COMPARISON OF THE ANTISPASTIC EFFECTS OF BI-TILDIEM(R) 120-MG AND TILDIEM(R) 60-MG

Diltiazem (Tildiem(R) 60 mg) is a calcium channel blocker with demonst rated efficacy and safety in the treatment of stable angina pectoris a nd spastic angina. The sustained release formulation of diltiazem, all owing two daily doses (Bi-Tildiem(R) 120 mg), is already marketed in F rance 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, Til diem(R) 60 mg, given at the same daily dose, i.e. 240 mg, in three div ided doses per day. We conducted a single-centre, randomized, double-b lind, cross-over clinical study in twelve patients, eleven men and one woman, between the ages of 42 and 70 years, presenting with angina an d normal coronary arteries and spasm documented by a positive methyler gonovine (Methergin(R)) test. They were divided into two groups of six patients receiving either Tildiem(R) followed by Bi-Tildiem(R), or Bi -Tildiem(R) followed by Tildiem(R). The characteristics of the two gro ups were comparable at the time of the selection visit. The methylergo novine test, used to assess the efficacy of the two treatments, was im proved by Tildiem(R) and Bi-Tildiem(R) compared to the placebo test (p = 0.001 and 0.002), without any significant difference between Tildie m(R) and Bi-Tildiem(R):an improvement was obtained in 11/12 and 10/12 patients, respectively. No deterioration of the test was observed with Tildiem(R) or Bi-Tildiem(R) compared to placebo. The coronary symptom s and blood diltiazem levels were similar with Tildiem(R) and Bi-Tildi em(R). The results confirmed the safety of Bi-Tildiem(R). A single adv erse effect was attributed to treatment: an episode of mild insomnia. No serious adverse effect were observed and none of the patients disco ntinued the study. The efficacy and safety of Tildiem(R) and Bi-Tildie m(R) are comparable in the treatment of spastic angina.