TRENTON, N.J. (AP) – A reanalysis of research data found a high dose of popular cholesterol pill Lipitor lowers risk of heart attack and stroke in some patients with both heart disease and kidney disease, the drug’s maker said.
Pfizer Inc. said the new analysis, which it funded, included patients with both those diseases who also were either obese or had metabolic syndrome. That’s a group of related heart risk factors including obesity, diabetes and high blood pressure. Lipitor is not approved to treat those conditions.
Compared with patients getting the starter dose of 10 milligrams of Lipitor, those getting 80 milligrams of Lipitor had one-third the risk of cardiovascular complications. Those include death from heart disease or surviving a heart attack, stroke or cardiac arrest.
The findings were presented at the annual meeting of the American College of Cardiology in Atlanta.
They came from a subanalysis of data from an earlier trial called Treating to New Targets, or TNT, which included 10,001 men and women with heart disease who were followed for five years on average. Those results were published in 2005.
The most common side effects noted were muscle pain and elevated liver enzymes, which can be a sign of the onset of liver damage or another serious condition.
In the 80 milligram group, 4.8 percent of patients reported muscle pain, about the same as the 4.7 percent in the low-dose group. Elevated liver enzymes were found more often in the high-dose Lipitor group, affecting 1.2 percent of study participants, compared with 0.2 percent of those getting 10 milligrams.
The new findings were based on one analysis of 1,859 of the TNT patients who had heart disease, kidney disease and metabolic syndrome and a separate analysis of 954 patients with heart disease, kidney disease and obesity.
Lipitor is the world’s top-selling drug, with revenue of nearly $13 billion last year. It loses patent protection at the end of November 2011, and Pfizer, the world’s biggest drugmaker, is trying to wring as much revenue out of the pill as possible before then.
About 26 million Americans have kidney disease. Many also have heart disease or other conditions that increase their risk of a heart attack or stroke.
Date: March 15, 2010
Source: Associated Press