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

Hypertens Res. 2013 Jul;36(7):620-6. doi: 10.1038/hr.2013.10. Epub 2013 Feb 21.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Amlodipine / administration & dosage*
  • Angiotensin II Type 1 Receptor Blockers / administration & dosage*
  • Antihypertensive Agents / administration & dosage*
  • Benzimidazoles / administration & dosage*
  • Benzoates / administration & dosage*
  • Blood Pressure Monitoring, Ambulatory
  • Calcium Channel Blockers / administration & dosage*
  • Drug Combinations
  • Epinephrine / blood
  • Female
  • Humans
  • Hypertension / drug therapy*
  • Male
  • Middle Aged
  • Tablets
  • Telmisartan

Substances

  • Angiotensin II Type 1 Receptor Blockers
  • Antihypertensive Agents
  • Benzimidazoles
  • Benzoates
  • Calcium Channel Blockers
  • Drug Combinations
  • Tablets
  • Amlodipine
  • Telmisartan
  • Epinephrine