http://onlinelibrary.wiley.com/store/10.1002/smrj.3/asset/smrj3.pdf?v=1&t=hktg8ul2&s=4165942497c87070779dd941969fd8c4181278c9
In contrast, several studies have demonstrated improvements of sexual AEs following drug discontinuation. The Proscar Long Term Efficacy and Safety Study (PLESS) randomized 3,040 men to finasteride 5 mg or placebo with self-reported assessments of sexual AEs [43]. Sexual AEs were statistically increased in finasteride patients in the first year (15% vs. 7%), with no statistical differ- ences identified at years 2–4. Of patients receiving finasteride, 4% discontinued therapy secondary to sexual AEs compared with 2% of placebo patients. Among patients who discontinued therapy due to AEs, 50% of finasteride, and perhaps more surprisingly 41% of placebo, expe- rienced subsequent resolution of symptoms. Oth- erwise stated, 59% of patients receiving placebo therapy continued to experience sexual AEs after drug discontinuation. This suggests that reported findings of persistent sexual AEs associated with 5ARI use may be due to factors other than the drug itself. Kaufman and colleagues similarly demonstrated resolution of sexual AEs in an RCT of 1,553 men following discontinuation of 2 years of finasteride 1 mg [16].
An additional study, highlighting the difficulty of obtaining true prevalence rates of 5ARIs asso- ciated sexual AEs, was provided by Mondaini and colleagues [36]. The authors randomized 120 patients with BPH and IIEF scores >24 to receive finasteride 5 mg for 12 months, with or without specific counseling of potential sexual AEs. At 6 months and 12 months of therapy, patients com- pleted MSHQs. Results demonstrated that patients who were reviewed potential sexual AEs experienced a higher rate of decreased libido, ED, and EjD (counseling/no counseling: 15.3%/7.7%, 43.6%/9.6%, 15.3%/5.7%, respectively) com- pared with those not receiving counseling. The authors termed this increased prevalence of symp- toms the “nocebo effect,” suggesting that the symptoms were secondary to factors other than the medication itself. The study is limited by the absence of placebo control, as the added patient counseling may have helped patients identify symptoms that they might otherwise neglect or be too embarrassed to self-report.
In contrast, several studies have demonstrated improvements of sexual AEs following drug discontinuation. The Proscar Long Term Efficacy and Safety Study (PLESS) randomized 3,040 men to finasteride 5 mg or placebo with self-reported assessments of sexual AEs [43]. Sexual AEs were statistically increased in finasteride patients in the first year (15% vs. 7%), with no statistical differ- ences identified at years 2–4. Of patients receiving finasteride, 4% discontinued therapy secondary to sexual AEs compared with 2% of placebo patients. Among patients who discontinued therapy due to AEs, 50% of finasteride, and perhaps more surprisingly 41% of placebo, expe- rienced subsequent resolution of symptoms. Oth- erwise stated, 59% of patients receiving placebo therapy continued to experience sexual AEs after drug discontinuation. This suggests that reported findings of persistent sexual AEs associated with 5ARI use may be due to factors other than the drug itself. Kaufman and colleagues similarly demonstrated resolution of sexual AEs in an RCT of 1,553 men following discontinuation of 2 years of finasteride 1 mg [16].
An additional study, highlighting the difficulty of obtaining true prevalence rates of 5ARIs asso- ciated sexual AEs, was provided by Mondaini and colleagues [36]. The authors randomized 120 patients with BPH and IIEF scores >24 to receive finasteride 5 mg for 12 months, with or without specific counseling of potential sexual AEs. At 6 months and 12 months of therapy, patients com- pleted MSHQs. Results demonstrated that patients who were reviewed potential sexual AEs experienced a higher rate of decreased libido, ED, and EjD (counseling/no counseling: 15.3%/7.7%, 43.6%/9.6%, 15.3%/5.7%, respectively) com- pared with those not receiving counseling. The authors termed this increased prevalence of symp- toms the “nocebo effect,” suggesting that the symptoms were secondary to factors other than the medication itself. The study is limited by the absence of placebo control, as the added patient counseling may have helped patients identify symptoms that they might otherwise neglect or be too embarrassed to self-report.
