Original ArticleSubgroup Analyses of an Efficacy and Safety Study of Concomitant Administration of Amlodipine Besylate and Olmesartan Medoxomil: Evaluation by Baseline Hypertension Stage and Prior Antihypertensive Medication UseOparil, Suzanne MD, FACC*; Lee, James PhD†; Karki, Sulekha BAMS†; Melino, Michael PhD†Author Information From the *Vascular Biology and Hypertension Program, Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham School of Medicine, Birmingham, AL; and †Daiichi Sankyo, Inc, Parsippany, NJ. Received for publication February 24, 2009; accepted July 16, 2009. Funding Support Provided by: Daiichi Sankyo, Inc., Parsippany, NJ. Conflict of interest disclosure: S. Oparil, is the recipient of grants-in-aid from Daiichi Sankyo, Inc., Forest Laboratories, Gilead, Novartis, and Takeda. Dr. S. Oparil is also a consultant for Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Inc., Forest Laboratories, NicOx, Novartis, sanofi-aventis, and the Salt Institute and is a member of the Board of Directors for Encysive Pharmaceuticals. J. Lee, S. Karki, and M. Melino are all employees of Daiichi Sankyo, Inc. Reprints: Suzanne Oparil, MD, FACC, Professor of Medicine, Physiology, and Biophysics, Vascular Biology and Hypertension Program, Division of Cardiovascular Diseases, University of Alabama at Birmingham, 703 19th Street South, ZRB 1034, Birmingham, AL 35294-0007 (e-mail: email@example.com). Journal of Cardiovascular Pharmacology: November 2009 - Volume 54 - Issue 5 - p 427-436 doi: 10.1097/FJC.0b013e3181bad74e Buy Metrics Abstract This report includes a prespecified secondary analysis of the COACH study (Combination of Olmesartan medoxomil and Amlodipine besylate in Controlling High blood pressure) based on baseline hypertension severity and prior antihypertensive medication use and a post hoc efficacy analysis of the subset of patients with baseline mean seated systolic blood pressure (SeSBP) ≥180 mm Hg. The efficacy and safety of placebo, amlodipine (5 or 10 mg/d), olmesartan medoxomil (OM) (10, 20, or 40 mg/d), and all possible combinations of the drugs (12 treatment arms in total) were evaluated for 8 weeks. Primary end point was seated diastolic blood pressure (SeDBP) decrease at study end. Secondary end points included decrease in SeSBP and proportion of patients achieving blood pressure (BP) goal and prespecified BP targets. In each subgroup, ≥1 dosage combination of amlodipine + OM significantly reduced SeDBP and SeSBP compared with constituent monotherapies. Combinations produced the greatest mean BP reductions in patients with baseline SeSBP ≥180 mm Hg. More patients with stage 1 than stage 2 hypertension achieved BP goal. Prior antihypertensive medication use did not seem to affect efficacy. Subgroup categorization did not affect safety. After 8 weeks of treatment, the combination of amlodipine + OM is safe and efficacious, irrespective of baseline hypertension stage or prior antihypertensive medication use. © 2009 Lippincott Williams & Wilkins, Inc.