Resumen de Estudio de efectividad y seguridad de la enoxaparina para la profilaxis de la enfermedad tromboembólica venosa en pacientes hospitalizados por patología médica
- español
De los resultados de nuestro trabajo en que evaluamos la efectividad y seguridad de la enoxaparina para la profilaxis de ETEV en una gran población de pacientes ingresados en las áreas médicas del hospital y en el que se obtiene la información de bases de datos administrativas, se concluye que:
1. El tratamiento tromboprofiláctico con enoxaparina en los pacientes médicos no seleccionados, es efectivo en prevenir la Enfermedad Tromboembólica Sintomática durante el ingreso y en reducir la mortalidad.
2. En la práctica clínica habitual la prescripción de enoxaparina para profilaxis de ETEV es mayoritariamente de 40 mg subcutánea al día y es la más efectiva en prevenir la ETEV y reducir la mortalidad. Los pacientes que reciben tromboprofilasis a dosis bajas de enoxaparina 20 mg presentan mayor mortalidad y una tendencia de mayor riesgo de ETV que los tratados con dosis estándar. Igualmente, los pacientes en los que se aumenta la dosis profiláctica, no obtienen mejores resultados.
3. Al retrasar la administración de la heparina durante el ingreso se observa una tendencia a presentar mayor riesgo de desarrollar Enfermedad Troboembólica Venosa, especialmente en el cuarto día.
4. La enoxaparina prescrita a dosis profilácticas es segura dado que no incrementa el riesgo de presentar complicaciones hemorrágicas graves ni trombopenias, evaluadas en una gran población de pacientes según la práctica clínica habitual. Se observa una ligera tendencia a mayor riesgo de complicaciones hemorrágicas a nivel del Sistema Nervioso Central, aunque no es significativa.
5. La seguridad de la enoxaparina a diferentes dosis es similar aunque hay mayor tendencia de complicaciones hemorrágicas con las dosis mayores, sin alcanzar significación estadística posiblemente por no tener la muestra suficiente.
6. El tratamiento tromboprofiláctico supone un coste incremental muy bajo sobre el coste total del ingreso del paciente, por lo que se considera un tratamiento muy eficiente.
7. La contribución de este estudio de investigación para las bases del conocimiento científico existentes, se podrían resumir en que la tromboprofilaxis con enoxaparina en pacientes hospitalizados con patología médica aguda, además de reducir la incidencia de ETEV, reduce la mortalidad y es segura.
- English
Background: Deep venous thromboembolism is a usual and dangerous complication among hospitalised patients that can be prevented. Clinical symptoms are usually absent or are unspecific.
Therefore, adequate primary prevention in high risk patients is of great importance. Thromboembolism prophylaxis is quite well established in surgical patients while knowledge about its benefit in medical patients is not as clear. Published studies are few and some important groups of patients with frequent syndromes have been excluded. Thus, it is very important to know how thromboporphylaxis is performed in daily clinical practice in the medical area, its effectiveness and its safety. The aims of this study were to assess the efficacy and safety of enoxaparin in the prevention of venous thromboembolism in medical inpatients in daily clinical practice, to assess the association between enoxaparin administration delay and venous thromboembolism development and to perform a pharmacoeconomic evaluation.
Methods: This was a retrospective, observational longitudinal descriptive study performed at the “Hospital Universitario Príncipe de Asturias”. Patients included were medical inpatients older than fifteen years that were hospitalized between April 1st 1999 and December 31st 2005. Haematological patients were excluded. Administrative databases and the patient’s clinical record were used to obtain the data (Conjunto Mínimo Básico de Datos, Pharmacy database, analytic database). Patients were stratified in those receiving subcutaneous enoxaparin daily and those who did not; those receiving 20 mg of enoxaparin, 40 mg of enoxaparin or more than 40 mg of enoxaparin. The efficacy outcome was thromboembolism event defined as the combination of deep vein thrombosis and symptomatic pulmonary embolism detected by imaging methods. Safety outcomes were bleeding complications and thrombocytopenia during the hospitalisation time. The outcomes were adjusted for confounding factors (age, sex and Charlson index).
Results: 20.515 patients in the “enoxaparin group” and 19.834 patients in the “non-enoxaparin group” were evaluated for effectiveness analysis. Among patients who received enoxaparin, 3.095 took 20 mg once daily, 17.003 received 40 mg once daily and 417 patients more than 40 mg. 36.052 patients (19.417 enoxaparin vs. 16.635 non-enoxaparin) and 40.165 patients (20.465 enoxaparin vs. non-enoxaparin) were evaluated for safety analysis of bleeding complications and thrombocytopenia respectively. Symptomatic venous thromboembolism was detected in 0,61 % (120/19.834) of patients not treated with enoxaparin and 0,44 % (91/20.515) of patients treated with enoxaparin (OR=0,73; 95% CI: 0,56-0,96; p=0,025). There was a significant reduction in mortality rates once adjusted for confounding factors (age, sex and Charlson Index). The incidence of adverse effects, either bleeding or thrombocytopenia, did not differ significantly between groups.
Conclusions:
- Anticoagulant prophylaxis with enoxaparin was effective in preventing symptomatic venous thromboembolic events in hospitalized medical patients and reduced mortality.
- 40 mg of subcutaneous enoxaparin once daily was the most effective dose in the preventing thromboembolic events and in reducing mortality rates.
- Prophylaxis administration of enoxaparin once daily was safe (it was associated with low risk of bleeding or thrombocytopenia). It was also considered cost-effective as it’s very low increase in total treatment cost per patient occurred.
