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1.

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:BIBFORM008217
Első szerző:Holubarsch, Christian J. F.
Cím:The efficacy and safety of Crataegus extract WS R 1442 in patients with heart failure : the SPICE trial / Holubarsch, C. J. F., Colucci, W. S., Meinertz, T., Gaus, W., Tendera, M., Investigation of Crataegus Extract WS R 1442 in CHF (SPICE) trial study group
Dátum:2008
Megjegyzések:Crataegus preparations have been used for centuries especially in Europe. To date, no proper data on their efficacy and safety as an add-on-treatment are available. Therefore a large morbidity/mortality trial was performed. Aim: To investigate the efficacy and safety of an add-on treatment with Crataegus extract WS R 1442 in patients with congestive heart failure. Methods: In this randomised, double-blind, placebo-controlled multicenter study, adults with NYHA class II or III CHF and reduced left ventricular ejection fraction (LVEF?35%) were included and received 900 mg/day WS R 1442 or placebo for 24 months. Primary endpoint was time until first cardiac event. Results: 2681 patients (WS R 1442: 1338; placebo: 1343) were randomised. Average time to first cardiac event was 620 days for WS R 1442 and 606 days for placebo (event rates: 27.9% and 28.9%, hazard ratio (HR): 0.95, 95% CI [0.82;1.10]; p=0.476). The trend for cardiac mortality reduction with WS R 1442 (9.7% at month 24; HR: 0.89 [0.73;1.09]) was not statistically significant (p=0.269). In the subgroup with LVEF?25%, WS R 1442 reduced sudden cardiac death by 39.7% (HR 0.59 [0.37;0.94] at month 24; p=0.025). Adverse events were comparable in both groups. Conclusions: In this study, WS R 1442 had no significant effect on the primary endpoint. WS R 1442 was safe to use in patients receiving optimal medication for heart failure. In addition, the data may indicate that WS R 1442 can potentially reduce the incidence of sudden cardiac death, at least in patients with less compromised left ventricular function.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:European Journal of Heart Failure. - 10 : 12 (2008), p. 1255-1263. -
További szerzők:Colucci, Wilson S. Meinertz, Thomas Gaus, Wilhelm Tendera, Michal Édes István (1952-) (kardiológus) Investigation of Crataegus Extract WS R 1442 in CHF (SPICE) trial study group
Internet cím:DOI
elektronikus változat
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4.

001-es BibID:BIBFORM010424
Első szerző:Metra, Marco
Cím:Effects of low-dose oral enoximone administration on mortality, morbidity, and exercise capacity in patients with advanced heart failure : the randomized, double-blind, placebo-controlled, parallel group ESSENTIAL trials / Marco Metra, Eric Eichhorn, William T. Abraham, Jennifer Linseman, Michael Böhm, Ramon Corbalan, David DeMets, Teresa De Marco, Uri Elkayam, Michael Gerber, Michel Komajda, Peter Liu, Vyacheslev Mareev, Sergio V. Perrone, Philip Poole-Wilson, Ellen Roecker, Jennifer Stewart, Karl Swedberg, Michal Tendera, Brian Wiens, Michael R. Bristow, The ESSENTIAL Investigators
Dátum:2009
ISSN:0195-668X (Print)
Megjegyzések:Use of inotropic agents in patients with heart failure (HF) has been limited by adverse effects on outcomes. However, administration of positive inotropes at lower doses and concomitant treatment with beta-blockers might increase benefit-risk ratio. We investigated the effects of low doses of the positive inotrope enoximone on symptoms, exercise capacity, and major clinical outcomes in patients with advanced HF who were also treated with beta-blockers and other guideline-recommended background therapy. METHODS AND RESULTS: The Studies of Oral Enoximone Therapy in Advanced HF (ESSENTIAL) programme consisted of two identical, randomized, double-blind, placebo-controlled trials that differed only by geographic location (North and South America: ESSENTIAL-I; Europe: ESSENTIAL-II). Patients with New York Heart Association class III-IV HF symptoms, left ventricular ejection fraction &lt; or = 30%, and one hospitalization or two ambulatory visits for worsening HF in the previous year were eligible for participation in the trials. The trials had three co-primary endpoints: (i) the composite of time to all-cause mortality or cardiovascular hospitalization, analysed in the two ESSENTIAL trials combined; (ii) the 6 month change from baseline in the 6 min walk test distance (6MWTD); and (iii) the Patient Global Assessment (PGA) at 6 months, both analysed in each trial separately. ESSENTIAL-I and -II randomized 1854 subjects at 211 sites in 16 countries. In the combined trials, all-cause mortality and the composite, first co-primary endpoint did not differ between the two treatment groups [hazard ratio (HR) 0.97; 95% confidence interval (CI) 0.80-1.17; and HR 0.98; 95% CI 0.86-1.12, respectively, for enoximone vs. placebo]. The two other co-primary endpoints were analysed separately in the two ESSENTIAL trials, as prospectively designed in the protocol. The 6MWTD increased with enoximone, compared with placebo, in ESSENTIAL-I (P = 0.025, not reaching, however, the pre-specified criterion for statistical significance of P &lt; 0.020), but not in ESSENTIAL-II. No difference in PGA was observed in either trial. CONCLUSION: Although low-dose enoximone appears to be safe in patients with advanced HF, major clinical outcomes are not improved.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:European Heart Journal. - 30 : 24 (2009), p. 3015-3026. -
További szerzők:Eichhorn, Eric Abraham, William T. Linseman, Jennifer Böhm, Michael Corbalan, Ramon DeMets, David De Marco, Teresa Elkayam, Uri Gerber, Michael Komajda, Michel Liu, Peter Mareev, Vyacheslev Perrone, Sergio V. Poole-Wilson, Philip A. Roecker, Ellen Stewart, Jennifer Swedberg, Karl Tendera, Michal Wiens, Brian Bristow, Michael R. Czuriga István (1948-2018) (kardiológus) Édes István (1952-) (kardiológus) The ESSENTIAL Investigators
Internet cím:Intézményi repozitóriumban (DEA) tárolt változat
DOI
Borító:

5.

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
Borító:
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