Pfizer Canada Inc. announced that Health Canada has approved the cholesterol-lowering therapy Lipitor(R) (atorvastatin calcium) to reduce the risk of myocardial infarction in patients with clinically evident coronary heart disease.
The approval is based on the wealth of evidence available to date and further reinforces the previous indication for reduction of cardiovascular events, such as myocardial infarction and stroke, in patients without clinically evident coronary heart disease (CHD), but with risk factors for CHD.
This new approval expands the use of Lipitor to patients at risk for cardiovascular events because of established heart disease such as a prior heart attack. “Lipitor is the world’s most extensively studied cholesterol-lowering medication, and is supported by a large clinical trial program that includes more than 10 cardiovascular outcomes trials with more than 50,000 patients across a broad spectrum of risk,” said Dr. Bernard Prigent, Vice President and Medical Director, Pfizer Canada Inc. “Lipitor is the only statin that offers a unique combination of proven significant cardiovascular event reductions, impressive average LDL lowering of 39 per cent to 60 per cent, and a well-established safety profile.”
For example, in a recent five-year trial involving 10,000 patients with both heart disease and elevated LDL levels, patients taking Lipitor 80 mg had a significant 22 per cent reduction in the risk of major cardiovascular events over and above patients taking Lipitor 10 mg. In addition, patients treated with Lipitor 80 mg had a significant 22 per cent reduction in the risk of heart attack. There were more serious adverse events and discontinuations due to adverse events with Lipitor 80 mg compared with Lipitor 10 mg. However, there was no difference in the overall frequency of treatment-related adverse events.
Lipitor is the most prescribed cholesterol-lowering therapy in the world, with nearly 139 million patient-years of experience. Lipitor is supported by an extensive clinical trial program involving more than 400 ongoing and completed trials with more than 80,000 patients.