Subgroup 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 Use

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) > or =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, > or =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 > or =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.