All this hype about the preventative aspects of AstraZeneca’s (AZN) Crestor study published in Sunday’s New England Journal of Medicine. Looking at Table 3 (“Outcomes”) shows only 49 fewer people died on Crestor than taking a placebo in a population of 17,802 study participants. Even less impressive, there were only 109 fewer participants who had a first time cardiac event taking Crestor versus the placebo.
It’s easy to tout percentage differences such as the endlessly reiterated 44% benefit of Crestor versus placebo, but that statistic is meaningless considering the infinitesimal number of actual events. Less than 400 cardiac events (2.2%) and under 450 total deaths (2.5%) were experienced in this extremely large study group. Given the side effects caused by statins which can necessitate additional medical treatment, it’s hard to justify the cost/benefit of medicating when the risks of this population are so low for cardiac events.
It’s fitting that the Crestor study is called Jupiter. Just like the largest planet in our solar system, AstraZeneca has big plans to expand Crestor sales to people with normal cholesterol profiles who have elevated levels of C-reactive protein (CRP) not caused by inflammatory conditions such as arthritis. Since 50% of all heart attacks occur in people with normal cholesterol levels, AstraZeneca believes CRP could be a factor in causing cardiovascular events. The Jupiter trial was fully funded and sponsored by AstraZeneca. 11,001 “apparently healthy” 60+ year old men and 6,801 50+ women with normal cholesterol profiles and no history of cardiovascular disease, but with elevated CRP levels participated. The study was divided equally between those taking Crestor and those taking a placebo. The five year study trial was halted early with a midpoint of 1.9 years of treatment. Crestor comes in 5, 10, 20, and 40 mg dosage levels. Study participants taking Crestor took the 20 mg dosage which according to information on the Crestor website, is for patients “with marked hypercholesterolemia, and aggressive lipid targets.”
This seems a bit extreme for the characteristics of this study group. Dr. Paul Ridker, a cardiologist at Harvard Medical School and Brigham and Women’s Hospital, led the Jupiter study and presented the results at yesterday’s annual scientific meeting of the American Heart Association. Dr. Ridker is an inventor of CRP-related patents held by Brigham. Dr. Ridker and his New England Journal co-authors have received grants and other fees from AstraZeneca. AstraZeneca is hoping the Jupiter study results will influence government- recommended cholesterol guidelines to be expanded next year to increase the number of prescriptions for Crestor.
Marketing Crestor specifically for elevated CRP will require the FDA to approve a label change which is not likely to happen until 2010, if at all. While Pfizer (PFE) is seeing reduced economic value in reinvesting in its cholesterol franchise (Lipitor), AstraZeneca appears to be pumping as much air in the cholesterol bubble as it can muster.