Frequency of bleeding in patients with cardiovascular disease on anticoagulant therapy with generic warfarin vs. Coumadin

Abstract

Objectives: to compare the frequency of bleeding complications in patients older than 18 years with cardiovascular diseases on anticoagulant therapy with generic warfarin with that of patients receiving Coumadin, and thus to obtain information allowing optimization of treatment for these patients. Methodology: a retrospective cohort study that examined a sample of 444 patients; 222 of them were in therapy with generic warfarin, and the remaining 222 with Coumadin. Results: it was possible to establish the age of 284 patients of the 444 included in the sample. It ranged from 19 to 99 years, with a mode of 70 years. The sex of 406 patients was known: 187 (46.1%) were women and 219 (53.9%) men. The most common diagnoses leadind to anticoagulant therapy were a mechanical valve replacement in 265 patients and atrial fibrillation in 123 patients. Of all the patients included in the study, 194 had some complication. At the moment of the complication, 152 (78.4%) patients were being treated with generic warfarin and 42 (21.6%) with Coumadin Of the 194 patients who had complications, 114 (58.76%) had some kind of bleeding episode. 7 patients had major bleeding, and 107 had a minor episode. Besides the bleeding there were other complications such as nausea, headaches, vomiting, diarrhea, and anaphylaxis. After the complication, 47 patients were switched from generic warfarin to Coumadin. An improvement was seen in 94.9%. 8 patients were switched from Coumadin to generic warfarin, and improvement was seen in only 12.5%. Conclusions: the frequency of minor bleeding episodes is significantly higher in patients treated with generic warfarin than in those treated with Coumadin. In patients who presented with complications and were switched from generic warfarin to Coumadin, a major improvement was observed. This finding was not observed in patients switched from Coumadin to generic warfarin