Medicine:Estrogen in Venous Thromboembolism Trial

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The Estrogen in Venous Thromboembolism Trial (EVTET) was a randomized controlled trial (RCT) of menopausal hormone therapy in 140 postmenopausal women with previous history of venous thromboembolism (VTE).[1][2] It was a double-blind RCT of the estrogen, oral estradiol 2 mg/day, plus the progestogen, norethisterone acetate (NETA) (n=71) 1 mg/day (brand name Kliogest) versus placebo (n=69).[1] The results of the trial were published in 2000 and 2001.[1][2] The incidence of VTE was 10.7% (8 women) in the hormone therapy group and 2.3% (1 woman) in the placebo group, with all events occurring within 261 days after study inclusion.[1] The difference did not reach statistical significance in the sequential analysis, but was statistically significant if the sequential design was ignored (p = 0.04).[1] Markers of coagulation were likewise increased by hormone therapy.[2] As a result of the high incidence of VTE in the treatment group, the trial was terminated prematurely.[1] The researchers concluded on the basis of their findings that menopausal hormone therapy should not be used in women with a previous history of VTE.[1] Although the findings of the EVTET and other studies warrant caution with respect to the use of oral estrogens in women with past VTE, research has found that transdermal estradiol, in contrast to oral estradiol and other oral estrogens, minimally influences coagulation,[3] and in systematic reviews and meta-analyses of observational studies, has not been associated with increased risk of VTE at doses of up to 100 μg/day.[4][5][6][7] Similarly, a small study found that transdermal estradiol did not influence coagulation in women with prior VTE,[8] and the observational Menopause, Estrogen and Venous Events (MEVE) study found that transdermal estradiol was not associated with increased risk of VTE in postmenopausal women with past VTE (HR = 1.0 (95% CI 0.4–2.4) for transdermal estradiol vs. HR = 6.4 (95% CI 1.5–27.3) for oral estrogens).[9][10][11][12][13] Accordingly, menopausal hormone therapy guidelines state that transdermal estradiol is likely to have less risk of VTE and recommend use of transdermal estradiol in women with past VTE or at high risk for VTE.[14][15][16][17] However, RCTs are still needed to confirm the findings.[15][16][17]

See also

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 "Increased risk of recurrent venous thromboembolism during hormone replacement therapy--results of the randomized, double-blind, placebo-controlled estrogen in venous thromboembolism trial (EVTET)". Thromb Haemost 84 (6): 961–7. December 2000. doi:10.1055/s-0037-1614156. PMID 11154141. 
  2. ↑ 2.0 2.1 2.2 "The effects of hormone replacement therapy (HRT) on hemostatic variables in women with previous venous thromboembolism--results from a randomized, double-blind, clinical trial". Thromb Haemost 85 (5): 775–81. May 2001. doi:10.1055/s-0037-1615717. PMID 11372667. 
  3. ↑ "Effects of non-oral postmenopausal hormone therapy on markers of cardiovascular risk: a systematic review". Fertil Steril 90 (3): 642–72. September 2008. doi:10.1016/j.fertnstert.2007.07.1298. PMID 17923128. 
  4. ↑ "Risk of venous thromboembolism events in postmenopausal women using oral versus non-oral hormone therapy: A systematic review and meta-analysis". Thromb Res 168: 83–95. August 2018. doi:10.1016/j.thromres.2018.06.014. PMID 29936403. 
  5. ↑ "Progestogens and venous thromboembolism in menopausal women: an updated oral versus transdermal estrogen meta-analysis". Climacteric 21 (4): 341–345. August 2018. doi:10.1080/13697137.2018.1446931. PMID 29570359. 
  6. ↑ "The route of administration, timing, duration and dose of postmenopausal hormone therapy and cardiovascular outcomes in women: a systematic review". Hum Reprod Update 25 (2): 257–271. March 2019. doi:10.1093/humupd/dmy039. PMID 30508190. 
  7. ↑ "Use of hormone replacement therapy and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases". BMJ 364: k4810. January 2019. doi:10.1136/bmj.k4810. PMID 30626577. 
  8. ↑ "Transdermal estrogen therapy effects on fibrinogen levels in women with a past history of venous thromboembolism: a pilot study". Clin Exp Obstet Gynecol 38 (3): 232–5. 2011. PMID 21995153. https://ceog.imrpress.com/EN/article/downloadArticleFile.do?attachType=PDF&id=6843. 
  9. ↑ "Hormone therapy and recurrence of venous thromboembolism among postmenopausal women". Menopause 18 (5): 488–93. May 2011. doi:10.1097/gme.0b013e3181f9f7c3. PMID 21178641. 
  10. ↑ "Risk of venous thromboembolism by route of administration of estrogen". Menopause 18 (5): 469–70. May 2011. doi:10.1097/gme.0b013e318211745b. PMID 21407136. 
  11. ↑ "Risk of venous thrombosis with oral versus transdermal estrogen therapy among postmenopausal women". Curr Opin Hematol 17 (5): 457–63. September 2010. doi:10.1097/MOH.0b013e32833c07bc. PMID 20601871. 
  12. ↑ "Hormone therapy and venous thromboembolism among postmenopausal women". Front Horm Res. Frontiers of Hormone Research 43: 21–32. 2014. doi:10.1159/000360554. ISBN 978-3-318-02673-3. PMID 24943295. 
  13. ↑ "What if the Women's Health Initiative had used transdermal estradiol and oral progesterone instead?". Menopause 21 (7): 769–83. July 2014. doi:10.1097/GME.0000000000000169. PMID 24398406. 
  14. ↑ "EMAS position statement: Managing menopausal women with a personal or family history of VTE". Maturitas 69 (2): 195–8. June 2011. doi:10.1016/j.maturitas.2011.03.011. PMID 21489728. 
  15. ↑ 15.0 15.1 "Treatment of Symptoms of the Menopause: An Endocrine Society Clinical Practice Guideline". J Clin Endocrinol Metab 100 (11): 3975–4011. November 2015. doi:10.1210/jc.2015-2236. PMID 26444994. 
  16. ↑ 16.0 16.1 "American Association of Clinical Endocrinologists and American College of Endocrinology position statement on menopause–2017 update". Endocr Pract 23 (7): 869–880. July 2017. doi:10.4158/EP171828.PS. PMID 28703650. 
  17. ↑ 17.0 17.1 The NAMS 2017 Hormone Therapy Position Statement Advisory Panel (July 2017). "The 2017 hormone therapy position statement of The North American Menopause Society". Menopause 24 (7): 728–753. doi:10.1097/GME.0000000000000921. PMID 28650869. 



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