Men's Sexual Health Questionnaire score changes vs spontaneous sexual adverse event reporting in men treated with dutasteride/tamsulosin combination therapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia: A post hoc analysis of a prospective, randomised, placebo-controlled study

Abstract

Aim: To assess the impact of baseline characteristics on Men's Sexual Health Questionnaire (MSHQ) total scores and to evaluate the clinical relevance of MSHQ changes and their association with spontaneously reported sexual adverse events (SexAEs) in patients with benign prostatic hyperplasia.

Methods: This was a post hoc analysis of the Phase 4 FDC116115 study, in which patients aged ≥50 years were randomised 1:1 to receive a fixed-dose combination of dutasteride 0.5 mg and tamsulosin 0.4 mg (DUT-TAM FDC), or placebo. End-points included: change in MSHQ total scores by baseline characteristics and SexAEs; cumulative distribution function for change from baseline to month 12 in MSHQ total score and the ejaculation, erection, satisfaction and sexual desire (libido) domain scores; and relationship between changes in MSHQ scores and SexAEs.

Results: The intent-to-treat population comprised 489 patients (DUT-TAM FDC, n = 243; placebo, n = 246). The mean reduction in total MSHQ score was greater in patients with SexAEs across both groups, compared with patients without SexAEs. Most patients reporting any SexAE (86% DUT-TAM FDC, 67% placebo) had a worsening of the MSHQ total score at month 12 compared with baseline. Specifically, 90% (DUT-TAM FDC) and 75% (placebo) of patients reporting an ejaculation SexAE and 73% (DUT-TAM FDC) and 87% (placebo) of patients reporting an erection SexAE had a worsening of MSHQ ejaculation and erection domain scores, respectively, at month 12. A threshold effect for incident SexAE was observed; patients showing a decrease of approximately 6-10 points in the total MSHQ score were more likely to report SexAEs.

Conclusion: Findings support the clinical utility of the MSHQ tool in assessing the impact of DUT-TAM on sexual function by linking numerical changes in MSHQ scores to spontaneously reported SexAEs for the first time. The threshold effect for incidence of SexAEs warrants further investigation to determine its clinical relevance.

Figure 1

Cumulative distribution function plot for change from baseline in MSHQ, illustrating the cumulative proportion of patients in each treatment group (y axis) who have a given change in MSHQ scores (x axis) at month 12 (LOCF). (A) total MSHQ, (B) ejaculation domain, (C) erection domain, (D) sexual desire (libido) domain and (E) satisfaction domain scores at month 12 (LOCF). DUT‐TAM FDC, fixed‐dose combination of dutasteride 0.5 mg and tamsulosin 0.4 mg; LOCF, last observation carried forward; MSHQ, Male Sexual Health Questionnaire

Figure 2

(A) MSHQ total, (B) ejaculation domain, (C) erection domain and (D) sexual desire domain score changes from baseline to month 12 (LOCF) and spontaneously reported SexAEs. DUT‐TAM FDC, fixed‐dose combination of dutasteride 0.5 mg and tamsulosin 0.4 mg; LOCF, last observation carried forward; MSHQ, Male Sexual Health Questionnaire; SexAE, sexual adverse event

Figure 3

Change from baseline at month 12 (LOCF) for (A) total MSHQ score (patients with ≥1 SexAE); (B) MSHQ ejaculation domain score (patients with ≥1 ejaculation‐related SexAE); (C) MSHQ erection domain score (patients with ≥1 impotence‐related SexAE); (D) MSHQ sexual desire (libido) domain score (patients with ≥1 altered [decreased] libido SexAE). Each data point represents one patient who was randomised to DUT‐TAM FDC or placebo. The solid rectangle and the outline rectangle denote those patients who had (A) a sexual AE; (B) an ejaculation‐related AE; (C) an impotence‐related AE; or (D) an altered (decreased) libido AE with onset after the first dose of randomised study drug or with missing onset date. The solid rectangle denotes those patients for whom every AE was resolved by month 12. AE, adverse event; DUT‐TAM FDC, fixed‐dose combination of dutasteride 0.5 mg and tamsulosin 0.4 mg; LOCF, last observation carried forward; MSHQ, Male Sexual Health Questionnaire; SexAE, sexual adverse event