Effects of an Inhibitor of Cholesteryl Ester Transfer Protein on HDL Cholesterol

doi:10.1056/NEJMoa031766

Volume 350:1505-1515		April 8, 2004		Number 15

Effects of an Inhibitor of Cholesteryl Ester Transfer Protein on HDL Cholesterol

Margaret E. Brousseau, Ph.D., Ernst J. Schaefer, M.D., Megan L. Wolfe, B.S., LeAnne T. Bloedon, M.S., R.D., Andres G. Digenio, M.D., Ph.D., Ronald W. Clark, M.S., James P. Mancuso, Ph.D., and Daniel J. Rader, M.D.

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by Brewer, H. B.

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ABSTRACT

Background Decreased high-density lipoprotein (HDL) cholesterollevels constitute a major risk factor for coronary heart disease;however, there are no therapies that substantially raise HDLcholesterol levels. Inhibition of cholesteryl ester transferprotein (CETP) has been proposed as a strategy to raise HDLcholesterol levels.

Methods We conducted a single-blind, placebo-controlled studyto examine the effects of torcetrapib, a potent inhibitor ofCETP, on plasma lipoprotein levels in 19 subjects with low levelsof HDL cholesterol (<40 mg per deciliter [1.0 mmol per liter]),9 of whom were also treated with 20 mg of atorvastatin daily.All the subjects received placebo for four weeks and then received120 mg of torcetrapib daily for the following four weeks. Sixof the subjects who did not receive atorvastatin also participatedin a third phase, in which they received 120 mg of torcetrapibtwice daily for four weeks.

Results Treatment with 120 mg of torcetrapib daily increasedplasma concentrations of HDL cholesterol by 61 percent (P<0.001)and 46 percent (P=0.001) in the atorvastatin and non-atorvastatincohorts, respectively, and treatment with 120 mg twice dailyincreased HDL cholesterol by 106 percent (P<0.001). Torcetrapibalso reduced low-density lipoprotein (LDL) cholesterol levelsby 17 percent in the atorvastatin cohort (P=0.02). Finally,torcetrapib significantly altered the distribution of cholesterolamong HDL and LDL subclasses, resulting in increases in themean particle size of HDL and LDL in each cohort.

Conclusions In subjects with low HDL cholesterol levels, CETPinhibition with torcetrapib markedly increased HDL cholesterollevels and also decreased LDL cholesterol levels, both whenadministered as monotherapy and when administered in combinationwith a statin.

Source Information

From the Lipid Research Laboratory, Division of Endocrinology, Metabolism, Diabetes, and Molecular Medicine, New England Medical Center and Tufts University School of Medicine, Boston (M.E.B., E.J.S.); the Department of Medicine and Center for Experimental Therapeutics, University of Pennsylvania School of Medicine, Philadelphia (M.L.W., L.T.B., D.J.R.); and the Departments of Cardiovascular and Metabolic Diseases (A.G.D., R.W.C.) and Clinical Biostatistics (J.P.M.), Pfizer, Groton, Conn.

Address reprint requests to Dr. Brousseau at the Lipid Research Laboratory, Division of Endocrinology, Metabolism, Diabetes, and Molecular Medicine, New England Medical Center, 750 Washington St., Box 216, Boston, MA 02111, or at margaret.brousseau{at}tufts.edu, or to Dr. Rader at the Department of Medicine and Center for Experimental Therapeutics, University of Pennsylvania School of Medicine, Philadelphia, PA 19104 or at rader{at}mail.med.upenn.edu.

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