Early data on compounded transdermal HT.(GYNECOLOGY)

NEW ORLEANS -- Compounded transdermal hormone therapy relieves menopausal symptoms while improving cardiovascular risk factors and inflammatory and thrombotic biomarkers, according to a preliminary study.

"By replacing the hormone that's deficient via transdermal dosing it may be possible to more closely mimic normal physiology and favorably impact cardiometabolic clinical biomarkers.

"Despite FDA expressed concerns of dangers of compounded hormone use, our data suggest that transdermal compounded hormones may offer a safe and effective treatment for hormone-related symptoms when utilizing dosages targeting physiologic reference ranges and compounds, which meet USP standards for potency," Dr. Kenna Stephenson said at the annual scientific sessions of the American Heart Association.

"Our study would suggest this is a superior way to treat women. Sure, Premarin [conjugated estrogens] gets rid of hot flashes, but it also increases C-reactive protein and increases thrombotic risk," added Dr. Stephenson, a family physician active in clinical research in women's health at the University of Texas Health Science Center at Tyler.

Her group's ongoing study involves 150 women, mean age 51.9 years, with menopausal symptoms, who were randomized to usual care or individualized transdermal plant-derived estrogen, progesterone, testosterone, and dehydroandrostenidione therapy prepared by a compounding pharmacist.

After 12 months of follow-up, the women on transdermal therapy showed significant reductions in triglycerides, blood pressure, fasting blood glucose, C-reactive protein, plasma fibrinogen, insulinlike growth factor--I, and factor VII along with significant symptomatic and quality of life improvements (see chart). The study will continue through 3 years of follow-up.

Ever since analysis of data from the Women's Health Initiative linked oral hormone replacement therapy to increased risks of breast cancer and cardiovascular events, women with menopausal symptoms have expressed growing interest in alternative forms of hormonal therapy.