Evaluation of patients’ satisfaction with Angeliq Micro in real clinical practice after 13 cycles of treatment in Russia
A decrease in estrogen production during the menopausal transition leads to the appearance of various symptoms that differ in intensity and duration and can have a significant impact on the quality of life. Hot flushes and night sweats are the most common symptoms of the menopause. The most effective treatment for menopausal symptoms is menopausal hormone therapy.Yureneva S.V., Prokofieva S.V., Spiridonova N.V., Yurasova E.A., Ilyina L.M.
Objective: To assess patients’ satisfaction with Angeliq Micro in real clinical practice during 13 cycles of treatment and to evaluate changes in menopausal symptoms and quality of life after 3–4 and 13 cycles of treatment, as well as the reasons for early discontinuation of treatment.
Materials and methods: This is a prospective multicenter non-interventional cohort study on the assessment of patients’ satisfaction with Angeliq Micro in real clinical practice. The study included 1570 patients aged 50–65 years who experienced moderate or severe vasomotor symptoms and needed treatment with ultra-dose drugs.
Results: The patients with moderate to severe intensity of menopausal vasomotor symptoms were satisfied with ultra-dose Angeliq Micro. The proportion of such women exceeded 99% after 13 cycles of treatment.
Conclusion: The results of treatment with Angeliq Micro in real clinical practice demonstrate high patients’ satisfaction rate with this method of treatment and provide a modern doctor with more opportunities to help middle-aged women.
Keywords
menopausal vasomotor symptoms
menopause hormone therapy (MHT)
ultra-dose MHT
Angeliq Micro
satisfaction with treatment
References
- Юренева С.В., Ермакова Е.И. Менопауза и климактерическое состояние у женщины. Акушерство и гинекология. 2018; 7: 32-8. [Yureneva S.V., Ermakova E.I. Menopause and menopausal status in a woman. Obstetrics and Gynecology. 2018; 7: 32-8. (in Russian)]. https://dx.doi.org/10.18565/aig.2018.7.32-38.
- Iliodromiti S., Wang W., Lumsden M.A. et al., the International COMMA (Core Outcomes in Menopause) Consortium. Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review. BJOG. 2020; 127: 320-33. https://dx.doi.org/10.1111/1471-0528.15990.
- Santoro N., Roeca C., Peters B.A. et al. The Menopause Transition: Signs, Symptoms, and Management Options. J Clin Endocrinol Metab. 2021;106(1): 1-15. https://dx.doi.org/10.1210/clinem/dgaa764.
- Paramsothy P., Harlow S.D., Nan B. et al. Duration of the menopausal transition is longer in women with young age at onset: the multiethnic Study of Women's Health Across the Nation. Menopause. 2017; 24(2): 142-9. https://dx.doi.org/10.1097/GME.0000000000000736.
- Col N.F., Guthrie J.R., Politi M., Dennerstein L. Duration of vasomotor symptoms in middle-aged women: a longitudinal study. Menopause. 2009; 16: 453-7. https://dx.doi.org/10.1097/gme.0b013e31818d414e.
- Maki P.M., Wu M., Rubin L.H. et al. Hot flashes are associated with altered brain function during a memory task. Menopause. 2020; 27(3): 269-77. https://dx.doi.org/10.1097/GME.0000000000001467.
- Dam V., Dobson A.J., Onland-Moret N.C. et al. Vasomotor menopausal symptoms and cardiovascular disease risk in midlife: a longitudinal study. Maturitas. 2020; 133: 32-41. https://dx.doi.org/10.1016/j.maturitas.2019.12.011.
- Gray K.E., Katon J.G., LeBlanc E.S. et al. Vasomotor Symptom Characteristics: Are They Risk Factors for Incident Diabetes? Menopause. 2018; 25(5): 520-30. https://dx.doi.org/10.1097/GME.0000000000001033.
- Converso D., Viotti S., Sottimano I. et al. The Relationship Between Menopausal Symptoms and Burnout. A Cross-Sectional Study Among Nurses. BMC Women's Health. 2019; 19: 148. https://doi.org/10.1186/s12905-019-0847-6.
- Hashimoto K., Yoshida M., Nakamura Y. et al. Relationship between number of menopausal symptoms and work performance in Japanese working women. Menopause. 2021; 28(2): 175-81. https://dx.doi.org/10.1097/GME.0000000000001698
- Organisation for Economic Co-operation and Development OECD. Stat Labour force participation rate, by sex and age group. https://stats.oecd.org [Accessed 20 April 2021]
- Rees M., Bitze J., Cano A. et al. Global consensus recommendations on menopause in the workplace: A European Menopause and Andropause Society (EMAS) position statement. Maturitas. 2021; 151: 55-62. https://dx.doi.org/10.1016/j.maturitas.2021.06.006.
- Stuenkel C.A., Davis S.R., Gompel A. et al. Treatment of Symptoms of the Menopause: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015; 100(11): 3975-4011. https://dx.doi.org/10.1210/jc.2015-2236.
- Baber R.J., Panay N., Fenton A., IMS Writing Group. IMS Recommendations on women’s midlife health and menopause hormone therapy. Climacteric. 2016; 19(2): 109-50. https://dx.doi.org/10.3109/13697137.2015.1129166.
- Armeni E., Lambrinoudaki I., Ceausu I. et al. Maintaining postreproductive health: A care pathway from the European Menopause and Andropause Society (EMAS). Maturitas. 2016; 89: 63-72. https://dx.doi.org/10.1016/j.maturitas.2016.04.013.
- The NAMS 2017 Hormone Therapy Position Statement Advisory Panel. The 2017 hormone therapy position statement of The North American Menopause Society. Menopause. 2017; 24: 728-53. https://dx.doi.org/10.1097/GME.0000000000000921.
- Российское общество акушеров-гинекологов. Клинические рекомендации. Менопауза и климактерическое состояние у женщины. М.; 2021. [Russian Society of Obstetricians and Gynecologists. Clinical recommendations. Menopause and menopausal condition in women. Moscow; 2021. (in Russian)].
- Harlow S.D., Gass M., Hall J.E. et al.; STRAW 10 Collaborative Group. Executive summary of the Stages of Reproductive Aging Workshop + 10: addressing the unfinished agenda of staging reproductive aging. Menopause. 2012; 19(4): 387-95. https://dx.doi.org/10.1097/gme.0b013e31824d8f40.
- ACOG Practice Bulletin No. 141: management of menopausal symptoms. Obstet Gynecol. 2014; 123: 202-16. https://dx.doi.org/10.1097/01.AOG.0000441353.20693.78.
- Gass M.L.S., Maki P., Shifren J.L. et al. NAMS supports judicious use of systemic hormone therapy for women aged 65 years and older. Menopause. 2015; 22(7): 685-6. https://dx.doi.org/10.1097/GME.0000000000000491.
- Archer D.F., Schmelter T., Schaefers M. et al. A randomized, double-blind, placebo-controlled study of the lowest effective dose of drospirenone with 17 β-estradiol for moderate to severe vasomotor symptoms in postmenopausal women. Menopause. 2014; 21(3): 227-35. https://dx.doi.org/10.1097/GME.0b013e31829c1431.
- Genazzani A.R., Schmelter T., Schaefers M., Gerlinger C., Gude K. One-year randomized study of the endometrial safety and bleeding pattern of 0.25 mg drospirenone/0.5 mg 17β-estradiol in postmenopausal women. Climacteric. 2013; 16: 490-8. https://dx.doi.org/10.3109/13697137.2013.783797.
- Heikinheimo O., Bitzer J., Rodríguez L.G. Real-world research and the role of observational data in the field of gynaecology – a practical review. Eur J Contracept Reprod Health Care. 2017; 22(4): 250-9. https://dx.doi.org/10.1080/13625187.2017.1361528.
- 19022; ANGEL; OS Report; v 2.0, 26 APR 2021.
- Tepper P.G., Brooks M.M., Randolph J.F. Jr et al. Characterizing the trajectories of vasomotor symptoms across the menopausal transition. Menopause. 2016; 23: 1067-74. https://dx.doi.org/10.1097/GME.0000000000000676.
- Avis N.E., Crawford S.L., Greendale G. et al. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015; 175: 531-9. https://dx.doi.org/10.1001/jamainternmed.2014.8063.
- Moyer A.M., Miller V.M., Faubion S.S. Could personalized management of menopause based on genomics become a reality? Pharmacogenomics. 2016; 17(7): 659-62. https://dx.doi.org/10.2217/pgs.16.17.
- Thurston R.C., Carroll J.E., Levine M. et al. Vasomotor symptoms and accelerated epigenetic aging in the Women's Health Initiative (WHI). J Clin Endocrinol Metab. 2020; 105(4): 1221-7. https://dx.doi.org/10.1210/clinem/dgaa081.
Received 09.11.2021
Accepted 16.11.2021
About the Authors
Svetlana V. Yureneva, Dr. Med. Sci., Leading Researcher, Department of Gynecological Endocrinology, Academician V.I. Kulakov National Medical Research Centre for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, syureneva@gmail.com, https://orcid.org/0000-0003-2864-066X, 4 Oparina str., Moscow, 117997, Russia.Svetlana V. Prokofieva, obstetrician-gynecologist of the highest category, ultrasound diagnostics doctor, I.I. Mechnikov Northwestern State Medical University,
Ministry of Health of Russia, Saint Petersburg.
Natalya V. Spiridonova, Dr. Med. Sci., Professor, Head of the Department of Obstetrics and Gynecology of the Institute of Professional Education, Samara State Medical University, Ministry of Health of Russia, Samara.
Elena A. Yurasova, Dr. Med. Sci., Professor of the Department of Obstetrics and Gynecology, Far Eastern State Medical University, Ministry of Health of Russia, Khabarovsk.
Lilia M. Ilyina, PhD, Medical adviser on menopaus, Association of Gynecologists and Endocrinologists, Moscow.
Authors’ contributions: Yureneva S.V. – chief researcher of study 19022, writing the article; Prokofieva S.V., Spiridonova N.V., Yurasova E.A. – researchers of study 19022, writing the article; Ilyina L.M. – collection and analysis of data from literature for discussion, writing the article.
Conflicts of interest: The authors declare that they have no competing interests.
Funding: The research was carried out within the framework of study 19022 (sponsored by Bayer, Moscow, Russia).
Patient Consent for Publication: All patients provided informed consent for the publication of their data.
Authors' Data Sharing Statement: The data supporting the findings of this study are available on request from the corresponding author after approval from the principal investigator.
For citation: Yureneva S.V., Prokofieva S.V., Spiridonova N.V., Yurasova E.A., Ilyina L.M. Evaluation of patients’ satisfaction with Angeliq Micro
in real clinical practice after 13 cycles of treatment in Russia.
Akusherstvo i Ginekologiya/ Obstetrics and gynecology. 2021; 11: 222-228 (in Russian)
https://dx.doi.org/10.18565/aig.2021.11.222-228
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