información científica


17FEB 2016
Blasiak RC1, Stamey CR2, Burkhart CN1, Lugo-Somolinos A1, Morrell DS1. JAMA Dermatol. 2013 Dec;149(12):1392-8. doi: 10.1001/jamadermatol.2013.6746 .
1Department of Dermatology, School of Medicine, University of North Carolina at Chapel Hill.
2Currently a medical student at the School of Medicine, University of North Carolina at Chapel Hill.
IMPORTANCE: Isotretinoin is the most effective treatment for acne. The ideal dosing regimen is unknown.
OBJECTIVE: To determine the rates of relapse of acne vulgaris and retrial of isotretinoin after high cumulative-dose treatment and the changes to the adverse effect profile.
DESIGN, SETTING, AND PARTICIPANTS: A prospective, observational, intervention study was conducted from August 1, 2008, to August 31, 2010, in a single academic tertiary care center with multiple providers. A total of 180 patients with acne resistant to other treatments were enrolled. Of these, 116 participated in the 12-month follow-up survey, for a response rate of 64.4%.
EXPOSURE: Patients received isotretinoin, with dosing based on the providers' judgment. Patients were divided into 2 groups on the basis of cumulative dosing (<220 mg/kg and ? 220 mg/kg).
MAIN OUTCOMES AND MEASURES: Relapse (treatment with a prescription topical or oral acne medication after a course of isotretinoin) or retrial (retreatment with isotretinoin) at 12-month follow-up and adverse effects experienced during and after 12 months of treatment. RESULTS The mean age of the participants was 19.3 years, 51.9% were female, and 74.1% were white. At 12 months' follow-up, 97.4% of the patients reported that their acne was improved. Overall, acne in 32.7% of patients in the study relapsed at 12 months, and 1.72% of the patients required a retrial. In the lower-dose treatment group (<220 mg/kg), the relapse ratewas 47.4% (95% CI, 32.3%-63.0%) compared with 26.9% (95% CI, 18.3%-37.8%) in the high-dose group (P = .03). Almost 100% of the patients in both treatment groups developed cheilitis and xerosis during treatment. Retinoid dermatitis was significantly more common in the high-dose treatment group (53.8% vs 31.6%; P = .02). None of the other adverse effects was significantly different between the 2 groups.
CONCLUSIONS AND RELEVANCE: The dosing regimen used in the present study is considerably higher than that used in previous studies of isotretinoin. At 1 year after completion of isotretinoin treatment, we found that patients receiving 220 mg/kg or more had a significantly decreased risk of relapse. Rash was the only adverse effect that wassignificantly more common in the high-dose group during treatment. This study suggests that significantly higher doses of isotretinoin are effective for treating acne and decreasing relapse rates without increasing adverse effects.

“Las recaídas son menores (con las dosis convencionales entre un 20 y un 60%), especialmente en el grupo de dosis más altas (?220 mg/kg) y además esta menor proporción de recaídas no supone aumento significativo de los efectos adversos.”


Rafael Botella Estrada.Jefe del Servicio de Dermatología. Hospital Universitario La Fe, Valencia. Profesor de Dermatología. Univ. de Valencia.

El objetivo de este estudio es conocer el porcentaje de recaídas, de necesidad de tratamiento y el perfil de efectos adversosde la isotretinoína a altas dosis.

Para ello dividen 180 pacientes con acné y con prescripción de isotretinoína en dos grupos con 12 meses de seguimiento. Un grupo al que le prescriben una dosis de <220 mg/Kg y otro grupo con dosis ?220 mg/kg.

La dosis media acumulada para cada grupo fue de 309.8 mg/kg para el grupo de dosis alta frente a una dosis media de 170.8 mg/kg para el grupo de menos dosis. La duración media del tratamiento fue de 6,3 meses.

Los resultados que obtienen en ambos grupos en global son, un 97,4% de mejoría, una recaída al año del 32,7% y una necesidad de retratamiento del 1,72%. La recaída al año del tratamiento fue mayor en el grupo de <220 mg/Kg de forma estadísticamente significativa (47,4% vs 26,9%). Sin embargo, los efectos adversos fueron similares con un 100% queilitis y xerosis en ambos grupos, aunque la dermatitis por retinoide fue mayor en el grupo de ?220 mg/kg.

Las dosis pautadas en este estudio son más altas que las convencionales de 120 - 150 mg/ Kg