較慢開始治療更年期可緩解症狀


  【24drs.com】根據針對5篇第3階段試驗進行的事後分析,併用結合型雌激素與bazedoxifene(商品名Duavee, Pfizer藥廠)可有效減少更年期症狀,不論是在停經開始時或在停經5年後開始治療。
  
  北美更年期協會(NAMS)執行主任、維吉尼亞大學醫學中心JoAnn Pinkerton醫師表示,在「SMART — Selective Estrogen, Menopause, and Response to Therapy 」臨床試驗中,前述併用療法可降低熱潮紅的頻率與嚴重度。
  
  她表示,它也增加骨密度、減少骨轉換標記值、減輕外陰部萎縮、改善一些睡眠檢測數據,且新發生停經婦女的停經相關生活品質問卷分數有所改善。
  
  Pinkerton醫師在奧蘭多舉辦的NAMS 2016年會中表示,不過,許多醫師們的一大問題是,這些效益對於已經停經一段時間的婦女是否依舊存在。
  
  在2013年,美國食品藥物管理局根據SMART試驗的證據,核准併用結合型雌激素與bazedoxifene於治療與更年期相關的中度到嚴重血管舒縮症狀,以及預防停經後骨質疏鬆。
  
  在他們針對5篇SMART試驗之數據進行的事後分析中,Pinkerton醫師與其研究團隊想要確定,根據相對於更年期時間何時開始治療,併用的效果是否有所不同。
  
  他們的分析包括了兩種劑量(0.45 mg 與0.625 mg)的結合型雌激素,併用bazedoxifene 20 mg。
  
  SMART試驗的婦女大部份年齡為40-75歲、白人、已停經;已停經的時間範圍介於1-35年,不過平均範圍是4-8年。
  
  分析顯示,不論是在停經開始後5年內或在停經開始5年之後開始併用療法,症狀改善程度相當。
  
  Pinkerton醫師報告指出,兩種劑量結合型雌激素之間,不論這些婦女是提早或延後開始服用併用療法,在減少令人困擾的熱潮紅、預防骨質流失、改善睡眠、改善生活品質、改善外陰部變化方面,沒有可辨別的差異。
  
  她解釋,在某些時間點,有些結果,根據自何時開始停經而略有統計上的顯著影響,但是,對於5年內或5年以上,在評估的各方面效益上沒有明顯的統計差異或模式。
  
  Pinkerton醫師指出,重要的研究發現是停經婦女大部份可以預期停經症狀之改善,不論是在開始停經的5年內或5年後開始治療。
  
  她表示,我們並不是說,荷爾蒙治療-不論是傳統的還是這個新的併用方法-應在60歲後開始或在停經後10年才開始,而是當症狀比較嚴重時,不論你是在開始停經的5年內或者5年後開始治療都是有效的。
  
  賓州雷丁醫院、費城湯瑪斯傑佛遜大學的Peter Schnatz醫師表示,Pinkerton醫師等人的這篇新報告對醫師們將會有所幫助。
  
  他表示,自從2002年「婦女健康促進計畫」這篇研究發表之後,有許多婦女停用荷爾蒙治療,其他有許多人則是避免開始使用。
  
  Schnatz醫師表示,隨著對風險與利益的更加瞭解,有比較多婦女願意延後開始使用,這些資料將有幫助且是令人放心的。
  
  資料來源:http://www.24drs.com/
  
  Native link:Late-Start Treatment for Menopause Eases Symptoms

Late-Start Treatment for Menopause Eases Symptoms

By Fran Lowry
Medscape Medical News

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 posthoc analysis of data from five phase3 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 posthoc 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 — 0.45mg and 0.625mg — in combination with bazedoxifene 20mg.

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: AbstractP-2. Presented October7, 2016.

    
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