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Amlodipine/valsartan/hydrochlorothiazide triple combination therapy in moderate/severe hypertension: Secondary analyses evaluating efficacy and safety.
Adv Ther. 2009 Nov; 26(11):1012-23.AT

Abstract

INTRODUCTION

An 8-week trial of amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCTZ) for moderate or severe hypertension demonstrated more-pronounced blood pressure (BP)-lowering effects compared with dual-component therapies. To elucidate the effects of time and baseline BP on the observed responses, exploratory analyses were performed.

METHODS

Patients aged 18-85 years with mean sitting systolic BP (MSSBP) 145 to <200 mmHg and mean sitting diastolic BP (MSDBP) 100 to <120 mmHg were randomized to Aml 10 mg/Val 320 mg/HCTZ 25 mg; Val 320 mg/HCTZ 25 mg; Aml 10 mg/Val 320 mg; or Aml 10 mg/HCTZ 25 mg. During the first 2 weeks, regimens were force-titrated in two stages.

RESULTS

All least-square mean reductions in MSSBP and MSDBP (baseline to Week 3 and end of study) were significantly greater with triple therapy than with each dual therapy in the overall population and the severe systolic subgroup (baseline MSSBP > or =180 mmHg; except vs. Aml 10 mg/Val 320 mg at Week 3). At Week 3, more patients on triple therapy achieved MSSBP reductions of > or =-60, > or =-50, > or =-40, > or =-30, and > or =-20 mmHg (2.5%, 9.7%, 23.2%, 46.9% and 74.5%, respectively) than those on dual therapy (1.1%-2%, 5.6%-5.9%, 14.5%-16.7%, 33.5%-39.1%, and 58.8%-65.5%, respectively); this was also true at study endpoint. End-of-study MSSBP reductions were greater in triple-therapy recipients who had higher (vs. lower) baseline MSSBPs. LSM reductions ranged from -27.2 mmHg for baseline MSSBP 145 to <150 mmHg, to > or =49.6 mmHg for baseline MSSBP > or =180 mmHg. All treatments were well tolerated regardless of baseline MSSBP.

CONCLUSION

Aml 10 mg/Val 320 mg/HCTZ 25 mg triple therapy is highly effective in reducing BP compared with dual components early in therapy, and systolic BP-lowering effects were proportionate to hypertension severity.

Authors+Show Affiliations

University of Alabama at Birmingham, Sleep/Wake Disorders Center, 35294, USA. dcalhoun@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

20024680

Citation

Calhoun, David A., et al. "Amlodipine/valsartan/hydrochlorothiazide Triple Combination Therapy in Moderate/severe Hypertension: Secondary Analyses Evaluating Efficacy and Safety." Advances in Therapy, vol. 26, no. 11, 2009, pp. 1012-23.
Calhoun DA, Crikelair NA, Yen J, et al. Amlodipine/valsartan/hydrochlorothiazide triple combination therapy in moderate/severe hypertension: Secondary analyses evaluating efficacy and safety. Adv Ther. 2009;26(11):1012-23.
Calhoun, D. A., Crikelair, N. A., Yen, J., & Glazer, R. D. (2009). Amlodipine/valsartan/hydrochlorothiazide triple combination therapy in moderate/severe hypertension: Secondary analyses evaluating efficacy and safety. Advances in Therapy, 26(11), 1012-23. https://doi.org/10.1007/s12325-009-0077-7
Calhoun DA, et al. Amlodipine/valsartan/hydrochlorothiazide Triple Combination Therapy in Moderate/severe Hypertension: Secondary Analyses Evaluating Efficacy and Safety. Adv Ther. 2009;26(11):1012-23. PubMed PMID: 20024680.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Amlodipine/valsartan/hydrochlorothiazide triple combination therapy in moderate/severe hypertension: Secondary analyses evaluating efficacy and safety. AU - Calhoun,David A, AU - Crikelair,Nora A, AU - Yen,Joseph, AU - Glazer,Robert D, Y1 - 2009/12/18/ PY - 2009/11/10/received PY - 2009/12/22/entrez PY - 2009/12/22/pubmed PY - 2010/3/24/medline SP - 1012 EP - 23 JF - Advances in therapy JO - Adv Ther VL - 26 IS - 11 N2 - INTRODUCTION: An 8-week trial of amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCTZ) for moderate or severe hypertension demonstrated more-pronounced blood pressure (BP)-lowering effects compared with dual-component therapies. To elucidate the effects of time and baseline BP on the observed responses, exploratory analyses were performed. METHODS: Patients aged 18-85 years with mean sitting systolic BP (MSSBP) 145 to <200 mmHg and mean sitting diastolic BP (MSDBP) 100 to <120 mmHg were randomized to Aml 10 mg/Val 320 mg/HCTZ 25 mg; Val 320 mg/HCTZ 25 mg; Aml 10 mg/Val 320 mg; or Aml 10 mg/HCTZ 25 mg. During the first 2 weeks, regimens were force-titrated in two stages. RESULTS: All least-square mean reductions in MSSBP and MSDBP (baseline to Week 3 and end of study) were significantly greater with triple therapy than with each dual therapy in the overall population and the severe systolic subgroup (baseline MSSBP > or =180 mmHg; except vs. Aml 10 mg/Val 320 mg at Week 3). At Week 3, more patients on triple therapy achieved MSSBP reductions of > or =-60, > or =-50, > or =-40, > or =-30, and > or =-20 mmHg (2.5%, 9.7%, 23.2%, 46.9% and 74.5%, respectively) than those on dual therapy (1.1%-2%, 5.6%-5.9%, 14.5%-16.7%, 33.5%-39.1%, and 58.8%-65.5%, respectively); this was also true at study endpoint. End-of-study MSSBP reductions were greater in triple-therapy recipients who had higher (vs. lower) baseline MSSBPs. LSM reductions ranged from -27.2 mmHg for baseline MSSBP 145 to <150 mmHg, to > or =49.6 mmHg for baseline MSSBP > or =180 mmHg. All treatments were well tolerated regardless of baseline MSSBP. CONCLUSION: Aml 10 mg/Val 320 mg/HCTZ 25 mg triple therapy is highly effective in reducing BP compared with dual components early in therapy, and systolic BP-lowering effects were proportionate to hypertension severity. SN - 1865-8652 UR - https://www.unboundmedicine.com/medline/citation/20024680/Amlodipine/valsartan/hydrochlorothiazide_triple_combination_therapy_in_moderate/severe_hypertension:_Secondary_analyses_evaluating_efficacy_and_safety_ L2 - https://dx.doi.org/10.1007/s12325-009-0077-7 DB - PRIME DP - Unbound Medicine ER -