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Journal articles on the topic 'Cardiovascular outcome'

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Published: 9 March 2023
Last updated: 10 March 2023

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1

Scheen, A. J. "Sibutramine on Cardiovascular Outcome." Diabetes Care 34, Supplement_2 (April 27, 2011): S114—S119. http://dx.doi.org/10.2337/dc11-s205.

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2

Voilliot, Damien, Julien Magne, Raluca Dulgheru, Seisyou Kou, Christine Henri, Luis Caballero, Carla De Sousa, et al. "Cardiovascular outcome in systemic sclerosis." Acta Cardiologica 70, no. 5 (October 2015): 554–63. http://dx.doi.org/10.1080/ac.70.5.3110516.

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3

Zoungas, Sophia, and Roland P. Asmar. "ARTERIAL STIFFNESS AND CARDIOVASCULAR OUTCOME." Clinical and Experimental Pharmacology and Physiology 34, no. 7 (July 2007): 647–51. http://dx.doi.org/10.1111/j.1440-1681.2007.04654.x.

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4

Ye, Yuanzi, and Ricardo Fonseca. "Overestimation of cardiovascular outcome incidence." Lancet 390, no. 10112 (December 2017): 2546–47. http://dx.doi.org/10.1016/s0140-6736(17)33084-2.

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5

McKay, Rachel Eshima. "Nitrous Oxide and Cardiovascular Outcome." Anesthesia & Analgesia 116, no. 5 (May 2013): 962–65. http://dx.doi.org/10.1213/ane.0b013e3182870e46.

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6

Hansen, M. Rix, A. Pottegård, A. Hróbjartsson, P. Damkier, R. dePont Christensen, M. Olesen, and J. Hallas. "Modelling of Outcome Postponement for Cardiovascular Outcomes in Statin Trials." Clinical Therapeutics 39, no. 8 (August 2017): e11. http://dx.doi.org/10.1016/j.clinthera.2017.05.036.

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7

Seufert, Jochen, and Katharina Laubner. "Neue Antidiabetika und kardiovaskuläre Outcome-Studien." Diabetologie und Stoffwechsel 12, no. 04 (August 2017): 273–85. http://dx.doi.org/10.1055/s-0042-121159.

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AbstractType 2 diabetes mellitus (T2DM) represents a major risk factor for the development of cardiovascular events, and cardiovascular mortality determines overall mortality in these patients. So far, glucose lowering per se has demonstrated a small effect in reduction of cardiovascular risk in T2DM patients. Due to regulatory purposes, since 2008 all novel antidiabetic medications, such as DPP4 inhibitors, GLP-1 receptor agonists and SGLT2 inhibitors are investigated in dedicated cardiovascular outcome trials to demonstrate cardiovascular safety (non-inferiority trials). While the currently completed cardiovascular outcome trials for the DPP4 inhibitors sitagliptin, saxagliptin and alogliptin consistently demonstrated a neutral effect on cardiovascular risk, those trials for the GLP-1 receptor agonists revealed differential outcomes. Lixisenatide effects were neutral on cardiovascular outcomes while Liraglutide and Semaglutide demonstrated a reduction in cardiovascular risk. Most impressively was cardiovascular mortality, overall mortality and hospitalisation for heart failure reduced by the SGLT2 inhibitor empagliflozin in its dedicated outcome trial. These results strongly imply that certain novel antihyperglycaemic agents bear the potential to strongly reduce cardiovascular risk in patients with T2DM beyond their glucose lowering potency. The potential to reduce cardiovascular risk in patients with T2DM will selectively determine the clinical application of antidiabetic medications in the future.
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8

Langslet, Gisle, Bernard Zinman, Christoph Wanner, Stefan Hantel, Rosa-Maria Espadero, David Fitchett, and Odd Erik Johansen. "Cardiovascular outcomes and LDL-cholesterol levels in EMPA-REG OUTCOME®." Diabetes and Vascular Disease Research 17, no. 6 (November 2020): 147916412097525. http://dx.doi.org/10.1177/1479164120975256.

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Objective: It is well established that higher low-density lipoprotein (LDL)-cholesterol levels are associated with increased cardiovascular risk. We analyzed whether effects of empagliflozin on cardiovascular outcomes varied by different LDL-cholesterol levels at baseline in EMPA-REG OUTCOME. Methods: Participants with type 2 diabetes and high cardiovascular risk received empagliflozin (10/25 mg) or placebo in addition to standard of care. We investigated the time to first 3P-MACE, cardiovascular death, hospitalization for heart failure (HHF) and all-cause mortality for empagliflozin versus placebo between baseline LDL-cholesterol categories <1.8, 1.8–<2.2, 2.2– <2.6, 2.6–3.0, and > 3.0 mmol/L, by a Cox regression including the interaction of baseline LDL-cholesterol category and treatment. Results: Of the 7020 participants randomized and treated, 81.0% received lipid lowering therapy (77.0% statins). Mean ± SD LDL-cholesterol was 2.2 ± 0.9 mmol/L, and 38%/18%, had LDL-cholesterol <1.8/>3.0 mmol/L. Age, BMI, and HbA1c levels were balanced between the LDL-cholesterol subgroups, but those in the lowest versus highest group, had more coronary artery disease (83.0% vs 59.9%) and statin treatment (88.2% vs 50.9%). Empagliflozin consistently reduced all outcomes across LDL-cholesterol categories (all interaction p-values > 0.05). Conclusion: The beneficial cardiovascular effects of empagliflozin was consistent across higher and lower LDL-cholesterol levels at baseline.
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9

Fisher, Miles. "Series: Cardiovascular outcome trials for diabetes drugs Empagliflozin and EMPA-REG OUTCOME." British Journal of Diabetes 20, no. 2 (December 13, 2020): 138–41. http://dx.doi.org/10.15277/bjd.2020.254.

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EMPA-REG OUTCOME was an FDA-mandated cardiovascular outcome trial with empagliflozin and was the first completed trial with a sodium-glucose co-transporter-2 (SGLT2) inhibitor. EMPA-REG OUTCOME compared empagliflozin and placebo in 7,020 subjects with type 2 diabetes and established atherosclerotic cardiovascular disease. The results were astounding as EMPA-REG OUTCOME demonstrated superiority for major cardiovascular events (cardiovascular death, myocardial infarction, stroke) and cardiovascular deaths were significantly reduced, as was all-cause mortality. Hospitalisation for heart failure, which was a secondary outcome, was also significantly reduced. Later trials with SGLT2 inhibitors have demonstrated reductions in major adverse cardiovascular events (MACE) and hospitalisation for heart failure, and trials with glucagon-like peptide 1 receptor agonists have demonstrated reductions in MACE. Collectively, these trials could transform the management of people with type 2 diabetes.
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10

Bayliss, Elizabeth A., Liza M. Reifler, Chan Zeng, Deanna B. McQuillan, Jennifer L. Ellis, and John F. Steiner. "Competing Risks of Cancer Mortality and Cardiovascular Events in Individuals with Multimorbidity." Journal of Comorbidity 4, no. 1 (January 2014): 29–36. http://dx.doi.org/10.15256/joc.2014.4.41.

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Background Cancer patients with cardiovascular and other comorbidities are at concurrent risk of multiple adverse outcomes. However, most treatment decisions are guided by evidence from single-outcome models, which may be misleading for multimorbid patients. Objective We assessed the interacting effects of cancer, cardiovascular, and other morbidity burdens on the competing outcomes of cancer mortality, serious cardiovascular events, and other-cause mortality. Design We analyzed a cohort of 6,500 adults with initial cancer diagnosis between 2001 and 2008, SEER 5-year survival ≥26%, and a range of cardiovascular risk factors. We estimated the cumulative incidence of cancer mortality, a serious cardiovascular event (myocardial infarction, coronary revascularization, or cardiovascular mortality), and other-cause mortality over 5 years, and identified factors associated with the competing risks of each outcome using cause-specific Cox proportional hazard models. Results Following cancer diagnosis, there were 996 (15.3%) cancer deaths, 328 (5.1%) serious cardiovascular events, and 542 (8.3%) deaths from other causes. In all, 4,634 (71.3%) cohort members had none of these outcomes. Although cancer prognosis had the greatest effect, cardiovascular and other morbidity also independently increased the hazard of each outcome. The effect of cancer prognosis on outcome was greatest in year 1, and the effect of other morbidity was greater in individuals with better cancer prognoses. Conclusion In multimorbid oncology populations, comorbidities interact to affect the competing risk of different outcomes. Quantifying these risks may provide persons with cancer plus cardiovascular and other comorbidities more accurate information for shared decision-making than risks calculated from single-outcome models.
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11

Ferguson, LD, and J. Logue. "Has IMPROVE-IT improved cardiovascular outcome?" Journal of the Royal College of Physicians of Edinburgh 45, no. 3 (2015): 215–17. http://dx.doi.org/10.4997/jrcpe.2015.309.

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12

Nakamura, Yasuyuki, Takako Yamamoto, Tomonori Okamura, Takashi Kadowaki, Takehito Hayakawa, Yoshikuni Kita, Shigeyuki Saitoh, Akira Okayama, Hirotsugu Ueshima, and The NIPPON DATA 80 Research Group. "Combined Cardiovascular Risk Factors and Outcome." Circulation Journal 70, no. 8 (2006): 960–64. http://dx.doi.org/10.1253/circj.70.960.

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13

Unlu, Murat, Ali Osman Yildirim, Mustafa Demir, Cengiz Ozturk, Turgay Celik, and Atila Iyisoy. "Ankle–Brachial Index and Cardiovascular Outcome." Angiology 67, no. 2 (August 10, 2015): 193. http://dx.doi.org/10.1177/0003319715599282.

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14

Khuseyinova, Natalie, and Wolfgang Koenig. "Biomarkers of outcome from cardiovascular disease." Current Opinion in Critical Care 12, no. 5 (October 2006): 412–19. http://dx.doi.org/10.1097/01.ccx.0000244119.16377.75.

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15

Hegarty, Janet, and Robert N. Foley. "Anaemia, renal insufficiency and cardiovascular outcome." Nephrology Dialysis Transplantation 16, suppl_1 (May 1, 2001): 102–4. http://dx.doi.org/10.1093/ndt/16.suppl_1.102.

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16

Holmqvist, Lina, Kristina B. Boström, Thomas Kahan, Linus Schiöler, Jan Hasselström, Per Hjerpe, Björn Wettermark, and Karin Manhem. "Cardiovascular outcome in treatment-resistant hypertension." Journal of Hypertension 36, no. 2 (February 2018): 402–9. http://dx.doi.org/10.1097/hjh.0000000000001561.

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17

Patel, Tejas, Bereket Tesfaldet, Iffat Chowdhury, Anna Kettermann, James P. Smith, Frank Pucino, and Eileen E. Navarro Almario. "Endpoints in diabetes cardiovascular outcome trials." Lancet 391, no. 10138 (June 2018): 2412. http://dx.doi.org/10.1016/s0140-6736(18)31184-x.

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18

Messerli, Franz H., Louis Hofstetter, Stefano F. Rimoldi, Emrush Rexhaj, and Sripal Bangalore. "Risk Factor Variability and Cardiovascular Outcome." Journal of the American College of Cardiology 73, no. 20 (May 2019): 2596–603. http://dx.doi.org/10.1016/j.jacc.2019.02.063.

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19

Weiss, B. M., L. K. von Segesser, E. Alon, B. Seifert, and M. I. Turina. "Outcome of Cardiovascular Surgery and Pregnancy." Obstetric Anesthesia Digest 19, no. 2 (June 1999): 68–71. http://dx.doi.org/10.1097/00132582-199906000-00003.

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20

Bloomgarden, Zachary. "The kidney and cardiovascular outcome trials." Journal of Diabetes 10, no. 2 (January 19, 2018): 88–89. http://dx.doi.org/10.1111/1753-0407.12616.

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21

Shroff, Rukshana. "Can dialysis modality influence cardiovascular outcome?" Pediatric Nephrology 27, no. 11 (June 3, 2012): 2001–5. http://dx.doi.org/10.1007/s00467-012-2207-8.

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22

Roos-Hesselink, Jolien W., and Mark R. Johnson. "Does Fertility Therapy Hamper Cardiovascular Outcome?" Journal of the American College of Cardiology 62, no. 18 (October 2013): 1713–14. http://dx.doi.org/10.1016/j.jacc.2013.07.012.

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23

Saponaro, F., C. Marcocci, and R. Zucchi. "Vitamin D status and cardiovascular outcome." Journal of Endocrinological Investigation 42, no. 11 (June 6, 2019): 1285–90. http://dx.doi.org/10.1007/s40618-019-01057-y.

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24

Fisher, Miles. "Series: Cardiovascular outcome trials for diabetes drugs." British Journal of Diabetes 22, no. 2 (December 21, 2022): 105–11. http://dx.doi.org/10.15277/bjd.2022.387.

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LEADER was a landmark cardiovascular outcome trial with the GLP-1 receptor agonist liraglutide, which demonstrated significant reductions in major adverse cardiovascular events (MACE, a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke), driven by a reduction in cardiovascular deaths and accompanied by a significant reduction in all-cause mortality. Shortly afterwards, the SUSTAIN-6 trial with once-weekly semaglutide demonstrated non-inferiority for MACE, with a nominal reduction in MACE that was driven by a reduction in the risk of non-fatal strokes. Since then, a further six cardiovascular trials have been published with GLP-1 receptor agonists, with major differences in study design and outcomes. Four trials have been performed with once-weekly formulations. The EXSCEL trial with once-weekly exenatide showed non-inferiority for MACE, but not superiority, with a reduction in all-cause mortality which was an exploratory outcome. The Harmony Outcomes trial with albiglutide demonstrated significant reductions in MACE, driven by reductions in fatal or non-fatal myocardial infarction. REWIND, with dulaglutide, also demonstrated significant reductions in MACE, this time driven by reductions in strokes. The AMPLITUDE-O trial with efpeglenatide showed significant reductions in MACE, but none of the individual components of MACE was significantly reduced as a secondary endpoint, and in contrast to other trials there was also a significant reduction in heart failure events. The fifth trial was the PIONEER 6 trial with the oral formulation of semaglutide, and this showed non-inferiority for MACE, but not superiority, with reductions in cardiovascular deaths and all-cause mortality which were secondary outcomes. Finally, FREEDOM-CVO with a subcutaneous mini-pump of exenatide showed non-inferiority for MACE and MACE plus hospitalisation for unstable angina. A reduction in albuminuria was seen in several of these trials, but there was no definite effect on eGFR or end-stage renal disease. Meta-analysis of the cardiovascular outcome trials with GLP-1 receptor agonists has demonstrated significant reductions in MACE, cardiovascular death, fatal or non-fatal stroke, fatal or non-fatal myocardial infarction, and all-cause mortality. It remains unclear why updated guidance from NICE on the management of T2DM in adults fails to acknowledge these evidence-based cardiovascular benefits.
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25

Inzucchi, Silvio E., Kamlesh Khunti, David H. Fitchett, Christoph Wanner, Michaela Mattheus, Jyothis T. George, Anne Pernille Ofstad, and Bernard Zinman. "Cardiovascular Benefit of Empagliflozin Across the Spectrum of Cardiovascular Risk Factor Control in the EMPA-REG OUTCOME Trial." Journal of Clinical Endocrinology & Metabolism 105, no. 9 (June 2, 2020): 3025–35. http://dx.doi.org/10.1210/clinem/dgaa321.

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Abstract Context Control of multiple cardiovascular (CV) risk factors reduces CV events in individuals with type 2 diabetes. Objective To investigate this association in a contemporary clinical trial population, including how CV risk factor control affects the CV benefits of empagliflozin, a sodium-glucose cotransporter-2 inhibitor. Design Post hoc analysis. Setting Randomized CV outcome trial (EMPA-REG OUTCOME). Participants Type 2 diabetes patients with established CV disease. Intervention Empagliflozin or placebo. Main Outcome Measures Risk of CV outcomes—including the treatment effect of empagliflozin—by achieving 7 goals for CV risk factor control at baseline: (1) glycated hemoglobin &lt;7.5%, (2) low-density lipoprotein cholesterol &lt;100 mg/dL or statin use, (3) systolic blood pressure &lt;140 mmHg and diastolic blood pressure &lt;90 mmHg, (4) pharmacological renin-angiotensin-aldosterone system blockade, (5) normoalbuminuria, (6) aspirin use, (7) nonsmoking. Results In the placebo group, the hazard ratio (HR) for CV death was 4.00 (95% CI, 2.26–7.11) and 2.48 (95% CI, 1.52–4.06) for patients achieving only 0–3 or 4–5 risk factor goals at baseline, respectively, compared with those achieving 6–7 goals. Participants achieving 0–3 or 4–5 goals also had increased risk for the composite outcome of hospitalization for heart failure or CV death (excluding fatal stroke) (HR 2.89 [1.82–4.57] and 1.90 [1.31–2.78], respectively) and 3-point major adverse CV events (HR 2.21 [1.53–3.19] and 1.42 [1.06–1.89]). Empagliflozin significantly reduced these outcomes across all risk factor control categories (P &gt; 0.05 for treatment-by-subgroup interactions). Conclusions Cardiovascular risk in EMPA-REG OUTCOME was inversely associated with baseline CV risk factor control. Empagliflozin’s cardioprotective effect was consistent regardless of multiple baseline risk factor control.
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Levin, Adeera, Vlado Perkovic, David C. Wheeler, Stefan Hantel, Jyothis T. George, Maximilian von Eynatten, Audrey Koitka-Weber, and Christoph Wanner. "Empagliflozin and Cardiovascular and Kidney Outcomes across KDIGO Risk Categories." Clinical Journal of the American Society of Nephrology 15, no. 10 (September 29, 2020): 1433–44. http://dx.doi.org/10.2215/cjn.14901219.

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Background and objectivesIn the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG Outcome), empagliflozin, in addition to standard of care, significantly reduced risk of cardiovascular death by 38%, hospitalization for heart failure by 35%, and incident or worsening nephropathy by 39% compared with placebo in patients with type 2 diabetes and established cardiovascular disease. Using EMPA-REG Outcome data, we assessed whether the Kidney Disease Improving Global Outcomes (KDIGO) CKD classification had an influence on the treatment effect of empagliflozin.Design, setting, participants, & measurementsPatients with type 2 diabetes, established atherosclerotic cardiovascular disease, and eGFR≥30 ml/min per 1.73 m2 at screening were randomized to receive empagliflozin 10 mg, empagliflozin 25 mg, or placebo once daily in addition to standard of care. Post hoc, we analyzed cardiovascular and kidney outcomes, and safety, using the two-dimensional KDIGO classification framework.ResultsOf 6952 patients with baseline eGFR and urinary albumin-creatinine ratio values, 47%, 29%, 15%, and 8% were classified into low, moderately increased, high, and very high KDIGO risk categories, respectively. Empagliflozin showed consistent risk reductions across KDIGO categories for cardiovascular outcomes (P values for treatment by subgroup interactions ranged from 0.26 to 0.85) and kidney outcomes (P values for treatment by subgroup interactions ranged from 0.16 to 0.60). In all KDIGO risk categories, placebo and empagliflozin had similar adverse event rates, the notable exception being genital infection events, which were more common with empagliflozin for each category.ConclusionsThe observed effects of empagliflozin versus placebo on cardiovascular and kidney outcomes were consistent across the KDIGO risk categories, indicating that the effect of treatment benefit of empagliflozin was unaffected by baseline CKD status.Clinical Trial registry name and registration number:EMPA-REG OUTCOME, NCT01131676
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27

Sharma, Abhinav, Silvio E. Inzucchi, Jeffrey Testani, Anne-Pernille Ofstad, David Fitchett, Michaela Mattheus, Subodh Verma, Faiez Zannad, Christoph Wanner, and Bettina J. Kraus. "Association Of Kidney And Cardiovascular Outcomes: Insights From The Empagliflozin Cardiovascular Outcome Event Trial In Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) Trial." Journal of Cardiac Failure 28, no. 5 (April 2022): S103. http://dx.doi.org/10.1016/j.cardfail.2022.03.262.

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28

Doumouras, Aristithes G., Jorge A. Wong, J. Michael Paterson, Yung Lee, Branavan Sivapathasundaram, Jean-Eric Tarride, Lehana Thabane, Dennis Hong, Salim Yusuf, and Mehran Anvari. "Bariatric Surgery and Cardiovascular Outcomes in Patients With Obesity and Cardiovascular Disease:." Circulation 143, no. 15 (April 13, 2021): 1468–80. http://dx.doi.org/10.1161/circulationaha.120.052386.

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Background: Bariatric surgery has been shown to significantly reduce cardiovascular risk factors. However, whether surgery can reduce major adverse cardiovascular events (MACE), especially in patients with established cardiovascular disease, remains poorly understood. The present study aims to determine the association between bariatric surgery and MACE among patients with cardiovascular disease and severe obesity. Methods: This was a propensity score–matched cohort study using province-wide multiple-linked administrative databases in Ontario, Canada. Patients with previous ischemic heart disease or heart failure who received bariatric surgery were matched on age, sex, heart failure history, and a propensity score to similar controls from a primary care medical record database in a 1:1 ratio. The primary outcome was the incidence of extended MACE (first occurrence of all-cause mortality, myocardial infarction, coronary revascularization, cerebrovascular events, and heart failure hospitalization). Secondary outcome included 3-component MACE (myocardial infarction, ischemic stroke, and all-cause mortality). Outcomes were evaluated through a combination of matching via propensity score and subsequent multivariable adjustment. Results: A total of 2638 patients (n=1319 in each group) were included, with a median follow-up time of 4.6 years. The primary outcome occurred in 11.5% (151/1319) of the surgery group and 19.6% (259/1319) of the controls (adjusted hazard ratio [HR], 0.58 [95% CI, 0.48–0.71]; P <0.001). The association was notable for those with heart failure (HR, 0.44 [95% CI, 0.31–0.62]; P <0.001; absolute risk difference, 19.3% [95% CI, 12.0%–26.7%]) and in those with ischemic heart disease (HR, 0.60 [95% CI, 0.48–0.74]; P <0.001; absolute risk difference, 7.5% [95% CI, 4.7%–10.5%]). Surgery was also associated with a lower incidence of the secondary outcome (HR, 0.66 [95% CI, 0.52–0.84]; P =0.001) and cardiovascular mortality (HR, 0.35 [95% CI, 0.15–0.80]; P =0.001). Conclusions: Bariatric surgery was associated with a lower incidence of MACE in patients with cardiovascular disease and obesity. These findings require confirmation by a large-scale randomized trial.
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Rahman, Mahboob, Nishigandha Pradhan, Zhengyi Chen, Radhika Kanthety, Raymond R. Townsend, Curtis Tatsuoka, and Jackson T. Wright. "Orthostatic Hypertension and Intensive Blood Pressure Control; Post-Hoc Analyses of SPRINT." Hypertension 77, no. 1 (January 2021): 49–58. http://dx.doi.org/10.1161/hypertensionaha.120.15887.

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We evaluated the association between orthostatic hypertension and cardiovascular outcomes and the effect of intensive blood pressure (BP) control on cardiovascular outcomes in patients with orthostatic hypertension. Post hoc analyses of the SPRINT (Systolic Blood Pressure Intervention Trial) data were conducted; orthostatic hypertension was defined as increase in systolic BP≥20 mm Hg or increase in diastolic BP≥10 mm Hg with standing. Of 9329 participants, 1986 (21.2%) had orthostatic hypertension at baseline. Within the intensive treatment group, participants with orthostatic hypertension were at higher risk of developing the composite cardiovascular outcome (hazard ratio, 1.44 [95% CI, 1.1–1.87], P =0.007) compared with participants without orthostatic hypertension. Within the standard treatment group, there were no significant differences in cardiovascular outcome between participants with and without orthostatic hypertension. In participants with orthostatic hypertension, there was no statistically significant difference in risk of the composite cardiovascular outcome between the intensive and the standard BP treatment group (hazard ratio, 1.07 [95% CI, 0.78–1.47], P =0.68). In participants without orthostatic hypertension at baseline, the intensive treatment group was associated with a lower risk of the composite cardiovascular outcome (hazard ratio, 0.67 [95% CI, 0.56–0.79], P <0.0001). Orthostatic hypertension was associated with a higher risk of cardiovascular outcomes in the intensive and not in the standard treatment group; intensive treatment of BP did not reduce the risk of cardiovascular outcomes compared with standard treatment in patients with orthostatic hypertension. These post hoc analyses are hypothesis generating and will need to be confirmed in future studies.
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Van der Niepen, Patricia, and Alexandre Persu. "Long-term cardiovascular outcome after renal revascularization." Polish Archives of Internal Medicine 129, no. 11 (November 29, 2019): 735–37. http://dx.doi.org/10.20452/pamw.15075.

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31

Peter, Elise, Jean-Baptiste Fraison, Brahim Harbaoui, Isabelle Koné-Paut, Claire Dauphin, Emeline Gomard-Mennesson, Baptiste Hervier, et al. "Cardiovascular outcome in adult-onset Kawasaki disease." Autoimmunity Reviews 20, no. 9 (September 2021): 102886. http://dx.doi.org/10.1016/j.autrev.2021.102886.

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32

Khunti, Kamlesh, Melanie J. Davies, and Samuel Seidu. "Cardiovascular outcome trials of glucose-lowering therapies." Expert Review of Pharmacoeconomics & Outcomes Research 20, no. 3 (May 3, 2020): 237–49. http://dx.doi.org/10.1080/14737167.2020.1763796.

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Harville, Emily W., Jorma S. A. Viikari, and Olli T. Raitakari. "Preconception Cardiovascular Risk Factors and Pregnancy Outcome." Epidemiology 22, no. 5 (September 2011): 724–30. http://dx.doi.org/10.1097/ede.0b013e318225c960.

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34

Grant, Peter J. "London buses: A cardiovascular outcome trial equivalent?" Diabetes and Vascular Disease Research 13, no. 6 (August 20, 2016): 382–83. http://dx.doi.org/10.1177/1479164116663051.

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Holman, Rury R. "Clinically relevant results from cardiovascular outcome trials." Nature Reviews Endocrinology 14, no. 2 (January 5, 2018): 67–68. http://dx.doi.org/10.1038/nrendo.2017.179.

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Kruger, Davida F. "Cardiovascular outcome trials in type 2 diabetes." Journal of the American Association of Nurse Practitioners 30 (October 2018): S43—S52. http://dx.doi.org/10.1097/jxx.0000000000000126.

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Cha, Seul Gi, Mi Kyung Song, Sang Yun Lee, Gi Beom Kim, Jae Gun Kwak, Woong Han Kim, and Eun Jung Bae. "Long‐term cardiovascular outcome of Williams syndrome." Congenital Heart Disease 14, no. 5 (June 5, 2019): 684–90. http://dx.doi.org/10.1111/chd.12810.

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38

Schumacher, Helmut, Felix Mahfoud, and Michael Böhm. "Overestimation of cardiovascular outcome incidence – Authors' reply." Lancet 390, no. 10112 (December 2017): 2547. http://dx.doi.org/10.1016/s0140-6736(17)33085-4.

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O'Brien, Bernard, and Julia Rushyby. "Outcome assessment in cardiovascular cost-benefit studies." American Heart Journal 119, no. 3 (March 1990): 740–48. http://dx.doi.org/10.1016/s0002-8703(05)80055-9.

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Triola, Brian, Marian B. Olson, Steven E. Reis, Pentti Rautaharju, C. Noel Bairey Merz, Sheryl F. Kelsey, Leslee J. Shaw, Barry L. Sharaf, George Sopko, and Samir Saba. "Electrocardiographic Predictors of Cardiovascular Outcome in Women." Journal of the American College of Cardiology 46, no. 1 (July 2005): 51–56. http://dx.doi.org/10.1016/j.jacc.2004.09.082.

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41

Sousa, José, João Lopes, Liliana Reis, Marta Madeira, Carolina Lourenço, and Lino Gonçalves. "P68 THE HIDDEN PREDICTOR OF CARDIOVASCULAR OUTCOME." Artery Research 24, no. C (2018): 68. http://dx.doi.org/10.1016/j.artres.2018.10.121.

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42

Holmes, Patrick. "Examining the results of cardiovascular outcome trials." Practice Nursing 30, no. 2 (February 2, 2019): 87–90. http://dx.doi.org/10.12968/pnur.2019.30.2.87.

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43

Thompson, David R., and Chantal F. Ski. "Patient-reported outcome measures in cardiovascular nursing." European Journal of Cardiovascular Nursing 14, no. 5 (September 17, 2015): 370–71. http://dx.doi.org/10.1177/1474515115601621.

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44

Stolarz-Skrzypek, Katarzyna. "SODIUM INTAKE IN RELATION TO CARDIOVASCULAR OUTCOME." Artery Research 12, no. C (2015): 2. http://dx.doi.org/10.1016/j.artres.2015.10.193.

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45

Muñoz Torres, Manuel, and Araceli Muñoz Garach. "Results from Cardiovascular Outcome Trials in Diabetes." Endocrinología y Nutrición (English Edition) 63, no. 7 (August 2016): 317–19. http://dx.doi.org/10.1016/j.endoen.2016.08.003.

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46

Böhm, Michael, Helmut Schumacher, Koon K. Teo, Eva M. Lonn, Felix Mahfoud, Johannes F. E. Mann, Giuseppe Mancia, et al. "Cardiovascular outcomes and achieved blood pressure in patients with and without diabetes at high cardiovascular risk." European Heart Journal 40, no. 25 (March 28, 2019): 2032–43. http://dx.doi.org/10.1093/eurheartj/ehz149.

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Abstract Aims Studies have shown a non-linear relationship between systolic blood pressure (SBP) and diastolic blood pressure (DBP) and outcomes, with increased risk observed at both low and high blood pressure (BP) levels. We hypothesized that the BP-risk association is different in individuals with and without diabetes at high cardiovascular risk. Methods and results We identified patients with (N = 11 487) or without diabetes (N = 19 450), from 30 937 patients, from 133 centres in 44 countries with a median follow-up of 56 months in the ONTARGET/TRANSCEND studies. Patients had a prior history of stroke, myocardial infarction (MI), peripheral artery disease, or were high-risk diabetics. Patients in ONTARGET had been randomized to ramipril 10 mg daily, telmisartan 80 mg daily, or the combination of both. Patients in TRANSCEND were ACE intolerant and randomized to telmisartan 80 mg daily or matching placebo. We analysed the association of mean achieved in-trial SBP and DBP with the composite outcome of cardiovascular death, MI, stroke and hospitalization for congestive heart failure (CHF), the components of the composite, and all-cause death. Data were analysed by Cox regression and restricted cubic splines, adjusting for risk markers including treatment allocation and accompanying cardiovascular treatments. In patients with diabetes, event rates were higher across the whole spectrum of SBP and DBP compared with those without diabetes (P < 0.0001 for the primary composite outcome, P < 0.01 for all other endpoints). Mean achieved in-trial SBP ≥160 mmHg was associated with increased risk for the primary outcome [diabetes/no diabetes: adjusted hazard ratio (HR) 2.31 (1.93–2.76)/1.66 (1.36–2.02) compared with non-diabetics with SBP 120 to <140 mmHg], with similar findings for all other endpoints in patients with diabetes, and for MI and stroke in patients without diabetes. In-trial SBP <120 mmHg was associated with increased risk for the combined outcome in patients with diabetes [HR 1.53 (1.27–1.85)], and for cardiovascular death and all-cause death in all patients. In-trial DBP ≥90 mmHg was associated with increased risk for the primary outcome [diabetes/no diabetes: HR 2.32 (1.91–2.82)/1.61 (1.35–1.93) compared with non-diabetics with DBP 70 to <80 mmHg], with similar findings for all other endpoints, but not for CHF hospitalizations in patients without diabetes. In-trial DBP <70 mmHg was associated with increased risk for the combined outcome in all patients [diabetes/no diabetes: HR 1.77 (1.51–2.06)/1.30 (1.16–1.46)], and also for all other endpoints except stroke. Conclusion High on treatment BP levels (≥160 or ≥90 mmHg) are associated with increased risk of cardiovascular outcomes and death. Also low levels (<120 or <70 mmHg) are associated with increased cardiovascular outcomes (except stroke) and death. Patients with diabetes have consistently higher risks over the whole BP range, indicating that achieving optimal BP goals is most impactful in this group. These data favour guidelines taking lower BP boundaries into consideration, in particular in diabetes. Clinical trial registration http://clinicaltrials.gov.Unique identifier: NCT00153101.
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47

Sharma, Abhinav, Neha J. Pagidipati, Robert M. Califf, Darren K. McGuire, Jennifer B. Green, Dave Demets, Jyothis Thomas George, et al. "Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus." Circulation 141, no. 10 (March 10, 2020): 843–62. http://dx.doi.org/10.1161/circulationaha.119.041022.

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Responding to concerns about the potential for increased risk of adverse cardiovascular outcomes, specifically myocardial infarction, associated with certain glucose-lowering therapies, the US Food and Drug Administration and the Committee for Medicinal Products for Human Use of the European Medicines Agency issued guidance to the pharmaceutical industry in 2008. Glucose-lowering therapies were granted regulatory approval primarily from smaller studies that have demonstrated reductions in glycated hemoglobin concentration. Such studies were overall underpowered and of insufficient duration to show any effect on cardiovascular outcomes. The 2008 guidance aimed to ensure the cardiovascular safety of new glucose-lowering therapies to treat patients with type 2 diabetes mellitus. This resulted in a plethora of new cardiovascular outcome trials, most designed primarily as placebo-controlled noninferiority trials, but with many also powered for superiority. Several of these outcome trials demonstrated cardiovascular benefits of the newer agents, resulting in the first-ever cardiovascular protection indications for glucose-lowering therapies. Determining whether the guidance continues to have value in its current form is critically important as we move forward after the first decade of implementation. In February 2018, a think tank comprising representatives from academia, industry, and regulatory agencies convened to consider the guidance in light of the findings of the completed cardiovascular outcome trials. The group made several recommendations for future regulatory guidance and for cardiovascular outcome trials of glucose-lowering therapies. These recommendations include requiring only the 1.3 noninferiority margin for regulatory approval, conducting trials for longer durations, considering studying glucose-lowering therapies as first-line management of type 2 diabetes mellitus, considering heart failure or kidney outcomes within the primary outcome, considering head-to-head active comparator trials, increasing the diversity of patients enrolled, evaluating strategies to streamline registries and the study of unselected populations, and identifying ways to improve translation of trial results to general practice.
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48

Gallwitz, Baptist. "The Cardiovascular Benefits Associated with the Use of Sodium-glucose Cotransporter 2 Inhibitors – Real-world Data." European Endocrinology 14, no. 1 (2018): 17. http://dx.doi.org/10.17925/ee.2018.14.1.17.

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Type 2 diabetes (T2D) is associated with numerous comorbidities that significantly reduce quality of life, increase mortality and complicate treatment decisions. In a recent cardiovascular outcomes trial, Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME), the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin was shown to reduce cardiovascular (CV) mortality and heart failure in high-risk patients with T2D with a previous CV event or with established CV disease (CVD). Recently published data from the Canagliflozin Cardiovascular Assessment Study (CANVAS-PROGRAM) study suggested that the cardiovascular benefits of empagliflozin are also seen with the SGLT2-inhibitor canagliflozin, indicating a class effect of SGLT2 inhibitors. Evidence for a class effect has also been shown by meta-analyses and real-world studies, including the Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors (CVD-REAL) and The Health Improvement Network (THIN) databases. These findings also suggest the results of EMPA-REG OUTCOME can be applied to patients with T2D with a broader CV risk profile, including people at low risk of CVD.
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Soveral, Iris, Laura Guirado, Maria C. Escobar-Diaz, María José Alcaide, Josep Maria Martínez, Víctor Rodríguez-Sureda, Bart Bijnens, et al. "Cord Blood Cardiovascular Biomarkers in Left-Sided Congenital Heart Disease." Journal of Clinical Medicine 11, no. 23 (November 30, 2022): 7119. http://dx.doi.org/10.3390/jcm11237119.

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Fetal echocardiography has limited prognostic ability in the evaluation of left-sided congenital heart defects (left heart defects). Cord blood cardiovascular biomarkers could improve the prognostic evaluation of left heart defects. A multicenter prospective cohort (2013–2019) including fetuses with left heart defects (aortic coarctation, aortic stenosis, hypoplastic left heart, and multilevel obstruction (complex left heart defects) subdivided according to their outcome (favorable vs. poor), and control fetuses were evaluated in the third trimester of pregnancy at three referral centers in Spain. Poor outcome was defined as univentricular palliation, heart transplant, or death. Cord blood concentrations of N-terminal precursor of B-type natriuretic peptide, Troponin I, transforming growth factor β, placental growth factor, and soluble fms-like tyrosine kinase-1 were determined. A total of 45 fetuses with left heart defects (29 favorable and 16 poor outcomes) and 35 normal fetuses were included, with a median follow-up of 3.1 years (interquartile range 1.4–3.9). Left heart defects with favorable outcome showed markedly increased cord blood transforming growth factor β (normal heart median 15.5 ng/mL (6.8–21.4) vs. favorable outcome 51.7 ng/mL (13.8–73.9) vs. poor outcome 25.1 ng/mL (6.9–39.0), p = 0.001) and decreased placental growth factor concentrations (normal heart 17.9 pg/mL (13.8–23.9) vs. favorable outcome 12.8 pg/mL (11.7–13.6) vs. poor outcome 11.0 pg/mL (8.8–15.4), p < 0.001). Poor outcome left heart defects had higher N-terminal precursor of B-type natriuretic peptide (normal heart 508.0 pg/mL (287.5–776.3) vs. favorable outcome 617.0 pg/mL (389.8–1087.8) vs. poor outcome 1450.0 pg/mL (919.0–1645.0), p = 0.001) and drastically reduced soluble fms-like tyrosine kinase-1 concentrations (normal heart 1929.7 pg/mL (1364.3–2715.8) vs. favorable outcome (1848.3 pg/mL (646.9–2313.6) vs. poor outcome 259.0 pg/mL (182.0–606.0), p < 0.001). Results showed that fetuses with left heart defects present a distinct cord blood biomarker profile according to their outcome.
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50

Yoshioka, Goro, Atsushi Tanaka, Kensaku Nishihira, Yoshisato Shibata, and Koichi Node. "Prognostic Impact of Serum Albumin for Developing Heart Failure Remotely after Acute Myocardial Infarction." Nutrients 12, no. 9 (August 29, 2020): 2637. http://dx.doi.org/10.3390/nu12092637.

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Low serum albumin (LSA) on admission for acute myocardial infarction (AMI) is related to adverse in-hospital outcomes. However, the relationship between LSA and long-term post-AMI cardiovascular outcomes is unknown. A single-center, non-randomized, retrospective study was performed to investigate the prognostic impact of LSA at admission for AMI on cardiovascular death or newly developed HF in the remote phase after AMI. Admission serum albumin tertiles (<3.8, 3.8–4.2, ≥4.2 g/dL) were used to divide 2253 consecutive AMI from February 2008 to January 2016 patients into three groups. Primary outcome was a composite of hospitalization for HF and cardiovascular death remotely after AMI. Cox proportional hazard models were used to explore the relationship between admission LSA and primary outcome. During follow-up (median: 3.2 years), primary composite outcome occurred in 305 patients (13.5%). Primary composite outcome occurred individually for hospitalization for HF in 146 patients (6.5%) and cardiovascular death in 192 patients (8.5%). The cumulative incidence of primary composite outcome was higher in the LSA group than the other groups (log-rank test, p < 0.001). Even after adjustments for relevant clinical variables, LSA (<3.8 mg/dL) was an independent predictor of remote-phase primary composite outcome, irrespective of the clinical severity and subtype of AMI. Thus, LSA on admission for AMI was an independent predictor of newly developed HF or cardiovascular death and has a useful prognostic impact even remotely after AMI.
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