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MERIT-HF: Metoprolol CR/XL Randomized Intervention Trial in congestive Heart Failure

MERIT-HF: Metoprolol CR/XL Randomized Intervention Trial in congestive Heart Failure. Purpose To determine whether metoprolol controlled/extended release (CR/XL) once daily, in addition to standard therapy, can lower mortality in patients with decreased ejection fraction and

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MERIT-HF: Metoprolol CR/XL Randomized Intervention Trial in congestive Heart Failure

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  1. MERIT-HF: MetoprololCR/XL Randomized Intervention Trial in congestive Heart Failure Purpose To determine whether metoprolol controlled/extended release (CR/XL) once daily, in addition to standard therapy, can lower mortality in patients with decreased ejection fraction and symptoms of heart failure Reference MERIT-HF Study Group. Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet 1999;353:2001–7.

  2. MERIT-HF: MetoprololCR/XL Randomized Intervention Trial in congestive Heart Failure- TRIAL DESIGN - Design Randomized, double-blind, placebo-controlled Patients 3991 patients with left ventricular ejection fraction <0.40 and NYHA class II-IV heart failure, stabilized by optimum standard therapy (any combination of diuretics + ACE inhibitor) Follow up and primary endpoint Aim 2.4 years follow up. Primary endpoint all-cause mortality Treatment Patients assigned metoprolol received 12.5 (NYHA III-IV) or 25 mg (NYHA II) once daily, increasing over 8 weeks to maximum target dose 200 mg once daily

  3. MERIT-HF: MetoprololCR/XL Randomized Intervention Trial in congestive Heart Failure- RESULTS - • Study halted at mean follow up of 1 year on recommendation of independent safety committee because predefined criteria met and exceeded: • All-cause mortality significantly lower in metoprolol CR/XL group (145 vs. 217, 34% risk reduction, P=0.0062) • Significantly fewer cardiovascular deaths (128 vs. 203), sudden deaths (79 vs. 132) and death from worsening heart failure (30 vs. 58) • Drug well tolerated, as defined by permanent early discontinuation of treatment (13.9% of metoprolol CR/XL group versus 15.3% placebo)

  4. MERIT-HF: MetoprololCR/XL Randomized Intervention Trial in congestive Heart Failure- RESULTS continued - MERIT-HF trial profile 3991 patients randomized 1990 patients 2001 patients metoprolol CR/XL placebo 217 patient 145 patient deaths deaths 1845 patients alive 1784 patients alive 1614 patients on treatment 1539 patients on treatment No patients lost to follow up MERIT-HF Study Group. Lancet 1999; 353 :2001 – 7.

  5. MERIT-HF: MetoprololCR/XL Randomized Intervention Trial in congestive Heart Failure- RESULTS continued - Cumulative all-cause mortality 20 Cumulative mortality (%) Placebo Metoprolol CR/XL 15 10 5 P = 0.0062 (adjusted for interim analysis) P = 0.00009 (nominal) 0 0 3 6 9 12 16 18 21 Follow up (months) MERIT-HF Study Group. Lancet 1999; 353 :2001 – 7.

  6. MERIT-HF: MetoprololCR/XL Randomized Intervention Trial in congestive Heart Failure- RESULTS continued - Relative risk for mortality Risk Mortality Metoprolol CR/XL better P reduction (%) Total mortality 34 0.0062 Cardiovascular mortality 38 0.00003 Sudden death 41 0.0002 Death from worsening 0.0023 49 heart failure 0 0.5 1.0 1.5 Relative risk (95% CI) MERIT-HF Study Group. Lancet 1999; 353 :2001 – 7.

  7. MERIT-HF: MetoprololCR/XL Randomized Intervention Trial in congestive Heart Failure- SUMMARY - Metoprololol CR/XL once daily in addition to optimum standard therapy: • Was well tolerated and did not increase risk in any of subgroups analyzed • Improved survival in clinically stable patients, equating to prevention of 1 death per 27 patients treated per year

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