Evaluation of the impact of dutasteride/tamsulosin combination therapy on libido in sexually active men with lower urinary tract symptoms ( LUTS LUTS ) secondary to benign prostatic hyperplasia ( BPH BPH ): A post hoc analysis of a prospective randomised placebo‐controlled study

摘要

Summary Aims Five‐α reductase inhibitor (5 ARI ) therapy has been associated with sexual dysfunction in some patients. This study assessed the impact of a fixed‐dose combination of the 5 ARI dutasteride 0.5?mg and the α 1 ‐adrenoceptor antagonist tamsulosin 0.4?mg ( DUT ‐ TAM FDC ) on Men's Sexual Health Questionnaire ( MSHQ ) domain scores in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia ( BPH ). Methods This was a post hoc analysis of a double‐blind, randomised, placebo‐controlled, parallel‐group, multicentre study in sexually active patients, aged ≥50?years, with a confirmed clinical diagnosis of BPH . Sexual activity, sexual desire, and bother domain scores of the MSHQ were assessed at baseline and at Months 1, 3, 6, 9, and 12. Correlation between MSHQ sexual activity/desire scores and ejaculation, erection, and satisfaction domains at baseline was also evaluated. Results In the intent‐to‐treat population (N?=?489), 243 and 246 patients were randomised to DUT ‐ TAM FDC and placebo groups, respectively. Compared with placebo, DUT ‐ TAM FDC therapy resulted in statistically significant reductions (worsening) from baseline in adjusted mean MSHQ sexual activity and bother domain scores at Months 1, 3, 6, 9, and 12 (all P ??0.05) and in adjusted mean MSHQ sexual desire domain scores at Months 6, 9, and 12 (all P ??0.05). Significant moderate correlations in the expected direction were observed at baseline between the sexual activity/desire domains and the ejaculation, erection, and satisfaction domains ( P ??0.0001). Conclusions These findings help clarify the degree and impact of libido changes in sexually active men treated with DUT ‐ TAM FDC and may support clinical decision‐making.