Persistence of the antihypertensive efficacy of amlodipine and nifedipine GITS after two 'missed doses': A randomised, double-blind comparative trial in Asian patients

Abstract

Suboptimal management of hypertension is often a result of poor patient compliance in the form of missed doses of their antihypertensive medication. This multicentre, randomised, double-blind, parallel-group trial was designed to compare the persistence of the antihypertensive efficacy of the amlodipine and nifedipine gastrointestinal therapeutic system (GITS) after two 'missed doses', and also to compare the drugs' overall efficacy and safety in Asian patients with mild-to-moderate essential hypertension. Following a 2-week placebo run-in period, 222 patients were randomised to receive either amlodipine (5 mg daily, increased after 6 weeks if necessary to 10 mg daily, n = 109) or nifedipine GITS (30 mg daily, increased after 6 weeks if necessary to 60 mg daily; n = 113) for 12 weeks. A placebo was then substituted for further 2 days with continuous ambulatory blood pressure (BP) monitoring. The increases in the last 9 h of mean ambulatory BP on day 2 after treatment withdrawal were significantly less with amlodipine than with nifedipine GITS: 4.4 ± 7.0 vs 11.2 ± 11.3 mmHg for systolic BP (P≤0.0001) and 2.4 ± 6.3 vs 6.0 ± 6.0 mmHg for diastolic BP (P≤0.0002). Significant differences between the two drugs in mean 24-h ambulatory BP levels were already evident on day 1 after withdrawal, even though there were no significant differences on the final day of treatment. No differences in safety parameters were observed, and neither drug caused any serious or severe treatment-related adverse events. In conclusions, amlodipine provides greater protection than nifedipine GITS against loss of BP control following missed doses.