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Anormalidades valvulares y estado cardiovascular después de la exposición a la dexfenfluramina o
J M Gardin1, D Schumacher, G Constantine
1Division of Cardiology, University of California, Irvine, USA.
JAMA
|February 7, 2001
Resumen
El uso de fenfluramina y fentermina / fenfluramina aumentó la prevalencia de regurgitación aórtica (AR), pero no la regurgitación mitral (MR) o eventos cardíacos graves. Este estudio comparó pacientes tratados con controles para evaluar los riesgos cardiovasculares asociados con estos medicamentos para la obesidad.
Área de la Ciencia:
- Cardiología Cardiología.
- Farmacología Farmacología.
- Salud Pública La salud pública.
Sus antecedentes:
- La fenfluramina y la dexfenfluramina fueron retiradas debido a preocupaciones por la anormalidad de la válvula cardíaca.
- Los estudios anteriores carecían de comparación con controles no tratados, lo que limita la comprensión de los riesgos asociados con las drogas.
Objetivo del estudio:
- Para evaluar el estado cardiovascular y las anomalías valvulares en pacientes tratados por obesidad con dexfenfluramina o fentermina/fenfluramina.
- Para comparar los parámetros cardiovasculares y los hallazgos ecocardiográficos entre los sujetos tratados con anorexigeno y un grupo de control sin tratar emparejado.
Principales métodos:
- Un estudio controlado y ciego al lector realizado en 25 centros clínicos estadounidenses.
- 1473 sujetos elegibles (479 dexfenfluramina, 455 fentermina/fenfluramina, 539 controles) proporcionaron datos clínicos y ecocardiográficos.
- La ecocardiografía evaluó la regurgitación aórtica (AR) y mitral (MR) utilizando criterios de la FDA, junto con la movilidad y el grosor del prospecto de la válvula.
Principales resultados:
- Los signos y síntomas cardiovasculares fueron similares entre los grupos tratados y no tratados.
- Se observó un aumento significativo en la prevalencia de AR tanto en los grupos de dexfenfluramina (8,9%) como en los de fentermina/fenfluramina (13,7%) en comparación con los controles (4,1%).
- No se encontraron diferencias significativas en la prevalencia de MR, cambios en el prospecto de la válvula, presión de la arteria pulmonar, fracción de eyección o eventos cardíacos graves.
Conclusiones:
- El uso de dexfenfluramina y fentermina/fenfluramina se asocia con un aumento de la prevalencia de regurgitación aórtica basada en los criterios ecocardiográficos de la FDA.
- Estos anorexígenos no se asociaron con un aumento de la regurgitación mitral o eventos cardíacos graves.
- Los hallazgos destacan un riesgo cardiovascular específico (RA) relacionado con estos medicamentos para la obesidad previamente recetados.
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