AstraZeneca’s Crestor Fails A Heart Failure Study
2 CommentsBy Ed Silverman // November 5th, 2007 // 9:25 am
More bad news for the drugmaker. The latest development is from a study that found its Crestor cholesterol pill didn’t reduce deaths in older people with heart failure, which means AstraZeneca will have a hard time generating new scrips for such patients. The research, reported today at the American Heart Association meeting in Orlando, Florida, found that 11.4 percent of those on Crestor died, or had a heart attack or stroke, compared with 12.3 percent given a placebo.
A successful result could have added $1 billion to U.S. revenues alone, according to industry analysts, although Reuters reports many had thought proving the drug’s benefits would be tough. Crestor sold $2 billion worldwide in the first nine months of 2007.
“Our findings suggest the major cause of death in these patients was likely not to be related to atherosclerotic events, where benefit with statins in non-heart failure patients has been demonstrated, but instead may have been caused by the deterioration of failing heart muscle damaged beyond repair,” he said in a statement. AstraZeneca described the 5,000-patient study as “novel and challenging” and, though unsuccessful, had established Crestor’s safety in heart failure patients. This is the study.
Frederick Masoudi of the Denver Health Medical Center in Denver, Colorado, wrote in the New England Journal of Medicine that several uncertainties meant doctors should not change medical practice for now. “Although the results suggest there was no benefit on the primary outcome…the study ends up raising almost more questions than it answers,” he tells Reuters. “One should not rush to take (heart failure) patients like these off statins.”
Heart failure is a hard-to-treat condition in which the weakened heart cannot pump enough blood to meet the body’s need for oxygen, causing shortage of breath and other problems. It is a leading cause of hospitalisation among the elderly. Although Crestor’s cholesterol-lowering ability has long been documented, the so-called CORONA study was the first to test whether the 4-year-old drug, which is known generically as rosuvastatin, actually improved patient outcomes.
All patients were given a number of drugs considered optimal therapy for heart failure - including diuretics, beta blockers and blood-pressure medicines. In addition, some were also given a daily dose of 10 milligrams of Crestor. After 33 months of treatment, 692 patients in the Crestor group had heart attacks, strokes or died of cardiovascular complications, against 732 of those who took standard treatments alone. The difference was not statistically significant.
Rival statins, including Pfizer’s Lipitor and Merck’s Zocor, have previously shown an ability to reduce the risk of strokes and heart attacks in other population groups by up to 30 percent. But no statin has before been tested to assess its ability to protect heart-failure patients from such long-term health consequences, AstraZeneca officials said. In fact, trials of statins have traditionally excluded heart-failure patients. Heart failure develops in an estimated 1 percent of the population, most commonly among the elderly
Carl
Help! Been on Crestor 10mg a day for 4 months. Sure it reduced my Triglycerides BUT at the expense of getting hard stool followed by constipation continuously. Stool softeners dont help. Does anyone else have this problem? Should I dump this crap? It needs to be taken off the market and re formulated to get the bugs out.
Nobody
It seems that a possible alternative would be to try other medications (i.e. Lipitor, Zocor) and see if their formulations are better for you. If nothing else, it looks like they coincide with a 30% decrease in HA and stroke risks.
Other than that, I recommend kefir (home made, not the butter-milk “stuff” from your supermarket). It certainly works as a stoll softener for me.