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[Not Available].

B Debrégeas¹, J Duchier

¹Laboratoires Ethypharm, Recherche Clinique, St Cloud, France.

Clinical Drug Investigation

|January 1, 1997

Summary

This summary is machine-generated.

This study found that sustained-release (SR) diltiazem did not significantly differ in anti-ischemic efficacy compared to conventional diltiazem for stable angina pectoris patients.

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Area of Science:

Cardiology
Pharmacology

Background:

Stable angina pectoris requires effective anti-ischemic therapy.
Diltiazem, a calcium channel blocker, is used for angina management.
Sustained-release (SR) formulations aim to improve dosing convenience and efficacy.

Purpose of the Study:

To compare the efficacy and tolerability of sustained-release (SR) diltiazem versus conventional diltiazem in patients with stable angina pectoris.
To evaluate potential dose-response relationships for SR diltiazem.

Main Methods:

Double-blind, dose-response, crossover study design.
26 patients with stable angina pectoris participated.
Patients received placebo, diltiazem SR (180, 240, 300mg once daily), or conventional diltiazem (60mg three times daily) for 2-week periods, followed by crossover.

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Main Results:

Both conventional and SR diltiazem formulations improved exercise time and reduced ischemic intensity.
No statistically significant differences in anti-ischemic efficacy were observed between the SR and conventional formulations.
No clear dose-response relationship was identified for SR diltiazem.

Conclusions:

Sustained-release diltiazem (180, 240, 300mg) demonstrated comparable anti-ischemic efficacy to conventional diltiazem in stable angina.
Tolerability was generally good for both formulations, with few adverse events leading to discontinuation.