Effects of controlled-release metoprolol on total mortality, hospitalizations, and well-being in patients with heart failure - The metoprolol CR/XL randomized intervention trial in congestive heart failure (MERIT-HF)

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Item Type:	Article
Title:	Effects of controlled-release metoprolol on total mortality, hospitalizations, and well-being in patients with heart failure - The metoprolol CR/XL randomized intervention trial in congestive heart failure (MERIT-HF)
Creators Name:	Hjalmarson, A., Goldstein, S., Fagerberg, B., Wedel, H., Waagstein, F., Kjekshus, J., Wikstrand, J., El Allaf, D., Vitovec, J., Aldershvile, J., Halinen, M., Dietz, R., Neuhaus, K.L., Janosi, A., Thorgeirsson, G., Dunselman, P.H.J.M., Gullestad, L., Kuch, J., Herlitz, J., Rickenbacher, P., Ball, S., Gottlieb, S. and Deedwania, P.
Abstract:	CONTEXT: Results from recent studies on the effects of beta1-blockade in patients with heart failure demonstrated a 34% reduction in total mortality. However, the effect of beta1-blockade on the frequency of hospitalizations, symptoms, and quality of life in patients with heart failure has not been fully explored. OBJECTIVE: To examine the effects of the beta1-blocker controlled-release/extended-release metoprolol succinate (metoprolol CR/XL) on mortality, hospitalization, symptoms, and quality of life in patients with heart failure. DESIGN: Randomized, double-blind controlled trial, preceded by a 2-week single-blind placebo run-in period, conducted from February 14, 1997, to October 31, 1998, with a mean follow-up of 1 year. SETTING: Three hundred thirteen sites in 14 countries. PARTICIPANTS: Patients (n = 3991) with chronic heart failure, New York Heart Association (NYHA) functional class II to IV, and ejection fraction of 0.40 or less who were stabilized with optimum standard therapy. INTERVENTIONS: Patients were randomized to metoprolol CR/XL, 25 mg once per day (NYHA class II), or 12.5 mg once per day (NYHA class III or IV), titrated for 6 to 8 weeks up to a target dosage of 200 mg once per day (n = 1990); or matching placebo (n = 2001). MAIN OUTCOME MEASURES: Total mortality or any hospitalization (time to first event), number of hospitalizations for worsening heart failure, and change in NYHA class, by intervention group; quality of life was assessed in a substudy of 741 patients. RESULTS: The incidence of all predefined end points was lower in the metoprolol CR/XL group than in the placebo group, including total mortality or all-cause hospitalizations (the prespecified second primary end point; 641 vs 767 events; risk reduction, 19%; 95% confidence interval [CI], 10%-27%; P<.001); total mortality or hospitalizations due to worsening heart failure (311 vs 439 events; risk reduction, 31%; 95% CI, 20%-40%; P<.001), number of hospitalizations due to worsening heart failure (317 vs 451; P<.001); and number of days in hospital due to worsening heart failure (3401 vs 5303 days; P<.001). NYHA functional class, assessed by physicians, and McMaster Overall Treatment Evaluation score, assessed by patients, both improved in the metoprolol CR/XL group compared with the placebo group (P = .003 and P = .009, respectively). CONCLUSIONS: In this study of patients with symptomatic heartfailure, metoprolol CR/XL improved survival, reduced the need for hospitalizations due to worsening heart failure, improved NYHA functional class, and had beneficial effects on patient well-being.
Keywords:	Adrenergic beta-Antagonists, Delayed-Action Preparations, Double-Blind Method, Heart Failure, Hospitalization, Metoprolol, Proportional Hazards Models, Quality of Life, Survival Analysis, Treatment Outcome
Source:	JAMA: Journal of the American Medical Association
ISSN:	0098-7484
Publisher:	American Medical Association
Volume:	283
Number:	10
Page Range:	1295-1302
Date:	8 March 2000
Official Publication:	http://jama.ama-assn.org/cgi/content/abstract/283/10/1295
PubMed:	View item in PubMed

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