[Treatment of benign prostatic hyperplasia with finasteride. Results after 7 years of follow-up].
Our centre took part in an international, multicentre, Phase III trial with Finasteride (MK-906) in the treatment of BPH. In the first year, this was a double-blind, randomised, placebo-controlled study which included 25 patients who were randomly assigned: 9 to treatment with placebo, 8 to finasteride 1 mg and 8 to finasteride 5 mg. After the first year, all patients were assigned to finasteride 5 mg as a single daily dose taken before breakfast. Of the 25 patients who started the trial, 7 have completed 7 years treatment (28%): 1 from the placebo group. 1 from finasteride 1 mg, and 5 who took finasteride 5 mg throughout the study. Total symptoms score, assessed by the modified Boyarsky questionnaire, improved during the first year 4.97 points (51%) and remained unchanged up to year 7 with a final reduction of 6.2 points (64%). Percentual increase in peak urinary flow during follow-up ranged between 21 and 45.9% with an absolute increase at 7 years of 4.2 mL/seg (47.5%) and a reduction in prostate volume of 26%. Finasteride tolerance was excellent at all times, and no serious clinical reaction was seen in laboratory parameters. Two patients reported decreased libido and sexual potency and 1 decreased libido. In summary, since after 7 years of treatment efficacy is maintained in at least 30% of patients with an excellent safety profile, finasteride can be considered an alternative in the medical treatment of BPH.
Martínez Sarmiento
M
M
Servicio de Urología, Hospital Universitario La Fe, Valencia.
Cuñat Albert
E
E
López Alcina
E
E
Pontones Moreno
J L
JL
Sanz Chinesta
S
S
Jiménez Cruz
J F
JF
D004311:Double-Blind Method; D018120:Finasteride / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011470:Prostatic Hyperplasia / Q000188:drug therapy*
D018120:Finasteride