Administration of gallopamil by long-term venous infusion in spontaneous angina. A single-blind, self-controlled study versus placebo.

In order to assess the efficacy and tolerability of gallopamil (D-600, CAS 16662-47-8) by long-term venous infusion in the treatment of spontaneous angina, 15 consecutive patients were studied in a single-blind, self-controlled trial versus placebo. Following a 24-h Holter ECG recording of the patients receiving a saline infusion (run-in phase), i.v. administration of gallopamil was started at a dose of 0.02 mg/kg/h preceded by a 0.03 mg/kg bolus. After 24 h, the dosage was increased to 0.03 mg/kg/h and the infusion was maintained for another 48 h. The Holter ECG recording was repeated in the last 24 h of treatment and after 6 h from withdrawal (washout phase). The reduction in the number of angina attacks, as shown by a comparison between the average of the two placebo periods (run-in and washout phases) and the three days of treatment, was 68.2%, 92.5%, and 87%, respectively. Consumption of glyceryl trinitrate decreased by 92.5% on each one of the three days of treatment. The reduction in the number of ischemic episodes (IEs) with symptomatic (-91.6%) and silent (-98.0%) ST elevation, and with symptomatic (-100%) and silent (-90%) ST depression, also proved significant. Heart rate decreased only moderately. One patient showed a mild first-degree heart block, while another suffered a transient episode of isorhythmic A-V dissociation. In conclusion, when administered by venous infusion, gallopamil has been found to be well tolerated and highly effective in the treatment of spontaneous angina.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes