Objectives: In a randomised, double-blind, placebo controlled study, we evaluated the tolerability and safety of draflazine, a nucleoside transport inhibitor, in the treatment of patients with unstable angina and non-Q-wave infarction.
Methods: Twenty-one patients were randomised to treatment with draflazine 3.5 mg or matching placebo given as an i.v. infusion and haemodynamic and symptomatic tolerability were investigated. Myocardial ischaemia was evaluated by means of vectorcardiography and blood analysis of the MB fraction of creatine kinase.
Results: The study drug was well tolerated by all patients and it did not cause any adverse haemodynamic effects, nor other serious adverse events. Three patients in the placebo group reported five adverse events, as compared to a single adverse event in the draflazine group. Cardiovascular events were detected in 7 patients in the placebo group and in 5 patients receiving draflazine. The mean duration of chest pain during the 24 hour observation period was 91.4 min in the placebo group compared to 75.5 min in draflazine treated patients. Neither the vectorcardiographic nor biochemical measures of ischaemia differed between treatment groups.
Conclusion: Nucleoside transport inhibition by draflazine was well tolerated by patients with unstable coronary disease. It seems to be a promising method of adenosine enhancement in acute myocardial ischaemia. The potential cardioprotective effect of the drug needs further evaluation in larger trials.