ABSTRACT
RATIONALE AND OBJECTIVE: The treatment of active moderate-severe Graves' ophthalmopathy (GO) is based on the administration of highdose intravenous glucocorticoids. The present study compares the efficacy and safety of 2 different intravenous methylprednisolone (MTPiv) dosing regimens. MATERIAL AND METHODS: We carry a retrospective descriptive study with sequential sampling of 24 patients (83% females) presenting moderatesevere GO (EUGOGO criteria) and receiving treatment in our center between January 2006 and June 2008. We use 2 dosing regimens: regimen A (12 weeks): 6 doses of 0.5g/week followed by 6 doses of 0.25 g/week, for a cumulative dose of 4.5 g of MTPiv (n=13); and regimen B (16 weeks): 4 cycles of 15 mg/kg, followed by 4 cycles of 7.5mg/kg, for a cumulative dose of 90 mg/kg (range, 4.9-7.4 g) (n=11). Comparisons were made for safety (fasting glucose, cytolysis-cholestasis enzymes, lipid profile) and efficacy data (clinical improvement and recurrence). RESULTS: Mild-moderate liver cytolysis was recorded in four patients, one with associated moderate cholestasis and another with hyperglycemia, leading to treatment suspension - with no differences between the 2 treatment regimens. Percentage clinical improvement with regimen A was 92% (CI, 65-94%) versus 100% with regimen B (CI, 74-100%). The recurrence rate was 43% with regimen A and 63% with regimen B (p>0.05). None of the variables examined in the univariate logistic regression study were associated to a lesser treatment response or increased risk of recurrence of GO. CONCLUSIONS: The treatment of GO with MTPiv is safe and effective, with a lower recurrence rate when using dosing regimen A.
Subject(s)
Graves Ophthalmopathy/drug therapy , Methylprednisolone/administration & dosage , Adult , Aged , Chemical and Drug Induced Liver Injury/epidemiology , Chemical and Drug Induced Liver Injury/etiology , Drug Administration Schedule , Female , Hashimoto Disease/drug therapy , Humans , Hyperglycemia/chemically induced , Hyperglycemia/epidemiology , Infusions, Intravenous , Male , Methylprednisolone/adverse effects , Methylprednisolone/therapeutic use , Middle Aged , Pulse Therapy, Drug , Recurrence , Retrospective Studies , Treatment OutcomeABSTRACT
Objetivo: El tratamiento de la oftalmopatía de Graves (OG) moderada-grave se basa en la administración de corticoides por vía intravenosa. El presente estudio compara la eficacia y la seguridad de dos regímenes de tratamiento intravenoso con metilprednisolona (MTPiv).Material y método: Se realizó un estudio descriptivo, retrospectivo, con muestreo secuencial de 24 pacientes (el 83% mujeres) que presentaban OG moderada-grave (criterios EUGOGO) y recibieron tratamiento en nuestro centro entre enero de 2006 y junio de 2008. Se utilizaron los dos regímenes siguientes: A (12 semanas), 6 dosis de 0,5 g/semana seguidas de 6 dosis de 0,25 g/semana, con una dosis acumulada de 4,5 g de MTPiv (n = 13);B (16 semanas), 4 ciclos de 15 mg/kg, seguidos de 4 ciclos de 7,5 mg/kg, para una dosis acumulada de 90 mg/kg (intervalo, 4,9-7,9 g) (n = 11). Se compararon las variables de seguridad (glucemia basal, enzimas de colestasis-citólisis, perfil lipídico) y de eficacia (mejoría clínica y recurrencia).Resultados: Se observó citólisis hepática de leve moderada en 4 pacientes, una de ellas asociada a colestasis moderada y otra a hiperglucemia, que determinaron la suspensión del tratamiento, sin diferencias entre regímenes. Hubo mejoría con el régimen A en el 92% (intervalo de confianza[IC] del 95%, 65-94) frente al 100% con el régimen B (IC del 95%, 74-100). La tasa de recurrencia fue del 43% con el régimen A y el 63% con el B (p > 0,05). Ninguna de las variables analizadas en el estudio univariable de regresión logística se asoció a menor respuesta al tratamiento o mayor recurrencia de OG.Conclusiones: El tratamiento de la OG mediante MTPiv es seguro y efectivo, con menor tasa de recurrencia con la dosificación del régimen A (AU)
Rationale and objective: The treatment of active moderate-severe Graves ophthalmopathy (GO) is based on the administration of high-dose intravenous glucocorticoids. The present study compares the efficacy and safety of 2 different intravenous methylprednisolone (MTPiv) dosing regimens.Material and methods: We carry a retrospective descriptive study with sequential sampling of 24 patients (83% females) presenting moderate-severe GO (EUGOGO criteria) and receiving treatment in our center between January 2006 and June 2008. We use 2 dosing regimens: regimen A (12 weeks): 6 doses of 0.5 g/week followed by 6 doses of 0.25 g/week, for a cumulative dose of 4.5 g of MTPiv (n = 13); and regimen B (16 weeks): 4 cycles of 15 mg/kg, followed by 4 cycles of 7.5 mg/kg, for a cumulative dose of 90 mg/kg (range, 4.9-7.4 g) (n = 11). Comparisons were made for safety (fasting glucose, cytolysis-cholestasis enzymes, lipid profile) and efficacy data (clinical improvement and recurrence).Results: Mild-moderate liver cytolysis was recorded in four patients, one with associated moderate cholestasis and another with hyperglycemia, leading to treatment suspension with no differences between the 2 treatment regimens. Percentage clinical improvement with regimen A was 92% (CI, 65-94%) versus 100% with regimen B (CI, 74-100%). The recurrence rate was 43% with regimen A and 63% with regimen B (p > 0.05). None of the variables examined in the univariate logistic regression study were associated to a lesser treatment response or increased risk of recurrence of GO.Conclusions: The treatment of GO with MTPiv is safe and effective, with a lower recurrence rate when using dosing regimen A (AU)
