Aim of the study: The antianginal efficacy of slow-release (SR) Diltiazem and change in ergometric parameters during treatment were evaluated in patients with stable effort angina.
Methods: Forty eight patients with documented ischemic cardiopathy were studied. The study design was double blind randomised cross over versus placebo. After a 7 days run-in period of pharmacological washout, patients were randomised to treatment with diltiazem SR (120 mgs bid) or placebo for 1 week, followed by crossover of treatments. No concomitant antianginal therapy, except sublingual nitro-glycerine was allowed during the trial. Exercise tests were performed during the run-in period and at the end of each week of treatment.
Results: After diltiazem administration, exercise duration increased significantly in comparison with placebo (645.6 +/- 196.31 vs 563.9 +/- 244.52 s, p < 0.01). Similarly, time to onset of angina and time to ischemic threshold increased in comparison to placebo (603.78 +/- 198.50 vs 459.69 +/- 239.40 s, p < 0.01 and 576.06 +/- 208.88 vs 463.16 +/- 246.12 s, p < 0.01 respectively). No significant changes in heart rate, blood pressure and double product at ischemic threshold and peak exercise were detected.
Conclusions: SR-diltiazem is effective and well tolerated in the treatment of patients with stable angina.