Association between Endogenous Testosterone (T) Levels, Sexual Dysfunction and PDE-5 Inhibitor (PDE5i) Use in the Registry of Hypogonadism in Men (RHYME)

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: SAT 554-583-Male Reproductive Endocrinology & Case Reports
Saturday, June 15, 2013: 1:45 PM-3:45 PM
Expo Halls ABC (Moscone Center)

Poster Board SAT-576
Raymond C. Rosen*1, Mario Maggi2, Hermann M. Behre3, Frederick C. W. Wu4, Glenn R. Cunningham5, Teresa M. Curto1, Julia F. Martha1 and Andre B. Araujo6
1New England Research Institutes, Inc., Watertown, MA, 2AOU Careggi - University of Florence, Florence, Italy, 3Martin Luther University, Halle, D, Germany, 4Central Manchester University Hospitals NHS Foundation Trust, Manchester, United Kingdom, 5St Luke's Episcopal Hospital, Houston, TX, 6New England Research Institutes, Watertown, MA
Introduction: Hypogonadism (HG) and sexual dysfunction are common disorders in the aging male. Community studies have revealed a moderate association between sub-normal T and decreased sexual desire and erectile function, although these findings have not been confirmed in untreated, patient populations and the impact of PDE5i use is unknown. We describe the baseline prevalence of sexual dysfunction (loss of desire, erectile dysfunction (ED)), as assessed by validated questionnaires (international index of erectile function (IIEF)) and medical record review, its association with endogenous T levels and whether this relationship is influenced by PDE5i use in a large, well-characterized registry cohort of hypogonadal men.

Methods: RHYME is a multi-center registry of 999 men with clinically-diagnosed HG (naïve to androgen treatment) from 25 sites in 6 European countries (DE/ES/IT/NL/SE/UK). ED, PDE5i use, and low sexual desire were assessed in all patients (n=999) by medical record review. In sexually active patients (N=752), ED and low sexual desire were also assessed by the IIEF sexual desire (SD) and erectile function (EF) domains. Serum T at baseline was assessed by mass spectrometry. Differences in geometric mean T in relation to sexual activity, ED, PDE5i use and low sexual desire were assessed via linear regression models.

Results: The mean age of the cohort was 59.1±10.5y and mean baseline T was 9.5±1.6nmol/L. More than three quarters (76.4%) of the sample were sexually active at the time of enrollment and sexually active hypogonadal men had higher baseline T relative to inactive men (9.9 vs 8.5nmol/L; p<.001). High overall rates of sexual dysfunction were observed in both sexually active and inactive participants. 64.7% of the total sample presented with decreased desire and 81.0% with loss of erection. Those with complaints of low desire had significantly lower mean T than those without (9.3 vs 10.0 nmol/L; p=0.03). Based on IIEF-EF scores in sexually active men, 34.8% had severe ED, 31.1% had moderate ED, and 34.1% had mild or no ED. While men with ED (presenting complaints or severe/moderate IIEF scores) did not have lower T overall, those being treated with PDE5i had significantly higher mean T than untreated men (11.0 vs 9.1nmol/L, p<0.0001). Rates of PDE5i use were highest in ES (44.2%) and lowest in Italy (9.4%), and were more than twice as high in urology (35.9%) compared to endocrinology or general medicine (16.1%) practices.

Conclusions: Prevalence of sexual dysfunction and rates of PDE5i use are high in our large cohort of European hypogonadal men before starting androgen treatment, although substantial variations were observed by practice specialty and country. PDE5i use was associated with higher endogenous T in men with ED whereas loss of sexual desire and sexual inactivity were associated with the lowest levels of T.

Disclosure: RCR: Consultant, Eli Lilly & Company, Consultant, Ferring Pharmaceuticals, Principal Investigator, Bayer Health Care. MM: Consultant, Eli Lilly & Company, Consultant, Bayer, Inc.. HMB: Speaker, Jenapharma, Consultant, Lilly USA, LLC. FCWW: Consultant, Eli Lilly & Company, Consultant, Galapagos ( Mechelen, Belgium), Consultant, Ligand Pharmaceuticals Inc (San Diego, CA), Consultant, Novartis Pharmaceuticals, Speaker, Bayer Schering Pharma, Speaker, Eli Lilly & Company. GRC: Consultant, Ligand Pharmaceuticals, Consultant, Clarus, Consultant, Repros Therapeutics, Member of advisory committees or review panels, Ferring Pharmaceuticals, Member of advisory committees or review panels, Abbott Laboratories, Clinical Researcher, Abbott Laboratories. ABA: Principal Investigator, Abbott Laboratories, Principal Investigator, GlaxoSmithKline, Consultant, Eli Lilly & Company. Nothing to Disclose: TMC, JFM

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Sources of Research Support: Bayer Pharma AG