Effects of telmisartan and amlodipine in combination on ambulatory blood pressure in stages 1-2 hypertension

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, 4×4 factorial design trial in which 562 patients with clinic diastolic BP at least 95 and 119mmHg or less were randomized to receive telmisartan (0, 20, 40, or 80mg) and/or amlodipine (0, 2.5, 5, or 10mg). 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 (≥10mmHg BP reduction from baseline and/or <130/80 mean 24-h BP) and controlled patients (<130/80mmHg 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 (80mg) and amlodipine (10mg) were -22.4/-14.6 versus -11.9/-6.9mmHg for amlodipine (10mg) and -11.0/-6.9mmHg for telmisartan (80mg) (P<0.0001 for each comparison). In addition, BP response and control rates (24-h BP <130/80mmHg) 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. © Lippincott Williams & Wilkins.