Rosuvastatin in older patients with systolic heart failure.
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.)
Kjekshus
John
J
Department of Cardiology, University of Oslo, Rikshospitalet University Hospital, Oslo, Norway. john.kjekshus@medisin.uio.no
Apetrei
Eduard
E
Barrios
Vivencio
V
Böhm
Michael
M
Cleland
John G F
JG
Cornel
Jan H
JH
Dunselman
Peter
P
Fonseca
Cândida
C
Goudev
Assen
A
Grande
Peer
P
Gullestad
Lars
L
Hjalmarson
Ake
A
Hradec
Jaromir
J
Jánosi
András
A
Kamenský
Gabriel
G
Komajda
Michel
M
Korewicki
Jerzy
J
Kuusi
Timo
T
Mach
François
F
Mareev
Vyacheslav
V
McMurray
John J V
JJ
Ranjith
Naresh
N
Schaufelberger
Maria
M
Vanhaecke
Johan
J
van Veldhuisen
Dirk J
DJ
Waagstein
Finn
F
Wedel
Hans
H
Wikstrand
John
J
D000368:Aged; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000401:mortality; D005260:Female; D005464:Fluorobenzenes / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006333:Heart Failure / Q000188:drug therapy* / Q000209:etiology; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000150:complications; D016016:Proportional Hazards Models; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D000068718:Rosuvastatin Calcium; D016037:Single-Blind Method; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D013599:Systole; D016896:Treatment Outcome
D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium