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001-es BibID:BIBFORM005629
Első szerző:Ferrari, Roberto
Cím:The BEAUTIFUL study : randomized trial of ivabradine in patients with stable coronary artery disease and left ventricular systolic dysfunction - baseline characteristics of the study population / Ferrari, R., Ford, I., Fox, K., Steg, P. G., Tendera, M., Yusuf, S., Teo, K. K., Pogue, J., Dyal, L., Copland, I., Schumacher, H., Dagenais, G., Sleight, P., Anderson, C., The BEAUTIFUL Study Group
Dátum:2008
ISSN:1421-9751 (Electronic)
Megjegyzések:Ivabradine is a selective heart rate-lowering agent that acts by inhibiting the pacemaker current If in sinoatrial node cells. Patients with coronary artery disease and left ventricular dysfunction are at high risk of death and cardiac events, and the BEAUTIFUL study was designed to evaluate the effects of ivabradine on outcome in such patients receiving optimal medical therapy. This report describes the study population at baseline. METHODS: BEAUTIFUL is an international, multicentre, randomized, double-blind trial to compare ivabradine with placebo in reducing mortality and cardiovascular events in patients with stable coronary artery disease and left ventricular systolic dysfunction (ejection fraction <40%). RESULTS: A total of 10,917 patients were randomized. At baseline, their mean age was 65 years, 83% were male, 98% Caucasian, 88% had previous myocardial infarction, 37% had diabetes, and 40% had metabolic syndrome. Mean ejection fraction was 32% and resting heart rate was 71.6 bpm. Concomitant medications included beta-blockers (87%), renin-angiotensin system agents (89%), antithrombotic agents (94%), and lipid-lowering agents (76%). CONCLUSIONS: Main results from BEAUTIFUL are expected in 2008, and should show whether ivabradine, on top of optimal medical treatment, reduces mortality and cardiovascular events in this population of high-risk patients.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Coronary artery disease
Heart rate
Ivabradine
Mortality
Left ventricular dysfunction
Megjelenés:Cardiology. - 110 : 4 (2008), p. 271-282. -
További szerzők:Ford, Ian Fox, K. Steg, Philippe Gabriel Tendera, Michal Yusuf, Salim (1929-2008) (belgyógyász) Teo, K. K. Pogue, J. Dyal, L. Copland, I. Schumacher, H. Dagenais, G. Sleight, Peter Anderson, C. Édes István (1952-) (kardiológus) The BEAUTIFUL Study Group
Internet cím:DOI
elektronikus változat
elektronikus változat
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2.

001-es BibID:BIBFORM007426
Első szerző:Fox, K.
Cím:Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL) : a randomised, double-blind, placebo-controlled trial / Fox, K., Ford, I., Steg, P. G., Tendera, M., Ferrari, R., The BEAUTIFUL Investigators
Dátum:2008
ISSN:1474-547X (Electronic)
Megjegyzések:Ivabradine specifically inhibits the I(f) current in the sinoatrial node to lower heart rate, without affecting other aspects of cardiac function. We aimed to test whether lowering the heart rate with ivabradine reduces cardiovascular death and morbidity in patients with coronary artery disease and left-ventricular systolic dysfunction. METHODS: Between December, 2004, and December, 2006, we screened 12 473 patients at 781 centres in 33 countries. We enrolled 10 917 eligible patients who had coronary artery disease and a left-ventricular ejection fraction of less than 40% in a randomised, double-blind, placebo-controlled, parallel-group trial. 5479 patients received 5 mg ivabradine, with the intention of increasing to the target dose of 7.5 mg twice a day, and 5438 received matched placebo in addition to appropriate cardiovascular medication. The primary endpoint was a composite of cardiovascular death, admission to hospital for acute myocardial infarction, and admission to hospital for new onset or worsening heart failure. We analysed patients by intention to treat. The study is registered with ClinicalTrials.gov, number NCT00143507. FINDINGS: Mean heart rate at baseline was 71.6 (SD 9.9) beats per minute (bpm). Median follow-up was 19 months (IQR 16-24). Ivabradine reduced heart rate by 6 bpm (SE 0.2) at 12 months, corrected for placebo. Most (87%) patients were receiving beta blockers in addition to study drugs, and no safety concerns were identified. Ivabradine did not affect the primary composite endpoint (hazard ratio 1.00, 95% CI 0.91-1.1, p=0.94). 1233 (22.5%) patients in the ivabradine group had serious adverse events, compared with 1239 (22.8%) controls (p=0.70). In a prespecified subgroup of patients with heart rate of 70 bpm or greater, ivabradine treatment did not affect the primary composite outcome (hazard ratio 0.91, 95% CI 0.81-1.04, p=0.17), cardiovascular death, or admission to hospital for new-onset or worsening heart failure. However, it did reduce secondary endpoints: admission to hospital for fatal and non-fatal myocardial infarction (0.64, 95% CI 0.49-0.84, p=0.001) and coronary revascularisation (0.70, 95% CI 0.52-0.93, p=0.016). INTERPRETATION: Reduction in heart rate with ivabradine does not improve cardiac outcomes in all patients with stable coronary artery disease and left-ventricular systolic dysfunction, but could be used to reduce the incidence of coronary artery disease outcomes in a subgroup of patients who have heart rates of 70 bpm or greater.
Tárgyszavak:Orvostudományok Elméleti orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Aged
Benzazepines
Coronary Disease
Double-Blind Method
Female
Follow-Up Studies
Heart Rate
Hospital Mortality
Humans
Kaplan-Meiers Estimate
Male
Middle Aged
Ventricular Dysfunction, Left
Megjelenés:Lancet. - 372 : 9641 (2008), p. 807-816. -
További szerzők:Ford, Ian Steg, Philippe Gabriel Tendera, Michal Ferrari, Roberto Édes István (1952-) (kardiológus) The BEAUTIFUL Investigators
Internet cím:elektronikus változat
DOI
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3.

001-es BibID:BIBFORM005643
Első szerző:Yusuf, Salim (belgyógyász)
Cím:Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors : a randomised controlled trial / Yusuf, S., Teo, K. K., Anderson, C., Pogue, J., Dyal, L., Copland, I., Schumacher, H., Dagenais, G., Sleight, P., Ferrari, R., Ford, I., Fox, K., Steg, P. G., Tendera, M., TRANSCEND Investigators
Dátum:2008
ISSN:1474-547X (Electronic)
Megjegyzések:Angiotensin-converting enzyme (ACE) inhibitors reduce major cardiovascular events, but are not tolerated by about 20% of patients. We therefore assessed whether the angiotensin-receptor blocker telmisartan would be effective in patients intolerant to ACE inhibitors with cardiovascular disease or diabetes with end-organ damage. METHODS: After a 3-week run-in period, 5926 patients, many of whom were receiving concomitant proven therapies, were randomised to receive telmisartan 80 mg/day (n=2954) or placebo (n=2972) by use of a central automated randomisation system. Randomisation was stratified by hospital. The primary outcome was the composite of cardiovascular death, myocardial infarction, stroke, or hospitalisation for heart failure. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00153101. FINDINGS: The median duration of follow-up was 56 (IQR 51-64) months. All randomised patients were included in the efficacy analyses. Mean blood pressure was lower in the telmisartan group than in the placebo group throughout the study (weighted mean difference between groups 4.0/2.2 [SD 19.6/12.0] mm Hg). 465 (15.7%) patients experienced the primary outcome in the telmisartan group compared with 504 (17.0%) in the placebo group (hazard ratio 0.92, 95% CI 0.81-1.05, p=0.216). One of the secondary outcomes-a composite of cardiovascular death, myocardial infarction, or stroke-occurred in 384 (13.0%) patients on telmisartan compared with 440 (14.8%) on placebo (0.87, 0.76-1.00, p=0.048 unadjusted; p=0.068 after adjustment for multiplicity of comparisons and overlap with primary outcome). 894 (30.3%) patients receiving telmisartan were hospitalised for a cardiovascular reason, compared with 980 (33.0%) on placebo (relative risk 0.92, 95% CI 0.85-0.99; p=0.025). Fewer patients permanently discontinued study medication in the telmisartan group than in the placebo group (639 [21.6%] vs 705 [23.8%]; p=0.055); the most common reason for permanent discontinuation was hypotensive symptoms (29 [0.98%] in the telmisartan group vs 16 [0.54%] in the placebo group). INTERPRETATION: Telmisartan was well tolerated in patients unable to tolerate ACE inhibitors. Although the drug had no significant effect on the primary outcome of this study, which included hospitalisations for heart failure, it modestly reduced the risk of the composite outcome of cardiovascular death, myocardial infarction, or stroke.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Aged
Angioedema/chemically induced
Angiotensin-Converting Enzyme Inhibitors/adverse effects/ therapeutic use
Benzimidazoles/adverse effects/ therapeutic use
Benzoates/adverse effects/ therapeutic use
Cardiovascular Diseases/ prevention and control
Cough/chemically induced
Female
Follow-Up Studies
Humans
Hypotension/chemically induced
Kaplan-Meiers Estimate
Male
Risk Reduction Behavior
Single-Blind Method
Therapeutic Equivalency
Benzazepines/ therapeutic use
Cardiovascular Agents/ therapeutic use
Coronary Artery Disease/complications/ drug therapy/mortality
Diabetes Complications
Double-Blind Method
Drug Therapy, Combination
Heart Failure/ drug therapy/etiology
Metabolic Syndrome X/complications
Middle Aged
Myocardial Infarction/complications
Ventricular Dysfunction, Left/drug therapy/etiology
Angiotensin II Type 1 Receptor Blockers/adverse effects/ therapeutic use
Blood Pressure/drug effects
Cardiovascular Diseases/ drug therapy/epidemiology/mortality
Creatinine/blood
Diabetes Mellitus/ drug therapy
Hospitalization
Ramipril/adverse effects/ therapeutic use
Risk
Megjelenés:Lancet. - 372 : 9644 (2008), p. 1174-1183. -
További szerzők:Teo, K. K. Anderson, C. Pogue, J. Dyal, L. Copland, I. Schumacher, H. Dagenais, G. Sleight, Peter Ferrari, Roberto Ford, Ian Fox, K. Steg, Philippe Gabriel Tendera, Michal Édes István (1952-) (kardiológus) Czuriga István (1948-2018) (kardiológus) TRANSCEND Investigators
Internet cím:DOI
elektronikus változat
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