Safety and efficacy of amlodipine added to hydrochlorothiazide therapy in essential hypertension.

Academic Article


  • We compared amlodipine, a dihydropyridine calcium antagonist, to placebo as add-on therapy to hydrochlorothiazide in 91 hypertensive patients inadequately controlled on hydrochlorothiazide (50 mg/d for four weeks). This was a double-blind, randomized, multicenter, parallel group-trial; 45 patients received placebo and 46 received amlodipine in doses of 2.5 to 10 mg qd (mean 9 mg/d). Supine blood pressure systolic/diastolic, mean +/- SE mm Hg) 24-hour postdose was significantly reduced by 14.2 +/- 2.3/11.7 +/- 1, compared to placebo, 4.5 +/- 2.7/5 +/- 1.2. Standing blood pressure was similarly reduced: amlodipine by 14 +/- 2.7/12.5 +/- 1.2; placebo by 3 +/- 2.1/5.8 +/- 1.2. This reduction in blood pressure was attained without any significant changes in pulse rate, EKG, and serum lipids (triglycerides were reduced in the amlodipine group by 42.9 mg/dL, P = .023). Only two patients had side effects requiring discontinuation from the study (both in the amlodipine group). Side effects occurred in 27 amlodipine-treated patients (11 with peripheral edema) and 18 patients in the placebo (three with peripheral edema) group. Investigator's assessment of therapeutic effect and tolerability, and the percent of responders v nonresponders was also in favor of amlodipine. Thus amlodipine administered once daily is an effective and safe agent for second-step therapy in mild to moderate essential hypertension.
  • Authors

    Published In


  • Adult, Aged, Amlodipine, Blood Pressure, Calcium Channel Blockers, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Hydrochlorothiazide, Hypertension, Male, Middle Aged, Multicenter Studies as Topic, Nifedipine, Random Allocation
  • Digital Object Identifier (doi)

    Author List

  • Glasser SP; Chrysant SG; Graves J; Rofman B; Koehn DK
  • Start Page

  • 154
  • End Page

  • 157
  • Volume

  • 2
  • Issue

  • 3 Pt 1