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    المساهمون: The clinical study was conducted with the support of Promomed RUS LLC. The sponsor had no influence on the selection of material for publication, analysis or interpretation of data., Клиническое исследование проводилось при поддержке компании ООО «Промомед Рус». Спонсор не оказывал влияние на выбор материала для публикации, анализ и интерпретацию данных.

    المصدر: Pharmacy & Pharmacology; Том 11, № 4 (2023); 324-346 ; Фармация и фармакология; Том 11, № 4 (2023); 324-346 ; 2413-2241 ; 2307-9266 ; 10.19163/2307-9266-2023-11-4

    وصف الملف: application/pdf

    Relation: https://www.pharmpharm.ru/jour/article/view/1385/998; https://www.pharmpharm.ru/jour/article/view/1385/997; Garber A.J., Handelsman Y., Grunberger G., Einhorn D., Abrahamson M.J., Barzilay J.I., Blonde L., Bush M.A., DeFronzo R.A., Garber J.R., Garvey W.T., Hirsch I.B., Jellinger P.S., McGill J.B., Mechanick J.I., Perreault L., Rosenblit P.D., Samson S., Umpierrez G.E. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm – 2020 EXECUTIVE SUMMARY // Endocr Pract. – 2020. – Vol. 26, No. 1. – P. 107–139. DOI:10.4158/CS-2019-0472; Алгоритмы специализированной медицинской помощи больным сахарным диабетом / Под редакцией И.И. Дедова, М.В. Шестаковой, А.Ю. Майорова. 11-й выпуск // Сахарный диабет. – 2023. – Т. 26, № 2S. – С. 1–231. DOI:10.14341/DM13042; Bancks M.P., Ning H., Allen N.B., Bertoni A.G., Carnethon M.R., Correa A., Echouffo-Tcheugui J.B., Lange L.A., Lloyd-Jones D.M., Wilkins J.T. Long-term absolute risk for cardiovascular disease stratified by fasting glucose level // Diabetes Care. – 2019. – Vol. 42, No. 3. – P. 457–465. DOI:10.2337/dc18-1773; Emerging Risk Factors Collaboration; Sarwar N., Gao P., Seshasai S.R., Gobin R., Kaptoge S., Di Angelantonio E., Ingelsson E., Lawlor D.A., Selvin E., Stampfer M., Stehouwer C.D., Lewington S., Pennells L., Thompson A., Sattar N., White I.R., Ray K.K., Danesh J. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies // Lancet. – 2010. – Vol. 375, No. 9733. – P. 2215–2222. DOI:10.1016/S0140-6736(10)60484-9. Erratum in: Lancet. – 2010. – Vol. 376, No. 9745. – P. 958.; Gaede P., Lund-Andersen H., Parving H.H., Pedersen O. Effect of a multifactorial intervention on mortality in type 2 diabetes // N Engl J Med. – 2008. – Vol. 358, No. 6. – P. 580–91. DOI:10.1056/NEJMoa0706245; Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group // Lancet. 1998. – Vol. 352, No. 9131. – P. 837–853. Erratum in: Lancet. – 1999. – Vol. 354, No. 9178. – P. 602.; Raghavan S., Vassy J.L., Ho Y.L., Song R.J., Gagnon D.R., Cho K., Wilson P.W.F., Phillips L.S. Diabetes mellitus-related all-cause and cardiovascular mortality in a national cohort of adults // J Am Heart Assoc. – 2019. – Vol. 8, No. 4. – P. e011295. DOI:10.1161/JAHA.118.011295; Svensson E., Baggesen L.M., Johnsen S.P., Pedersen L., Nørrelund H., Buhl E.S., Haase C.L., Thomsen R.W. Early glycemic control and magnitude of hba1c reduction predict cardiovascular events and mortality: population-based cohort study of 24,752 metformin initiators // Diabetes Care. – 2017. – Vol. 40, No. 6. – P. 800–807. DOI:10.2337/dc16-2271; Mannucci E., Dicembrini I., Lauria A., Pozzilli P. Is glucose control important for prevention of cardiovascular disease in diabetes? // Diabetes Care. – 2013. – Vol. 36, Suppl 2. – P. S259–S263. DOI:10.2337/dcS13-2018; ElSayed N.A., Aleppo G., Aroda V.R., Bannuru R.R., Brown F.M., Bruemmer D., Collins B.S., Hilliard M.E., Isaacs D., Johnson E.L., Kahan S., Khunti K., Leon J., Lyons S.K., Perry M.L., Prahalad P., Pratley R.E., Seley J.J., Stanton R.C., Gabbay R.A., on behalf of the American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2023 // Diabetes Care. – 2023. – Vol. 46, Suppl 1. – P. S140–S157. DOI:10.2337/dc23-S009; Knudsen L.B., Lau J. The discovery and development of liraglutide and semaglutide // Front Endocrinol (Lausanne). – 2019. – Vol. 10. – Art. ID: 155. DOI:10.3389/fendo.2019.00155; Kristensen S.L., Rørth R., Jhund P.S., Docherty K.F., Sattar N., Preiss D., Køber L., Petrie M.C., McMurray J.J.V. Cardiovascular, mortality, and kidney outcomes with GLP-1 receptor agonists in patients with type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials // Lancet Diabetes Endocrinol. – 2019. – Vol. 7, No. 10. – P. 776–785. DOI:10.1016/S2213-8587(19)30249-9. Erratum in: Lancet Diabetes Endocrinol. – 2020. – Vol. 8, No. 3. – P. e2.; Yu M., Benjamin M.M., Srinivasan S., Morin E.E., Shishatskaya E.I., Schwendeman S.P., Schwendeman A. Battle of GLP-1 delivery technologies // Adv Drug Deliv Rev. – 2018. – Vol. 130. – P. 113–130. DOI:10.1016/j.addr.2018.07.009; Hussein H., Zaccardi F., Khunti K., Davies M.J., Patsko E., Dhalwani N.N., Kloecker D.E., Ioannidou E., Gray L.J. Efficacy and tolerability of sodium-glucose co-transporter-2 inhibitors and glucagon-like peptide-1 receptor agonists: A systematic review and network meta-analysis // Diabetes Obes Metab. – 2020. – Vol. 22, No. 7. – P. 1035–1046. DOI:10.1111/dom.14008; Lyseng-Williamson K.A. Glucagon-like peptide-1 receptor analogues in type 2 diabetes: their use and differential features // Clin Drug Investig. – 2019. – Vol. 39, No. 8. – P. 805–819. DOI:10.1007/s40261-019-00826-0. Erratum in: Clin Drug Investig. – 2019. Erratum in: Clin Drug Investig. – 2019. Erratum in: Clin Drug Investig. – 2020. – Vol. 40, No. 3. – P. 291.; Карпов Ю.А., Старостина Е.Г. Семаглутид (Оземпик) с точки зрения эндокринолога и кардиолога: возможности аналогов глюкагоноподобного пептида-1 далеко не исчерпаны // Атмосфера. Новости кардиологии. – 2019. – № 4. – С. 3–17. DOI:10.24411/2076-4189-2019-12170; Kapitza C., Nosek L., Jensen L., Hartvig H., Jensen C.B., Flint A. Semaglutide, a once-weekly human GLP-1 analog, does not reduce the bioavailability of the combined oral contraceptive, ethinylestradiol/levonorgestrel // J Clin Pharmacol. – 2015. – Vol. 55, No. 5. – P. 497–504. DOI:10.1002/jcph.443; Kapitza C., Dahl K., Jacobsen J.B., Axelsen M.B., Flint A. Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial // Diabetologia. – 2017. – Vol. 60, No. 8. – P. 1390–1399. DOI:10.1007/s00125-017-4289-0; Nauck M.A., Petrie J.R., Sesti G., Mannucci E., Courrèges J.P., Lindegaard M.L., Jensen C.B., Atkin S.L.; Study 1821 Investigators. A phase 2, randomized, dose-finding study of the novel once-weekly human GLP-1 analog, semaglutide, compared with placebo and open-label liraglutide in patients with type 2 diabetes // Diabetes Care. – 2016. – Vol. 39, No. 2. – P. 231–241. DOI:10.2337/dc15-0165; Marbury T.C., Flint A., Jacobsen J.B., Derving Karsbøl J., Lasseter K. Pharmacokinetics and tolerability of a single dose of semaglutide, a human glucagon-like peptide-1 analog, in subjects with and without renal impairment // Clin Pharmacokinet. – 2017. – Vol. 56, No. 11. – P. 1381–1390. DOI:10.1007/s40262-017-0528-2; Jensen L., Kupcova V., Arold G., Pettersson J., Hjerpsted J.B. Pharmacokinetics and tolerability of semaglutide in people with hepatic impairment // Diabetes Obes Metab. – 2018. – Vol. 20, No. 4. – P. 998–1005. DOI:10.1111/dom.13186; Jensen L., Helleberg H., Roffel A., van Lier J.J., Bjørnsdottir I., Pedersen P.J., Rowe E., Derving Karsbøl J., Pedersen M.L. Absorption, metabolism and excretion of the GLP-1 analogue semaglutide in humans and nonclinical species // Eur J Pharm Sci. – 2017. – Vol. 104. – P. 31–41. DOI:10.1016/j.ejps.2017.03.020; Baekdal T.A., Thomsen M., Kupčová V., Hansen C.W., Anderson T.W. Pharmacokinetics, Safety, and tolerability of oral semaglutide in subjects with hepatic impairment // J Clin Pharmacol. – 2018. – Vol. 58, No. 10. – P. 1314–1323. DOI:10.1002/jcph.1131; Blundell J., Finlayson G., Axelsen M., Flint A., Gibbons C., Kvist T., Hjerpsted J.B. Effects of once-weekly semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity // Diabetes Obes Metab. – 2017. – Vol. 19, No. 9. – P. 1242–1251. DOI:10.1111/dom.12932; Johnson-Agbakwu C., Brown L., Yuan J., Kissling R., Greenblatt D.J. Effects of flibanserin on the pharmacokinetics of a combined ethinylestradiol/levonorgestrel oral contraceptive in healthy premenopausal women: a randomized crossover study // Clin Ther. – 2018. – Vol. 40, No. 1. – P. 64–73. DOI:10.1016/j.clinthera.2017.08.021; Granhall C., Søndergaard F.L., Thomsen M., Anderson T.W. Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects with Renal Impairment // Clin Pharmacokinet. – 2018. – Vol. 57, No. 12. – P. 1571–1580. DOI:10.1007/s40262-018-0649-2; Sorli C., Harashima S.I., Tsoukas G.M., Unger J., Karsbøl J.D., Hansen T., Bain S.C. Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial // Lancet Diabetes Endocrinol. – 2017. – Vol. 5, No. 4. – P. 251–260. DOI:10.1016/S2213-8587(17)30013-X; Ahrén B., Masmiquel L., Kumar H., Sargin M., Karsbøl J.D., Jacobsen S.H., Chow F. Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial // Lancet Diabetes Endocrinol. – 2017. – Vol. 5, No. 5. – P. 341–354. DOI:10.1016/S2213-8587(17)30092-X; Ahmann A.J., Capehorn M., Charpentier G., Dotta F., Henkel E., Lingvay I., Holst A.G., Annett M.P., Aroda V.R. Efficacy and safety of once-weekly semaglutide versus exenatide ER in subjects with type 2 diabetes (SUSTAIN 3): a 56-week, open-label, randomized clinical trial // Diabetes Care. – 2018. – Vol. 41, No. 2. – P. 258–266. DOI:10.2337/dc17-0417; Aroda V.R., Bain S.C., Cariou B., Piletič M., Rose L., Axelsen M., Rowe E., DeVries J.H. Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial // Lancet Diabetes Endocrinol. – 2017. – Vol. 5, No. 5. – P. 355–366. DOI:10.1016/S2213-8587(17)30085-2; Rodbard H.W., Lingvay I., Reed J., de la Rosa R., Rose L., Sugimoto D., Araki E., Chu P.L., Wijayasinghe N., Norwood P. Semaglutide added to basal insulin in type 2 diabetes (SUSTAIN 5): a randomized, controlled trial // J Clin Endocrinol Metab. – 2018. – Vol. 103, No. 6. – P. 2291–2301. DOI:10.1210/jc.2018-00070; Pratley R.E., Aroda V.R., Lingvay I., Lüdemann J., Andreassen C., Navarria A., Viljoen A.; SUSTAIN 7 investigators. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial // Lancet Diabetes Endocrinol. – 2018. – Vol. 6, No. 4. – P. 275–286. DOI:10.1016/S2213-8587(18)30024-X; Napoli R., Berra C., Catarig A.M., Di Loreto C., Donatiello E., Berentzen T.L., Pitocco D., Giorgino F. Once-weekly semaglutide use in patients with type 2 diabetes: Real-world data from the SURE Italy observational study // Diabetes Obes Metab. – 2023. – Vol. 25, No. 6. – P. 1658–1667. DOI:10.1111/dom.15020; Wolffenbuttel B.H.R., Brugts M.P., Catarig A.M., Clark A., Kok M., Lieverse A.G., van Soest J. Once-weekly semaglutide use in type 2 diabetes: real-world data from the SURE Netherlands observational study // Adv Ther. – 2023. – Vol. 40, No. 3. – P. 920–933. DOI:10.1007/s12325-022-02385-x; Di Folco U., Vallecorsa N., Nardone M.R., Pantano A.L., Tubili C. Effects of semaglutide on cardiovascular risk factors and eating behaviors in type 2 diabetes // Acta Diabetol. – 2022. – Vol. 59, No. 10. – P. 1287–1294. DOI:10.1007/s00592-022-01936-6; Witkowski M., Wilkinson L., Webb N., Weids A., Glah D., Vrazic H. A Systematic literature review and network meta-analysis comparing once-weekly semaglutide with other glp-1 receptor agonists in patients with type 2 diabetes previously receiving 1-2 oral anti-diabetic drugs // Diabetes Ther. – 2018. – Vol. 9, No. 3. – P. 1149–1167. DOI:10.1007/s13300-018-0424-2; Kanters S., Wilkinson L., Vrazic H., Sharma R., Lopes S., Popoff E., Druyts E. Comparative efficacy of once-weekly semaglutide versus SGLT-2 inhibitors in patients inadequately controlled with one to two oral antidiabetic drugs: a systematic literature review and network meta-analysis // BMJ Open. – 2019. – Vol. 9, No. 7. – P. e023458. DOI:10.1136/bmjopen-2018-023458.; Hu S., Su X., Fan G. Efficacy and tolerability of the Subcutaneous Semaglutide for type 2 Diabetes patients: an updated systematic review and meta-analysis // Diabetol Metab Syndr. – 2023. – Vol. 15. – P. 218. DOI:10.1186/s13098-023-01195-7; Romera I., Cebrián-Cuenca A., Álvarez-Guisasola F., Gomez-Peralta F., Reviriego J. A review of practical issues on the use of glucagon-like peptide-1 receptor agonists for the management of type 2 diabetes // Diabetes Ther. – 2019. – Vol. 10, No. 1. – P. 5–19. DOI:10.1007/s13300-018-0535-9; Leiter L.A., Bain S.C., Bhatt D.L., Buse J.B., Mazer C.D., Pratley R.E., Rasmussen S., Ripa M.S., Vrazic H., Verma S. The effect of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across baseline blood pressure categories: Analysis of the LEADER and SUSTAIN 6 trials // Diabetes Obes Metab. – 2020. – Vol. 22, No. 9. – P. 1690–1695. DOI:10.1111/dom.14079; Husain M., Bain S.C., Holst A.G., Mark T., Rasmussen S., Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials // Cardiovasc Diabetol. – 2020. – Vol. 19, No. 1. – P. 156. DOI:10.1186/s12933-020-01106-4; Wilding J.P.H., Batterham R.L., Calanna S., Davies M., Van Gaal L.F., Lingvay I., McGowan B.M., Rosenstock J., Tran M.T.D., Wadden T.A., Wharton S., Yokote K., Zeuthen N., Kushner R.F.; STEP 1 Study Group. once-weekly semaglutide in adults with overweight or obesity // N Engl J Med. – 2021. – Vol. 384, No. 11. – P. 989–1002. DOI:10.1056/NEJMoa2032183; Wadden T.A., Bailey T.S., Billings L.K., Davies M., Frias J.P., Koroleva A., Lingvay I., O’Neil P.M., Rubino D.M., Skovgaard D., Wallenstein S.O.R., Garvey W.T.; STEP 3 Investigators. Effect of subcutaneous semaglutide vs placebo as an adjunct to intensive behavioral therapy on body weight in adults with overweight or obesity: The STEP 3 Randomized Clinical Trial // JAMA. – 2021. – Vol. 325, No. 14. – P. 1403–1413. DOI:10.1001/jama.2021.1831; Rubino D., Abrahamsson N., Davies M., Hesse D., Greenway FL., Jensen C., Lingvay I., Mosenzon O., Rosenstock J., Rubio M.A., Rudofsky G., Tadayon S., Wadden T.A., Dicker D.; STEP 4 Investigators. Effect of continued weekly subcutaneous semaglutide vs placebo on weight loss maintenance in adults with overweight or obesity: The STEP 4 Randomized Clinical Trial // JAMA. – 2021. – Vol. 325, No. 14. – P. 1414–1425. DOI:10.1001/jama.2021.3224; Rubino D.M., Greenway F.L., Khalid U., O’Neil P.M., Rosenstock J., Sørrig R., Wadden T.A., Wizert A., Garvey W.T.; STEP 8 Investigators. Effect of weekly subcutaneous semaglutide vs daily liraglutide on body weight in adults with overweight or obesity without diabetes: The STEP 8 Randomized Clinical Trial // JAMA. – 2022. – Vol. 327, No. 2. – P. 138–150. DOI:10.1001/jama.2021.23619; Garvey W.T., Batterham R.L., Bhatta M., Buscemi S., Christensen L.N., Frias J.P., Jódar E., Kandler K., Rigas G., Wadden T.A., Wharton S.; STEP 5 Study Group. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial // Nat Med. – 2022. – Vol. 28, No. 10. – P. 2083–2091. DOI:10.1038/s41591-022-02026-4; Davies M., Færch L., Jeppesen O.K., Pakseresht A., Pedersen S.D., Perreault L., Rosenstock J., Shimomura I., Viljoen A., Wadden T.A., Lingvay I.; STEP 2 Study Group. Semaglutide 2•4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial // Lancet. – 2021. – Vol. 397, No. 10278. – P. 971–984. DOI:10.1016/S0140-6736(21)00213-0; Bandyopadhyay S., Das S., Samajdar S.S., Joshi S.R. Role of semaglutide in the treatment of nonalcoholic fatty liver disease or non-alcoholic steatohepatitis: A systematic review and meta-analysis // Diabetes Metab Syndr. – 2023. – Vol. 17, No. 10. – P. 102849. DOI:10.1016/j.dsx.2023.102849; Gumieniczek A., Berecka-Rycerz A. Metabolism and chemical degradation of new antidiabetic drugs: a review of analytical approaches for analysis of glutides and gliflozins // Biomedicines. – 2023. – Vol. 11, No. 8. – P. 2127. DOI:10.3390/biomedicines11082127; D’Hondt M., Bracke N., Taevernier L., Gevaert B., Verbeke F., Wynendaele E., De Spiegeleer B. Related impurities in peptide medicines // J Pharm Biomed Anal. – 2014. – Vol. 101. – P. 2–30. DOI:10.1016/j.jpba.2014.06.012; Li X., Fu Y., Zhang L., Yao L., Li W. Preparation method for semaglutide. WO2021143073A1, 2021.; Lester J., Lobo M., Chandrakesan C., Doshi S., Lalchand C., Nandlal GY., Nikhil UM., Kodandaraman V. An improved process for fmoc synthesis of semaglutide. WO2023012709A1, 2023.; Zhang B., Xu W., Yin C., Tang Y. Characterization of low-level D-amino acid isomeric impurities of Semaglutide using liquid chromatography-high resolution tandem mass spectrometry // J Pharm Biomed Anal. – 2023. – Vol. 224. – Art. ID: 115164. DOI:10.1016/j.jpba.2022.115164; Hong S.Y., Oh J.E., Lee K.H. Effect of D-amino acid substitution on the stability, the secondary structure, and the activity of membrane-active peptide // Biochem Pharmacol. – 1999. – Vol. 58, No. 11. – P. 1775–1780. DOI:10.1016/s0006-2952(99)00259-2; Гурова О.Ю., Фадеев В.В., Малолеткина Е.С. Инъекционная терапия при сахарном диабете 2 типа: существуют ли эффективные способы повышения приверженности лечению? // Сахарный диабет. – 2018. – Т. 21, № 6. – С. 524–533. DOI:10.14341/DM9603; https://www.pharmpharm.ru/jour/article/view/1385

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    المؤلفون: N. G. Rogozhina

    المصدر: Контуры глобальных трансформаций: политика, экономика, право, Vol 15, Iss 2, Pp 49-65 (2023)

    وصف الملف: electronic resource

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    المؤلفون: Rogozhina , Elena I.

    المصدر: Известия Саратовского университета. Новая серия. Серия Филология: Журналистика, Vol 22, Iss 4, Pp 385-391 (2022)

    وصف الملف: electronic resource

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