Frecuencia de sangrado en pacientes con enfermedades cardiovasculares anticoagulados con warfarina genérica vs. Coumadin / Frequency of bleeding in patients with cardiovascular disease on anticoagulant therapy with generic warfarin vs. Coumadin

RESUMEN

Objetivos: comparar la frecuencia de complicaciones hemorrágicas en pacientes mayores de dieciocho años con enfermedades cardiovasculares que se encuentren anticoagulados con warfarina genérica y en aquellos anticoagulados con Coumadin. Metodología: se realizó un estudio de cohortes de tipo retrospectivo, se tomó una muestra total de 444 pacientes, 222 en terapia con warfarina genérica y 222 en terapia con Coumadin. Resultados: en la muestra de 444 se conoció el género en 406 pacientes, 187 (46.1%) fueron mujeres y 219 (53.9%) hombres. Los diagnósticos más frecuentes por los cuales los pacientes se encontraban anticoagulados fueron reemplazo valvular 265 pacientes y fibrilación auricular 123 pacientes. De todos los pacientes presentaron alguna complicación 194. Al momento de la complicación se encontraban en tratamiento con warfarina genérica 152 pacientes (78.4%) y 42 pacientes se encontraban en tratamiento con Coumadin (21.6%). De los 194 pacientes que presentaron complicaciones, 114 (58.76%) presentaron algún episodio de sangrado. De ellos, presentaron sangrado mayor siete pacientes y sangrado menor 107 pacientes.. Después de la complicación cambiaron de medicamento 47 pacientes, de los cuales lo hicieron de warfarina genérica a Coumadin 39 pacientes, de los cuales mejoraron 94.9% y de Coumadin a warfarina genérica ocho pacientes, con mejoría sólo en 12.5%. Conclusiones: la frecuencia de episodios de sangrado menor es significativamente mayor entre los pacientes anticoagulados con warfarina genérica que en los anticoagulados con Coumadin. Además en los pacientes que presentaron alguna complicación, se observó una mejoría significativa con el cambio de warfarina genérica a Coumadin (Acta Med Colomb 2010; 35: 175-178).

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 (Acta Med Colomb 2010; 35: 175-178).