Rosuvastatin in older patients with systolic heart failure

John Kjekshus, Eduard Apetrei, Vivencio Barrios, Michael Böhm, John G F Cleland, Jan H. Cornel, Peter Dunselman, Cândida Fonseca, Assen Goudev, Peer Grande, Lars Gullestad, Åke Hjalmarson, Jaromir Hradec, András Jánosi, Gabriel Kamenský, Michel Komajda, Jerzy Korewicki, Timo Kuusi, François Mach, Vyacheslav Mareev & 8 others John J V McMurray, Naresh Ranjith, Maria Schaufelberger, Johan Vanhaecke, Dirk J. Van Veldhuisen, Finn Waagstein, Hans Wedel, John Wikstrand

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Abstract

BACKGROUND: Patients with systolic heart failure have generally been excluded from statin trials. Acute coronary events are uncommon in this population, and statins have theoretical risks in these patients. METHODS: A total of 5011 patients at least 60 years of age with New York Heart Association class II, III, or IV ischemic, systolic heart failure were randomly assigned to receive 10 mg of rosuvastatin or placebo per day. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Secondary outcomes included death from any cause, any coronary event, death from cardiovascular causes, and the number of hospitalizations. RESULTS: As compared with the placebo group, patients in the rosuvastatin group had decreased levels of low-density lipoprotein cholesterol (difference between groups, 45.0%; P<0.001) and of high-sensitivity C-reactive protein (difference between groups, 37.1%; P<0.001). During a median follow-up of 32.8 months, the primary outcome occurred in 692 patients in the rosuvastatin group and 732 in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.83 to 1.02; P=0.12), and 728 patients and 759 patients, respectively, died (hazard ratio, 0.95; 95% CI, 0.86 to 1.05; P=0.31). There were no significant differences between the two groups in the coronary outcome or death from cardiovascular causes. In a prespecified secondary analysis, there were fewer hospitalizations for cardiovascular causes in the rosuvastatin group (2193) than in the placebo group (2564) (P<0.001). No excessive episodes of muscle-related or other adverse events occurred in the rosuvastatin group. CONCLUSIONS: Rosuvastatin did not reduce the primary outcome or the number of deaths from any cause in older patients with systolic heart failure, although the drug did reduce the number of cardiovascular hospitalizations. The drug did not cause safety problems. (ClinicalTrials.gov number, NCT00206310.)

Original languageEnglish
Pages (from-to)2248-2261
Number of pages14
JournalNew England Journal Of Medicine
Volume357
Issue number22
DOIs
Publication statusPublished - 29 Nov 2007

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Systolic Heart Failure
Cause of Death
Placebos
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hospitalization
Confidence Intervals
Rosuvastatin Calcium
Pharmaceutical Preparations
C-Reactive Protein
LDL Cholesterol
Stroke
Myocardial Infarction
Safety
Muscles

Keywords

  • MYOCARDIAL-INFARCTION
  • CHOLESTEROL LEVELS
  • MERIT-HF
  • TRIAL
  • STATINS
  • DISEASE
  • PRAVASTATIN
  • SURVIVAL
  • EVENTS
  • DEATH

Cite this

Kjekshus, J., Apetrei, E., Barrios, V., Böhm, M., Cleland, J. G. F., Cornel, J. H., ... Wikstrand, J. (2007). Rosuvastatin in older patients with systolic heart failure. New England Journal Of Medicine, 357(22), 2248-2261. https://doi.org/10.1056/NEJMoa0706201
Kjekshus, John ; Apetrei, Eduard ; Barrios, Vivencio ; Böhm, Michael ; Cleland, John G F ; Cornel, Jan H. ; Dunselman, Peter ; Fonseca, Cândida ; Goudev, Assen ; Grande, Peer ; Gullestad, Lars ; Hjalmarson, Åke ; Hradec, Jaromir ; Jánosi, András ; Kamenský, Gabriel ; Komajda, Michel ; Korewicki, Jerzy ; Kuusi, Timo ; Mach, François ; Mareev, Vyacheslav ; McMurray, John J V ; Ranjith, Naresh ; Schaufelberger, Maria ; Vanhaecke, Johan ; Van Veldhuisen, Dirk J. ; Waagstein, Finn ; Wedel, Hans ; Wikstrand, John. / Rosuvastatin in older patients with systolic heart failure. In: New England Journal Of Medicine. 2007 ; Vol. 357, No. 22. pp. 2248-2261.
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abstract = "BACKGROUND: Patients with systolic heart failure have generally been excluded from statin trials. Acute coronary events are uncommon in this population, and statins have theoretical risks in these patients. METHODS: A total of 5011 patients at least 60 years of age with New York Heart Association class II, III, or IV ischemic, systolic heart failure were randomly assigned to receive 10 mg of rosuvastatin or placebo per day. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Secondary outcomes included death from any cause, any coronary event, death from cardiovascular causes, and the number of hospitalizations. RESULTS: As compared with the placebo group, patients in the rosuvastatin group had decreased levels of low-density lipoprotein cholesterol (difference between groups, 45.0{\%}; P<0.001) and of high-sensitivity C-reactive protein (difference between groups, 37.1{\%}; P<0.001). During a median follow-up of 32.8 months, the primary outcome occurred in 692 patients in the rosuvastatin group and 732 in the placebo group (hazard ratio, 0.92; 95{\%} confidence interval [CI], 0.83 to 1.02; P=0.12), and 728 patients and 759 patients, respectively, died (hazard ratio, 0.95; 95{\%} CI, 0.86 to 1.05; P=0.31). There were no significant differences between the two groups in the coronary outcome or death from cardiovascular causes. In a prespecified secondary analysis, there were fewer hospitalizations for cardiovascular causes in the rosuvastatin group (2193) than in the placebo group (2564) (P<0.001). No excessive episodes of muscle-related or other adverse events occurred in the rosuvastatin group. CONCLUSIONS: Rosuvastatin did not reduce the primary outcome or the number of deaths from any cause in older patients with systolic heart failure, although the drug did reduce the number of cardiovascular hospitalizations. The drug did not cause safety problems. (ClinicalTrials.gov number, NCT00206310.)",
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Kjekshus, J, Apetrei, E, Barrios, V, Böhm, M, Cleland, JGF, Cornel, JH, Dunselman, P, Fonseca, C, Goudev, A, Grande, P, Gullestad, L, Hjalmarson, Å, Hradec, J, Jánosi, A, Kamenský, G, Komajda, M, Korewicki, J, Kuusi, T, Mach, F, Mareev, V, McMurray, JJV, Ranjith, N, Schaufelberger, M, Vanhaecke, J, Van Veldhuisen, DJ, Waagstein, F, Wedel, H & Wikstrand, J 2007, 'Rosuvastatin in older patients with systolic heart failure', New England Journal Of Medicine, vol. 357, no. 22, pp. 2248-2261. https://doi.org/10.1056/NEJMoa0706201

Rosuvastatin in older patients with systolic heart failure. / Kjekshus, John; Apetrei, Eduard; Barrios, Vivencio; Böhm, Michael; Cleland, John G F; Cornel, Jan H.; Dunselman, Peter; Fonseca, Cândida; Goudev, Assen; Grande, Peer; Gullestad, Lars; Hjalmarson, Åke; Hradec, Jaromir; Jánosi, András; Kamenský, Gabriel; Komajda, Michel; Korewicki, Jerzy; Kuusi, Timo; Mach, François; Mareev, Vyacheslav; McMurray, John J V; Ranjith, Naresh; Schaufelberger, Maria; Vanhaecke, Johan; Van Veldhuisen, Dirk J.; Waagstein, Finn; Wedel, Hans; Wikstrand, John.

In: New England Journal Of Medicine, Vol. 357, No. 22, 29.11.2007, p. 2248-2261.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Rosuvastatin in older patients with systolic heart failure

AU - Kjekshus, John

AU - Apetrei, Eduard

AU - Barrios, Vivencio

AU - Böhm, Michael

AU - Cleland, John G F

AU - Cornel, Jan H.

AU - Dunselman, Peter

AU - Fonseca, Cândida

AU - Goudev, Assen

AU - Grande, Peer

AU - Gullestad, Lars

AU - Hjalmarson, Åke

AU - Hradec, Jaromir

AU - Jánosi, András

AU - Kamenský, Gabriel

AU - Komajda, Michel

AU - Korewicki, Jerzy

AU - Kuusi, Timo

AU - Mach, François

AU - Mareev, Vyacheslav

AU - McMurray, John J V

AU - Ranjith, Naresh

AU - Schaufelberger, Maria

AU - Vanhaecke, Johan

AU - Van Veldhuisen, Dirk J.

AU - Waagstein, Finn

AU - Wedel, Hans

AU - Wikstrand, John

PY - 2007/11/29

Y1 - 2007/11/29

N2 - BACKGROUND: Patients with systolic heart failure have generally been excluded from statin trials. Acute coronary events are uncommon in this population, and statins have theoretical risks in these patients. METHODS: A total of 5011 patients at least 60 years of age with New York Heart Association class II, III, or IV ischemic, systolic heart failure were randomly assigned to receive 10 mg of rosuvastatin or placebo per day. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Secondary outcomes included death from any cause, any coronary event, death from cardiovascular causes, and the number of hospitalizations. RESULTS: As compared with the placebo group, patients in the rosuvastatin group had decreased levels of low-density lipoprotein cholesterol (difference between groups, 45.0%; P<0.001) and of high-sensitivity C-reactive protein (difference between groups, 37.1%; P<0.001). During a median follow-up of 32.8 months, the primary outcome occurred in 692 patients in the rosuvastatin group and 732 in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.83 to 1.02; P=0.12), and 728 patients and 759 patients, respectively, died (hazard ratio, 0.95; 95% CI, 0.86 to 1.05; P=0.31). There were no significant differences between the two groups in the coronary outcome or death from cardiovascular causes. In a prespecified secondary analysis, there were fewer hospitalizations for cardiovascular causes in the rosuvastatin group (2193) than in the placebo group (2564) (P<0.001). No excessive episodes of muscle-related or other adverse events occurred in the rosuvastatin group. CONCLUSIONS: Rosuvastatin did not reduce the primary outcome or the number of deaths from any cause in older patients with systolic heart failure, although the drug did reduce the number of cardiovascular hospitalizations. The drug did not cause safety problems. (ClinicalTrials.gov number, NCT00206310.)

AB - BACKGROUND: Patients with systolic heart failure have generally been excluded from statin trials. Acute coronary events are uncommon in this population, and statins have theoretical risks in these patients. METHODS: A total of 5011 patients at least 60 years of age with New York Heart Association class II, III, or IV ischemic, systolic heart failure were randomly assigned to receive 10 mg of rosuvastatin or placebo per day. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Secondary outcomes included death from any cause, any coronary event, death from cardiovascular causes, and the number of hospitalizations. RESULTS: As compared with the placebo group, patients in the rosuvastatin group had decreased levels of low-density lipoprotein cholesterol (difference between groups, 45.0%; P<0.001) and of high-sensitivity C-reactive protein (difference between groups, 37.1%; P<0.001). During a median follow-up of 32.8 months, the primary outcome occurred in 692 patients in the rosuvastatin group and 732 in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.83 to 1.02; P=0.12), and 728 patients and 759 patients, respectively, died (hazard ratio, 0.95; 95% CI, 0.86 to 1.05; P=0.31). There were no significant differences between the two groups in the coronary outcome or death from cardiovascular causes. In a prespecified secondary analysis, there were fewer hospitalizations for cardiovascular causes in the rosuvastatin group (2193) than in the placebo group (2564) (P<0.001). No excessive episodes of muscle-related or other adverse events occurred in the rosuvastatin group. CONCLUSIONS: Rosuvastatin did not reduce the primary outcome or the number of deaths from any cause in older patients with systolic heart failure, although the drug did reduce the number of cardiovascular hospitalizations. The drug did not cause safety problems. (ClinicalTrials.gov number, NCT00206310.)

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KW - CHOLESTEROL LEVELS

KW - MERIT-HF

KW - TRIAL

KW - STATINS

KW - DISEASE

KW - PRAVASTATIN

KW - SURVIVAL

KW - EVENTS

KW - DEATH

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U2 - 10.1056/NEJMoa0706201

DO - 10.1056/NEJMoa0706201

M3 - Article

VL - 357

SP - 2248

EP - 2261

JO - New England Journal Of Medicine

JF - New England Journal Of Medicine

SN - 0028-4793

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Kjekshus J, Apetrei E, Barrios V, Böhm M, Cleland JGF, Cornel JH et al. Rosuvastatin in older patients with systolic heart failure. New England Journal Of Medicine. 2007 Nov 29;357(22):2248-2261. https://doi.org/10.1056/NEJMoa0706201