Pfizer has reported promising data which shows that its cholesterol-lowering blockbuster Lipitor reduced the risk of stroke and coronary heart events in type 2 diabetes patients who had already experienced a recent stroke or mini-stroke, compared with placebo.
The results from a new analysis of 794 patients on the SPARCL trial, presented at the American Diabetes Association meeting in Chicago, showed that Lipitor (atorvastatin) 80mg reduced the risk of stroke by 30%, and coronary heart disease and major coronary events by 51%, compared with placebo. An additional analysis evaluated 781 patients who were classified as having metabolic syndrome and who had a recent stroke or mini-stroke but no known coronary heart disease. In these patients, Lipitor significantly reduced the risk of coronary heart disease events by 43% compared with those taking placebo and while the risk of stroke was reduced by 12% and major coronary events by 26%, these results were not statistically significant.
Pfizer noted that according to the National Institute of Diabetes and Digestive and Kidney Diseases, the risk for stroke is two to four times higher among people with diabetes, and heart disease and stroke account for nearly two-thirds of deaths in people with the disease.
Exubera lung side effects are temporary
The Lipitor data followed presentations by Pfizer at the ADA on its inhaled insulin drug Exubera. The company reported results from three-year interim analyses of two ongoing long-term clinical trials which showed that small mean declines in lung function in diabetes patients who took Exubera reversed when the drug was discontinued. Upon re-initiation of Exubera, lung function changes similar to first time users of the treatment were observed.
The studies also showed that patients on an Exubera regimen maintained blood sugar control and generally gained less weight over the three-year period than those on an injected insulin regimen. Lung problems have been cited as one of the main reasons why Exubera has had a slow start despite having been approved by the US Food and Drug Administration in early 2006 and Pfizer has recently stepped up its marketing efforts.