The approval is based on evidence available to date and 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 only statin that offers a unique combination of proven significant cardiovascular event reductions, impressive average LDL lowering of 39% to 60%, and a well-established safety profile,” said Dr Bernard Prigent, vice president, Pfizer Canada.
In a recent trial involving 10,000 patients with both heart disease and elevated LDL levels, patients taking Lipitor 80mg had a significant 22% reduction in the risk of major cardiovascular events over and above patients taking Lipitor 10mg. In addition, patients treated with Lipitor 80mg had a significant 22% reduction in the risk of heart attack.