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Effects of demographics on the antihypertensive efficacy of triple therapy with amlodipine, valsartan, and hydrochlorothiazide for moderate to severe hypertension.

ABSTRACT: To compare the antihypertensive efficacy and safety of once-daily triple therapy with amlodipine (Aml) 10 mg, valsartan (Val) 320 mg, and hydrochlorothiazide (HCTZ) 25 mg versus dual-therapy combinations of these components in patients with moderate to severe hypertension.Subgroup analysis of a multinational, randomized, double-blind, parallel-group, active-controlled trial.After antihypertensive washout and a placebo run-in of up to 4 weeks, 2271 patients were randomly allocated in a 1:1:1:1 ratio to receive Aml/Val/HCTZ triple therapy or dual therapy with Val/HCTZ, Aml/Val, or Aml/HCTZ for 8 weeks. Forced titration to the full dose was done over the first 2 weeks of treatment. Efficacy and safety parameters were determined by age group (<65 vs. ?65 years), gender, race (White vs. Black), ethnicity (Hispanic/Latino vs. non-Hispanic/Latino), and body mass index (BMI, <30 vs. ?30 kg/m²).Change from baseline to endpoint in mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP); blood pressure (BP) control rate <140/90 mmHg.Triple therapy was numerically superior and, for the majority of comparisons, statistically superior to each dual therapy in reducing MSSBP and MSDBP and in improving BP control rates in all subgroups. Across subgroups, triple therapy reduced MSSBP by 5.7-10.7 mmHg more than Val/HCTZ, 3.4-8.3 mmHg more than Aml/Val, and 4.4-9.4 mmHg more than Aml/HCTZ. Triple therapy was well tolerated across all subgroups. Limitations of our analysis included the lack of stratification of patients by subgroup at randomization and the small sample size of some subgroups (e.g., Blacks, elderly).Triple therapy with Aml/Val/HCTZ is effective and well tolerated in patients with moderate to severe hypertension regardless of age, gender, race, ethnicity, or BMI.NCT00327587.

SUBMITTER: Calhoun DA

PROVIDER: S-EPMC4098842 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature

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Effects of demographics on the antihypertensive efficacy of triple therapy with amlodipine, valsartan, and hydrochlorothiazide for moderate to severe hypertension.

Calhoun David A DA Lacourcière Yves Y Crikelair Nora N Jia Yan Y Glazer Robert D RD

Current medical research and opinion 20130701 8

<h4>Objective</h4>To compare the antihypertensive efficacy and safety of once-daily triple therapy with amlodipine (Aml) 10 mg, valsartan (Val) 320 mg, and hydrochlorothiazide (HCTZ) 25 mg versus dual-therapy combinations of these components in patients with moderate to severe hypertension.<h4>Research design</h4>Subgroup analysis of a multinational, randomized, double-blind, parallel-group, active-controlled trial.<h4>Methods</h4>After antihypertensive washout and a placebo run-in of up to 4 we ...[more]

PMID: 23721363

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Project description:BACKGROUND:To determine whether the effectiveness and safety of fixed-dose combinations (FDCs) of amlodipine orotate/valsartan (AML/VAL) 5/160?mg are noninferior to those of valsartan/hydrochlorothiazide (VAL/HCTZ) 160/12.5?mg in hypertensive patients with inadequate response to valsartan 160?mg monotherapy. METHODS:This 8-week, active-controlled, parallel-group, fixed-dose, multicenter, double-blind randomized controlled, and noninferiority trial was conducted at 17 cardiovascular centers in the Republic of Korea. Eligible patients had mean sitting diastolic blood pressure (msDBP) ?90?mm?Hg despite monotherapy with valsartan 160?mg for 4 weeks. Patients were randomly assigned to treatment with AML/VAL 5/160?mg FDC (AML/VAL) group or VAL/HCTZ 160/12.5?mg FDC (VAL/HCTZ) group once daily for 8 weeks. A total of 238 patients were enrolled (AML/VAL group, n?=?121; VAL/HCTZ group, n?=?117), of whom 228 completed the study. RESULTS:At 8 weeks after randomization, msDBP was significantly decreased in both groups (-9.44?±?0.69?mm?Hg in the AML/VAL group and -7.47?±?0.71?mm?Hg in the VAL/HCTZ group, both P?<?.001 vs baseline). Between group difference was -1.96?±?1.00?mm?Hg, indicating that AML/VAL 5/160?mg FDC was not inferior to VAL/HCTZ 160/12.5?mg FDC at primary efficacy endpoint. Control rate of BP defined as the percentage of patients achieving mean sitting SBP (msSBP) <140?mm?Hg or msDBP <90?mm?Hg (target BP) from baseline to week 8 was significantly higher in the AML/VAL group than that in the VAL/HCTZ group (84.3% [n?=?102] in the AML/VAL group vs 71.3% [n?=?82] in the VAL/HCTZ group, P?=?.016). At 8 weeks after randomization, mean uric acid level was significantly increased in the VAL/HCTZ group compared to that at baseline (0.64?±?0.08?mg/dL; P?<?.001). However, it was slightly decreased from baseline in the AML/VAL group (-0.12?±?0.08?mg/dL; P?=?.085). The intergroup difference was significant (P?<?.001). CONCLUSION:The effectiveness and safety AML/VAL 5/160?mg FDC are noninferior to those of VAL/HCTZ 160/12.5?mg FDC in patients with hypertension inadequately controlled by valsartan 160?mg monotherapy.

Dataset Information

Effects of demographics on the antihypertensive efficacy of triple therapy with amlodipine, valsartan, and hydrochlorothiazide for moderate to severe hypertension.

Publications

Effects of demographics on the antihypertensive efficacy of triple therapy with amlodipine, valsartan, and hydrochlorothiazide for moderate to severe hypertension.

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