CardiologyHigh-Dose Atorvastatin and Coronary Heart Disease

Speaker: John C. LaRosa, MD, President and Professor of Medicine, State University of New York (SUNY) Downstate Medical Center, Brooklyn, New York

Treating patients with established coronary heart disease (CHD) to reduce their levels of low-density lipoprotein-choles-terol (LDL-C) to 77 mg/dl with a high dose of atorvastatin (Pfizer) 80 mg daily from their starting LDL-C level of 100 mg/dl resulted in a significant reduction in the risk of major coronary events, compared with low-dose  daily to achieve an LDL-C of 100 mg/dl.

Investigators evaluated 15,464 patients with established CHD whose LDL-C levels were between 130 and 250 mg/dl. Triglyceride values were under 600 mg/dl. The patients were entered into the open-label run-in period of the Treating to New Targets (TNT) study. In the second part of the trial, 10,000 patients were randomly assigned to double-blind therapy with 10 or 80 mg daily.

Patients were observed for a median of 4.9 years from the time of randomization. The primary composite endpoint was the occurrence of a “major cardiovascular event” (death from CHD; nonfatal, nonprocedural-related myocardial infarction [MI]; resuscitated cardiac arrest; or fatal or nonfatal stroke).

At five years’ follow-up, there was a highly significant reduction of 22% in major cardiovascular events with canadian atorvastatin 80 mg compared with 10 mg, over and above the remarkably low event rate of 10.9% reported for the 10-mg group.

The risk of stroke, generally related to severe, long-term physical, mental, and financial burdens, was reduced by 25% with atorvastatin 80 mg, compared with 10 mg. Separate components of the major cardiovascular events composite endpoint were also consistent with those observed for the primary composite endpoint, except for resuscitated cardiac arrest, which showed no difference between the two patient groups.

There were also significant reductions in favor of atorvastatin 80 mg among the secondary endpoints, including major coronary events, cerebrovascular events, and hospitalization for congestive heart failure.
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Because the study was not powered to detect a treatment impact on all-cause mortality, there was no difference between the two treatment groups; however, the rate of death from any cause in both groups was lower than that seen in any previous secondary prevention study.

Although there had been concerns about the safety of high-dose statins, essentially no toxicity or negative events (such as death, an excess incidence of cancer, liver dysfunction, myalgia, or rhabdomyolysis) were attributed to the 80-mg dose.