Lipitor's Safety Again Confirmed In Extensive Analysis Of 49 Clinical Trials, Pfizer Inc. Says
NEW YORK, Jan. 17 /PRNewswire-FirstCall/ -- Results of a recent analysis of 49 Lipitor clinical trials involving more than 14,000 patients showed that the overall rates of treatment-related adverse events reported by patients taking the highest dose of Lipitor were low and similar to those reported by patients who received placebo or the lowest dose of Lipitor. The analysis is published in the current edition of the American Journal of Cardiology.
"As more and more evidence has become available on the significant risks of high cholesterol, physicians are now being advised to aggressively lower their patients' cholesterol levels so that they get to their goal," said Dr. Gregg Larson, Pfizer vice president of U.S. cardiovascular medical. "The cost of not getting to goal, both human and financial, can be very high. That's why this information is important and timely: it demonstrates to physicians that they can continue to feel confident in intensively treating their patients' cholesterol even with higher doses of Lipitor, as part of the drive to that all-important goal. As a result, patients get the benefit of even more reduction in their cardiovascular risk -- safely."
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 men and women in the analysis was 59 -- with the oldest patients over 90 years of age. The patients had varying degrees of cardiovascular risk.
Results include: * Lipitor was well-tolerated, with the most common adverse events related to the digestive system. * There was no direct relationship observed between the dose of Lipitor and the frequency of muscle adverse events. * The incidence of myalgia (muscle weakness or pain) was low and similar in patients taking Lipitor 10mg and 80mg doses. * Myopathy (muscle weakness or pain combined with a 10-fold increase in muscle enzymes and more severe than myalgia) was rare and unlikely to be dose related in Lipitor patients. * There were no reported cases of rhabdomyolysis (a rare form of skeletal muscle breakdown) in patients taking Lipitor. In Lipitor-treated patients, 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 Lipitor.
As in all Pfizer-sponsored clinical trials, adverse events were recorded by the investigators on the basis of symptoms reported by the patient, physical examination findings and abnormal results of any laboratory tests. The adverse events were recorded during the treatment phase and up to 30 days after trial discontinuation.
Since 2004, the Lipitor 80mg dose has also been studied in the Treating to New Targets Trial (TNT) and the Incremental Decrease in End Points through Aggressive Lipid Lowering (IDEAL) clinical trials which have completed and published.
Since the introduction of Lipitor nearly nine years ago, its safety and effectiveness have been supported through an extensive clinical trial program, the Atorvastatin Landmark Program, with more than 400 ongoing and completed trials involving more than 80,000 patients. Lipitor is the most-prescribed cholesterol-lowering therapy in the world with more than 109 million patient years of experience.
"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. Larson.
About Lipitor
Lipitor(R) (atorvastatin calcium) is a prescription drug. It is used in patients with multiple risk factors for heart disease such as family history, high blood pressure, low HDL cholesterol or smoking, to reduce the risk of heart attack or stroke and, along with a low-fat diet, to lower cholesterol.
Lipitor is used in patients with type 2 diabetes and one other risk factor such as high blood pressure, smoking, or other complications of diabetes, including eye disease and protein in urine, to reduce the risk of stroke and heart attack. Lipitor is not for everyone. It is not for those with liver problems. And it is not for women who are nursing, pregnant, or may become pregnant
If you take Lipitor, tell your doctor if you feel any unusual muscle pain or weakness. This could be a sign of serious muscle side effects. Tell your doctor about all medicines you take. This may help avoid serious drug interactions. Your doctor should do blood tests to check your liver function before and during drug treatment and may adjust your dose. The most common side effects are gas, constipation, stomach pain, and heartburn. They tend to be mild and often go away.
For additional important information about Lipitor, visit http://www.lipitor.com or 1-888-LIPITOR.
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