[Comparison of the antispastic effect of Bi-Tildiem 120 mg and Tildiem 60mg]

Diltiazem (Tildiem 60 mg) is a calcium channel blocker with demonstrated efficacy and safety in the treatment of stable angina pectoris and spastic angina. The sustained release formulation of diltiazem, allowing two daily doses (Bi-Tildiem 120 mg), is already marketed in France for the treatment of stable angina. It was therefore interesting to evaluate the efficacy and safety of this form, administered in two daily doses, in coronary spasm, versus the classical formulation, Tildiem 60 mg, given at the same daily dose, i.e. 240 mg, in three divided doses per day. We conducted a single-centre, randomized, double-blind, cross-over clinical study in twelve patients, eleven men and one woman, between the ages of 42 and 70 years, presenting with angina and normal coronary arteries and spasm documented by a positive methylergonovine (Methergin) test. They were divided into two groups of six patients receiving either Tildiem followed by Bi-Tildiem, or Bi-Tildiem followed by Tildiem. The characteristics of the two groups were comparable at the time of the selection visit. The methylergonovine test, used to assess the efficacy of the two treatments, was improved by Tildiem and Bi-Tildiem compared to the placebo test (p = 0.001 and 0.002), without any significant difference between Tildiem and Bi-Tildiem: an improvement was obtained in 11/12 and 10/12 patients, respectively. No deterioration of the test was observed with Tildiem or Bi-Tildiem compared to placebo. The coronary symptoms and blood diltiazem levels were similar with Tildiem and Bi-Tildiem. The results confirmed the safety of Bi-Tildiem. A single adverse effect was attributed to treatment: an episode of mild insomnia. No serious adverse effect were observed and none of the patients discontinued the study. The efficacy and safety of Tildiem and Bi-Tildiem are comparable in the treatment of spastic angina.