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Femhrt Increases Endothelial Vasodilation in Postmenopausal Non-Smokers: Presented at ACOG
By Bruce Sylvester
NEW ORLEANS, LA -- May 6, 2003 -- Researchers report that Femhrt (norethindrone acetate/ethinyl estradiol tablets) significantly increases endothelium-dependent vasodilation compared to placebo in healthy postmenopausal women who have never smoked.
Lead author Michael Bolognese, MD, senior researcher at Bethesda Health Research Center, in Bethesda, Maryland, presented the data in a poster here on April 30th at the 51st Annual Meeting of the American College of Obstetrics and Gynecology.
The investigators enrolled 270 postmenopausal women, 65 years-old or younger and each with an intact uterus. The multicenter study trial lasted 12 weeks.
Thirty subjects were randomised to placebo, 55 to Femhrt (1 mg norethindrone acetate/5 mg ethinyl estradiol), 63 women to 1 mg norethindrone/10 mg ethinyl estradiol, 63 to Prempro (0.625 mg conjugated equine estrogens/2.5 mg medroxyprogesterone acetate), and 58 to Evista (60 mg raloxifene hydrochloride).
Researchers gathered the women's self-reported history of smoking. They used a standard ultrasound to evaluate endothelium-dependent vasodilation in response to reactive hyperemia in the brachial artery (flow mediated dilation-brachial or FMD-brachial).
At baseline and end point the investigators measured the diameter of the brachial artery. For the 233 women who completed the treatment period, they analysed data on FMD-brachial diameter using analysis of covariance (ANCOVA).
Among women who had never smoked, there was a significantly greater adjusted mean percentage change in FMD-brachial diameter from baseline to end point. For Femhrt versus placebo it was 3.93% versus -1.92% (P=0.031). Mean changes for the other agents over the 12 weeks did not differ significantly from placebo.
"Femhrt subjects showed a statistically significant mean increase in vasodilation versus placebo in healthy women who never smoked," said Dr. Bolognese. "Prempro and Evista showed no such endothelial benefits for this subgroup or the smoker group."
[Study title: Effect of Femhrt® on Endothelial Dysfunction in Non-Smoking Postmenopausal Women.]
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