Cholesterol Drug Gets Wider OK by E.U., but Concerns Persist

AstraZeneca (AZN) announced Tuesday that its drug, Crestor, had been approved in the European Union to prevent heart attacks and strokes in patients with normal -- and even low -- cholesterol levels. While these patients may still be considered high risk for cardiovascular disease, the announcement likely made some people in the medical community cringe.

Crestor, along with Pfizer's (PFE) Lipitor and Merck's (MRK) Zocor, belongs to a class of drugs called statins often prescribed to people with high levels of LDL cholesterol, the so-called "bad cholesterol." A high level of LDL is a known cardiovascular risk factor. These medicines generated $33.8 billion in 2008 global sales, according to IMS Health, a health care research firm.

In February, the U.S. Food and Drug Administration approved Crestor for use in people with normal cholesterol to prevent major cardiovascular events. Now, the E.U. has followed suit. The new indication for the drug, whose generic name is rosuvastatin, is only for people deemed to be at high risk of cardiovascular events. Its approval was granted based on a trial called Jupiter.

But not everybody agrees taking Crestor as a preventive measure is such a good idea. First, there are questions about the results from the Jupiter study -- a long-term trial of 17,802 patients designed to determine if the drug decreased the risk of cardiovascular events in patients with low to normal cholesterol.

Data Suggests Crestor May Not Help New Class of Patients

While results from the trial showed Crestor significantly reduced the relative risk of cardiovascular events by an average of 44%, "The Jupiter study had several significant weaknesses in design," Dr. Gordon Guyatt of McMaster University in Ontario, Canada, pointed out in an interview with The Health Care Channel. Results were skewed, Guyatt said, and in his analysis of the unpublished data, he determined there was actually no reduction in deaths caused by the heart-related events.

Then there are the drug's side effects, not the least among them being an increased risk of diabetes, which the FDA cautioned against when it approved Crestor. MedPage Today added that there were other risks associated with Crestor, including 13 deaths due to gastrointestinal disorders. And Dr. Mark A. Hlatky of Stanford University in California told HealthDay that in addition to diabetes, he's concerned about another side effect: myalgia, i.e., severe muscle pain. He added that he's worried that the FDA approval will lead more people to rely on a pill rather than diet and exercise to cut their heart disease risks.

AstraZeneca has yet to respond to DailyFinance's inquiries regarding the criticisms. But regardless of its critics, AstraZeneca has won the sought-after approvals for Crestor. "This new indication is a significant milestone and means that rosuvastatin can now be prescribed to high-risk patients to prevent CV [cardiovascular] events including heart attacks and strokes," a company executive said.

Crestor sales in 2009 amounted to $4.5 billion. The FDA had previously said that up to 6.5 million Americans meet the new criteria for the drug; it is unclear how many Europeans do. At $4 a day, this new market can be expected to give a significant boost to Crestor sales at a time when some analysts are concerned about the looming loss of patent protection for the rival drug Lipitor in 2011. Generic Zocor (simvastatin) is available for for $4 a month.

Meanwhile, AstraZeneca has confirmed a New York Times report, saying it has finalized a previously announced agreement relating to the company's past marketing and promotion of its atypical antipsychotic Seroquel. AstraZeneca will pay a previously disclosed $520 million that was taken as a reserve in 2009, but under the terms of the agreement, the company denies the allegations that it illegally marketed the drug.