BACKGROUND: Evaluation of combination therapy with antihypertensive agents by clinic blood pressure (BP) measurements may yield results that differ from out-of-office BP readings. This is of clinical relevance because out-of-office BP values are of prognostic importance. We studied the effects of combining telmisartan and amlodipine on ambulatory BP in patients with stages 1-2 hypertension. METHODS: We conducted an 8-week, placebo-controlled, double-blind, 4x4 factorial design trial in which 562 patients with clinic diastolic BP at least 95 and 119 mmHg or less were randomized to receive telmisartan (0, 20, 40, or 80 mg) and/or amlodipine (0, 2.5, 5, or 10 mg). Ambulatory BP monitoring was performed at baseline and after 8 weeks of treatment; the end points of interest were the changes from baseline in 24-h systolic and diastolic BP. Secondary end points included the proportion of responders (> or =10 mmHg BP reduction from baseline and/or <130/80 mean 24-h BP) and controlled patients (<130/80 mmHg mean 24-h BP). RESULTS: Combination therapies of telmisartan and amlodipine lowered 24-h BP to a larger extent than the corresponding monotherapies at all doses. Mean reductions from baseline in 24-h BP for the combination of the highest doses of telmisartan (80 mg) and amlodipine (10 mg) were -22.4/-14.6 versus -11.9/-6.9 mmHg for amlodipine (10 mg) and -11.0/-6.9 mmHg for telmisartan (80 mg) (P<0.0001 for each comparison). In addition, BP response and control rates (24-h BP <130/80 mmHg) were significantly higher with the combination therapy versus the monotherapy groups. CONCLUSION: These findings show that telmisartan and amlodipine in combination provide substantial 24-h BP efficacy that is superior to either monotherapy in patients with stages 1 and 2 hypertension.
RCT Entities:
BACKGROUND: Evaluation of combination therapy with antihypertensive agents by clinic blood pressure (BP) measurements may yield results that differ from out-of-office BP readings. This is of clinical relevance because out-of-office BP values are of prognostic importance. We studied the effects of combining telmisartan and amlodipine on ambulatory BP in patients with stages 1-2 hypertension. METHODS: We conducted an 8-week, placebo-controlled, double-blind, 4x4 factorial design trial in which 562 patients with clinic diastolic BP at least 95 and 119 mmHg or less were randomized to receive telmisartan (0, 20, 40, or 80 mg) and/or amlodipine (0, 2.5, 5, or 10 mg). Ambulatory BP monitoring was performed at baseline and after 8 weeks of treatment; the end points of interest were the changes from baseline in 24-h systolic and diastolic BP. Secondary end points included the proportion of responders (> or =10 mmHg BP reduction from baseline and/or <130/80 mean 24-h BP) and controlled patients (<130/80 mmHg mean 24-h BP). RESULTS: Combination therapies of telmisartan and amlodipine lowered 24-h BP to a larger extent than the corresponding monotherapies at all doses. Mean reductions from baseline in 24-h BP for the combination of the highest doses of telmisartan (80 mg) and amlodipine (10 mg) were -22.4/-14.6 versus -11.9/-6.9 mmHg for amlodipine (10 mg) and -11.0/-6.9 mmHg for telmisartan (80 mg) (P<0.0001 for each comparison). In addition, BP response and control rates (24-h BP <130/80 mmHg) were significantly higher with the combination therapy versus the monotherapy groups. CONCLUSION: These findings show that telmisartan and amlodipine in combination provide substantial 24-h BP efficacy that is superior to either monotherapy in patients with stages 1 and 2 hypertension.