Retrospective, observational study on the effects and tolerability of flutamide in a large population of patients with acne and seborrhea over a 15-year period.
The long-term effects and tolerability of flutamide (Flu) in women with acne and seborrhea were evaluated. Over the 15-year period, which spans from January 1991 to January 2006, a total of 230 Caucasian women with acne, 211 of which also with seborrhea, received yearly reducing doses (250, 125, and 62.5 mg/day) of Flu alone or combined with oral contraceptive for a period varying from 3 to 6 years and more. Clinical and endocrine evaluations were performed half-yearly and yearly, respectively, in the first 3 years of the study, and yearly in the following years. Liver function evaluations were performed quarterly. Both the groups of patients under Flu therapy showed a similar, marked decrease in acne and seborrhea scores after 6 months of treatment compared with basal values. The maximum drug effect was observed after 1 year, and it was maintained during the following years of treatment. Androgens were strongly suppressed during treatment. During the first year of treatment with 250 mg/day, 4.8% of patients interrupted the study due to hepatic disorders. During the following years on the 125 and 62.5 mg/day doses, no transaminase elevation was observed. The study supports very low-dose Flu as a first-line therapy for women with acne and seborrhea.
Department of Obstetrics and Gynecology and Reproductive Biology, S. Orsola Hospital, University Alma Mater Studiorum of Bologna, Bologna, Italy. roberto.paradisi@unibo.it
Roberto
R
Paradisi
Raffaella
R
Fabbri
Eleonora
E
Porcu
Cesare
C
Battaglia
Renato
R
Seracchioli
Stefano
S
Venturoli
D000152:Acne Vulgaris / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D000293:Adolescent; D000328:Adult; D000726:Androgen Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D056486:Chemical and Drug Induced Liver Injury / Q000503:physiopathology; D003276:Contraceptives, Oral / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012628:Dermatitis, Seborrheic / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D016903:Drug Monitoring; D004359:Drug Therapy, Combination; D005260:Female; D005485:Flutamide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008099:Liver / Q000503:physiopathology; D010352:Patient Dropouts; D017060:Patient Satisfaction; D012189:Retrospective Studies; D012720:Severity of Illness Index; D055815:Young Adult
D000726:Androgen Antagonists; D003276:Contraceptives, Oral; D003879:Dermatologic Agents; D005485:Flutamide