Adult urology: CME articleIncidence and severity of sexual adverse experiences in finasteride and placebo-treated men with benign prostatic hyperplasia☆
Section snippets
Study design and patient entry criteria
PLESS was a 4-year, randomized, double-blind, placebo-controlled trial in which 3040 men aged 45 to 78 years with moderate to severe symptomatic BPH, an enlarged prostate by digital rectal examination, and no evidence of prostate cancer were randomized to receive placebo or finasteride 5 mg.5 The exclusion criteria included treatment with alpha-adrenergic-blocking agents or clonidine within 2 weeks or with anti-androgenic or investigational drugs during the preceding 3 months. At a screening
Results
Of the 3040 men randomized into the study, 1524 received finasteride and 1516 received placebo. The baseline characteristics of the randomized patients were similar in both treatment groups (Table I). During the course of the 4-year study, 22% and 14% of the finasteride and placebo-treated patients, respectively, reported one or more drug-related sexual AEs (P <0.001). The baseline levels of prostate-specific antigen, testosterone, or DHT were not different in men with or without sexual AEs
Comment
The results of this double-blind, randomized, placebo-controlled, 4-year trial in men with BPH and enlarged prostate glands confirm the high background prevalence of sexual dysfunction in this patient population. Nearly one half of the men (46%) in both treatment arms reported having sexual dysfunction that was present either before or during screening, with 33% of men in each arm having a history of erectile dysfunction. These data are consistent with two previous studies of finasteride in
Conclusions
Baseline sexual dysfunction is prevalent in men with moderate to severe symptoms of BPH. Finasteride therapy is associated with a greater incidence of sexual AEs during the first year of therapy, after which they are no more common than with placebo treatment. The likelihood of developing sexual AEs during finasteride treatment is not predicted by pre-existing sexual dysfunction, serum testosterone levels (in men with normal levels) or serum DHT levels. In the vast majority of patients, sexual
Acknowledgements
To the many investigators, study coordinators, and patients who contributed to this study; the individual primary investigators who participated in this study have been listed in a previously published report.5
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This study was supported by a grant from Merck & Co., Inc.
J. Culbertson, M. Lee, M. A. Bach, and J. Waldstreicher are employees of, and hold stock in, the sponsor. H. Wessells, J. Bannow, J. Grayhack, A. M. Matsumoto, R. Herlihy, W. Fitch, R. F. Labasky, R. Parra, and J. Rajfer are study investigators funded by the sponsor. J. B. Roy is a study investigator funded by, a paid consultant to, a member of the speaker’s bureau for, and holds stock in, the sponsor.