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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.
J Cardiovasc Pharmacol. 2009 Nov; 54(5):427-36.JC

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) > 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.

Authors+Show Affiliations

Department of Medicine, University of Alabama at Birmingham School of Medicine, 35294-0007, USA. soparil@uab.eduNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19730391

Citation

Oparil, Suzanne, et al. "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." Journal of Cardiovascular Pharmacology, vol. 54, no. 5, 2009, pp. 427-36.
Oparil S, Lee J, Karki S, et al. 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. J Cardiovasc Pharmacol. 2009;54(5):427-36.
Oparil, S., Lee, J., Karki, S., & Melino, M. (2009). 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. Journal of Cardiovascular Pharmacology, 54(5), 427-36. https://doi.org/10.1097/FJC.0b013e3181bad74e
Oparil S, et al. 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. J Cardiovasc Pharmacol. 2009;54(5):427-36. PubMed PMID: 19730391.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Oparil,Suzanne, AU - Lee,James, AU - Karki,Sulekha, AU - Melino,Michael, PY - 2009/9/5/entrez PY - 2009/9/5/pubmed PY - 2010/4/10/medline SP - 427 EP - 36 JF - Journal of cardiovascular pharmacology JO - J Cardiovasc Pharmacol VL - 54 IS - 5 N2 - 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. SN - 1533-4023 UR - https://www.unboundmedicine.com/medline/citation/19730391/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_ L2 - https://doi.org/10.1097/FJC.0b013e3181bad74e DB - PRIME DP - Unbound Medicine ER -