Pfizer Inc. on Tuesday said a review of 49 clinical trials showed the highest dose of cholesterol fighter Lipitor was as safe as a placebo and the lowest dose of the top selling medicine in avoiding side effects, including potentially fatal muscle breakdown.
Pfizer said the findings from trials involving heart patients should bolster confidence among patients and doctors about the safety of the highest 80-milligram dose of Lipitor, which is best able to drive down levels of artery-clogging “bad” LDL cholesterol.
The New York-based drugmaker said the trials were completed between 1992 and 2004 and involved more than 14,000 men and women whose average age was 59. It said they showed no direct relationship between the dose of Lipitor and the frequency of side effects - including harm to muscles.
Muscle side effects, especially a form of potentially fatal muscle breakdown called rhabdomyolysis, are the most worrisome side effect of the “statin” class of cholesterol drugs that includes Lipitor.
Concerns about the possibility of such muscle side effects have mounted since German drugmaker Bayer AG in 2001 withdrew its Baycol statin after it was linked to a number of deaths, including from rhabdomyolysis. Baycol has now been linked to more than 100 deaths and Bayer has agreed to pay out over $1.1 billion in settlements over the drug.
Pfizer said its review of past Lipitor trials tracked the incidence of non-serious and serious muscle, liver and kidney adverse events.
The review compared 7,258 patients who received 10-milligram doses of Lipitor to 4,798 patients taking 80-milligram Lipitor and 2,180 patients taking placebos. The patients had varying levels of cardiovascular risk.
Revision date: June 14, 2011
Last revised: by Sebastian Scheller, MD, ScD