J Clin Pharmacol
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CLINICAL TRIALS

A Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacodynamic Interaction of Coadministered Amlodipine and Atorvastatin in 1660 Patients With Concomitant Hypertension and Dyslipidemia: The Respond Trial

Richard A. Preston, MD, Peter Harvey, MRCGP, Ottmar Herfert, MD, Gary Dykstra, DO, J. Wouter Jukema, MD, Franklin Sun, MPhil, MS and David Gillen, MD

From the Division of Clinical Pharmacology Clinical Research Center, Department of Medicine, Miller School of Medicine, University of Miami, Florida (Dr Preston); Crouch Oak Family Practice, Addlestone, Surrey, UK (Dr Harvey); General Practice, Linzer Strasse 4, 70469, Stuttgart, Germany (Dr Herfert); Bluestem Cardiology, Bartlesville, Oklahoma (Dr Dykstra); Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands (Dr Jukema); and Pfizer Inc, New York (Mr Sun, Dr Gillen).

Guidelines stress the importance of the simultaneous management of multiple cardiovascular risk factors. This can in part be achieved by coadministration of lipid-lowering and antihypertensive treatments. Potential pharmacodynamic interaction between drugs should be investigated as part of developing single-pill combinations. The Respond trial assessed whether combining amlodipine to treat hypertension and atorvastatin to treat dyslipidemia affected the action of either monotherapy. A total of 1660 hypertensive patients with dyslipidemia received 1 of 15 combinations of amlodipine (placebo, 5, or 10 mg) and atorvastatin (placebo, 10, 20, 40, or 80 mg) in a 3 x 5 factorial randomized, placebo-controlled design. At 8 weeks, combination-treated patients experienced dose-related and statistically significant reductions in systolic blood pressure, low-density lipoprotein cholesterol, and Framingham risk score. Overall, coadministered atorvastatin and amlodipine was well tolerated and without adverse pharmacodynamic interaction; combination treatment did not affect the low-density lipoprotein cholesterol-lowering efficacy and safety of atorvastatin, or the systolic blood pressure-lowering efficacy and safety of amlodipine.

Key Words: Amlodipine • atorvastatin • Framingham coronary heart disease estimated risk • drug interaction

Address for correspondence: Richard A. Preston, MD, Professor of Clinical Medicine, Director, Division of Clinical Pharmacology Clinical Research Center, Department of Medicine, Miller School of Medicine, University of Miami, 1500 NW 12th Avenue, 15th Floor West Tower, Miami, FL 33136; e-mail: rpreston{at}med.miami.edu.






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