Lipitor Reduces Heart Attacks and Strokes by 25% for Diabetes Patients

Patients with diabetes and coronary heart disease (CHD) on Lipitor who lowered their cholesterol to well below currently recommended levels experienced significantly fewer heart attacks and strokes than those who achieved recommended levels. These findings are from a subgroup analysis of the 5-year TNT study, involving 1,500 people with diabetes and CHD with an LDL-Cholesterol level of <3.34 mmol/L randomized to treatment with either 10mg/day or 80 mg/day of Lipitor.2 Mean LDL-C levels at 3 months were lower in the 80 mg group (1.86 mmol/L) compared to the 10 mg group (2.54 mmol/L).1

Those patients who received atorvastatin 80 mg also experienced 25 percent fewer major cardiovascular events (CHD death, non-fatal heart attacks, resuscitated cardiac arrest, and fatal or non-fatal strokes).1 Furthermore, event rates in both the Lipitor 10 mg and Lipitor 80 mg arms were lower than in other secondary prevention trials. 2

“These data are the first to demonstrate the CV benefits of lowering LDL-C 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.

TNT was an investigator-led trial coordinated by an independent steering committee and was funded by Pfizer. The study enrolled men and women between 35 and 75 years of age in 14 countries.4

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.

In this subgroup analysis, the musculoskeletal safety profile of atorvastatin 80 mg was comparable to atorvastatin 10 mg, and the incidence of repeat liver enzyme elevations was 0.4 percent in the 10 mg group and 0.8 percent in the 80 mg group.1 TNT and the diabetes subgroup analysis build upon the well-established safety profile of Lipitor. TNT is the longest study to date evaluating the safety and efficacy of atorvastatin 80 mg.

Atorvastatin is currently not licensed for the prevention of coronary or cardiovascular events.

Shepherd J, LaRosa JC, Waters DD. Intensive lipid-lowering with atorvastatin in patients with diabetes and stable coronary disease. Abstract 2005.

2. LaRosa JC, Grundy, SM, Waters DD. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med; 2005; 352:1425-1435
Presented at the ADA 65th Scientific Sessions