Pfizer Lipitor study has mixed results

Heart disease patients who took high doses of Pfizer Inc.‘s cholesterol-treatment Lipitor had fewer Heart Attack and Strokes, but the risk of death from other causes rose slightly, according to a study presented on Tuesday.

The Pfizer-funded study of 10,000 patients, presented at the American College of Cardiology in Orlando and published in The New England Journal of Medicine, found that lowering LDL or “bad” cholesterol beyond current guidelines improved heart health.

The study found that a high dose of Lipitor could reduce the chance of a Heart attack or Stroke by 22 percent.

Yet researchers pointed to one troubling finding - patients’ risk of dying from other causes increased slightly. As a result, the study failed to show an overall reduction in deaths.

In both groups, cancer was responsible for more than half the deaths unrelated to heart disease. There were 85 cancer fatalities in the high-dose group compared with 75 in the low-dose group.

But there seemed to be no single cause for the extra deaths.

“Although this increase in deaths from noncardiovascular causes could be due to chance, it is a matter of concern,” said Bertram Pitt of the University of Michigan School of Medicine in an editorial scheduled to be published along with the study in the April 7 New England Journal of Medicine.

John LaRosa, a cardiologist from the State University of New York and lead researcher of the study, downplayed the increased death rate from other causes, saying the numbers were too small to reach any conclusion.

“I think Lipitor is absolutely safe (in high doses),” he said.

The study found that, while a 10 milligram tablet brought the level of “bad” cholesterol close to the recommended level of 100 milligrams per deciliter of blood, a dose eight times greater lowered the LDL count to 77.

Previous research has suggested that the lower the count, the bigger the benefit.

Pfizer, which leads the cholesterol drug market, is aiming to expand sales of Lipitor, which had worldwide sales of $10.86 billion in 2004.

Overall, I think the results are somewhat positive for Pfizer, but the lack of reduction in overall mortality… does not make it a slam dunk for Pfizer,” said Cathay Financial analyst Sena Lund.

“Going forward, I don’t think the results will change the treatment pattern of physicians.”

Pfizer shares were down less than 1 percent at $27.01 in early afternoon trading on the New York Stock Exchange on Tuesday.

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Provided by ArmMed Media
Revision date: July 6, 2011
Last revised: by David A. Scott, M.D.