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 Article Swipe
YOU?
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· 2023
· Open Access
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· DOI: https://doi.org/10.1210/jendso/bvad114.1704
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 <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 >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), <52 years; 38.8 (21.9), 52-70 years; 26.8 (21.1), >70 years; P<0.001), body mass index (BMI) (mean IIEF-15: 40.0 (22.2), <30.6kg/m2; 34.4 (21.9), ≥30.6kg/m2; P<0.001), and baseline serum testosterone (mean IIEF-15: 42.2 (23.9), ≥9.8nmol/L; 30.7 (22.1), <9.8nmol/L; P<0.001). Interpretation: In men aged >40 years with serum baseline testosterone <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
Related Topics
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1210/jendso/bvad114.1704
- OA Status
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- Related Works
- 10
- OpenAlex ID
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Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4387380061Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1210/jendso/bvad114.1704Digital Object Identifier
- Title
-
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-analysesWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2023Year of publication
- Publication date
-
2023-10-01Full publication date if available
- Authors
-
Jemma Hudson, Moira Cruickshank, Richard Quinton, Lorna Aucott, Frederick C. W. Wu, Mathis Grossmann, Shalender Bhasin, Peter J. Snyder, Susan S. Ellenberg, Thomas G. Travison, Gerald Brock, Emily Gianatti, Yvonne T. van der Schouw, Mariëlle H. Emmelot‐Vonk, Erik J. Giltay, Hackett Geoff, Sudarshan Ramachandran, Johan Svartberg, Kerry L. Hildreth, Kristina Groti Antonič, Joyce S. Tenover, Hui Meng Tan, Christopher C.K. Ho, Tan Wei Shen, Leonard S. Marks, Richard Ross, Robert S. Schwartz, Stephen A. Roberts, Marianne Andersen, Line Magnussen, Magaly Aceves‐Martins, Siladitya Bhattacharya, Waljit S. Dhillo, Miriam Brazzelli, Channa JayasenaList of authors in order
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https://doi.org/10.1210/jendso/bvad114.1704Publisher landing page
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YesWhether a free full text is available
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goldOpen access status per OpenAlex
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https://doi.org/10.1210/jendso/bvad114.1704Direct OA link when available
- Concepts
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Testosterone (patch), Medicine, Erectile dysfunction, Internal medicine, Placebo, Sexual function, Gynecology, Alternative medicine, PathologyTop concepts (fields/topics) attached by OpenAlex
- Cited by
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0Total citation count in OpenAlex
- Related works (count)
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.P&lt;0.001). | 398 |
| abstract_inverted_index.&gt;40years). | 282 |
| abstract_inverted_index.&lt;12nmol/L, | 409 |
| abstract_inverted_index.&lt;30.6kg/m2; | 381 |
| abstract_inverted_index.&lt;9.8nmol/L; | 397 |
| cited_by_percentile_year | |
| countries_distinct_count | 9 |
| institutions_distinct_count | 35 |
| sustainable_development_goals[0].id | https://metadata.un.org/sdg/3 |
| sustainable_development_goals[0].score | 0.6800000071525574 |
| sustainable_development_goals[0].display_name | Good health and well-being |
| citation_normalized_percentile.value | 0.28688931 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | False |