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.
RCT (n=1,078)
4x4 factorial
Does telmisartan plus amlodipine combination therapy improve blood pressure reduction compared to monotherapy in patients with moderate or severe hypertension?
Combination therapy with telmisartan and amlodipine provides superior blood pressure reduction and lower rates of peripheral edema compared to high-dose amlodipine monotherapy in patients with moderate-to-severe hypertension.
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.
Littlejohn et al. (Sun,) conducted a rct in Moderate or Severe Hypertension (n=1,078). Telmisartan plus amlodipine vs. Respective monotherapies and placebo was evaluated on Change in the in-clinic seated trough cuff DBP from baseline to study end for combination versus respective monotherapies. 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.
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