OR25-05 Clinical Predictors Of Symptomatic Benefit In Men With Low Testosterone During Testosterone Treatment Compared With Placebo: Results Of Individual Patient And Aggregate Data Meta-analyses
Authors: Hudson Jemma , Cruickshank Moira , Quinton Richard , Aucott Lorna , Wu Frederick C , Grossmann Mathis , Bhasin Shalender , Snyder Peter J , Ellenberg Susan , Travison Thomas G , Brock Gerald B , Jaye Gianatti Emily , van der Schouw Yvonne T , Emmelot-Vonk Marielle H , Giltay Erik J , Geoff Hackett , Ramachandran Sudarshan , Bernhard Svartberg Johan , Hildreth Kerry L , Groti Antonic Kristina , Tenover Joyce S , Meng Tan Hui , Chee Kong Christopher Ho , Wei Shen Tan , Marks Leonard S , Ross Richard John M , Schwartz Robert S , Roberts Stephen , Andersen Marianne , Magnussen Line , Aceves-Martins Magaly , Bhattacharya Siladitya , Singh Dhillo Waljit , Brazzelli Miriam , Nalin Jayasena Channa 
Published: October 2023

Disclosure: J. Hudson: None. M. Cruickshank: None. R. Quinton: Speaker; Self; Bayer Schering Pharma, Besins. L. Aucott: None. F.C. Wu: None. M. Grossmann: None. S. Bhasin: None. P.J. Snyder: None. S. Ellenberg: None. T.G. Travison: None. G.B. Brock: None. E.J. Gianatti: None. Y.T. van der Schouw: None. M.H. Emmelot-Vonk: None. E. Giltay: None. H. Geoff: None. S. Ramachandran: None. J.B. Svartberg: None. K.L. Hildreth: None. K. Groti Antonic: None. J.S. Tenover: None. H. Tan: None. C. Ho Chee Kong: None. T. Wei Shen: None. L.S. Marks: None. R.J. Ross: None. R.S. Schwartz: None. S. Roberts: None. M. Andersen: None. L. Magnussen: None. M. Aceves-Martins: None. S. Bhattacharya: None. W.S. Dhillo: None. M. Brazzelli: None. C.N. Jayasena: Grant Recipient; Self; Logixx Pharma Ltd.

Background: Testosterone treatment increases the international index of erectile function 15 (IIEF-15) in young men with pathological hypogonadism. However, testosterone is most frequently prescribed to middle-aged and older men, and men with obesity, whose sexual dysfunction may be unrelated to their low testosterone; prior studies suggest that symptomatic responses to testosterone treatment may be attenuated in older men and those with obesity. To identify subgroups of men with low testosterone experiencing the greatest symptomatic benefit during testosterone therapy, we utilised individual participant data (IPD) from the Testosterone Efficacy and Safety (TestES) Consortium. Methods: Systematic review of randomised controlled trials including IPD meta-analysis (PROSPERO CRD42018111005) identifying clinical efficacy outcomes, and subgroups associated with outcomes in RCTs comparing testosterone with placebo in men with baseline total testosterone &lt;12nmol/L (348ng/dL). One-stage meta-analyses used IPD, and two-stage meta-analyses integrated IPD with aggregate data from studies not providing IPD. Findings: Seventeen of 35 trials provided IPD (3431/5601 participants; mean duration 9.5months; 97% men aged &gt;40years). As expected, testosterone increased IIEF-15 compared with placebo (MD 5.52 (95% CI 3.95, 7.10; τ^2=1.17). However, no significant increment in IIEF-15 during testosterone compared with placebo was observed in smokers (interaction -9.03, 99% CI -48.90, 30.84). Increases in IIEF-15 during testosterone compared with placebo were not associated with patient age, obesity, presence of diabetes, or baseline total testosterone. However, absolute levels of sexual function achieved during testosterone treatment were subject to thresholds in patient age (mean IIEF-15: 46.8 (19.4), &lt;52 years; 38.8 (21.9), 52-70 years; 26.8 (21.1), &gt;70 years; P&lt;0.001), body mass index (BMI) (mean IIEF-15: 40.0 (22.2), &lt;30.6kg/m2; 34.4 (21.9), ≥30.6kg/m2; P&lt;0.001), and baseline serum testosterone (mean IIEF-15: 42.2 (23.9), ≥9.8nmol/L; 30.7 (22.1), &lt;9.8nmol/L; P&lt;0.001). Interpretation: In men aged &gt;40 years with serum baseline testosterone &lt;12nmol/L, we were surprised to observe that increments in IIEF-15 during testosterone treatment are not significantly affected by age, obesity, or baseline testosterone status. However, baseline factors may influence the absolute post-treatment IIEF-15 achieved during testosterone treatment.

Funding: National Institute for Health Research Health Technology Assessment programme (NIHR HTA 17/68/01).

Presentation Date: Saturday, June 17, 2023