PS-BPC08-4: IMPACT OF TESTOSTERONE REPLACEMENT THERAPY ON 24-HOUR AMBULATORY BLOOD PRESSUR E MEASUREMENTS IN MALES WITH OPIOID-INDUCED ANDROGEN DEFICIENCY. A PLACEBO-CONTROLLED RCT

Abstract

Objective: The primary aim was to investigate the effects of testosterone replacement therapy (TRT) on 24-hour ambulatory blood pressure (24hABPM) in opioid-treated men with relative hypogonadism. The secondary aim was to evaluate potential effect modification of baseline body composition and red blood cell measurements on the impact of TRT on 24hABPM. Design and methods: This was a double blinded and placebo controlled study. Men aged > 18 years, treated with an opioid dosage > 50 mg opioid/day were eligible for inclusion if total testosterone (TT) was < 12 nmol/L. Participants were randomized to TRT (1,000 mg testosterone undecanoate) or placebo at 0, 6 and 18 weeks. Participants were examined before and during 24 weeks of TRT/placebo. Results: The two groups (TRT, n = 15 and placebo, n = 20) were comparable at baseline. TRT was associated with numerical increase in 24hABPM. The difference in changes from baseline of daytime systolic blood pressure (SBP) was 5.2 mmHg (P = 0.134) between the TRT group and the placebo group. In subgroup analysis, baseline values of body mass index (BMI), hematocrit (Hct) and hemoglobin (Hgb) levels displayed significant positive interaction on the effect of TRT on change in SBP compared to placebo. In participants with BMI above the study median (30.7 m2/kg), daytime SBP change from baseline was 17.6 mmHg [10.6, 24.6] (P = 0.002) in the TRT group and 0.4 mmHg [-5.5, 4.7] (P = 0.864) in the placebo group. In participants with Hct levels above the study median (0.43%), daytime SBP increased 8.4 mmHg [-1.9, 18.8] (P = 0.09) in the TRT group and decreased -2.3 mmHg [-11.3, 6.8] (P = 0.564) in the placebo group. Similarly, in participants with Hgb> 8.7 mmol/L daytime, SBP change was 11.2mmHg [0.6–21.7] (P = 0.041) in the TRT group and -2.9 mmHg [-4.1, 9.9] (P = 0.367) in the placebo group. Baseline cIMT also increased the strength of association between TRT and change in SBP. After adjusting for delta-BMI, delta-Hct remained significantly associated with increase in daytime SBP. An increase in 1 mmHg SBP was associated with an increase in Hct of 0.11% [0.10–0.22] (P = 0.032). Conclusions: Baseline levels of BMI, Hct, Hgb and cIMT, influence the effect of TRT on BP. The magnitude of BP increase is associated with increase in Hct levels.