A randomized, double-blind, parallel-group study to compare the anti-hypertensive effects of imidapril and nifedipine in the treatment of mild-to-moderate essential hypertension.
This 12-week, multicentre, double-blind, placebo-controlled, parallel-group study compared efficacy of the angiotensin-converting enzyme (ACE) inhibitor imidapril 5 - 10 mg/day and the calcium channel blocker nifedipine slow-release (SR) formulation 20 - 40 mg twice daily. In total 320 patients aged 18 - 75 years, with mean sitting diastolic blood pressures of 95 - 115 mmHg, were randomized to treatment with imidapril (n = 157) or nifedipine SR (n = 163). Efficacy evaluations were based on the intent-to-treat principle. On study completion, there was no difference between the groups with respect to the primary efficacy variable of response to treatment (imidapril 63.1%; nifedipine SR 61.3%). After 2 weeks' treatment, clinically relevant decreases in blood pressure were observed in both groups, with a trend towards further reductions until study end. Fewer patients in the imidapril-treated group than the nifedipine group withdrew due to adverse events that occurred on treatment with study medication (3.2% versus 16.0%) or experienced adverse events (40.1% versus 49.7%). In addition, fewer adverse events were causally related to imidapril (24.2%) compared with nifedipine SR (41.7%). These results show that imidapril is effective in the treatment of essential hypertension and is better tolerated than nifedipine SR.
van der Does
R
R
IST GmbH, Mannheim, Germany.
Euler
R
R
D000328:Adult; D000368:Aged; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002121:Calcium Channel Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D048289:Imidazolidines; D008297:Male; D008875:Middle Aged; D009543:Nifedipine / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos
D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D007093:Imidazoles; D048289:Imidazolidines; D010919:Placebos; C065166:imidapril; D009543:Nifedipine