Authors
Kjekshus J, Apetrei E, Barrios V. et al.
Title
Rosuvastatin in older patients with systolic heart failure
References
N Engl J Med. 2007 Nov 29;357(22):2248-61.
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. In addition, in this population of patients, low levels of total cholesterol are common and are associated with worse outcomes.
Purpose
To determine if rosuvastatin would outweigh any theoretical hazards and improve survival, reduce morbidity, and increase well-being in patients with chronic, symptomatic, systolic, ischemic heart failure.
Design
  • Multicenter, randomized, double blinded placebo controlled trial
  • 2514 pts (rosuvastatin) 2497 pts (placebo), aged >60 years with chronic symptomatic heart failure from ischemic etiology (NYHA II-IV)
  • LVEF<40% on optimal med treatment, stable for 2 weeks
Exclusion Criteria
  • Previous statin-induced myopathy
  • Decompensated heart failure
  • MI within past 6 months, unstable angina or stroke, ICD or CRT within past 3 months
  • CK>2.5x ULN
  • Creatinine>221 umol/L
  • Chronic liver disease; ALT>2x ULN
  • Uncorrected valvular disease, HCM or myocarditis
Follow-Up
Median 32.8 months
Treatment Regimen
  • Rosuvastatin 10mg/day or placebo
  • Follow-up visits scheduled at 6 weeks, 3 months after randomization and 3 months thereafter. Compliance, lipid and routine blood work assessed at each visit.
Results

Primary Endpoints

In the rosuvastain group, LDL decreased by 45.0%; P<0.001 and hsCRP decreased by 37.1%; P<0.001.

Rosuvastatin
n=2514
per 100 patient-year		 Placebo
n=2487
per 100 patient-year		Hazard Ratiop
Cardiac death, non-fatal MI, and non-fatal stroke
11.412.30.92 (0.83-1.02)0.12

Secondary Outcomes

(see paper for complete list)

Rosuvastatin
n=2514
per 100 patient-year		 Placebo
n=2487
per 100 patient-year		Hazard Ratiop
Total mortality
11.612.20.95 (0.86-1.05)0.31
Coronary event
9.310.00.92 (0.82-1.04)0.18
Summary
Daily treatment with rosuvastatin 10mg did not reduce the composite outcome of death from cardiovascular causes or nonfatal myocardial infarction or stroke in elderly patients with ischemic, systolic heart failure who had already received extensive treatment with drugs for cardiovascular disease. The drug did not cause safety problems.