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ACC: Torcetrapib Does Not Add Benefit Over Statin Alone

Drug alters cholesterol levels but does not slow disease

MONDAY, March 26 (HealthDay News) -- Although torcetrapib reduces levels of low-density lipoprotein cholesterol and raises levels of high-density lipoprotein cholesterol, it does not slow the progression of coronary atherosclerosis more than atorvastatin alone, according to two reports published early online March 26 in the New England Journal of Medicine. The studies were presented at the American College of Cardiology's annual meeting in New Orleans.

Steven E. Nissen, M.D., of the Cleveland Clinic Foundation in Ohio, and colleagues studied 1,188 coronary disease patients who underwent intravascular ultrasonography and were all treated with atorvastatin to bring levels of low-density lipoprotein cholesterol down to less than 100 mg per deciliter. The patients were then randomized to receive either atorvastatin monotherapy or atorvastatin plus 60 mg of torcetrapib a day. After 24 months, 910 patients underwent ultrasound scanning again to ascertain progression of the disease.

Although the dual therapy favorably altered cholesterol levels, there was no impact on disease progression and the treatment was associated with a 4.6 mm Hg increase in mean systolic blood pressure.

In the second study, John J.P. Kastelein, M.D., Ph.D., of the University of Amsterdam, and colleagues found similar results in a trial of 850 patients with familial hypercholesterolemia.

"The lack of efficacy may be related to the mechanism of action of this drug or to molecule-specific adverse effects," Nissen and colleagues conclude. "Our findings demonstrate the great difficulty in developing therapies to interrupt the atherosclerotic disease process. Twenty years after the introduction of statins, we are still waiting for the next breakthrough."

The studies were supported by Pfizer.

Abstract - Nissen
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Abstract - Kastelein
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