Study Might Prompt Expanded Use of Crestor, Increase U.S. Health Care Costs by $10B Annually, Analysis Finds

Use of the cholesterol medication Crestor, manufactured by AstraZeneca, to prevent cardiovascular events in patients who do not have high cholesterol levels but have high levels of C-reactive protein would increase U.S. health care costs by $10 billion annually, according to an analysis released on Monday, USA Today reports (Sternberg, USA Today, 11/10).

According to a study presented on Sunday at the annual meeting of the American Heart Association in New Orleans, Crestor, part of a class of cholesterol medications called statins, can reduce by about half the risk for heart attack, stroke and death among such patients. For the study, called JUPITER, researchers led by Paul Ridker, director of the Center for Cardiovascular Disease in Women at Brigham and Women's Hospital, examined almost 18,000 patients worldwide. Participants included men ages 50 and older and women ages 60 and older who did not have histories of heart disease or high cholesterol levels. However, participants had high levels of C-reactive protein, which indicates inflammation in the body. Participants took either Crestor or a placebo (Kaiser Daily Health Policy Report, 11/10).

Experts maintain that the study might prompt physicians to test patients for CRP levels and prescribe statins to those who have high levels, and some have raised concerns about the cost. As a result of the study, U.S. physicians might prescribe statins to as many as seven million more patients at a cost of about $9.7 billion annually, according to an analysis conducted by James Stein of the University of Wisconsin School of Medicine and Public Health. He said that the practice would prevent about 28,000 heart attacks, strokes and deaths annually and that the cost of saving one life would total about $557,000 (USA Today, 11/10).

Some cardiologists also raised concerns because AstraZeneca funded the study and because the research did not involve younger participants. In addition, some cardiologists said that the public should continue to follow standard guidelines to reduce risk for cardiovascular events (Fernandez, San Francisco Chronicle, 11/11).

Crestor Sales
Meanwhile, AstraZeneca CEO David Brennan on Monday said that the effect of the study on sales of Crestor remains undetermined, the Wall Street Journal reports. UBS pharmaceutical industry analyst Gbola Amusa on Monday said that sales of Crestor might increase to more than $7 billion in 2012 from $2.7 billion last year as a result of the study. Brennan said, "We've seen a flurry of estimates from analysts about the commercial impact of (the study), some of them pretty bullish," adding, "I would urge caution when forecasting the speed of such changes."

He said that medical groups, such as the American College of Cardiology, will help determine whether more physicians should test patients for CRP levels and prescribe statins to those who have high levels. In addition, AstraZeneca cannot market Crestor for use in patients with high CRP levels because FDA has not approved the medication for that use. AstraZeneca will apply for approval of Crestor for use in patients with high CRP levels in the first half of 2009, according to company officials (Whalen, Wall Street Journal, 11/11).

ABC's "Good Morning America" on Monday reported on the study in a segment called "Cutting Your Cholesterol" (Roberts, "Good Morning America," ABC, 11/10).

PBS' "NewsHour with Jim Lehrer" on Monday also reported on the study (Lehrer, "NewsHour with Jim Lehrer," PBS, 11/10).