Late Breaking Clinical Trials session: Intensive Lipid Lowering with Atorvastatin in Patients with Diabetes and Stable Coronary Disease

In patients with diabetes and stable coronary heart disease, lowering cholesterol level to well below the recommended level with atorvastatin significantly decreased incidence of myocardial infarctions and stroke compared with lowering cholesterol to recommended levels, according to a presentation at the annual meeting of the American Diabetes Association.

The findings come from a post-hoc analysis that involved 1,500 people with heart disease and diabetes and a low-density lipoprotein (LDL) cholesterol level of <130 mg/dL who were enrolled in the five-year Treating to New Targets Trial (TNT).

In the analysis, patients who received atorvastatin 80 mg experienced 25 percent fewer cardiovascular events, including coronary-related death, non-fatal myocardial infarction, resuscitated cardiac arrest, and fatal or non-fatal strokes, compared with patients who took atorvastatin 10 mg. By the end of the study, LDL cholesterol levels were significantly lower in the 80 mg group (~77 mg/dL) than in the 10-mg group (99 mg/dL).

"These data are the first to demonstrate the cardiovascular benefits of lowering LDL beyond recommended guidelines with atorvastatin 80 mg in this high-risk diabetic population. Moreover, patients achieved these results without additional muscle risks," said James Shepherd, MD, Clinical Academic Consultant Department of Pathological Biochemistry, University of Glasgow Medical School, Glasgow, UK.

The main TNT study and the post-hoc analysis of patients with diabetes demonstrated that the musculoskeletal safety profile of atorvastatin 80 mg was comparable to that of atorvastatin 10 mg, and the incidence of repeat liver enzyme elevations in both groups was within product labeling. TNT is the longest study to date of atorvastatin 80 mg efficacy and safety.

"The results seen with 80 mg of atorvastatin in the TNT post-hoc analysis are even more impressive because, unlike in placebo-controlled trials, the reductions are beyond those already seen in the active treatment arm of this study with 10 mg of atorvastatin," said Gregg Larson, PhD, vice president, Pfizer Medical.

TNT was an investigator-led trial coordinated by an independent steering committee and funded by Pfizer. The study enrolled men and women between 35 and 75 years of age in 14 countries. The TNT study is part of the Atorvastatin Landmark Program, an extensive clinical trial program with more than 400 ongoing and competed trials involving more than 80,000 patients.