 (31%) remained on the initial dose throughout the observation period. Overall, consistent with prior research data, patients with a gradual dose up-titration (i. e., prolonged titration interval) tended to have greater persistence with therapy. There were no new safety findings. Presentation: Monday, June 13, 2022 12:30 p.m. - 2:30 p.m.
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Shastry, R., P. Adhikari, A. Kamath, M. Chowta, S. Ullal i MRSM Pai. "Do geriatrics require dose titration for antidiabetic agents?" Journal of Postgraduate Medicine 59, nr 4 (2013): 271. http://dx.doi.org/10.4103/0022-3859.123153.
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Marushko, Yu V., Yu I. Todyka i Ye Yu Marushko. "Clinical Effectiveness and Dose Titration in Pediatric Practice". CHILD`S HEALTH, nr 1.69 (10.03.2016): 41. http://dx.doi.org/10.22141/2224-0551.1.69.2016.73704.
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Albsoul-Younes, Abla M., Hazem A. Salem, Saleh F. Ajlouni i Saafan A. Al-Safi. "Topiramate slow dose titration: Improved efficacy and tolerability". Pediatric Neurology 31, nr 5 (listopad 2004): 349–52. http://dx.doi.org/10.1016/j.pediatrneurol.2004.04.012.
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Harris, A. G., T. M. O'Dorisio, E. A. Woltering, L. B. Anthony, F. R. Burton, R. B. Geller, J. H. Grendell, B. Levin i J. S. Redfern. "Consensus statement: Octreotide dose titration in secretory diarrhea". Digestive Diseases and Sciences 40, nr 7 (lipiec 1995): 1464–73. http://dx.doi.org/10.1007/bf02285194.
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Vikre-Jørgensen, Jennifer, Lone Agertoft i Søren Pedersen. "Dose titration of nebulized budesonide in young children". Pediatric Pulmonology 23, nr 4 (kwiecień 1997): 270–77. http://dx.doi.org/10.1002/(sici)1099-0496(199704)23:4<270::aid-ppul4>3.0.co;2-q.
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Finkelman, Brian S., Benjamin French, Luanne Bershaw, Colleen M. Brensinger, Michael B. Streiff, Andrew E. Epstein i Stephen E. Kimmel. "Predicting prolonged dose titration in patients starting warfarin". Pharmacoepidemiology and Drug Safety 25, nr 11 (26.07.2016): 1228–35. http://dx.doi.org/10.1002/pds.4069.
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Banefelt, Jonas, Maria Lindh, Maria K. Svensson, Björn Eliasson i Ming-Hui Tai. "Statin dose titration patterns and subsequent major cardiovascular events in very high-risk patients: estimates from Swedish population-based registry data". European Heart Journal - Quality of Care and Clinical Outcomes 6, nr 4 (1.04.2020): 323–31. http://dx.doi.org/10.1093/ehjqcco/qcaa023.
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Abstract Aims Clinical studies have demonstrated the efficacy of intensive statin therapy in lowering low-density lipoprotein cholesterol and cardiovascular (CV) events. Our objective was to examine statin titration patterns and the association between titration patterns and subsequent CV events in very high-risk patients. Methods and results Using Swedish national population-based registry data, we identified 192 435 patients with very high risk of atherosclerotic CV disease initiated on moderate-intensity statin therapy between 2006 and 2013. Outcomes of interest were titration to high-intensity therapy and the major adverse cardiovascular events (MACE) composite (myocardial infarction, ischaemic stroke, and CV death) outcome. Cumulative incidence of MACE was assessed by titration status 1-year post-treatment initiation in patients adherent to treatment during the first year, using a 12-week cut-off from initiation to define early, delayed and no up-titration to high-intensity statins. Cox regression analysis was used to estimate adjusted hazard ratios (HRs). In 144 498 eligible patients, early titration was associated with significantly lower risk of MACE in the subsequent 2 years compared to no up-titration (HR 0.76, P < 0.01]. Delayed up-titration was associated with a smaller reduction (HR 0.88, P = 0.08). The majority of patients did not up-titrate. Conclusion Early up-titration to high-intensity statins was independently associated with lower risk of subsequent CV events compared to no up-titration. Delayed up-titration was not associated with the same benefit. Despite the higher risk associated with no up-titration, few patients at very high CV risk who started treatment on moderate-intensity up-titrated to high intensity, indicating a potential need for more aggressive lipid management of these patients in clinical practice.
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Khaw, Chelsea, i Tami Argo. "Prazosin initiation and dose titration in a patient with posttraumatic stress disorder on concurrent carvedilol". Mental Health Clinician 9, nr 5 (1.09.2019): 326–30. http://dx.doi.org/10.9740/mhc.2019.09.326.
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Abstract One mechanism involved in the pathophysiology of posttraumatic stress disorder (PTSD) is increased noradrenergic stimulation. Prazosin, a commonly utilized treatment for PTSD nightmares, works to block noradrenergic stimulation of the alpha-1 adrenoreceptor. Dual antagonism of this receptor would be expected to increase risk of adverse effects. Carvedilol has both alpha-1 adrenergic and nonselective beta-adrenoreceptor antagonist activity. To our knowledge, there is no clinical guidance on use of prazosin in patients concomitantly prescribed carvedilol for hypertension. This case describes the successful titration of prazosin for PTSD symptoms in a 49-year-old male concurrently prescribed carvedilol for hypertension. This patient had a previous unsuccessful prazosin trial due to adverse effects. His second trial of prazosin was efficacious and well tolerated using individualized titration with close monitoring by mental health clinical pharmacy specialists in the pharmacist-managed prazosin titration clinic. This case details the importance of utilizing caution and close follow-up in prazosin dose titration in patients prescribed concomitant alpha-1 antagonists. This appears to be the first case report describing the successful dose titration of prazosin for PTSD in a patient on a concurrent alpha-1 antagonist antihypertensive agent.
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Thorpy, Michael, Danielle Hyman, Gregory Parks, Abby Chen, Catherine Foley, Diane Ito i Haramandeep Singh. "482 Solriamfetol Titration & AdministRaTion (START): dosing and titration strategies in patients with narcolepsy starting solriamfetol". Sleep 44, Supplement_2 (1.05.2021): A190. http://dx.doi.org/10.1093/sleep/zsab072.481.
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Abstract Introduction Solriamfetol (Sunosi®), a dopamine/norepinephrine reuptake inhibitor, is approved (US and EU) to treat excessive daytime sleepiness (EDS) in adults with narcolepsy (75–150 mg/day) or obstructive sleep apnea (OSA) (37.5–150 mg/day). Previous research examined the use of solriamfetol in clinical trial settings but research in real-world settings was not previously conducted. This study characterized real-world dosing and titration with solriamfetol. Methods This virtual, descriptive study included a quantitative retrospective patient chart review among US-based physicians prescribing solriamfetol. Target enrollment was 25 physicians treating patients with EDS associated with OSA or narcolepsy. Titration strategies were classified as de novo (no prior EDS medication), transition (switched/switching from existing EDS medications onto solriamfetol), or add-on (adding solriamfetol to current EDS medication). Results Twenty-six physicians participated. Seventy patients with narcolepsy were analyzed (type 1, n=24; type 2, n=46; mean±SD age, 40±11 years; 57% female; 6 also had OSA); EDS was primarily moderate (59%) or severe (36%). Solriamfetol initiation was de novo for 19 (27%) patients, transition for 31 (44%), and add-on for 20 (29%). Most patients (86%) started solriamfetol at 75 mg; 11% and 3% started at 37.5 mg and 150 mg, respectively. The final/stable dose was 150 mg for 76% (53/70) of patients and 75 mg for 24% (17/70). Most patients (67%) had 1 dose adjustment to reach their final dose; 4% had 2 adjustments, 4% had 3 adjustments, and 24% had none. Mean±SD time to reach a stable dose was 15.1±11.8 days overall, 19.4±9.3 days with de novo treatment, 15.0±13.7 days for transition, and 11.9±8.6 days for add-on. Physicians most frequently considered EDS severity (44% of patients) when titrating. Among patients transitioning, 14/22 (64%) taking a wake-promoting agent (WPA) discontinued it abruptly while 5/9 (56%) taking a stimulant were tapered off. Physicians were overall likely (n=33, 47%) or very likely (n=30, 43%) to recommend their approach for similar patients. Conclusion In a real-world study, the majority of physicians prescribing solriamfetol for patients with narcolepsy started at the 75-mg dose, tapered stimulants but abruptly discontinued WPAs, and made 1 adjustment to reach a stable dose across 15 days on average. Support (if any) Jazz Pharmaceuticals
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Castellana, Marco, Filippo Procino, Rodolfo Sardone, Pierpaolo Trimboli i Gianluigi Giannelli. "Efficacy and safety of patient-led versus physician-led titration of basal insulin in patients with uncontrolled type 2 diabetes: a meta-analysis of randomized controlled trials". BMJ Open Diabetes Research & Care 8, nr 1 (lipiec 2020): e001477. http://dx.doi.org/10.1136/bmjdrc-2020-001477.
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IntroductionInsulin is the most effective antihyperglycemic treatment and basal insulin is the preferred initial formulation in patients with type 2 diabetes. However, its effects are dose-dependent, so adequate titration is necessary to reach targets. We performed a meta-analysis to compare the efficacy and safety of patient-led versus physician-led titration of basal insulin in patients with uncontrolled type 2 diabetes.Research design and methodsFour databases were searched from database inception through March 2020. Randomized controlled studies with at least 12 weeks of follow-up of patients with type 2 diabetes allocated to patient-led versus physician-led titration of basal insulin were selected. Data on glycemic endpoints (hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), hypoglycemia) and other outcomes (insulin dose, body weight, patient-reported outcomes, adverse events, rescue medication, discontinuation) were extracted. Data were pooled using a random-effects model.ResultsSix studies evaluating 12 409 patients were finally included. Compared with the physician-led performance, patient-led titration was associated with a statistically significant higher basal insulin dose (+6 IU/day), leading to benefits on HbA1c (−0.1%) and FPG (−5 mg/dL), despite a higher risk of any level hypoglycemia (relative risk=1.1) and a slight increase in body weight (+0.2 kg). No difference was found for the other outcomes.ConclusionsThe present study showed that patient-led titration of basal insulin was not inferior to physician-led titration in patients with uncontrolled type 2 diabetes. Therefore, diabetes self-management education and support programs on basal insulin should be widely adopted in clinical practice and patients provided with tools to self-adjust their dose when necessary.
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Wertheim, M. S., H. Jhangiani, G. Niebler i V. Charu. "Finding an effective dose of fentanyl effervescent buccal tablets: Combined results of open-label titration". Journal of Clinical Oncology 24, nr 18_suppl (20.06.2006): 18521. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.18521.
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18521 Background: Standard recommendations for short-acting oral opioid doses to manage breakthrough pain (BTP) assume some relation with the stable opioid dose used to treat persistent pain. Fentanyl effervescent buccal tablets (FEBT) are designed to enhance the efficiency of fentanyl absorption through the buccal mucosa. They may provide rapid-onset analgesia. This pooled analysis of data from 3 studies examined the relationship between effective FEBT dose and around-the-clock (ATC) dose in patients who completed open-label titration to an effective FEBT dose. Methods: Patients were 18–80 years of age with cancer, persistent pain, and BTP. Eligible patients experienced an average of 1–4 episodes of BTP per day and were receiving stable doses of opioids (≥60 mg/day of morphine or equivalent) for persistent pain. Titration guidelines were uniform across studies; the maximum allowed dose of FEBT was 800 μg. Results: Of 304 patients enrolled, 208 completed titration to an effective FEBT dose; of these, 100 μg was effective in 21 patients, 200 μg in 32, 400 μg in 45, 600 μg in 49, and 800 μg in 61. The effective dose of FEBT showed no relationship to the dose of either ATC or supplemental opioids. No correlation was found between the effective dose of FEBT and the average dose of prior supplemental opioids (r2 = .0322; Pearson’s coefficient = .1793), the effective dose of FEBT and the dose of ATC opioids in patients using oral ATC opioids (r2 = .0353; Pearson’s coefficient = .1878), or the effective dose of FEBT and the dose of ATC opioids in patients using transdermal fentanyl alone or in combination with other opioids as ATC medication (r2 = .0289; Pearson’s coefficient = .1701). Conclusions: No predictable relationship between the effective dose of FEBT and the dose of ATC opioids was observed. Titration will allow the identification of each patient’s effective dose of FEBT for relief of BTP. [Table: see text]
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Kovačević, Dragan, i Sanja Kovačević. "Significance of beta-blocker dose titration in heart failure". Galenika Medical Journal 1, nr 4 (2022): 53–58. http://dx.doi.org/10.5937/galmed2204055k.
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Heart failure is a clinical syndrome, characterized by the inability of the heart to pump an adequate amount of blood according to the needs of the organs and tissues, at rest and during exertion, despite normal blood flow to the heart. Treatment includes hygienic and dietary measures, pharmacological treatment, installation of an appropriate device, surgical treatment and heart transplantation. Indispensable groups of drugs that reduce mortality in the treatment of this disease are beta-blockers, angiotensin-converting enzyme inhibitors (ACE inhibitors)/angiotensin receptor neprilysin inhibitors (ARNI), mineralocorticoid receptor agonists (MRA), sodium-glucose cotransporter type 2 inhibitors (SGLT inhibitors). By blocking beta receptors and sympathies, beta-blockers relieve the cell, which tried to compensate for the weak function by "accumulating" them. Their gradual introduction is necessary in order to achieve the appropriate effect. Therapy with beta-blockers is started with the lowest dose, which, depending on the clinical condition of the patient, is increased every two weeks until the full dose is reached. The rule of thumb is that a smaller dose is better than none. Thanks to the high selectivity of beta-blockers, they can be used in patients who have comorbidities and heart failure, which is unfortunately a very common case. They can be administered to the patients with chronic obstructive pulmonary disease, diabetes mellitus, peripheral occlusive disease and similar. Beta-blockers, in addition to angiotensinconverting enzyme inhibitors/angiotensin receptor neprilysin inhibitors, mineralocorticoid receptor agonists and sodium-glucose cotransporter type 2 inhibitors, represent the most significant group of drugs that have the greatest impact on disease prognosis, quality of life, morbidity and mortality in patients with heart failure with reduced ejection fraction. Today, they are not used enough because of the fear of developing hypotension and bradycardia, and they are often mistakenly considered contraindicated in the presence of numerous comorbidities.
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Nauta, J. F., B. T. Santema, M. H. L. van der Wal, A. Koops, J. Warink-Riemersma, K. van Dijk, F. Inkelaar i in. "Improvement in left ventricular ejection fraction after pharmacological up-titration in new-onset heart failure with reduced ejection fraction". Netherlands Heart Journal 29, nr 7-8 (14.06.2021): 383–93. http://dx.doi.org/10.1007/s12471-021-01591-6.
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Abstract Objective Recent studies have reported suboptimal up-titration of heart failure (HF) therapies in patients with heart failure and a reduced ejection fraction (HFrEF). Here, we report on the achieved doses after nurse-led up-titration, reasons for not achieving the target dose, subsequent changes in left ventricular ejection fraction (LVEF), and mortality. Methods From 2012 to 2018, 378 HFrEF patients with a recent (< 3 months) diagnosis of HF were referred to a specialised HF-nurse led clinic for protocolised up-titration of guideline-directed medical therapy (GDMT). The achieved doses of GDMT at 9 months were recorded, as well as reasons for not achieving the optimal dose in all patients. Echocardiography was performed at baseline and after up-titration in 278 patients. Results Of 345 HFrEF patients with a follow-up visit after 9 months, 69% reached ≥ 50% of the recommended dose of renin-angiotensin-system (RAS) inhibitors, 73% reached ≥ 50% of the recommended dose of beta-blockers and 77% reached ≥ 50% of the recommended dose of mineralocorticoid receptor antagonists. The main reasons for not reaching the target dose were hypotension (RAS inhibitors and beta-blockers), bradycardia (beta-blockers) and renal dysfunction (RAS inhibitors). During a median follow-up of 9 months, mean LVEF increased from 27.6% at baseline to 38.8% at follow-up. Each 5% increase in LVEF was associated with an adjusted hazard ratio of 0.84 (0.75–0.94, p = 0.002) for mortality and 0.85 (0.78–0.94, p = 0.001) for the combined endpoint of mortality and/or HF hospitalisation after a mean follow-up of 3.3 years. Conclusions This study shows that protocolised up-titration in a nurse-led HF clinic leads to high doses of GDMT and improvement of LVEF in patients with new-onset HFrEF.
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Salonen, K., M. Leisola i T. Eerikäinen. "Developing a multipoint titration method with a variable dose implementation for anaerobic digestion monitoring". Water Science and Technology 59, nr 12 (1.06.2009): 2395–403. http://dx.doi.org/10.2166/wst.2009.275.
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Determination of metabolites from an anaerobic digester with an acid base titration is considered as superior method for many reasons. This paper describes a practical at line compatible multipoint titration method. The titration procedure was improved by speed and data quality. A simple and novel control algorithm for estimating a variable titrant dose was derived for this purpose. This non-linear PI-controller like algorithm does not require any preliminary information from sample. Performance of this controller is superior compared to traditional linear PI-controllers. In addition, simplification for presenting polyprotic acids as a sum of multiple monoprotic acids is introduced along with a mathematical error examination. A method for inclusion of the ionic strength effect with stepwise iteration is shown. The titration model is presented with matrix notations enabling simple computation of all concentration estimates. All methods and algorithms are illustrated in the experimental part. A linear correlation better than 0.999 was obtained for both acetate and phosphate used as model compounds with slopes of 0.98 and 1.00 and average standard deviations of 0.6% and 0.8%, respectively. Furthermore, insensitivity of the presented method for overlapping buffer capacity curves was shown.
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Nerurkar, N. K., i T. P. Banu. "Spasmodic dysphonia: a seven-year audit of dose titration and demographics in the Indian population". Journal of Laryngology & Otology 128, nr 7 (lipiec 2014): 649–53. http://dx.doi.org/10.1017/s002221511400142x.
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AbstractObjectives:This study aimed to evaluate the demographics of spasmodic dysphonia in the Indian population and to analyse the optimum dose titration of botulinum toxin type A in this group. A comparative analysis with international studies was also performed.Method:The study involved a retrospective analysis and audit of botulinum toxin type A dose titration in spasmodic dysphonia patients who visited our voice clinic between January 2005 and January 2012.Results:The average total therapeutic dose required for patients with adductor spasmodic dysphonia was 4.2 U per patient per vocal fold (total 8.4 U per patient), and for patients with abductor spasmodic dysphonia, it was 4.6 U per patient.Conclusion:Our audit revealed that 80 per cent of the spasmodic dysphonia patients were male, which contrasts dramatically with international studies, wherein around 80 per cent of spasmodic dysphonia patients were female. Our study also revealed a higher dose titration of botulinum toxin for the Indian spasmodic dysphonia population in both adductor and abductor spasmodic dysphonia cases.
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Getchell, R. G., G. A. Wooster, C. A. Sutton, J. W. Casey i P. R. Bowser. "Dose Titration of Walleye Dermal Sarcoma (WDS) Tumor Filtrate". Journal of Aquatic Animal Health 14, nr 4 (grudzień 2002): 247–53. http://dx.doi.org/10.1577/1548-8667(2002)014<0247:dtowds>2.0.co;2.
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