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Group of Older Men Have Cardio Events With Testosterone Gel

Study in older men with limited mobility stopped early because of excess risk tied to testosterone

WEDNESDAY, June 30 (HealthDay News) -- Older men with limited mobility have improved muscle strength but an increased risk of cardiovascular events when they receive testosterone gel supplementation, according to research published online June 30 in the New England Journal of Medicine.

Shehzad Basaria, M.D., of the Boston University School of Medicine, and colleagues conducted a six-month randomized controlled trial of testosterone gel versus placebo in 209 men with low total or free testosterone levels. The men were all community-dwelling and had limited mobility. They had a high prevalence of hypertension, diabetes, obesity, and hyperlipidemia. The mean age of the men was 74, and all were at least 65 years of age.

During the study period, the researchers found that 23 of 106 patients in the testosterone group had a cardiovascular-related adverse event, compared to five of 103 in the placebo group. The relative risk of a cardiovascular-related adverse event remained the same over the course of the study period. The men in the testosterone group did develop increased strength compared with the placebo group, as measured by chest press, leg press, and stair climbing with a load. Because of the marked increased number of adverse events in the testosterone group, the study was stopped early.

"Caution is warranted in interpreting this finding, because of the small numbers of events and because of limitations with respect to the ascertainment of adverse events. Caution is also warranted in extrapolating these findings to other doses and formulations of testosterone or to other populations, particularly young men who have hypogonadism without cardiovascular disease or limitations in mobility," the authors write.

Testosterone gel and placebo gel were supplied by Auxilium Pharmaceuticals. Several study authors disclosed financial ties to Auxilium and/or other pharmaceutical companies.

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