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| |  Trial of Experimental Testosterone Gel Shows Fewer Than Expected Cardiovascular Events: Presented at NAMS By John Otrompke SAN DIEGO -- October 4, 2009 -- A phase 3 trial of an experimental testosterone gel for postmenopausal women shows lower adverse cardiovascular (CV) events in patients with high cardiac risk than would be expected when extrapolating from the findings of the Women’s Health Initiative. Researchers anticipated 16 adverse CV events in the ongoing study, but to date only 4 have been recorded, researchers stated here at the 20th Annual Meeting of the North American Menopause Society (NAMS). “So far we’ve seen 4 events out of 800 subject years,” said Michael C. Snabes, MD, BioSante Pharmaceuticals, Inc, in Lincolnshire, Illinois, on October 1. “We expected an event rate of 2%, and we have only 0.61%.” The testosterone gel is being developed for the indication of hypoactive sexual desire disorder (HSDD) in oestrogen-treated, oophorectomised, postmenopausal women. HSDD is defined as low sexual desire in a woman who is bothered by the condition, according to Dr. Snabes. The adaptive-design, randomised, double-blind, placebo-controlled, multicentre comparison study of testosterone and identical placebo gel in postmenopausal women with HSDD and known CV risk has accrued over 1,000 postmenopausal women to date. The accrual process is half complete, and the study remains blinded. The mean age of the participants is 57.4 years (range 48 to 77 years). The women are randomised to receive either 300 mcg per day of the testosterone gel, or an identical placebo. The primary safety outcome measure is the effect of treatment on the incidence of a comprehensive, adjudicated CV event composite of cardiac death, nonfatal myocardial infarction, and stroke in addition to coronary revascularisation, hospitalised angina, and venous thromboembolic events. The coprimary safety endpoint is the incidence of invasive breast cancer, 1 of which has been recorded so far. Risk factors for CV disease are identified as being 60 years of age or older, having diabetes, hypertension, dyslipidaemia, a documented history of CV disease, or being a current smoker. Based on the prevalence of CV endpoints observed in the progestin/oestrogen arm of the Women’s Health Initiative, the estimated CV event was 2%, the poster explained, but the actual rate to date has been only approximately one-quarter that number. Funding for this study was provided by BioSante Pharmaceuticals, Inc. [Presentation title: Low Cardiovascular Event Rate in Post-Menopausal Women With Increased Cardiac Risk: Initial Findings From the Ongoing Blinded LibiGel (Testosterone Gel) Cardiovascular Safety Study. Abstract P53]
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