Top News November 9, 2008, 6:51PM EST

Crestor Study Will Boost Statin Demand

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A CRP blood test costs $50 to $80, and Crestor is $3.95 per pill. There are far cheaper generic statins available, and Pfizer's (PFE) Lipitor, the best-selling statin, is due to go off patent in 2011. Dr. Gordon Tomaselli, chief of cardiology at Johns Hopkins, said that, although no similar study has been done or is being planned with other statins, probably the entire class of drugs has some effect on CRP.

Currently the AHA recommends a CRP test only when a doctor is unsure whether to treat a patient (BusinessWeek, 1/17/08) at intermediate risk of heart disease. The underlying assumption to that recommendation is that patients at low risk do not need treatment—but Jupiter could change that equation. "Can our society afford to put millions more people on an expensive drug, and screen them with an expensive test, when the money might better be used elsewhere?" asks Hayes. "We have to think long and hard about that."

Women and Minorities Tested

Dr. Andrew Tonkin, head of cardiovascular research at Monash University in Melbourne, Australia, cautioned that the actual number of heart attacks and other cardiovascular events was low, even in the study participants that were taking placebos. There were 83 cardiac events of all types in the Crestor group, an 0.9% actual risk, compared with 157, or 1.8%, in the placebo group. "You would have to treat 180 people for two years to prevent one death," he said.

The Crestor therapy did appear to be very safe, however, mitigating concerns that an increase of patients on statins will lead to unforeseen consequences. The investigators found little or no difference between the Crestor and placebo groups on most side effects, including muscle soreness, often associated with statins. There was a small increase in diabetes in the Crestor group, an effect observed in most statins, and one case of rhabdomyolysis, a rare and dangerous muscle disease also associated with statin use. The statin group had a lower rate of cancer, but Tonkin said there would need to be a 5-to-20-year follow-up to accurately determine the risk of increased cancer.

The Jupiter study was also notable because it included large numbers of women and minorities, groups often overlooked in heart disease trials. The results were the same for all subgroups in the trial, no matter their gender or ethnicity. Crestor's sales rose 28% in the third quarter, according to AstraZeneca, and Wall Street analysts estimate that Jupiter could end up doubling Crestor's sales by 2015, to $6.3 billion. AstraZeneca's stock has climbed 45% since Jupiter was halted last March.

Arnst is a senior writer for BusinessWeek based in New York.

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