The maker of <"http://www.yourlawyer.com/topics/overview/crestor">Crestor is about to start marketing it to people who don’t have cholesterol problems as a preventive measure. According to The New York Times, while the Food & Drug Administration (FDA) has approved this expanded use of Crestor, some worry that treating healthy people with the drug could be risky.
The new criteria for Crestor was approved by the FDA last month, after the agency reviewed a clinical study which showed a small reduction of strokes, heart attacks and other â€œcardiovascular eventsâ€ among people taking the statin, compared with patients taking a placebo. According to the Times, the international study involved nearly 18,000 people who had low cholesterol readings and an elevated level of inflammation in the body as measured by a test called high-sensitivity C-reactive protein , or CRP.
The new Crestor label says it may be prescribed for apparently healthy people if they are older â€” men 50 and over and women 60 and over â€” and have one risk factor like smoking or high blood pressure, along with elevated inflammation in the body indicated by the CRP test. According to the Times, an estimated 6.5 million healthy people in the U.S. could now be considered candidates for Crestor. AstraZeneca, which makes the drug, plans to launch a big advertising blitz next month touting the statin’s preventative benefits.
But do those benefits outweigh the drugs’ risks? According to the Times, maybe not. Like all drugs, statins such as Crestor have side effects. Muscle aches are a common complaint of people taking statins, and patients taking the drugs have to be checked periodically to make sure their liver enzymes aren’t elevated.
Most disturbing, one recent study in The Lancet found that treating healthy people with statins like Crestor could raise a personâ€™s risk of developing Type 2 diabetes by nine percent. According to The Times, that study was based on an analysis of most of the major clinical studies of statins. It included unpublished data and the results of the clinical study that the FDA reviewed before approving expanded use of Crestor. Because of the findings, the FDA did require AstraZeneca to add the diabetes risk to the Crestor label.
The Times article also raised questions about the CRP test used to determine if a healthy person is a candidate for Crestor. For one thing, there is no agreement in the medical community that inflammation is a direct cause of cardiovascular problems.
According to the Times, the study the FDA reviewed prior to approving the expanded use of Crestor was led by Paul M. Ridker, a Harvard medical professor and cardiologist at Brigham and Womenâ€™s Hospital. When Ridker convinced AstraZeneca to pay for his study, it had already been rejected by the National Institutes of Health and at least two other companies.
Ridker is also the inventor of the CRP test. According to the Times, he receives undisclosed amounts of royalties from the CRP test.
Ridker told the Times his study found a 55 percent reduction in heart attacks, a 48 percent reduction in stroke, and a 45 percent reduction in angioplasty bypass surgery in healthy people treated with Crestor. But critics of the study point out that these claims may be misleading because the patients were so healthy that they had little risk to begin with.
As the Times points out, the 55 percent relative difference in heart attacks between the two groups translates to only 0.2 percentage points in absolute terms â€” or 2 people out of 1,000. In real numbers, 500 people would need to be treated with Crestor for a year to avoid one usually survivable heart attack. One cardiologist told the Times that while the difference seen in Ridker’s study was statistically significant, it wasn’t clinically significant.