|Crestor, or rosuvastatin, in 3D.
Clinical results of the efficacy and safety of adding 10 mg of rosuvastatin, commercially known as Crestor, to optimal therapy in patients with ischemic heart disease and systolic heart failure (HF) were presented as late-breaking research at the American Heart Association scientific sessions held this week in Orlando, Fla.
Åke Hjalmarson, MD, of Wallenberg Laboratory at the Gotenberg University, presented the finding of the Sweden-based Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA), which was designed to clarify the role of statin therapy in treating patients with systolic HF.
CORONA is a randomized, double-blind, placebo-controlled study of 5,011 patients with chronic symptomatic systolic HF caused by coronary artery disease. The average patient age was 73 years. The average ejection fraction was 31 percent, about 20 percent lower than normal.
At the press conference, Hjalmarson acknowledged that the patients in the study were older and quite sick, as a result “they already have scarring and electrical events.”
The average total cholesterol was 200 mg/dL, but the participants were not previously taking cholesterol-lowering drugs. The patients’ medical histories included 60 percent with a history of heart attack, 63 percent with hypertension and 30 percent with diabetes.
“These patients were well-treated for their HF,” Hjalmarson said, with 87 percent on loop or thiazide diuretics, 39 percent on aldosterone antagonists, 91 percent taking an ACE inhibitor or AT-I blocker, 75 percent taking a beta-blocker and 33 percent on digitalis. Additionally, 51 percent were taking aspirin, and 36 percent were on anticoagulants.
Patients were randomized to receive either 10 mg of rosuvastatin or a placebo, along with all their other medications, with an average follow-up of 2.7 years.
In this previously unstudied population of older patients with moderate to severe systolic heart failure, there was no significant reduction in the primary endpoint, total mortality, coronary event endpoint, sudden death or death from worsening HF with the use of Crestor. Overall, there were very few heart attack deaths in either group.
With the use of 10 mg of rosuvastatin, the total number of cardiovascular hospitalizations and HF hospitalizations were reduced. There also were very few hospitalizations for unstable angina in either group. Overall, Crestor “was well-tolerated in this vulnerable and older population that was well treated,” according to Hjalmarson.
The researchers concluded that the primary endpoint “was not reduced to the extent anticipated” with the use of Crestor.
For example, 692 patients using rosuvastatin had heart attacks, strokes or cardiovascular events in comparison to the 732 patients who took standard treatments, the difference of which is not statistically significant.
Gordon Tomaselli, MD, moderator of the session, chairman of the AHA committee on scientific sessions program, as well as chief of the cardiology division at Johns Hopkins University School of Medicine, said these results “might stay my hand” from administering a statin to HF patients a statin if they have no other need for it.
AstraZeneca sponsored the CORONA study.