Elsevier

Urology

Volume 61, Issue 3, March 2003, Pages 579-584
Urology

Adult urology: CME article
Incidence and severity of sexual adverse experiences in finasteride and placebo-treated men with benign prostatic hyperplasia

https://doi.org/10.1016/S0090-4295(02)02401-9Get rights and content

Abstract

Objectives

To evaluate the incidence and resolution of sexual adverse experiences (AEs) in men with benign prostatic hyperplasia treated with finasteride 5 mg compared with placebo.

Methods

The Proscar Long-term Efficacy and Safety Study (PLESS) was a 4-year, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of finasteride 5 mg in 3040 men, aged 45 to 78 years, with symptomatic benign prostatic hyperplasia, enlarged prostates, and no evidence of prostate cancer. Patients completed a questionnaire at screening regarding their history of sexual dysfunction. During treatment, spontaneously self-reported sexual AEs were recorded.

Results

At screening, 46% of patients in each treatment group reported some history of sexual dysfunction. During year 1 of the study, 15% of finasteride-treated patients and 7% of placebo-treated patients had sexual AEs that were considered drug related by the investigator (P <0.001). During years 2 to 4, no between-group difference was noted in the incidence of new sexual AEs (7% in each group). The drug-related sexual AE profile for finasteride was similar for men with or without a history of sexual dysfunction. Sexual AEs resolved while continuing therapy in 12% of finasteride patients and 19% of placebo patients. Only 4% of finasteride and 2% of placebo patients discontinued the study because of sexual AEs. In men who discontinued with a sexual AE, 50% and 41% experienced resolution of their sexual AE after discontinuing finasteride or placebo therapy, respectively.

Conclusions

Compared with placebo, men treated with finasteride experienced new drug-related sexual AEs with an increased incidence only during the first year of therapy.

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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      There was found to be an increased risk of hypoactive sexual desire (odds ratio [OR], 1.54 (1.30; 1.81); P<.0001) and ED (OR, 1.47 (1.29; 1.68); P<.0001) compared with placebo, with no difference in effect between finasteride and dutasteride. The negative effects were inversely related to the trial duration, which has been noted in other studies although underlying reasons are unclear (17–19). Therefore, although some of these effects may resolve within the first year of treatment, it may be permanent for some men and should be discussed with the patient.

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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.

    *

    A complete list of the PLESS Study Group is provided in the Appendix.

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