Persistence of the Antihypertensive Efficacy of Amlodipine and Nifedipine GITS after Two 'missed doses': A Randomised, Double-blind Comparative Trial in Asian Patients
I Ongtengco, D Morales, J Sanderson, Z-R Lu, L J Beilin, V Burke, I B Puddey, S Tanomsup, H Dayi, P Rahardjo, Dato R Zambahari, C-Y Chen, A A Soenarta, P Buranakitjaroen, C Tan, T K Soon, D-J Wu
Rm 105 Medical Arts Bldg, St Luke’s Medical Center, E Rodriguez Sr Blvd, Quezon City, Philippines
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-tomoderate essential hypertension. Following a 2-week placebo run-in period, 222 patients were randomised to receive either amlodipine (5mg daily, increased after 6 weeks if necessary to 10mg daily, n=109) or nifedipine GITS (30mg daily, increased after 6 weeks if necessary to 60mg 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±11.3mmHg for systolic BP (P≤0.0001) and 2.4±6.3 vs 6.0±6.0mmHg 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 conclusion, amlodipine provides greater protection than nifedipine GITS against loss of BP control following missed doses.
ปี 2545, November ปีที่: 16 ฉบับที่ 11 หน้า 805-513
Efficacy, Amlodipine, Essential hypertension, Medication compliance, Missed doses, Nifedipine GITS