What is the clinical evidence from this study?

Study design: RCT. Population: Moderate or Severe Hypertension (n=1078). Intervention: Telmisartan plus amlodipine vs. Respective monotherapies and placebo. Primary outcome: Change in the in-clinic seated trough cuff DBP from baseline to study end for combination versus respective monotherapies.

March 1, 2009

Original Research: Telmisartan plus Amlodipine in Patients with Moderate or Severe Hypertension: Results from a Subgroup Analysis of a Randomized, Placebo-Controlled, Parallel-Group, 4 × 4 Factorial Study

Key Result

Telmisartan plus amlodipine combination therapy significantly reduced blood pressure compared to monotherapies, achieving maximum SBP/DBP reductions of -26.5/-21 mm Hg with the 80 mg/10 mg dose.

Study Design

Type

RCT (n=1,078)

Randomization

4x4 factorial

PICO

Population

Moderate or Severe Hypertension (n=1,078)

Intervention / Comparator

Telmisartan plus amlodipine vs Respective monotherapies and placebo (telmisartan 20, 40, or 80 mg plus amlodipine 2.5, 5, or 10 mg)

Primary Outcome

Change in the in-clinic seated trough cuff DBP from baseline to study end for combination versus respective monotherapies

Abstract

BACKGROUND: Patients with moderate-to-severe hypertension frequently require > or = 2 antihypertensives to achieve blood pressure (BP) control. An angiotensin receptor blocker (ARB) plus a calcium channel blocker (CCB) seems particularly attractive for these difficult-to-control patients. METHODS: Patients with Stage 1 or 2 hypertension were randomized to telmisartan 0, 20, 40, or 80 mg plus amlodipine 0, 2.5, 5, or 10 mg for 8 weeks. Only those with a diastolic BP (DBP) > or = 100 mm Hg at baseline were included in this subgroup analysis. The primary endpoint was the change in the in-clinic seated trough cuff DBP from baseline to study end for combination versus respective monotherapies. Secondary endpoints included the change in the in-clinic seated trough systolic BP (SBP), BP response, and control rates. RESULTS: A total of 1078 patients (mean standard deviation baseline in-clinic BP: 154.7 +/- 11.7/103.5 +/- 3.5 mm Hg) were analyzed. In-clinic DBP and SBP reductions were significantly greater with combination therapies than respective monotherapies. The greatest least-square mean (standard error) SBP/DBP reductions (-26.5 +/- 1.2/-21 +/- 0.8 mm Hg) were observed with telmisartan 80 mg plus amlodipine 10 mg; 77% and 85% of patients in this treatment group achieved BP control (< 140/90 mm Hg) and DBP control (< 90 mm Hg), respectively. Peripheral edema was reported in 17.2% of patients in the amlodipine 10 mg group; however, this was substantially lower when telmisartan was used in combination: 7% (telmisartan 40 mg/amlodipine 10 mg) and 9.5% (telmisartan 80 mg/ amlodipine 10 mg). CONCLUSIONS: Telmisartan plus amlodipine provides effective BP lowering at all clinically relevant doses (up to -26.5 mm Hg SBP), and almost 9 out of 10 patients may achieve DBP control. Peripheral edema is up to 59% less when telmisartan 40 mg is used in combination with amlodipine 10 mg compared with amlodipine 10 mg monotherapy alone.

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