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Amlodipine/valsartan/hydrochlorothiazide triple combination therapy in moderate/severe hypertension: Secondary

David A Calhoun1, Nora A Crikelair, Joseph Yen

  • 1University of Alabama at Birmingham, Sleep/Wake Disorders Center, 35294, USA. dcalhoun@uab.edu

Advances in Therapy
|December 22, 2009
PubMed

Insights

Triple therapy with amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCTZ) significantly lowers blood pressure (BP) more effectively than dual therapies. These BP reductions are greater in patients with severe hypertension and are evident early in treatment.

Area of Science:

  • Cardiovascular Medicine
  • Pharmacology
  • Clinical Trials

Background:

  • A 8-week trial indicated amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCTZ) triple therapy offers superior blood pressure (BP) reduction compared to dual-component regimens for moderate to severe hypertension.
  • Exploratory analyses were conducted to assess the impact of treatment duration and baseline BP on therapeutic responses.

Purpose of the Study:

  • To evaluate the efficacy of Aml/Val/HCTZ triple therapy versus dual therapies in reducing BP.
  • To investigate the influence of baseline BP severity on treatment outcomes.
  • To determine the time course of BP reduction with triple versus dual therapy.

Main Methods:

  • Patients (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.
  • Treatment arms included Aml 10 mg/Val 320 mg/HCTZ 25 mg, Val 320 mg/HCTZ 25 mg, Aml 10 mg/Val 320 mg, and Aml 10 mg/HCTZ 25 mg.
  • Regimens underwent force-titration over the initial 2 weeks.

Main Results:

  • Triple therapy demonstrated significantly greater reductions in MSSBP and MSDBP from baseline to Week 3 and end of study compared to each dual therapy in the overall population and severe systolic subgroup.
  • At Week 3 and study endpoint, a higher proportion of patients on triple therapy achieved greater MSSBP reductions across multiple thresholds (≥-20 to ≥-60 mmHg) compared to dual therapy groups.
  • End-of-study BP reductions were positively correlated with baseline MSSBP severity, with reductions up to ≥49.6 mmHg observed in patients with baseline MSSBP ≥180 mmHg.

Conclusions:

  • Aml 10 mg/Val 320 mg/HCTZ 25 mg triple therapy provides significant BP reduction compared to dual-component therapies, particularly early in treatment.
  • The magnitude of systolic BP lowering is proportionate to the initial severity of hypertension.
  • All investigated treatment regimens were well-tolerated, irrespective of baseline BP levels.
Abstract

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