Efficacy and Safety of Combination Therapy With Low Dose of Telmisartan and S-Amlodipine in Patients With Hypertension: A Randomized, Double-Blind, Multicenter, Therapeutic Confirmatory, Phase III Clinical Trial

Lee et al. (Sun,) conducted a rct in Adult patients with hypertension, mean sitting systolic blood pressure (msSBP) ≥ 140 mm Hg and < 180 mm Hg (or ≥130 mm Hg and < 180 mm Hg if previously treated), mean sitting diastolic blood pressure (msDBP) < 110 mm Hg after ≥4-week wash-out/therapeutic lifestyle change (n=235). Telmisartan 20 mg/S-amlodipine 1.25 mg combination therapy vs. Telmisartan 20 mg single therapy and S-amlodipine 1.25 mg single therapy was evaluated on Change in mean sitting systolic blood pressure (msSBP) from baseline to 8 weeks (Difference in change between arms LS-mean difference −3.60 mm Hg (95% CI −7.13 to −0.08) vs Tel, P=0.0451; LS-mean difference −5.53 mm Hg (95% CI −8.72 to −2.35) vs S-Amlo, P=0.0008, 95% CI 95% CI −7.13 to −0.08 mm Hg (vs Tel); 95% CI −8.72 to −2.35 mm Hg (vs S-Amlo), p=0.0451 (vs Tel), 0.0008 (vs S-Amlo)). Telmisartan 20 mg/S-amlodipine 1.25 mg combination therapy reduced mean sitting systolic blood pressure by 20.04 mm Hg at 8 weeks, significantly more than telmisartan 20 mg (−16.44 mm Hg, difference −3.60 mm Hg, P=0.0451) or s-amlodipine 1.25 mg (−15.58 mm Hg, difference −5.53 mm Hg, P=0.0008) monotherapies in hypertensive adults.