Single-Pill Combination of Telmisartan 80 Mg/Amlodipine 10 Mg Provides Superior Blood Pressure Reductions in Patients With Severe Hypertension: Teamsta Severe HTN Study: Ht.1.04

Purpose: Investigate the efficacy and safety of the single-pill combination of telmisartan 80 mg/amlodipine 10 mg (T80/A10) vs. its respective monotherapy components in patients with severe hypertension. Methods: An 8-week, double-blind, parallel-group study, in 858 patients aged ≥18 years with severe hypertension (i.e. SBP ≥180 and DBP ≥95 mmHg) randomized to T80/A10 (n = 421) or to monotherapy with T80 (n = 217) or A10 (n = 220). The primary endpoint was change from baseline in seated trough cuff SBP. Results: Baseline characteristics were comparable between the treatment groups. At 8 weeks, significantly greater reductions from baseline in seated trough SBP/DBP were observed with T80/A10 vs. T80 or A10 monotherapy, with superior reductions evident at 1 week. BP control and response rates were consistently higher with T80/A10 vs. T80 or A10 alone. T80/A10 was well tolerated, with similar rates of common adverse events (AEs) vs. T80 or A10 monotherapy. Treatment-related AEs were less frequent with T80/A10 (12.6%) vs. A10 (16.4%), with a numerically lower incidence of peripheral edema and rate of treatment discontinuation.Conclusions: Treatment of severe hypertensive patients with a single-pill combination containing T80/A10 results in significantly greater BP reductions (-47.5/-18.7 mmHg) and higher BP control/response rates than the respective monotherapies. The safety profile of T80/A10 single-pill combination is comparable to that of its respective components.