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CV biomarkers unchanged following oral testosterone therapy
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NASHVILLE, Tenn. — Daily oral testosterone did not significantly increase biomarkers of cardiovascular risk in hypogonadal men, compared with transdermal testosterone, according to data presented here.
In a 1-year, open-label noninferiority study called CLAR-09007, Merrell Magelli, PharmD, senior director of medical affairs for Clarus Therapeutics, and colleagues at other institutions randomly assigned 182 hypogonadal men to receive either an investigational oral testosterone undecanoate product (Rextoro, Clarus Therapeutics), (n = 88) or to transdermal testosterone (AndroGel, AbbVie; n = 94), both dosed daily and adjusted based on serum testosterone levels. Researchers measured serum hs-CRP and lipoprotein-associated phospholipase A2 (LpPLA2) — two cardiovascular biomarkers — at baseline, 90 or 150 days, and 180 and 1 year.
Merrell Magelli
At baseline, mean hs-CRP in the oral therapy group was 1.73 ± 1.61 mg/L and in the transdermal group 2.20 ± 2.04 mg/L. At 1 year, absolute mean decrease in hs-CRP was 0.37 ± 3.68 mg/L in the oral group compared with 1.05 ± 4.08 mg/L in the transdermal group; mean hs-CRP levels were within the normal range for both treatment groups and not statistically significantly different between groups.
LpPLA2 levels were not statistically significantly different between groups at baseline or at 1 year.
The results demonstrated noninferiority of the oral to the transdermal testosterone (95% CI, 0.049 [-0.07 to 0.17]).
Robert Dudley
In a sub-study, blood samples from 28 patients in the oral group and 29 in the transdermal group were assayed for novel biomarkers of CV risk due to endothelial injury or immune response factors to modified lipid fractions. Statistically significant decreases from baseline were observed in phosphocholine oxidized phospholipids (PC OxPL) and in the modified lipid fraction IgG-immune complex to apolipoprotein B; elevated levels are associated with increased risk of coronary artery disease events, according to researchers.
“I think the take-home message from the two studies, one showing novel biomarkers for cardiovascular disease and the one looking at more traditional biomarkers LpPLA2 and hsc reactive protein show that neither an oral testosterone product or testosterone gel really have much of a negative impact … that should reassure people that for testosterone therapy over a period of a year’s treatment, one doesn’t see changes in any of the markers that are particularly associated with cardiovascular outcomes,” Robert Dudley, PhD, chairman of Clarus, told Endocrine Today. — by Jill Rollet
Reference:
Megelli M, et al. Abstracts #418 and #915. Presented at: AACE 24th Annual Scientific & Clinical Congress; May 13-17, 2014; Nashville, Tenn.
Disclosure: Magelli and Dudley report employment by Clarus Therapeutics. See full abstract for list of other authors’ relevant financial disclosures.