Comparison of a new microcrystalline dicoumarol preparation with warfarin under routine treatment conditions.

1 To determine whether two different oral anticoagulants show difference under routine clinical conditions, 71 patients were randomized to treatment with Apekumarol, a microcrystalline dicoumarol preparation, and 72 patients to treatment with warfarin. 2 During the inpatient phase of treatment both drug groups remained for about 94% of their treatment time within prothrombin value limits of 5-25% (Simplastin A). No statistically significant difference was found between the drugs. 3 While under outpatient care, both drug groups remained for about 80% of their treatment time within prothrombin value limits of 5-25%. No statistically significant difference was found between the drugs. 4 The intensity of control and number of prothrombin-determinations did not differ significantly between the groups. 5 Variations in the daily dose did not differ significantly between the groups. 6 The mean daily dose could not be correlated to mean body weight. 7 The mean daily dose decreased with age for the male patients taking warfarin, not for the female patients. There was no such decrease for either male or female patients taking Apekumarol. An additional 137 patients who at the time of the trial were under routine treatment with warfarin were also studied with regard to mean daily dose, age and sex. In this additional group the mean daily dose could be correlated with age in both males and females. 8 No difference between Apekumarol and warfarin could be demonstrated when tested under routine clinical conditions according to the design of the present study. Sensitivity for warfarin, but not for Apekumarol, seems to increase with age, this sensitivity has been demonstrated in both sexes.

RCT Entities:   Population Interventions Outcomes