Aim. A randomized, double-blind, multicentre study was undertaken to evaluate the 8-h and 24-h anti-ischaemic efficacy and plasma drug levels of amlodipine vs sustained-release isosorbide-5-mononitrate (IS-5-MN sr) once daily in patients with chronic stable angina pectoris. Patients and methods. Ninety-three male patients were randomized to receive either 5-10 mg of amlodipine once daily, or 50 mg of IS-5-MN sr once daily, and evaluated with 8-h and 24-h post-dose exercise tolerance tests (ETTs) after 4 and 8 weeks. The primary end-point of the study was the time to 1 mm ST-segment depression. Results. Both amlodipine and IS-5-MN sr significantly improved all ETT parameters 8 h after administration, at both 4 and 8 weeks compared with baseline. No between-group differences were observed. At 24 h post-dose, amlodipine showed a statistically significantly greater improvement than did IS-5-MN sr in time to 1 mm ST-segment depression, time to maximum ST-segment depression, total exercise time and total duration of ST-segment depression at weeks 4 and 8. There was no significant difference in the mean plasma amlodipine levels at 8 h and 24 h at 8 weeks. while the mean plasma IS-5-MN sr levels decreased significantly during the period from 8 h to 24 h at 8 weeks after administration. Conclusions. This study provides evidence that once-daily amlodipine improves exercise tolerance to a significantly greater degree than IS-5-MN sr when compared at 24 h post-dose. The prolonged duration of the action OF amlodipine was associated with maintenance of therapeutic plasma levels and little peak/trough variability.
|Journal||European Heart Journal, Supplement|
|Publication status||Published - 1999|
- Chronic stable angina
- Effort-induced ischaemia
- Sustained-release isosorbide-5-mononitrate
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine