Key result
Imidapril matches enalapril for BP control but significantly reduces incidence of cough to ~1%.
Why the study?
The clinical efficacy and safety of imidapril hydrochloride, a long-acting ACE inhibitor developed in Japan, needed assessment compared to enalapril maleate in essential hypertension.
Does imidapril hydrochloride improve antihypertensive response compared to enalapril maleate in outpatients with essential hypertension?
RCT (n=231)
Double-blind
Does imidapril hydrochloride improve antihypertensive response compared to enalapril maleate in outpatients with essential hypertension?
Absolute Event Rate: 71.3% vs 66.1%
p-value: p=no significant difference
Imidapril provides similar antihypertensive efficacy to enalapril but with a notably lower incidence of ACE inhibitor-induced cough.
Imidapril matches enalapril efficacy with lower cough; supports its use as a cough-sparing ACE inhibitor alternative in hypertension.
OBJECTIVE: To assess the value of using imidapril hydrochloride (ACE/TA-6366), a long-acting angiotensin converting enzyme (ACE) inhibitor developed in Japan, to treat patients with essential hypertension. PATIENTS AND METHODS: A double-blind, comparative, phase III study was carried out using enalapril maleate as a control, with a 4-week observation period and a 12-week treatment period. Both drugs were started at a dose of 5 mg once a day, increasing to 10 mg in patients whose antihypertensive response was insufficient after 4 weeks. The study included 231 outpatients aged 30-74 years; of these, 108 in the imidapril group and 115 in the enalapril group were assessed. There were no differences in background factors between groups. RESULTS: An adequate antihypertensive effect was observed in 71.3% (77/108) in the imidapril group in in 66.1% (76/115) in the enalapril group, with no significant difference between groups. The pulse rate was unchanged in both groups. The drug had no adverse effects in 86.1% (93/108) of the imidapril group and 79.1% (91/115) of the enalapril group, with no significant difference between groups. Adverse drug effects were observed din 5.6% (6/108) of the imidapril group and 12.2% (14/115) of the enalapril group. Cough was the most frequent side effect, reported in 0.9% (1/108) of the imidapril group and 7.0% (8/115) of the enalapril group. Other side effects were reported in 4.6% (5/108) of the imidapril group and 5.2% (6/115) of the enalapril group. Abnormal laboratory values were observed in 3.7% (4/108) of the imidapril group and 0.9% (1/115) of the enalapril group. CONCLUSIONS: Imidapril showed excellent clinical efficacy and safety compared to enalapril. The low incidence of cough is of particular interest.
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Saruta et al. (1995) conducted an RCT in Essential hypertension (n=231). Imidapril hydrochloride vs. Enalapril maleate was evaluated on Adequate antihypertensive effect (p=no significant difference). Imidapril hydrochloride provided an adequate antihypertensive effect in 71.3% of patients compared to 66.1% with enalapril, with a lower incidence of cough (0.9% vs 7.0%).
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