Crestor Does Not Reduce Heart Failure Deaths, Study SaysNov 29, 2007 | Parker Waichman LLP
Crestor, a cholesterol lowering statin, does not appear to reduce deaths in heart failure patients, according to a new study published in the New England Journal of Medicine. The results of the 5,000 person CORONA study are a big blow to AtraZeneca, which had hoped to market Crestor as the first statin to show clear benefits in treating chronic heart conditions in the elderly.
Crestor was approved by the Food & Drug Administration (FDA) in 2003. It is a member of a drug class called statins, which lower so-called "bad" cholesterol, otherwise known as LDL cholesterol. Although Crestor's cholesterol lowering ability was already established, the CORONA study was the first to explore whether Crestor improved patient outcomes in heart failure patients.
The CORONA study was conducted with 5,000 heart failure patients in Europe, Russia and South Africa. All of the study participants where over 60-years-old, and all suffered from ischemic heart failure, a type of heart failure caused by coronary artery disease. This type of heart failure weakens the heart's ability to pump blood efficiently. During the study, all of the patients continued their usual heart medications, but half added Crestor to their regimens. Most patients in the study participated for three years.
While the Crestor patients did have reduce levels of LDL -"bad"- cholesterol and an inflammatory marker called C-reactive protein, as well as reduced heart-related hospitalizations, these benefits did not translate to a lower death rate from heart failure in the Crestor patients. After 33 months of treatment, 692 Crestor patients had heart attacks, strokes or died of heart complications. Of those taking a placebo in place of Crestor, 732 suffered the same problems. The small difference between the two groups is not considered to be statistically significant.
Crestor's August 2003 FDA approval came after a delay because of safety concerns. During Crestor's clinical trials, seven cases of the potentially fatal, muscle-destroying condition Rhabdomyolysis occurred. Rhabdomyolysis is a serious disorder that causes kidney damage resulting from toxic effects of the contents of muscle cells. These studies also linked Crestor with cases of kidney abnormalities not seen with other statins. The FDA decided to approve Crestor but at lower dosages. However, records from the FDA and health agencies in Canada and Britain show life-threatening Crestor side effects occur even at those lower doses. In 2005, the FDA issued a public health advisory to further explain the risks and benefits of Crestor. The drug now carries a new label that includes new recommended doses for patients at a higher risk of muscle damage, including Asian patients.