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Dose finding studies with imidapril--a new ACE inhibitor
M J Vandenburg1, E M Mackay, I Dews
1MCRC, Romford, Essex, UK.
British Journal of Clinical Pharmacology
|March 1, 1994
Summary
Imidapril, a new ACE inhibitor, effectively lowered blood pressure in patients with essential hypertension. Doses of 10 mg and higher demonstrated significant antihypertensive effects with a good safety profile.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Essential hypertension is a prevalent cardiovascular condition requiring effective treatment.
- Angiotensin-Converting Enzyme (ACE) inhibitors are a key class of antihypertensive medications.
Purpose of the Study:
- To investigate the antihypertensive effects of ascending doses of imidapril, a novel ACE inhibitor.
- To determine the optimal and safe dosage range for imidapril in patients with mild to moderate essential hypertension.
Main Methods:
- Prospective, placebo-controlled studies involving patients with essential hypertension (baseline SDBP 95-115 mm Hg).
- Patients received escalating doses of imidapril (2.5-40 mg) or placebo over 2 or 4 weeks.
- Sitting diastolic blood pressure (SDBP) was the primary efficacy endpoint.
Main Results:
- Imidapril at 10 mg, 20 mg, and 40 mg significantly reduced SDBP compared to placebo.
- No significant differences in efficacy were observed between the 10 mg, 20 mg, and 40 mg doses.
- The 2.5 mg dose showed no significant effect, while the 5 mg dose had an intermediate effect.
- Adverse event incidence was similar between imidapril and placebo groups, indicating a favorable safety profile.
Conclusions:
- Imidapril demonstrates significant antihypertensive efficacy in patients with mild to moderate essential hypertension.
- A dose of 10 mg imidapril appears sufficient to achieve maximal ACE inhibition and blood pressure reduction in most patients.
- Imidapril is well-tolerated, with an adverse event profile comparable to placebo.