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Effect of testosterone treatment on cardiac biomarkers in a randomized controlled trial of men with type 2 diabetes
Author(s) -
Gianatti Emily J.,
Hoermann Rudolf,
Lam Que,
Dupuis Philippe,
Zajac Jeffrey D.,
Grossmann Mathis
Publication year - 2016
Publication title -
clinical endocrinology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.055
H-Index - 147
eISSN - 1365-2265
pISSN - 0300-0664
DOI - 10.1111/cen.12842
Subject(s) - medicine , testosterone (patch) , endocrinology , placebo , type 2 diabetes , natriuretic peptide , diabetes mellitus , troponin t , myocardial infarction , heart failure , alternative medicine , pathology
Summary Objective To assess the effect of testosterone treatment on cardiac biomarkers in men with type 2 diabetes (T2D). Design Randomized double‐blind, parallel, placebo‐controlled trial. Patients Men aged 35–70 years with T2D and a total testosterone level ≤12·0 nmol/l (346 ng/dl) at high risk of cardiovascular events, median 10‐year United Kingdom Prospective Diabetes Study ( UKPDS ) coronary heart disease ( CHD ) risk 21% ( IQR 16%, 27%). Eighty‐eight participants were randomly assigned to 40 weeks of intramuscular testosterone undecanoate ( n = 45) or matching placebo ( n = 43). Main Outcome Measures N‐terminal pro B‐type natriuretic peptide ( NT ‐pro BNP ) and high‐sensitivity cardiac troponin T (hs‐ cTnT ). Result Testosterone treatment reduced NT ‐pro BNP (mean adjusted difference ( MAD ) in change over 40 weeks across the testosterone and placebo groups, −17·9 ng/l [95% CI −32·4, −3·5], P = 0·047), but did not change hs‐ cTnT ( MAD , 0·41 ng/l (95% CI −0·56, 1·39), P = 0·62). Six men, three in each group experienced an adverse cardiac event, displaying already higher baseline NT ‐pro BNP ( P < 0·01) and hs‐ cTnT levels ( P = 0·01). At baseline, 10‐year UKPDS CHD risk was associated positively with NT ‐pro BNP (τ = 0·21, P = 0·004) and hs‐ cTnT (τ = 0·23, P = 0·003) and inversely with testosterone (total testosterone τ = −0·18, P = 0·02, calculated free testosterone τ = −0·19, P = 0·01), but there was no significant association between testosterone and cardiac biomarkers ( P > 0·05). Conclusions In this trial of men with T2D and high cardiovascular risk, testosterone treatment reduced NT ‐pro BNP and did not change hs‐ cTnT . Further studies should determine whether men with increased cardiac biomarkers prior to testosterone therapy are at higher risk of testosterone treatment‐associated adverse cardiac events.