Crestor shows equal or better benefit to women
ORLANDO, Florida (Reuters) - A fresh look at data from a landmark study showed that AstraZeneca's powerful cholesterol fighter Crestor dramatically cut deaths, heart attacks and strokes in women at least as much as in men, providing new evidence of the drug's benefits in a previously understudied population.
The Jupiter study, which was presented a year ago, demonstrated that Crestor reduced heart attack, stroke, need for bypass or angioplasty procedures and cardiovascular death by 45 percent over less than two years. The results were especially surprising because patients in the study had healthy cholesterol levels but high levels of a protein associated with inflammation and heart disease, suggesting the drug may have substantial benefits even for those who do not have high levels of bad LDL cholesterol.
A new analysis of the 6,801 women included in the study found that Crestor reduced major adverse heart events by 46 percent compared with 42 percent for men in the study.
The new analysis was presented on Tuesday at the American Heart Association scientific meeting in Orlando.
"Women have been an underrepresented population in primary prevention statin outcomes trials and there has been limited evidence that women can benefit from statin therapy," Alex Gold, AstraZeneca's U.S. director for Crestor clinical development, said in a statement.
"Jupiter, which used Crestor 20 milligrams, is the first statin study to have shown a significant reduction in the risk of cardiovascular events in women without established cardiovascular disease," Gold added.
Dr. Paul Ridker, who led the Jupiter study, said the findings on equivalent benefit for women will help cardiologists write guidelines about getting their LDL to target levels.
"The big message is women should sit down with their doctors to see if they can lower the risk of heart attack," Ridker said.
Statins are by far the most widely prescribed medicines and the data on Crestor in women could give it a leg up in marketing.
Among the various adverse events included in the study, the largest benefit for women was seen in need for repeat artery-clearing procedures, which was reduced by a whopping 76 percent, the company said.
In a different look at the Jupiter data, researchers found that patients whose LDL fell to very low levels below 50 had a 63 percent reduction in serious cardiovascular events, compared with placebo, and an impressive 51 percent greater reduction in events than patients who took Crestor but did not achieve such low LDL levels.
Current guidelines call for LDL levels of 100 with expectations that they will be lowered to about 70 for high risk patients.
The Jupiter findings could dampen earlier speculation that reaching extremely low LDL levels might be harmful in some way, such as possibly raising the risk of cancer.
The analysis of 4,100 patients in the study found the safety profile to be similar in those whose LDL fell below 50 and those whose did not, potentially alleviating fears of unknown side effects in extreme LDL reduction.
"Within Jupiter, we did not see increased risk of cancer," said Ridker, director of the Center for Cardiovascular Disease Prevention at Brigham & Women's Hospital in Boston.
"If anything, there were fewer cancer deaths" among Crestor users, he said.
(Reporting by Bill Berkrot and Ransdell Pierson; Editing by Richard Chang)
