Modern tactics in prescribing drug therapy for genital endometriosis


Cite item

Full Text

Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription or Fee Access

Abstract

Endometriosis is considered to be a chronic progressive recurrent disease that affects every 10 reproductive-aged women, which has a negative impact on various aspects of quality of life in patients. Treatment for endometriosis should minimize the progression of the disease, preserve fertility, and relieve pain syndrome in the patient. Surgical and medical treatments should not be contrasted. Medical treatment includes the use of nonsteroidal anti-inflammatory drugs, neuromodulators, and hormone therapy (gonadotropin releasing hormone agonists, progestins which are considered as first-line therapy), levonorgestrel intrauterine system, and combined oral contraceptives*. Conclusion. Based on experimental models, randomized clinical trials, and real clinical practice studies, the authors have obtained data on the favorable safety profile, efficacy, and good tolerability of dienogest in the treatment of different types of genital endometriosis, which allows this progestogene to be regarded as a rational strategy for long-term therapy and prevention of disease relapses.

Full Text

Restricted Access

About the authors

Maria I. Yarmolinskaya

D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology; I.I. Mechnikov North-Western State Medical University, Ministry of Health of Russia

Email: m.yarmolinskaya@gmail.com
professor of RAS, Dr. Med. Sci., professor, Head of the Department of Gynecology and Endocrinology, Head of Center “Diagnostics and treatment of endometriosis”

Chimnaz I. Seyidova

D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology

Email: seidov_46@mail.ru
resident physician

Valeriia O. Pyankova

D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology

Email: pyankova.valeriia@rambler.ru
resident physician

References

  1. Santulli P., Tran C., Gayet V., Bourdon M., Maignien C., Marcellin L. et al. Oligo-anovulation is not a rarer feature in women with documented endometriosis. Fertil. Steril. 2018; 110(5): 941-8. https://doi.org/10.1016/ j.fertnstert.2018.06.012.
  2. Adamson G.D., Pasta D.J. Endometriosis fertility index: the new, validated endometriosis staging system. Fertil. Steril. 2010; 94(5): 1609-15. https://doi. org/10.1016/j.fertnstert.2009.09.035.
  3. Mohammed Rasheed H.A, Hamid P. Inflammation to Infertility: Panoramic View on Endometriosis. Cureus. 2020; 12(11): e11516. https://doi.org/10.7759/ cureus.11516.
  4. Falcone T., Flyckt R. Clinical Management of Endometriosis. Obstet. Gynecol. 2018; 131(3): 557-71. https://doi.org/10.1097/AOG.0000000000002469.
  5. Ярмолинская М.И., Флорова М.С. Возможности терапии диеногестом 2 мг у больных наружным генитальным эндометриозом. Проблемы репродукции. 2017; 23(1): 70-9. [Yarmolinskaya M.I., Florova M.S. The possibility of treatment with dienogest 2 mg in patients with genital endometriosis. Problemy reprodukcii/Russian Journal of Human Reproduction. 2017; 23(1): 70-9. (in Russian)].
  6. Лисовская Е.В., Хилькевич Е.Г., Чупрынин В.Д., Мельников М.В., Ипатова М.В. Качество жизни женщин с глубоким инфильтративным эндометриозом. Акушерство и гинекология. 2020; 3: 116 26. https://dx.doi.org/10.18565/aig.2020.3.116-126
  7. Zondervan K.T., Becker C.M., Missmer S.A. Endometriosis. N. Engl. J. Med. 2020; 382(13): 1244-56. https://doi.org/10.1056/NEJMra1810764.
  8. Ahn S.H., Singh V., Tayade C. Biomarkers in endometriosis: challenges and opportunities. Fertil. Steril. 2017; 107(3): 523-32. https://doi.org/10.1016/ j.fertnstert.2017.01.009.
  9. De Sanctis V., Matalliotakis M., Soliman A.T., Elsefdy H., Di Maio S., Fiscina B. A focus on the distinctions and current evidence of endometriosis in adolescents. Best Pract. Res. Clin. Obstet. Gynaecol. 2018; 51: 138-50. https:// doi.org/10.1016/j.bpobgyn.2018.01.023.
  10. Ярмолинская М.И., ред. Медикаментозная терапия генитального эндометриоза: реалии и перспективы: руководство для врачей. М: ГЭОТАР-Медиа; 2021. 384 с. [Yarmolinskaya M.I., ed. Pharmacological treatment of endometriosis: realities and prospects: guide for doctors. M: GEOTAR-Media; 2021. 384 p. (in Russian)]. https://doi.org/10.33029/ 9704-6034-4-MET-20221-1-384.
  11. Ярмолинская М.И., Сейидова Ч.И. Влияние генитального эндометриоза на репродуктивную функцию и течение беременности. Журнал акушерства и женских болезней. 2020;69(3):47-56. [Yarmolinskaya M.I., Sejidova Ch.I. Effect of genital endometriosis on fertility and gestation course. Zhurnal akusherstva i zhenskih boleznej/ Journal of Obstetrics and Women’s Diseases. 2020; 69(3): 47-56 (in Russian)]. https://doi.org/10/17816/ JOWD69347-56.
  12. Эндометриоз. Клинические рекомендации. М.: Министерство здравоохранения Российской Федерации. РОАГ; 2020. 60 с. [Endometriosis. Guideline. M.: Ministry of Health of Russian Federation. ROAG; 2020: 60. (in Russian)]. https://yadi.sk/i/yYPwxWe4uTZcWg.
  13. Casper R.F. Progestin-only pills may be a better first-line treatment for endometriosis than combined estrogen-progestin contraceptive pills. Fertil. Steril. 2017;107(3):533-6. https://doi.org/10.1016/j.fertnstert.2017.01.003.
  14. Chaichian S., Kabir A., Mehdizadehkashi A., Rahmani K., Moghimi M., Moazzami B. Comparing the Efficacy of Surgery and Medical Therapy for Pain Management in Endometriosis: A Systematic Review and Meta-analysis. Pain Physician. 2017; 20(3): 185-95.
  15. Leonardi M., Horne A.W., Armour M., Missmer S.A., Roman H., Rombauts L. et al. Endometriosis and the Coronavirus (COVID-19) Pandemic: Clinical Advice and Future Considerations. Front. Reprod. Health. 2020; 2: 5. https:// doi.org/10.3389/frph.2020.00005.
  16. Fang L., Karakiulakis G., Roth M. Are patients with hypertension and diabetes mellitus at increased risk for COVID-19 infection? The Lancet. Respiratory Medicine. 2020; 8(4): e21. https://doi.org/10.1016/s2213-2600(20)30116-8.
  17. Food and Drug Administration: FDA advises patients on use of non-steroidal anti-inflammatory drugs (NSAIDs) for COVID-19. https://www.fda.gov/ drugs/drug-safety-and-availability/fda-advises-patients-use-non-steroidal-anti-inflammatory-drugs-nsaids-covid-19.
  18. Endometriosis: diagnosis and management. Guideline. UK: NICE; 2017.
  19. Vilasagar S., Bougie O., Singh S.S. A Practical Guide to the Clinical Evaluation of Endometriosis-Associated Pelvic Pain. J Minim. Invasive Gynecol. 2020; 27(2): 270-9. https://doi.org/10.1016/j.jmig.2019.10.012.
  20. Приказ Министерства здравоохранения Российской Федерации от 28 февраля 2019 г. №103н (с изменениями от 23 июня 2020 г.) «Об утверждении порядка и сроков разработки клинических рекомендаций, их пересмотра, типовой формы клинических рекомендаций и требований к их структуре, составу и научной обоснованности, включаемой в клинические рекомендации информации» (с изменениями и дополнениями). [Order of the Ministry of Health of Russian Federation, dated 28.02.2019 №103n (as amended on 23.06.2020) «On approval of the procedure and timelines of the development of Clinical Practice Guidelines, their revision, the standard form of Clinical Practice Guidelines and requirements for their structure, composition and scientific validity of information included in Clinical Practice Guidelines (with changes and additions) (in Russian)]. http://base.garant.ru/72240714/7661232856ba68dc46f62e66276a4ba6/ #ixzz6p5HKUHHY
  21. Ярмолинская М.И., Адамян Л.В. Гормональные контрацептивы и эндометриоз: современный взгляд на проблему. Проблемы репродукции. 2020; 26(3): 39-45. [Yarmolinskaya M.I., Adamyan L.V. Hormonal contraceptives and endometriosis: modern view on the problem. Problemy reprodukcii/Russian Journal of Human Reproduction. 2020; 26(3): 39-45. (in Russian)]. https:// doi.org/10.17116/repro20202603139.
  22. Vercellini P., Buggio L., Berlanda N., Barbara G., Somigliana E., Bosari S. Estrogen-progestins and progestins for the management of endometriosis. Fertil. Steril. 2016; 106(7): 1552-71.e2. https://doi.org/10.1016/j.fertnstert.2016.10.022.
  23. Vercellini P., Eskenazi B., Consonni D., Somigliana E., Parazzini F., Abbiati A et al. Oral contraceptives and risk of endometriosis: a systematic review and metaanalysis. Hum. Reprod. Update. 2011; 17(2): 159-70. https://doi.org/10.1093/ humupd/dmq042.
  24. Chapron C., Souza C., Borghese B., Lafay-Pillet M.C., Santulli P., Bijaoui G. Et al. Oral contraceptives and endometriosis: the past use of oral contraceptives for treating severe primary dysmenorrhea is associated with endometriosis, especially deep infiltrating endometriosis. Hum. Reprod. 2011; 26(8): 2028-35. https://doi.org/10.1093/humrep/der156.
  25. Vercellini P., Buggio L., Borghi A., Monti E., Gattei U., Frattaruolo M.P Medical treatment in the management of deep endometriosis infiltrating the proximal rectum and sigmoid colon: a comprehensive literature review. Acta Obstet. Gynecol. Scand. 2018; 97(8): 942-55. https://doi.org/10.1111/ aogs.13328.
  26. Vercellini P., Ottolini F., Frattaruolo M.P., Buggio L., Roberto A., Somigliana E. Is Shifting to a Progestin Worthwhile When Estrogen-Progestins Are Inefficacious for Endometriosis-Associated Pain? Reprod. Sci. 2018; 25(5): 674-82. https:// doi.org/10.1177/1933719117749759.
  27. Andres M. de P., Lopes L.A., Baracat E.C., Podgaec S. Dienogest in the treatment of endometriosis: systematic review. Arch. Gynecol. Obstet. 2015; 292(3): 523-9. https://doi.org/10.1007/s00404-015-3681-6.
  28. McCormack P.L. Dienogest: a review of its use in the treatment of endometriosis. Drugs. 2010; 70(16): 2073-88. https://doi.org/10.2165/ 11206320-000000000-00000.
  29. Mita S., Shimizu Y., Sato A., Notsu T., Imada K., Kyo S. Dienogest inhibits nerve growth factor expression induced by tumor necrosis factor-а or interleukin-1e. Fertil. Steril. 2014; 101(2): 595-601. https://doi.org/10.1016/ j.fertnstert.2013.10.038.
  30. Grandi G., Mueller M., Bersinger N.A, Cagnacci A., Volpe A., McKinnon B. Does dienogest influence the inflammatory response of endometriotic cells? A systematic review. Inflamm. Res. 2016;65(3):183-92. https://doi.org/10.1007/ s00011-015-0909-7.
  31. Prechapanich J., Kajihara T., Fujita K., Sato K., Uchino S., Tanaka K. et al. Effect of a dienogest for an experimental three-dimensional endometrial culture model for endometriosis. Med. Mol. Morphol. 2014; 47(4): 189-95. https:// doi.org/10.1007/s00795-013-0059-3.
  32. Mori T., I to F., Matsushima H., Takaoka O., Koshiba A., Tanaka Y. et al. Dienogest reduces HSD17e1 expression and activity in endometriosis. J. Endocrinol. 2015; 225(2): 69-76. https://doi.org/10.1530/ JOE-15-0052.
  33. Choi J., Jo M., Lee E., Lee D.-Y., Choi D. Dienogest enhances autophagy induction in endometriotic cells by impairing activation of AKT, ERK1/2, and mTOR. Fertil. Steril. 2015;104(3): 655-64.e1. https://doi.org/10.1016/ j.fertnstert.2015.05.020.
  34. Kurman R.J., Shih Ie-M. The Dualistic Model of Ovarian Carcinogenesis: Revisited, Revised, and Expanded. Am. J. Pathol. 2016; 186(4): 733-47. https://doi.org/10.1016/j.ajpath.2015.11.011.
  35. Dahiya A, Sebastian A, Thomas A., George R., Thomas V., Peedicayil A. Endometriosis and malignancy: The intriguing relationship. Int. J. Gynaecol. Obstet. 2021. https://doi.org/10.1002/ijgo.13585.
  36. Saito F, Tashiro H., Yamaguchi M., Honda R., Ohba T., Suzuki A. et al. Development of a mouse model for testing therapeutic agents: the anticancer effect of dienogest on endometrial neoplasms. Gynecol. Endocrinol. 2016;3 2(5): 403-7. https://doi.org/10.3109/09513590.2015.1124411.
  37. Ярмолинская М.И., Петросян М.А., Флорова М.С., Молотков А. С., Денисова А. С., Суслова Е.В. и др. Сравнительная оценка эффективности перспективных препаратов для таргетной терапии эндометриоза на основании экспериментальной модели заболевания. Гинекология. 2018; 20(5): 46-51. [Yarmoliskaya M. I., Petrosyan M. A., Florova M. S., Molotkov A. S., Denisova A. S., Suslova E. V. et al. Comparative assessment of effectiveness of new drugs for targeted therapy of endometriosis by experimental model. Ginekologija/ Gynecology. 2018; 20(5): 46-51. (in Russian)]. https:// doi.org/10.26442/2079-5696_2018.5.46-51.
  38. Liang B., Wu L., Xu H., Cheung C.W., Fung W.Y., Wong S.W. et al. Efficacy, safety and recurrence of new progestins and selective progesterone receptor modulator for the treatment of endometriosis: a comparison study in mice. Reprod. Biol. Endocrinol. 2018; 16(1): 32. https://doi.org/10.1186/ s12958-018-0347-9.
  39. Kim Y.S., Kim Y.J., Kim M.J., Lee S.J., Kwon H., Lee J.H. Novel Medicine for Endometriosis and Its Therapeutic Effect in a Mouse Model. Biomedicines. 2020; 8(12): 619. https://doi.org/10.3390/biomedicines8120619.
  40. Murji A, Biberoglu K., Leng J., Mueller M.D., Romer T., Vignali M. et al. Use of dienogest in endometriosis: a narrative literature review and expert commentary. Curr. Med. Res. Opin. 2020; 36(5): 895-907. https://doi.org/10.1080/ 03007995.2020.1744120.
  41. Ярмолинская М.И., Шалина М. А., Хачатурян А. Р., Не треба Е.А., Флорова М.С., Мехтиханова С.В. Аденомиоз: от научных открытий к практическим аспектам назначения медикаментозной терапии. Акушерство и гинекология. 2020; 3: 182-90. [Yarmolinskaya M.I.,Shalina M.A., Khachaturyan A.R., Netreba E.A., Florova M.S., Mekhtikhanova S.V. Adenomyosis: from scientific discoveries to the practical aspects of prescribing drug therapy. Akusherstvo i Ginekologiya/ Obstetrics and gynecology. 2020; 3: 182-190. (in Russian)]. https://dx.doi.org/10.18565/aig.2020.3.182-190.
  42. Strowitzki T., Faustmann T., Gerlinger C., Schumacher U., Ahlers C., Seitz C. Safety and tolerability of dienogest in endometriosis: pooled analysis from the European clinical study program. Int. J. Womens Health. 2015; 7: 393-401. https://doi.org/10.2147/IJWH.S77202.
  43. Ebert A.D., Dong L., Merz M., Kirsch B., Francuski M., Bottcher B. et al. Dienogest 2 mg Daily in the Treatment of Adolescents with Clinically Suspected Endometriosis: The VISanne Study to Assess Safety in ADOlescents. J. Pediatr. Adolesc. Gynecol. 2017; 30(5): 560-7. https://doi.org/10.1016/ j.jpag.2017.01.014.
  44. Hatem T.H., Mohammed M.A., Fawzi H.A. Comparison of the Efficacy and Safety between Dienogest and Dydrogesterone in Treatment of Endometriosis: Prospective Study. International Journal of Science and Research (IJSR). 2018; 7(3): 1704-7. https://doi.org/10.21275/ART20179838.
  45. Angioni S., Pontis A., Malune M.E., Cela V., Luisi S., Litta P. et al. Is dienogest the best medical treatment for ovarian endometriomas? Results of a multicentric case control study. Gynecol. Endocrinol. 2020; 36(1): 84-6. https://doi.org/ 10.1080/09513590.2019.1640674.
  46. Barra F., Scala C., Leone Roberti Maggiore U., Ferrero S. Long-Term Administration of Dienogest for the Treatment of Pain and Intestinal Symptoms in Patients with Rectosigmoid Endometriosis. J. Clin. Med. 2020; 9(1): 154. https://doi.org/10.3390/jcm9010154.
  47. Zakhari A., Edwards D., Ryu M., Matelski J.J., Bougie O., Murji A. Dienogest and the Risk of Endometriosis Recurrence Following Surgery: A Systematic Review and Meta-analysis. J. Minim. Invasive Gynecol. 2020; 27(7):1503-10. https:// doi.org/10.1016/j.jmig.2020.05.007.
  48. Pietri G., Masoura P. Market Access and Reimbursement: The Increasing Role of Real-World Evidence. Value Health. 2014; 17(7): A450-1. https:// doi.org/10.1016/j.jval.2014.08.1216.
  49. Yarmolinskaya M.I., Makarova I., Veremiova R., Von Ludwig C., Gude K. A noninterventional study with dienogest 2 mg to assess the quality of life in patients with endometriosis (Diva study). 2 Congress of the Society of Endometriosis and Uterine Disorders. Barselona, 2016. Abs. 1576.
  50. Techatraisak K., Hestiantoro A., Ruey S., Banal-Silao M.J., Kim M.R., Seong S.J. et al. Effectiveness of dienogest in improving quality of life in Asian women with endometriosis (ENVISIOeN): interim results from a prospective cohort study under real-life clinical practice. BMC Womens Health. 2019; 19(1): 68. https:// doi.org/10.1186/s12905-019-0758-6.
  51. Heinemann K., Imthurn B., Marions L., Gerlinger C., BeckerK., Moehner S. et al. Safety of Dienogest and Other Hormonal Treatments for Endometriosis in Real-World Clinical Practice (VIPOS): A Large Noninterventional Study. Adv. Ther. 2020; 37(5): 2528-37. https://doi.org/10.1007/s12325-020-01331-z.
  52. Moehner S., Becker K., Lange J.A., von Stockum S., Heinemann K. Risk of depression and anemia in users of hormonal endometriosis treatments: Results from the VIPOS study. Eur. J. Obstet. Gynecol. Reprod. Biol. 2020; 251: 212-7. https://doi.org/10.1016/j.ejogrb.2020.05.049.
  53. Cho B., Roh J.W., Park J., Jeong K., Kim T.H., Kim Y.S. et al. Safety and Effectiveness of Dienogest (Visanne®) for Treatment of Endometriosis: A Large Prospective Cohort Study. Reprod. Sci. 2020; 27(3): 905-15. https:// doi.org/10.1007/s43032-019-00094-5.

Supplementary files

Supplementary Files
Action
1. JATS XML
Download

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies