Reporting on adverse events in clinical trials involving sexually active men with benign prostatic hyperplasia (BPH) are inaccurate and doctors fear this may lead to incorrect estimates of the treatment impact on sexual function.
“Spontaneous adverse event reporting including sexually related AEs in clinical trials is imprecise, arbitrary and may lead to under or overestimation of the treatment impact on sexual function,’’ reported Prof. Claus Roerhrborn during Plenary Session 5’s Breaking News segment.
Roerhrborn led the study, which looked into the impact of dutasteride/tamsulosin combination therapy on sexual function domains in sexually active men with benign prostatic hyperplasia (BPH).
The study is considered the first prospective study using a validated questionnaire that provides a domain-specific assessment of the effects of dutasteride and tamsulosin FDC treatment on sexual function.
Roerhrborn noted that the vast body of male LUTS/BPH literature contains hundreds of studies in which adverse events, including sexual dysfunction, are recorded as spontaneously reported by patients during follow-up visits.
The study’s primary aim was to assess the change in sexual function from baseline to one year in sexually active men with at least moderate BPH (IPSS >12) who were treated with the fixed dose combination (FDC) of dutasteride 0.5 mg and tamsulosin 0.4 mg (one capsule daily) versus treatment with placebo.
“Existing evidence endorsed by clinical guidelines supports the long-term use of dutasteride plus tamsulosin FDC treatment in men with moderate-to-severe LUTS/BPH at increased risk of progression,” said Roerhrbron in his summary remarks.
He also gave the following take-home messages:
- The GlaxoSmithKline FDC116115-sexual function study provides clear evidence that our interpretation of sexually related AEs based on spontaneous event reporting was incomplete;
- There is no evidence for persistent erectile dysfunction 6 months after cessation of therapy as the rates of erectile dysfunction are identical in both treatment groups; and
- The persistence of higher rates of ejaculatory dysfunction is a direct reflection of the mechanism of action resulting in decreased prostate volume and semen fluid, which is not fully recovered after 6 months off-therapy.