The analysis, which included Lipitor clinical trials that were initiated and completed between 1992 and 2004, tracked the incidence of non-serious and serious muscle, liver and kidney adverse events and laboratory tests.
The analysis compared 7,258 patients who received Lipitor 10mg to 4,798 patients taking Lipitor 80mg and 2,180 patients taking placebo. The average age of participants was 59 and the oldest were over 90 years of age. Each had varying degrees of cardiovascular risk.
The results showed that the drug was well-tolerated, with the most common adverse events related to the digestive system, and there was no direct relationship observed between the dose of Lipitor and the frequency of muscle adverse events.
There were no reported cases of rhabdomyolysis, a rare form of skeletal muscle breakdown, in patients taking Lipitor, and the overall incidence of elevated liver enzymes was low. However, elevated liver enzymes were more frequently observed in patients taking 80mg doses of Lipitor compared to patients taking 10mg doses of the medicine.
“The knowledge that we have gained about cardiovascular disease as a result of this comprehensive clinical trial program has been instrumental in helping us better understand the benefits of the full dose range of Lipitor, which can help both physicians and patients chart the right course for cholesterol treatment,” said Dr Gregg Larson, Pfizer vice president of US cardiovascular medical.