Fran Lowry

October 13, 2016

The combination of conjugated estrogens and bazedoxifene (Duavee, Pfizer) effectively reduces the symptoms of menopause, whether started at the beginning of menopause or more than 5 years later, according to a post hoc analysis of data from five phase 3 trials.

In the SMART — Selective Estrogen, Menopause, and Response to Therapy — clinical trials, "the combination reduced the frequency and severity of hot flushes," said JoAnn Pinkerton, MD, from the University of Virginia Medical Center in Charlottesville, who is executive director of the North American Menopause Society (NAMS).

It also "increased bone mineral density, reduced bone turnover marker levels, alleviated vulva–vaginal atrophy, improved some measures of sleep, and improved scores on the Menopause-Specific Quality-of-Life Questionnaire in newly menopausal women," she told Medscape Medical News.

"But the big question many clinicians have is whether these benefits would be similar in women who were further from menopause," Dr Pinkerton said at the NAMS 2016 Annual Meeting in Orlando.

The combination of conjugated estrogens and bazedoxifene was approved in 2013 by the US Food and Drug Administration — on the basis of evidence from the SMART trials — for the treatment of moderate to severe vasomotor symptoms associated with menopause and for the prevention of postmenopausal osteoporosis.

SMART Trials

In their post hoc analysis of data from the five SMART trials, Dr Pinkerton and her team wanted to determine whether the effects of the combination would differ, depending on when it was started in relation to menopause.

Their analysis involved two different doses of conjugated estrogens — 0.45 mg and 0.625 mg — in combination with bazedoxifene 20 mg.

Most of the women in the SMART trials were 40 to 75 years of age, white, and postmenopausal. Years since menopause ranged from 1 to 35 years, but the mean range was approximately 4 to 8 years.

The analysis showed that menopausal symptoms improved to a similar degree, regardless of whether a woman started taking the combination less than 5 years after the start of menopause or more than 5 years after.

Whether the women started taking the combination sooner or later, there were no discernable differences in the reduction in bothersome hot flushes, prevention of bone loss, improvement in sleep, improvement in quality of life, or improvement in vulvovaginal changes — for either dose of conjugated estrogens — Dr Pinkerton reported.

"At some time points for some outcomes, there were a few statistically significant interactions by years since menopause, but there was no clear significant difference or pattern in benefits for less than or greater than 5 years in any of the areas that were evaluated," she explained.

The "important findings" are that postmenopausal women can largely expect improvement in menopausal symptoms, "regardless of whether they are less than or greater than 5 years since menopause," Dr Pinkerton added.

"We're not saying that hormone therapy — whether it is traditional or this new combination — should be started after age 60, or more than 10 years out from menopause, we are just saying that whether you are within that first 5 years when symptoms are often more severe, or out 5 years, it's effective," she said.

A Helpful, Reassuring Study

"This new report by Dr Pinkerton and her group will be helpful for clinicians," said Peter Schnatz, DO, from Thomas Jefferson University in Philadelphia and Reading Hospital in Pennsylvania.

"Since the release of the Women's Health Initiative in 2002, there have been large numbers of women stopping hormonal therapy, and others avoiding new starts," he told Medscape Medical News.

"With an improved understanding of the risks and benefits, and more women wanting to start at later time periods, these data are helpful and reassuring," Dr Schnatz said.

The study was sponsored by Pfizer. Dr Pinkerton reports financial relationships with Pfizer, Henry Stewart, and TherapeuticsMD. Dr Schnatz has disclosed no relevant financial relationships.

North American Menopause Society (NAMS) 2016 Annual Meeting: Abstract P-2. Presented October 7, 2016.

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