Circulation. 2002;105:2159-2165
Published online before print April 15, 2002, doi: 10.1161/01.CIR.0000015857.31889.7B
Published online before print April 15, 2002, doi: 10.1161/01.CIR.0000015857.31889.7B
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(Circulation. 2002;105:2159.)
© 2002 American Heart Association, Inc.
Clinical Investigation and Reports |
Efficacy and Safety of a Novel Cholesteryl Ester Transfer Protein Inhibitor, JTT-705, in Humans
A Randomized Phase II Dose-Response Study
From the Department of Vascular Medicine (G.J.d.G., J.A.K., J.J.P.K.) and Department of Statistics (A.H.Z.), Academic Medical Center, University of Amsterdam; Department of General Internal Medicine, University Medical Center (A.F.H.S., J.d.G.), Nijmegen; Department of Cardiology, Martini Hospital (J.L.P.), Groningen; and Cardiovascular Research Institute COEUR Biochemistry, Erasmus University (A.v.T.), Rotterdam, the Netherlands.
Correspondence to Dr J.J.P. Kastelein, Department of Vascular Medicine G1-146, Academic Medical Center, PO Box 22700, 1100 DE Amsterdam, The Netherlands. E-mail e.vandongen{at}amc.uva.nl
Background— Cholesteryl ester transfer protein (CETP) mediates the transfer of neutral lipids between lipoproteins. High plasma levels of CETP are correlated with low HDL cholesterol levels, a strong risk factor for coronary artery disease. In earlier studies, JTT-705, a novel CETP inhibitor, was shown to increase plasma HDL cholesterol and to inhibit the progression of atherosclerosis in cholesterol-fed rabbits. This study describes the first results using this CETP inhibitor in humans.
Methods and Results— In a randomized, double-blind, and placebo-controlled trial, we evaluated the efficacy and safety of daily treatment with 300, 600, and 900 mg JTT-705 in 198 healthy subjects with mild hyperlipidemia. Treatment with 900 mg JTT-705 for 4 weeks led to a 37% decrease in CETP activity (P<0.0001), a 34% increase in HDL cholesterol (P<0.0001), and a 7% decrease in LDL cholesterol (P=0.017), whereas levels of triglycerides, phospholipid transfer protein, and lecithin-cholesterol acyltransferase were unaffected. In line with the increase of total HDL, a rise of HDL2, HDL3, and apolipoprotein A-I was also noted. JTT-705 showed no toxicity with regard to physical examination and routine laboratory tests.
Conclusions— We show that the use of the CETP inhibitor JTT-705 in humans is an effective means to raise HDL cholesterol levels with minor gastrointestinal side effects (P=0.06). Although these results hold promise, further studies are needed to investigate whether the observed increase in HDL cholesterol translates into a concomitant reduction in coronary artery disease risk.
Key Words: cholesterol • lipoproteins • atherosclerosis • cardiovascular diseases
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