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Imidapril Hydrochloride in Essential Hypertension: A Double-Blind Comparative Study Using Enalapril Maleate as a Control

Imidapril Hydrochloride in Essential Hypertension: A Double-Blind Comparative Study Using Enalapril Maleate as a Control

T Saruta, T Omae, M Kuramochi, O Iimura, K Yoshinaga, K Abe, M Ishii, T Watanabe, T Takeda, K Ito

J Hypertens Suppl. 1995 Sep;13(3):523-30.

PMID: 8592249

Abstract:

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.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP89396941	Imidapril hydrochloride		89396-94-1	Price

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