COMET TRIAL |
|
|---|---|
| Problem | Heart failure (EF < 35%; Stage II - IV) |
| Format | Multicenter, double-blind, parallel-group, randomised controlled trial |
| Treatment | Carvedilol OR Metoprolol |
| Control | Nil |
| Population | 3,029 patients |
| Inclusion criteria | LVEF <35% NYHA class II-IV Previous admission for a cardiovascular reason Optimal treatment with diuretics and ACE inhibitors |
| Exclusion criteria | Study objective-related -Recent change of heart failure treatment -Treatment with calcium channel blocker (diltiazem or verapamil) -Unstable angina or myocardial infarction within past 2 months -Heart transplantation anticipated within 2 months -Hemodynamically significant valvular disease -Arrhythmias (unless adequately treated) Contraindications to beta-blocker therapy -Heart rate < 60 beats per minute -Systolic blood pressure < 85 mm Hg -Atrioventricular block (unless treated with a pacemaker) -History of asthma or chronic obstructive pulmonary disease -Unstable insulin-dependent diabetes mellitus General exclusion criteria -Hepatic disease -Pregnancy or childbearing potential (unless using adequate contraception) -Stroke in past 2 months -Some specific endocrine disorders |
| Follow-up | Mean 4.8 years |
| Primary endpoint | All-cause mortality |
| Secondary endpoint(s) | Composite endpoint of all-cause mortality or all-cause admission |
| Details | - |
| Brief summary: | Carvedilol superior to metoprolol reducing mortality in NYHA II+ & EF <35% |
| PAPER: Comparison of carvedilol and metoprolol on clinical outcomes in patients with chronic heart failure in the Carvedilol Or Metoprolol European Trial (COMET): randomised controlled trial. | |
|---|---|
| Date | 5 Jul 2003 |
| Journal | Lancet. 2003 Jul 5;362(9377):7-13. |
| Information | Significant reduction for carvedilol (vs. metoprolol) for: -All-cause mortality (17%) No significant difference in: -Composite of mortality or all-cause hospitalisation -Side effects |