Comparison of telmisartan/amlodipine and telmisartan/hydrochlorothiazide in the treatment of Japanese patients with uncontrolled hypertension: the TAT-Kobe study.

Objective The aim of this study was to compare the efficacy and safety of telmisartan plus amlodipine with telmisartan plus hydrochlorothiazide for the treatment of uncontrolled hypertension. Methods Japanese hypertensive patients with uncontrolled hypertension, despite taking angiotensin II receptor blockers, were assigned randomly to either a fixed-dose combination of telmisartan/amlodipine (n = 36) or telmisartan/hydrochlorothiazide (n = 39). The primary endpoint was the change in office blood pressure from the baseline value at 12 weeks. Results Both telmisartan/amlodipine and telmisaratan/hydrochlorothiazide reduced the office blood pressure efficiently (systole: -25.5 +/- 12.1 vs. -24.3 +/- 15.0 mmHg, P=0.705; diastole: -10.8 +/- 13.8 vs. -11.4 +/- 12.3 mmHg, P = 0.832). Treatment with telmisartan/hydrochlorothiazide resulted in the quicker onset of blood pressure-lowering effects compared with telmisartan/amlodipine. The target therapeutic blood pressure was similar in both groups at the 12-week visit. Home blood pressure measurements taken in the mornings and evenings were also similar in both groups. Compared with the telmisartan/amlodipine group, serum potassium and brain natriuretic peptide levels decreased and uric acid and hemoglobin A1c levels increased significantly in the telmisartan/hydrochlorothiazide group. Both treatment groups showed a significant reduction in urine albumin. However, the estimated glomerular filtration rate decreased slightly but significantly in the telmisartan/hydrochlorothiazide group alone. Severe adverse effects were not observed in both groups. Conclusion Combination therapy with telmisartan/amlodipine or telmisartan/hydrochlorothiazide led to efficient blood pressure reduction among Japanese patients with previously uncontrolled hypertension with angiotensin II receptor blocker monotherapy. Copyright (C) 2016 Wolters Kluwer Health, Inc. All rights reserved.