[Comparative study of the mid-term electrocardiographic and clinical tolerability of bepridil versus diltiazem in patients with coronary disease].
A randomized, double-blind, multicentric study has been carried out to compare the electrocardiographic tolerance and the clinical benefit of bepridil (B) (300 to 500 mg/day) and of diltiazem (D) (180 to 300 mg/day). 227 patients with stable coronary disease, aged 70 years or less (mean = 59.4 +/- 7.2 years) have received treatment (116 B vs 111 D) during 16 weeks. The standard ECGs at each visit (D 0-inclusion-, D 14, D 28, D 70, D 112) show that, in group D, 9 first degree auriculo-ventricular blocks (ABV), occur during the study while no ABV occur in group B. A significant prolongation of the QTc (+5%) is observed as from D 14 in group B patients compared to those in group D. This difference persists during all the study. The study of Holters of 24 hours, carried out on D 0, D 70 and D 112, shows the good tolerance of B in this type of population. The number of patients presenting attacks of angina, the frequency of these attacks and the amount of TNT consumed are not different for the two groups under treatment, whatever the period studied. The frequency of extracardiac and cardiovascular undesirable effects is not different for the two groups. The number of patients who left the trial is not different for the two groups. The biological tolerance remained within normal limits in both groups. The analysis of the individual data has never shown any pro-arrhythmic effect, attributable to B or D, in the patients with no initial arrhythmia.(ABSTRACT TRUNCATED AT 250 WORDS)
Puech
P
P
Service de Cardiologie B, Cliniques Saint-Eloi, Montpellier.
Coumel
P
P
Maison Blanche
P
P
Coudray
P
P
D000368:Aged; D015764:Bepridil / Q000009:adverse effects / Q000627:therapeutic use*; D003327:Coronary Disease / Q000188:drug therapy*; D004110:Diltiazem / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004562:Electrocardiography; D015716:Electrocardiography, Ambulatory; D006801:Humans; D013997:Time Factors
D015764:Bepridil; D004110:Diltiazem
Etude comparative de la tolérance électrocardiographique et clinique à moyen terme du bépridil par rapport au diltiazem chez le coronarien.