Testosterone undecanoate is associated with improved ageing male symptoms score in men with type 2 diabetes and adult-onset testosterone deficiency: re-analyzed results from a randomised controlled trial-Reference-Cited by-同舟云学术

Testosterone undecanoate is associated with improved ageing male symptoms score in men with type 2 diabetes and adult-onset testosterone deficiency: re-analyzed results from a randomised controlled trial

Published:2024-08-13 Issue: Volume: Page:177-190
ISSN:
Container-title:Exploration of Endocrine and Metabolic Diseases
language:
Short-container-title:Explor Endocr Metab Dis

Author:

Ramachandran Pravinath¹^ORCID,Zitzmann Michael²^ORCID,König Carola S.³^ORCID,Mulhern Joseph⁴,Ramachandran Sudarshan⁵^ORCID,Hackett Geoffrey⁶^ORCID

Affiliation:

1. College of Psychology, Birmingham City University, B4 7BD Birmingham, United Kingdom

2. Department of Clinical and Surgical Andrology, Centre of Reproductive Medicine and Andrology, Münster University Hospital, 48149 Münster, Germany

3. Department of Mechanical and Aerospace Engineering, Brunel University London, UB8 3PH London, United Kingdom

4. Department of Clinical Biochemistry, University Hospitals Birmingham NHS Foundation Trust, B75 7RR West Midlands, United Kingdom

5. Department of Mechanical and Aerospace Engineering, Brunel University London, UB8 3PH London, United Kingdom; Department of Clinical Biochemistry, University Hospitals Birmingham NHS Foundation Trust, B75 7RR West Midlands, United Kingdom; Department of Clinical Biochemistry, University Hospitals of North Midlands, ST4 6QG Staffordshire, United Kingdom; School of Pharmacy and Bioengineering, Keele University, ST5 5BG Staffordshire, United Kingdom

6. School of Health and Life Sciences, Aston University, B4 7ET Birmingham, United Kingdom

Abstract

Aim: To evaluate changes in quality of life via the ageing male symptom scale (AMSS) and somatic, psychological, and sexual sub-scales following testosterone undecanoate (TU) or placebo (P) treatment in men with type 2 diabetes mellitus (T2DM) and adult-onset testosterone deficiency (TD) via a re-analysis of the BLAST (Burntwood, Lichfield, Atherstone, Sutton Coldfield, and Tamworth) randomised controlled trial (RCT). Methods: Analysis of data from the BLAST RCT in men with T2DM and adult-onset TD was performed. Summation baseline and study-end AMSS data were available in 170 men (94: P; 76: TU) with subscale data available in 82 men. Rank-sum and sign-rank tests determined inter/intra-group differences, whilst linear/multiple regression models identified predictors of AMSS change. Results: AMSS improved significantly in P [–2 (median), p = 0.010] and TU [–6 (median), p < 0.0001)] arms, with greater improvement observed in men on TU (p = 0.014). No significant change was seen in either arm with baseline AMSS < 27 (asymptomatic). TU was significantly associated with AMSS improvement in all symptomatic AMSS categories. Improvement in the P arm was confined to men with baseline AMSS > 49. In the cohort with subscale AMSS data, TU was associated with improvements in somatic, psychological, and sexual subscales, whilst improvement was limited to the somatic subscale in the men on P. TU (reference: P) and higher baseline AMSS were significantly and independently associated with AMSS improvement. The improvement in summation AMSS associated with TU (reference: P) was only evident in men with mild depression and no anxiety (based on baseline Hospital Anxiety and Depression Scale data). Conclusions: TU appeared associated with improved AMSS (summation and subscales) in men with T2DM and adult-onset TD demonstrating symptoms (AMSS ≥ 27) with this benefit mediated by levels of depression and anxiety (European Union Clinical Trials Register, EudraCT 2008-000931-16).

Publisher

Open Exploration Publishing

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