NEW YORK (Reuters Health) May 26 - Treating diabetics who have clinical signs of coronary heart disease with a high dose of atorvastatin (80 mg daily), rather than the normal dose of 10 mg daily, can lower the rate of major cardiovascular events by 25%, according to a report in the June issue of Diabetes Care.
In the main analysis of data from the Treating to New Targets (TNT) study, increasing the atorvastatin dose was shown to provide significant clinical benefits for patients with stable coronary heart disease. The focus of this subanalysis, conducted by Dr. James Shepherd of the University of Glasgow and colleagues, was to determine if this benefit applied to patients with heart disease and diabetes as well.
The study involved 1501 patients with baseline LDL-C levels of less than 130 mg/dL who were randomized to atorvastatin at a dose of 10 or 80 mg per day and followed for a median of 4.9 years. The primary endpoint was the time to a first major cardiovascular event, including death from heart disease, non-fatal MI, resuscitated cardiac arrest or stroke.
The final LDL-C levels reached in the 10- and 80-mg atorvastatin groups were 98.6 and 77.0 mg/dL, respectively.
The primary event rate in the higher dose atorvastatin group was 13.8%, significantly lower than the 17.9% rate noted in the lower dose group (p = 0.026). In addition, the higher dose was also linked to a delay in the occurrence of cerebrovascular events and any cardiovascular event.
Side effects were similar in both groups and no persistent elevations in liver enzymes were noted, the report indicates.
"Pending a definitive trial, these data suggest that the use of high-dose statin to achieve an LDL cholesterol level considerably lower than 100 mg/dL may be appropriate for patients with diabetes and coronary heart disease, irrespective of their initial LDL cholesterol level, age, duration of diabetes, or glycemic control," the authors conclude.
Diabetes Care 2006.