A statin in the treatment of heart failure? Controlled rosuvastatin multinational study in heart failure (CORONA): study design and baseline characteristics.
BACKGROUND
Previous prospective outcome studies of statins have not provided any guidance on benefit-risk in patients with heart failure.


OBJECTIVE
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.


CONCLUSIONS
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.
Kjekshus
John
J
Department of Cardiology, Rikshospitalet University Hospital, University of Oslo, Sognsvannsveien 20, Oslo 0027, Norway.
Dunselman
Peter
P
Blideskog
Malin
M
Eskilson
Christina
C
Hjalmarson
Ake
A
McMurray
John V
JV
Waagstein
Finn
F
Wedel
Hans
H
Wessman
Peter
P
Wikstrand
John
J
D000367:Age Factors; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005464:Fluorobenzenes / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006333:Heart Failure / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage*; D006937:Hypercholesterolemia / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality*; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D011336:Probability; D011446:Prospective Studies; D011743:Pyrimidines / Q000008:administration & dosage*; D018570:Risk Assessment; D000068718:Rosuvastatin Calcium; D012720:Severity of Illness Index; D013449:Sulfonamides / Q000008:administration & dosage*; D016019:Survival Analysis; D016896:Treatment Outcome
D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium