Previous prospective outcome studies of statins have not provided any
guidance on benefit-risk in patients with heart failure.
AIM:
The primary objective is to determine whether rosuvastatin (10 mg) reduces
the combined endpoint of cardiovascular mortality, non-fatal myocardial
infarction or non-fatal stroke (time to first event). The first secondary
endpoint is all-cause mortality.
METHODS:
CORONA is a randomized, double-blind, placebo-controlled trial. Briefly, men
and women, aged > or =60 years with chronic symptomatic systolic heart
failure of ischemic aetiology and ejection fraction < or =0.40 (NYHA class
III and IV) or < or =0.35 (NYHA class II) were eligible if they were not
using or in need of cholesterol lowering drugs.
RESULTS:
Mean age was 73 years (n=5016; 24% women), with 37% in NYHA II and 62% in
NYHA III, ejection fraction 0.31, total cholesterol 5.2 mmol/L. Sixty
percent have a history of myocardial infarction, 63% hypertension, and 30%
diabetes. Patients are well treated for heart failure with 90% on loop or
thiazide diuretics, 42% aldosterone antagonists, 91% ACE inhibitor or AT-I
blocker, 75% beta-blockers, and 32% digitalis.
CONCLUSION:
CORONA is important for three main reasons: (1) A positive result is very
important because of the high risk of the population studied, the increasing
prevalence of elderly patients with chronic symptomatic systolic heart
failure in our society, and the health economic issues involved. (2) If
negative, new mechanistic questions about heart failure have to be raised.
(3) If neutral we can avoid unnecessary polypharmacy.
Reference:
Eur J Heart Fail. 2005 Oct;7(6):1059-69 |