Effect of tablets with a combination of telmisartan and amlodipine on patients with hypertension: the Cotalo study

Feb 22, 2013Hypertension research : official journal of the Japanese Society of Hypertension

Effects of tablets combining telmisartan and amlodipine on high blood pressure patients

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Abstract

In a trial with 44 patients, fixed-dose combination therapy with telmisartan 40 mg and amlodipine 5 mg significantly decreased 24-hour mean blood pressure.

Clinical blood pressure and mean blood pressure measured with ambulatory monitoring were significantly reduced after 8 weeks compared to baseline.
There were no significant differences in blood pressure changes based on the time of administration (morning vs. evening).
The reduction in blood pressure was consistent regardless of the presence of metabolic syndrome among patients.
This therapy was evaluated in patients whose hypertension was not adequately controlled with 5 mg of amlodipine daily.

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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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Effect of tablets with a combination of telmisartan and amlodipine on patients with hypertension: the Cotalo study

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