Amlodipine/valsartan/hydrochlorothiazide triple combination therapy in moderate/severe hypertension: Secondary analyses evaluating efficacy and safety.

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: David A Calhoun, Nora A Crikelair, Joseph Yen, Robert D Glazer
• Journal: Advances in therapy (Adv Ther) Vol. 26 Issue 11 Pg. 1012-23 (Nov 2009) ISSN: 1865-8652 [Electronic] United States
• PMID: 20024680 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antihypertensive Agents
• Drug Combinations
• Tetrazoles
• Hydrochlorothiazide
• Amlodipine
• Valsartan
• Valine

Topics

• Adolescent
• Adult
• Amlodipine (administration & dosage, adverse effects, therapeutic use)
• Antihypertensive Agents (administration & dosage, adverse effects, therapeutic use)
• Blood Pressure (drug effects)
• Double-Blind Method
• Drug Combinations
• Female
• Humans
• Hydrochlorothiazide (administration & dosage, adverse effects, therapeutic use)
• Hypertension (drug therapy)
• Male
• Tetrazoles (administration & dosage, adverse effects, therapeutic use)
• Valine (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Valsartan