Prevalence of Aging Male Symptoms and Relationship to Testosterone (T) 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-577
Raymond C. Rosen*1, Julia F. Martha1, Stefan T. E. Arver2, Hermann M. Behre3, Thomas Hugh Jones4, Glenn R. Cunningham5, Teresa M. Curto1 and Andre B. Araujo6
1New England Research Institutes, Inc., Watertown, MA, 2Karolinska University Hospital, Stockholm, Sweden, 3Martin Luther University, Halle, D, Germany, 4Barnsley Hospital NHS Foundation Trust, Barnsley, United Kingdom, 5St Luke's Episcopal Hospital, Houston, TX, 6New England Research Institutes, Watertown, MA
Introduction: Hypogonadism (HG) is a common disorder in the aging male with an impact on quality of life. Symptoms experienced by men with this condition are complex. Our objective was to describe the baseline prevalence and severity of aging male symptoms (psychological, somatovegetative, sexual), as assessed by a validated patient questionnaire (Aging Male Symptom Scale (AMS)), and their association with serum T levels in a large, well-characterized 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).  Psychological, somatovegetative and sexual symptoms were assessed using the AMS. Serum T was assessed by mass spectrometry. Differences in geometric mean T in relation to AMS scores were assessed via multivariable linear regression models controlling for age, BMI, HG duration, smoking, exercise, self-rated health, number of comorbidities, time of blood sampling, and country. Sensitivity, specificity and positive/negative predictive value (PPV/NPV) of AMS total scores were examined in relation to unequivocally low T levels (<8nmol/L).

Results: Mean age and T were 59y and 9.5±1.6nmol/L. The prevalence and severity of AMS symptoms by total and subscale scores are shown in Figure 1. More than half the sample (54%) had moderate-severe composite scores, a similar percentage (52%) had moderate-severe psychological, 69% had moderate-severe somatovegetative, and 91% had moderate-severe sexual symptom scores. More than one quarter (28.9%) had T <8nmol/L. A significant association was observed between AMS total scores and T adjusted for age (p=0.01), which was not significant in multivariable analyses (p=0.38). Estimated sensitivity, specificity, PPV and NPV of moderate-severe AMS score for predicting T < 8nmol/L were 0.63, 0.50, 0.33, and 0.78, respectively.

Conclusions: Prevalence of male aging symptoms was high in European hypogonadal men naïve to androgen treatment, with the majority of men reporting moderate to severe sexual and somatovegetative symptoms. T level is unrelated to the severity of aging male symptoms among this group of hypogonadal men. However, the AMS total scores performed modestly well in identifying patients with very low T levels, insofar as sensitivity and specificity were reasonably well-balanced, and NPV was high.

Disclosure: RCR: Consultant, Ferring Pharmaceuticals, Consultant, Eli Lilly & Company, Principal Investigator, Bayer Health Care. STEA: Speaker, Bayer, Inc., Consultant, Bayer, Inc., Speaker, Eli Lilly & Company, Speaker, Ferring Pharmaceuticals, Consultant, Ferring Pharmaceuticals. HMB: Speaker, Jenapharma, Consultant, Lilly USA, LLC. THJ: Consultant, Bayer Healthcare, Researcher, Bayer Healthcare, Speaker, Bayer Healthcare, Consultant, Eli Lilly & Company, Consultant, Pro Strakan, Researcher, Pro Strakan, Speaker, Pro Strakan, Consultant, Merck, Consultant, Clarus. GRC: Member of advisory committees or review panels, Abbott Laboratories, Member of advisory committees or review panels, Ferring Pharmaceuticals, Consultant, Repros Therapeutics, Consultant, Clarus, Consultant, Ligand Pharmaceuticals, Clinical Researcher, Abbott Laboratories. ABA: Principal Investigator, Abbott Laboratories, Principal Investigator, GlaxoSmithKline, Consultant, Eli Lilly & Company. Nothing to Disclose: JFM, TMC

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Sources of Research Support: Bayer Pharma AG