A double-blind clinical and ECG-evaluation ofIidoflazine(R7904) in the treatment of stabilized angina pectoris

SummaryThirty-nine patients with stabilized angina pectoris were selected and allocated at random to either lidoflazine or placebo treatment.Lidoflazine tablets each containing 60 mg. were matched with placebo tablets under double-blind conditions and the patients were given 1 tablet t.i.d.for the first 5 weeks and thereafter 2 tablets t.i.d. or less, according to either individual subjective improvement or side-effects, for 25 more weeks. Previously prescribed prenylamine was initially maintained in all patients. Dosage reduction took place according to individual subjective requirements.At the end of the trial, the comparison between lidoflazine and placebo patients revealed the following significant differences in favour of lidoflazine: improvement of social performance and working capacity (p=0.033); less need for prenylamine (p=0.013) and smaller 'optimum' daily dose of the double-blind medication (p=0.018); a more frequent improvement according to the global appreciation of the ST-T changes (p=0.0037), with an increase in the amplitude of the T-wave (p=0.0035) and a decrease in both J-point depression (p=0.0097) and negative ST-integral per sec (p=0.0097); increased (TI-TIII) and (TV6-TV1) (p=0.044 and p=0.00017 respectively); shorter P-waves and a lower Macruz' index (p=0.013 and 0.00017 respectively).There was no difference between both treatments as regards incidence and type of clinical and ECG side-effects, and changes in the investigated biochemical and haematological variables. Drug interactions, especially those between lidoflazine and prenylamine or anticoagulants, never occurred.