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Purpose To determine whether metoprolol controlled/extended release

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Presentation on theme: "Purpose To determine whether metoprolol controlled/extended release"— Presentation transcript:

1 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 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: Metoprolol CR/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: Metoprolol CR/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: Metoprolol CR/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 145 patient 217 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: Metoprolol CR/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 = (adjusted for interim analysis) P = (nominal) 3 6 9 12 16 18 21 Follow up (months) MERIT-HF Study Group. Lancet 1999; 353 :2001 7.

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

7 Metoprololol CR/XL once daily in addition to optimum standard therapy:
MERIT-HF: Metoprolol CR/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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