title: Effect of tablets with a combination of telmisartan and amlodipine on patients with hypertension: the Cotalo study.
abstract: Fixed-dose combination (FDC) therapy with telmisartan 40 mg+amlodipine 5 mg (T40/A5) is expected to achieve tight blood pressure (BP) control because of the strong efficacy and long half-life of each drug. The aims of this study were to evaluate the 24-h antihypertensive efficacy of T40/A5 FDC therapy and to explore differences that may arise owing to different administration times in Japanese patients whose hypertension was not controlled by 5 mg of amlodipine per day. In this randomized clinical trial, 44 patients who had been taking amlodipine 5 mg per day and did not achieve their optimal BP target were enrolled (mean age: 67.8±10.2 years). The subjects were then randomly assigned to a T40/A5 morning or evening administration group (22 patients per group). At baseline and 8 weeks after randomization, we evaluated clinical BP and various laboratory values and performed ambulatory BP monitoring (ABPM). Clinical and mean BP evaluated with ABPM at 8 weeks (24 h, daytime, nighttime and early morning) were significantly decreased compared with BP at baseline. There were no significant differences in the diurnal BP profile change from baseline to 8 weeks between subjects in the morning and evening administration groups. There were also no significant differences in the diurnal BP profile change from baseline to 8 weeks between subjects with or without metabolic syndrome. We conclude that T40/A5 FDC therapy significantly decreased the 24-h mean and clinical BP, independent of administration time, in patients whose hypertension was not controlled by 5 mg of amlodipine.
authors: Department of Geriatric Medicine and Nephrology, Osaka University Graduate School of Medicine, Osaka, Japan. ohishi@geriat.med.osaka-u.ac.jp
authors: Mitsuru
authors: M
authors: Ohishi
authors: Tatsuo
authors: T
authors: Kawai
authors: Norihiro
authors: N
authors: Hayashi
authors: Shoichi
authors: S
authors: Kitano
authors: Tomohiro
authors: T
authors: Katsuya
authors: Masahiro
authors: M
authors: Nagano
authors: Atsushi
authors: A
authors: Hirotani
authors: Koichi
authors: K
authors: Yamamoto
authors: Kei
authors: K
authors: Kamide
authors: Hiromi
authors: H
authors: Rakugi
mesh_terms: D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage*; D047228:Angiotensin II Type 1 Receptor Blockers / Q000008:administration & dosage*; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D001562:Benzimidazoles / Q000008:administration & dosage*; D001565:Benzoates / Q000008:administration & dosage*; D018660:Blood Pressure Monitoring, Ambulatory; D002121:Calcium Channel Blockers / Q000008:administration & dosage*; D004338:Drug Combinations; D004837:Epinephrine / Q000097:blood; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D013607:Tablets; D000077333:Telmisartan
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D001562:Benzimidazoles; D001565:Benzoates; D002121:Calcium Channel Blockers; D004338:Drug Combinations; D013607:Tablets; D017311:Amlodipine; D000077333:Telmisartan; D004837:Epinephrine