Effect of tablets with a combination of telmisartan and amlodipine on patients
with hypertension: the Cotalo study.
Author(s): Ohishi M(1), Kawai T, Hayashi N, Kitano S, Katsuya T, Nagano M, Hirotani A,
Yamamoto K, Kamide K, Rakugi H.
Affiliation(s): Author information:
(1)Department of Geriatric Medicine and Nephrology, Osaka University Graduate School
of Medicine, Osaka, Japan. ohishi@geriat.med.osaka-u.ac.jp
Publication date & source: 2013, Hypertens Res. , 36(7):620-6
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.
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