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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.
Roehrborn, Claus G; Rosen, Raymond C; Manyak, Michael J; Palacios-Moreno, Juan Manuel; Wilson, Timothy H; Lulic, Zrinka; Giuliano, François.
Afiliação
  • Roehrborn CG; Department of Urology, UT Southwestern Medical Centre, University of Texas, Dallas, TX, USA.
  • Rosen RC; HealthCore/New England Research Institutes, Watertown, MA, USA.
  • Manyak MJ; GSK, Washington, DC, USA.
  • Palacios-Moreno JM; GSK, Madrid, Spain.
  • Wilson TH; PAREXEL International, Durham, NC, USA.
  • Lulic Z; GSK, Brentford, UK.
  • Giuliano F; Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, Garches, France.
Int J Clin Pract ; 74(5): e13480, 2020 May.
Article em En | MEDLINE | ID: mdl-31927774
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 11 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.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Hiperplasia Prostática / Sintomas do Trato Urinário Inferior / Saúde Sexual / Dutasterida / Tansulosina Tipo de estudo: Clinical_trials / Diagnostic_studies / Etiology_studies / Observational_studies / Risk_factors_studies Limite: Aged / Humans / Male / Middle aged Idioma: En Revista: Int J Clin Pract Assunto da revista: MEDICINA Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Hiperplasia Prostática / Sintomas do Trato Urinário Inferior / Saúde Sexual / Dutasterida / Tansulosina Tipo de estudo: Clinical_trials / Diagnostic_studies / Etiology_studies / Observational_studies / Risk_factors_studies Limite: Aged / Humans / Male / Middle aged Idioma: En Revista: Int J Clin Pract Assunto da revista: MEDICINA Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Estados Unidos