problendoПроблемы ЭндокринологииProblems of Endocrinology0375-96602308-1430Endocrinology Research Centre10.14341/probl13197problendo-13197Research ArticleБолезни костной и жировой тканиBones & Adipose tissues diseasesСемаглутид — эффективность в снижении веса и побочные эффекты при применении по данным исследований SUSTAIN, PIONEER, STEPSemaglutide — effectiveness in weight loss and side effects when used according to studies by SUSTAIN, PIONEER, STEPhttps://orcid.org/0000-0001-8054-4443ШабутдиноваО. Р.ShabutdinovaO. R.

Шабутдинова Ольга Рафисовна.

450008, Уфа, ул. Ленина, д. 3

Olga R. Shabutdinova.

450008, Ufa, Lenin str., 3

oshabutdinova@mail.ruhttps://orcid.org/0000-0003-2204-009XДаутовА. Р.DautovA. R.

Даутов Азат Русланович.

Уфа

Azat R. Dautov.

Ufa

796592@mail.ruhttps://orcid.org/0000-0002-9833-8135СамковА. А.SamkovA. A.

Самков Антон Алексеевич.

Уфа

Anton A. Samkov.

Ufa

tony.samkov@yandex.ruhttps://orcid.org/0000-0001-5120-7835КононенкоА. В.KononenkoA. V.

Кононенко Александр Валерьевич.

Уфа

Alexandr V. Kononenko.

Ufa

kononenko.doctor@yandex.ruhttps://orcid.org/0000-0002-8034-0544СаргалиевА. Ф.SargalievA. F.

Саргалиев Азат Финатович.

Уфа

Azat F. Sargaliev.

Ufa

sargaliev3@mail.ruhttps://orcid.org/0000-0002-0278-6807ДавлетшинА. Р.DavletshinA. R.

Давлетшин Айнур Ринатович.

Уфа

Ainur R. Davletshin.

Ufa

davletshinbulls23@gmail.comhttps://orcid.org/0000-0003-4873-8867АндресоваП. А.AndresovaP. A.

Андресова Полина Анатольевна.

Уфа

Polina A. Andresova.

Ufa

polinaandresova10@gmail.comhttps://orcid.org/0000-0002-6239-5576ЗарбееваК. Р.ZarbeevaK. R.

Зарбеева Карина Радиковна.

Уфа

Karina R. Zarbeeva.

Ufa

k.zarbeeva@yandex.ruhttps://orcid.org/0000-0002-0660-5890ТоршхоеваД. А.TorshkhoevaD. A.

Торшхоева Дана Амерхановна.

Махачкала

Dana A. Torshkhoeva.

Mahachkala

Dana.torshkhoeva16@gmail.comhttps://orcid.org/0000-0002-1834-1095РахмонкуловУ. А.RakhmonkulovU. A.

Рахмонкулов Улугбек Азамкулович.

Уфа

Ulugbek A. Rakhmonkulov.

Ufa

ulugbekrahm@mail.ruhttps://orcid.org/0000-0003-2948-4507АфанасьевА. А.AfanasyevA. A.

Афанасьев Андрей Алексеевич.

Самара

Andrey A. Afanasyev.

Samara

andrewafanasev@yandex.ruБашкирский государственный медицинский университетРоссияBashkir state medical universityRussian FederationДагестанский государственный медицинский университетРоссияDagestan state medical universityRussian FederationСамарский государственный медицинский университетРоссияSamara state medical universityRussian Federation2023300620236936882Copyright © Шабутдинова О.Р., Даутов А.Р., Самков А.А., Кононенко А.В., Саргалиев А.Ф., Давлетшин А.Р., Андресова П.А., Зарбеева К.Р., Торшхоева Д.А., Рахмонкулов У.А., Афанасьев А.А., 20232023Шабутдинова О.Р., Даутов А.Р., Самков А.А., Кононенко А.В., Саргалиев А.Ф., Давлетшин А.Р., Андресова П.А., Зарбеева К.Р., Торшхоева Д.А., Рахмонкулов У.А., Афанасьев А.А.Shabutdinova O.R., Dautov A.R., Samkov A.A., Kononenko A.V., Sargaliev A.F., Davletshin A.R., Andresova P.A., Zarbeeva K.R., Torshkhoeva D.A., Rakhmonkulov U.A., Afanasyev A.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.probl-endojournals.ru/jour/article/view/13197

Избыточный вес и ожирение являются всемирно распространенной проблемой и диагностируются при значении индекса массы тела (ИМТ) в пределах 25,0–29,9 кг/ м2 и ≥30,0 кг/м2 соответственно. Пациенты с ожирением подвержены высокому риску развития сопутствующих заболеваний, таких как гипертоническая болезнь, сахарный диабет 2 типа (СД2), гиперлипидемия, инсульт и даже некоторые виды онкологических заболеваний. В Российской Федерации на 2016 г. доля лиц с избыточной массой тела составила 62,0%, с ожирением — 26,2%. Авторами был произведен электронный поиск в информационной базе данных PubMed. Были использованы два элемента поиска: «Semaglutide» и «Obesity». В поиск включались исследования, опубликованные с даты основания базы данных по август 2022 г. ­Поиск был ограничен только результатами клинических исследований. Авторами было получено 26 результатов, однако были рассмотрены только исследования SUSTAIN, PIONEER (Peptide Innovation for Early Diabetes Treatment) и STEP, поскольку они были оригинальными рандомизированными контролируемыми клиническими испытаниями, проведенными до утверждения семаглутида для терапии СД2 и ожирения.

Overweight and obesity are a worldwide common problem and are diagnosed with a body mass index (BMI) value in the range of 25.0–29.9 kg/m2 and ≥30.0 kg/m2, respectively. Obese patients are at high risk of developing concomitant diseases, such as hypertension, type 2 diabetes mellitus (DM2), hyperlipidemia, stroke and even some types of cancer. In the Russian Federation in 2016, the proportion of overweight people was 62.0%, with obesity — 26.2%. The authors performed an electronic search in the PubMed information database. Two search elements were used: «Semaglutide» and «Obesity». The search included studies published from the date of foundation of the database to August 2022. The search was limited only to the results of clinical trials. The authors obtained 26 results, but only the studies of SUSTAIN, PIONEER (Peptide Innovation for Early Diabetes Treatment) and STEP were considered, since they were original, randomized, controlled clinical trials conducted before the approval of semaglutide for the treatment of DM2 and obesity.

ожирениесемаглутидсахарный диабетSUSTAINPIONEERSTEPтерапия ожиренияobesitysemaglutidediabetes mellitusSUSTAINPIONEERSTEPobesity therapyIsaacs Diana Prasad-Reddy Lalita Srivastava Sneha Baxi Role of glucagon-like peptide 1 receptor agonists in management of obesity American Journal of Health-System Pharmacy 2016 09 1493 1507 73 19 10.2146/ajhp150990World Health Organization. Obesity and overweight. 2020 [cited 21.05.2023]. Available from: https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweightDedov Ivan I. Mokrysheva Natalia G. Mel’nichenko Galina A. Troshina Ekaterina A. Mazurina Natalya V. Ershova Ekaterina V. Komshilova Kseniya A. Andreeva Elena N. Antsiferov Mikhail B. Biriukova Elena V. Bordan Natalia S. Vagapova Gulnar R. Volkova Anna R. Volkova Natalia I. Volynkina Anna P. Dzgoeva Fatima Kh. Kiseleva Tatiana P. Neimark Aleksandr E. Romantsova Tatiana I. Ruiatkina Liudmila A. Suplotova Liudmila A. Khalimov Yury Sh. Yashkov Yury I. Obesity Consilium Medicum 2021 07 311 325 23 4 10.26442/20751753.2021.4.200832Troshina Ekaterina A. Ershova Ekaterina V. Pharmacotherapy of obesity: what’s new? Problems of Endocrinology 2018 09 270 276 64 4 10.14341/probl9315Matheus Alessandra Saldanha de Mattos Tannus Lucianne Righeti Monteiro Cobas Roberta Arnoldi Palma Catia C. Sousa Negrato Carlos Antonio Gomes Marilia de Brito Impact of Diabetes on Cardiovascular Disease: An Update International Journal of Hypertension 2013 03 1 15 2013 10.1155/2013/653789U. S. Food and Drug Administration. FDA requests the withdrawal of weight-loss drug Belviq, Belviq XR (Lorcaserin) from the market: potential risk of cancer outweighs the benefits. Washington, DC: Center for Drug Evaluation and Research; 2020.U. S. Food and Drug Administration. FDA approves new drug treatment for chronic weight management, first since 2014. Washington, DC: Center for Drug Evaluation and Research; 2021.Blundell John Finlayson Graham Axelsen Mads Flint Anne Gibbons Catherine Kvist Trine Hjerpsted Julie B. Effects of once‐weekly semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity Diabetes, Obesity and Metabolism 2017 03 1242 1251 19 9 10.1111/dom.12932Ahrén Bo Masmiquel Luis Kumar Harish Sargin Mehmet Karsbøl Julie Derving Jacobsen Sanja Hald Chow Francis 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 The Lancet Diabetes & Endocrinology 2017 04 341 354 5 5 10.1016/s2213-8587(17)30092-xAhmann Andrew J. Capehorn Matthew Charpentier Guillaume Dotta Francesco Henkel Elena Lingvay Ildiko Holst Anders G. Annett Miriam P. Aroda Vanita 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 2017 12 258 266 41 2 10.2337/dc17-0417Wilding John P.H. Batterham Rachel L. Calanna Salvatore Davies Melanie Van Gaal Luc F. Lingvay Ildiko McGowan Barbara M. Rosenstock Julio Tran Marie T.D. Wadden Thomas A. Wharton Sean Yokote Koutaro Zeuthen Niels Kushner Robert F. Once-Weekly Semaglutide in Adults with Overweight or Obesity New England Journal of Medicine 2021 02 989 1002 384 11 10.1056/nejmoa2032183Davies Melanie Færch Louise Jeppesen Ole K Pakseresht Arash Pedersen Sue D Perreault Leigh Rosenstock Julio Shimomura Iichiro Viljoen Adie Wadden Thomas A Lingvay Ildiko 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 The Lancet 2021 03 971 984 397 10278 10.1016/s0140-6736(21)00213-0Wadden Thomas A. Bailey Timothy S. Billings Liana K. Davies Melanie Frias Juan P. Koroleva Anna Lingvay Ildiko O’Neil Patrick M. Rubino Domenica M. Skovgaard Dorthe Wallenstein Signe O. R. Garvey W. Timothy Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity JAMA 2021 02 1403 325 14 10.1001/jama.2021.1831Rubino Domenica Abrahamsson Niclas Davies Melanie Hesse Dan Greenway Frank L. Jensen Camilla Lingvay Ildiko Mosenzon Ofri Rosenstock Julio Rubio Miguel A. Rudofsky Gottfried Tadayon Sayeh Wadden Thomas A. Dicker Dror Friberg Mette Sjödin Anders Dicker Dror Segal Gabriella Mosenzon Ofri Sabbah Muhammad Sofer Yael Vishlitzky Victor Meesters Eelco W. Serlie Mirelle van Bon Arianne Cardoso Helena Freitas Paula Carneiro de Melo Pedro Monteiro Margarida Monteiro Mariana Rodrigues Dírcea Badat Aysha Joshi Pankaj Latiff Gulam Mitha Essack A. Snyman Hans H. van Nieuwenhuizen Elane González Albarrán Olga Caixas Assumpta de al Cuesta Carmen Garcia Luna Pedro Pablo Morales Portillo Cristobal Mezquita Raya Pedro Rubio Miguel Angel Abrahamsson Niclas Hoffstedt Johan von Wowern Fredrik Uddman Erik Bach-Kliegel Birgit Beuschlein Felix Bilz Stefan Golay Alain Rudofsky Gottfried Strey Christopher Fadieienko Galyna Kosei Nataliia Tatarchuk Tetiana Velychko Valentyna Zinych Olesya Aronoff Stephen L. Bays Harold E. Brockmyre Andrew P. Call Robert S. Crump Charles Desouza Cyrus V. Espinosa Valerie Free Almena L. Gandy Winston H. Geller Steven A. Gottschlich Gregory M. Greenway Frank L. Han-Conrad Laurie Harper Wayne Herman Lee Hewitt Mitzie Hollander Priscilla Kaster Steven R. Manessis Anastasios Martin Frederick A. McNeill Robert E. Murray Alexander V. Norwood Paul C. Reed John C.H. Rosenstock Julio Rubino Domenica M. Schear Martin J. Warren Mark L. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity JAMA 2021 03 1414 325 14 10.1001/jama.2021.3224Garvey W. Timothy Batterham Rachel L. Bhatta Meena Buscemi Silvio Christensen Louise N. Frias Juan P. Jódar Esteban Kandler Kristian Rigas Georgia Wadden Thomas A. Wharton Sean Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial Nature Medicine 2022 10 2083 2091 28 10 10.1038/s41591-022-02026-4Marso Steven P. Bain Stephen C. Consoli Agostino Eliaschewitz Freddy G. Jódar Esteban Leiter Lawrence A. Lingvay Ildiko Rosenstock Julio Seufert Jochen Warren Mark L. Woo Vincent Hansen Oluf Holst Anders G. Pettersson Jonas Vilsbøll Tina Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes New England Journal of Medicine 2016 09 1834 1844 375 19 10.1056/nejmoa1607141Ji Linong Dong Xiaolin Li Yiming Li Yufeng Lim Soo Liu Ming Ning Zu Rasmussen Søren Skjøth Trine Vang Yuan Guoyue Eliaschewitz Freddy G. Efficacy and safety of once‐weekly semaglutide versus once‐daily sitagliptin as add‐on to metformin in patients with type 2 diabetes in SUSTAIN China : A 30‐week, double‐blind, phase 3a, randomized trial Diabetes, Obesity and Metabolism 2020 10 404 414 23 2 10.1111/dom.14232Seino Yutaka Terauchi Yasuo Osonoi Takeshi Yabe Daisuke Abe Nobuyuki Nishida Tomoyuki Zacho Jeppe Kaneko Shizuka Safety and efficacy of semaglutide once weekly vs sitagliptin once daily, both as monotherapy inJapanese people with type 2 diabetes Diabetes, Obesity and Metabolism 2017 08 378 388 20 2 10.1111/dom.13082Kaku Kohei Yamada Yuichiro Watada Hirotaka Abiko Atsuko Nishida Tomoyuki Zacho Jeppe Kiyosue Arihiro Safety and efficacy of once‐weekly semaglutide vs additional oral antidiabetic drugs in Japanese people with inadequately controlled type 2 diabetes: A randomized trial Diabetes, Obesity and Metabolism 2018 01 1202 1212 20 5 10.1111/dom.13218Rodbard Helena W Lingvay Ildiko Reed John de la Rosa Raymond Rose Ludger Sugimoto Danny Araki Eiichi Chu Pei-Ling Wijayasinghe Nelun Norwood Paul Semaglutide Added to Basal Insulin in Type 2 Diabetes (SUSTAIN 5): A Randomized, Controlled Trial The Journal of Clinical Endocrinology & Metabolism 2018 04 2291 2301 103 6 10.1210/jc.2018-00070Sorli Christopher Harashima Shin-ichi Tsoukas George M Unger Jeffrey Karsbøl Julie Derving Hansen Thomas Bain Stephen 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 The Lancet Diabetes & Endocrinology 2017 01 251 260 5 4 10.1016/s2213-8587(17)30013-xZinman Bernard Bhosekar Vaishali Busch Robert Holst Ingrid Ludvik Bernhard Thielke Desirée Thrasher James Woo Vincent Philis-Tsimikas Athena Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial The Lancet Diabetes & Endocrinology 2019 03 356 367 7 5 10.1016/s2213-8587(19)30066-xAroda Vanita R Bain Stephen C Cariou Bertrand Piletič Milivoj Rose Ludger Axelsen Mads Rowe Everton DeVries J Hans 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 The Lancet Diabetes & Endocrinology 2017 03 355 366 5 5 10.1016/s2213-8587(17)30085-2Pratley Richard E Aroda Vanita R Lingvay Ildiko Lüdemann Jörg Andreassen Camilla Navarria Andrea Viljoen Adie Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial The Lancet Diabetes & Endocrinology 2018 02 275 286 6 4 10.1016/s2213-8587(18)30024-xLingvay Ildiko Catarig Andrei-Mircea Frias Juan P Kumar Harish Lausvig Nanna L le Roux Carel W Thielke Desirée Viljoen Adie McCrimmon Rory J Efficacy and safety of once-weekly semaglutide versus daily canagliflozin as add-on to metformin in patients with type 2 diabetes (SUSTAIN 8): a double-blind, phase 3b, randomised controlled trial The Lancet Diabetes & Endocrinology 2019 09 834 844 7 11 10.1016/s2213-8587(19)30311-0Capehorn M.S. Catarig A.-M. Furberg J.K. Janez A. Price H.C. Tadayon S. Vergès B. Marre M. Efficacy and safety of once-weekly semaglutide 1.0 mg vs once-daily liraglutide 1.2 mg as add-on to 1–3 oral antidiabetic drugs in subjects with type 2 diabetes (SUSTAIN 10) Diabetes & Metabolism 2019 09 100 109 46 2 10.1016/j.diabet.2019.101117Jendle Johan Birkenfeld Andreas L. Polonsky William H. Silver Robert Uusinarkaus Kari Hansen Thomas Håkan‐Bloch Jonas Tadayon Sayeh Davies Melanie J. Improved treatment satisfaction in patients with type 2 diabetes treated with once‐weekly semaglutide in the SUSTAIN trials Diabetes, Obesity and Metabolism 2019 06 2315 2326 21 10 10.1111/dom.13816Rodbard Helena W. Rosenstock Julio Canani Luis H. Deerochanawong Chaicharn Gumprecht Janusz Lindberg Søren Østergaard Lingvay Ildiko Søndergaard Anette Luther Treppendahl Marianne Bach Montanya Eduard Cruz Pablo Loredo Luis De Luquez Cecilia Moisello Maria Augusto Gustavo Akerman Castro Marise Canani Luis Akrap Branko Bulum Tomislav Rahelic Dario Sunic-Grcic Ivana Tusek Srecko Avramidis Iakovos Benroubi Marian Didangelos Triantafyllos Karousos Gerasimos Pagkalos Emmanouil Sampanis Christos Somali Maria Domboróczki Zsolt Faludi Péter Gaál Zsolt Kis-Gombos Piroska Kocsis Gyozo Marton Zoltán Sudár Zsolt Buscemi Silvio Di Carlo Alberto Dotta Francesco Gambineri Alessandra Lauro Davide Maranghi Marianna Arciszewska Malgorzata Gumprecht Janusz Matuszewska Krystyna Skokowska Ewa Stasinska Teresa Feofanova Svetlana Filippova Ekaterina Galstyan Gagik Gaysina Leylya Kunitsyna Marina Suplotova Lyudmila Antic Slobodan Djukic Aleksandar Mitrovic Milena Pesic Milica Stokic Edita Jodar Esteban Martínez Encarna Raya Pedro Mezquita Montanya Eduard Portillo Cristobal Morales Vera Mercè Pérez Fernández Margarita Rivas San Jose Patricia Riera Manel Terns Boonyavarakul Apussanee Deerochanawong Chaicharn Sriwijitkamol Apiradee Ajani Dilawar Armas Eddie Barbel-Johnson Kim Bartilucci Darlene Bonabi Gholamreza Busch Robert Butuk David Cannon Kevin Chase Craig Chaykin Louis Cheekati Vasundhara Davis Thomas Delgado Belkis Farris Neil Graves Mark Ha Chi Harper Linda Herring Sharon Hewitt Mitzie Hsia Daniel Jackson Richard Jardula Michael Joyce Mark Juarez Mario Kapoor Anoop Karounos Dennis Kayne David Lacour Audrey Ledesma Gilbert Lingvay Ildiko Lipetz Robert Lomboy Joseph Lynd Sean Morawski Emily Morin Robert Murphy Richard Overcash J. Scott Pullman John Rodbard Helena W. Rosenstock Julio Ruoff Gary Steenkamp Devin Toro Hugo Trachtenbarg David Tulloch Brian Weisbrot Albert Wright Alison Oral Semaglutide Versus Empagliflozin in Patients With Type 2 Diabetes Uncontrolled on Metformin: The PIONEER 2 Trial Diabetes Care 2019 09 2272 2281 42 12 10.2337/dc19-0883Thethi Tina K. Pratley Richard Meier Juris J. Efficacy, safety and cardiovascular outcomes of once‐daily oral semaglutide in patients with type 2 diabetes: ThePIONEERprogramme Diabetes, Obesity and Metabolism 2020 04 1263 1277 22 8 10.1111/dom.14054Rosenstock Julio Allison Dale Birkenfeld Andreas L. Blicher Thalia Marie Deenadayalan Srikanth Jacobsen Jacob Bonde Serusclat Pierre Violante Rafael Watada Hirotaka Davies Melanie Effect of Additional Oral Semaglutide vs Sitagliptin on Glycated Hemoglobin in Adults With Type 2 Diabetes Uncontrolled With Metformin Alone or With Sulfonylurea JAMA 2019 03 1466 321 15 10.1001/jama.2019.2942Aroda Vanita R. Rosenstock Julio Terauchi Yasuo Altuntas Yuksel Lalic Nebojsa M. Morales Villegas Enrique C. Jeppesen Ole K. Christiansen Erik Hertz Christin L. Haluzík Martin Belkacem Krim Chiali Nabil Bourezane Samia Guermaz Rachida Popivanov Plamen Lefterov Ivaylo Tankova Tsvetalina Penchev Ivan Koskova Martina Hudcova Miroslava Vesela Alica Rancova Anna Haluzik Martin Kiyosue Arihiro Matsuoka Osamu Inoue Satoshi Terauchi Yasuo Fukushima Yasushi Ide Yumiko Violante Ortiz Rafael Margarito Morales Villegas Enrique Golovach Albina Alpenidze Diana Frolova Elena Zhdanova Elena Ruyatkina Ludmila Ershova Olga Samoilova Yulia Zyangirova Svetlana Lalic Katarina Lalic Nebojsa Beljic Zivkovic Teodora Ataoglu Esra Bakiner Okan Dayan Akin Sargin Mehmet Mert Meral Adas Mine Tabak Omur Altuntas Yuksel Murray Alexander Iranmanesh Ali Schlau Aron Wieskopf Bram Snyder Brian Griffin Carl Fogarty Charles Lovell Charles Allison Dale Fitz-Patrick David Grant David Klonoff David Williams Dwayne Armas Eddie Palace Eileen Ruoff Gary Martinez Gilbert Perez Gilberto Bays Harold Tatu Horia Maynard James Cedeno Jeanne-Elyse Aroda Vanita Park Jean Sutton Jennefer Pouzar Joe Bertsch John Condit Jonathan Serje Jorge Cabaccan Josel Risser Joseph Frias Juan Rosenstock Julio Sivalingam Kanagaratnam Maw Kelli Hanson Lenita Billings Liana Connery Lisa Juarez Mario Lillestol Michael Fraser Neil Beckett Paul Wade Ralph Gaona Raul Jackson Richard DeLuca Robert Alpizar Sady Herring Sharon Stringam Stanley Bauer Steven Gangi Sumana Sligh Teresa Jarrett Wentworth Fitzgibbons William PIONEER 1: Randomized Clinical Trial of the Efficacy and Safety of Oral Semaglutide Monotherapy in Comparison With Placebo in Patients With Type 2 Diabetes Diabetes Care 2019 06 1724 1732 42 9 10.2337/dc19-0749Mosenzon Ofri Blicher Thalia Marie Rosenlund Signe Eriksson Jan W Heller Simon Hels Ole Holm Pratley Richard Sathyapalan Thozhukat Desouza Cyrus Abramof R Alpenidze D Aronoff S Astamirova K Barker B Bedel G Belousova L Benson M Beshay I Biggs W Blaze K Bogdanski P Busch R Chaidarun S Chandran S Chang A Chilka S Cleland A Connery L Cornett G Delgado B Desouza C Donner T Eliasson K Eriksson J Folkerth S Forshaw K Frandsen H A Frolova E Gandy W Gatipon G Golovach A Gonzalez-Orozco L Gumprecht J Haddad E Hansen T K Hart T Hasan S Hella B Heller S Hellgren M Hewitt M Hietaniemi S Hitz M Houser P Huntley R Jackson R Jakobsen P E Kapoor A Kargina L Kazakova E Khan K Klein E Knoble H Krasnopeeva (Kabachkova) N Krzeminski A Kunitsyna M Lawhead J Levin K Levin P Lewy-Alterbaum L Lindmark S Lindsay R Luts A Lysenko T Madsbad S Maxwell T Mbogua C Mcknight J Metsärinne K Milovanova T Morawski E Mosenzon O Nabriski D Nguyen H Nicol P Nieminen S Nikkola A Norwood P O'Donnell P Odugbesan A Parker J Pergaeva Y Peskov A Plevin S Pouzar J Pratley R Reed J Rossing P Sathyapalan T Sergeeva-Kondrachenko M Shaikh Z Shamkhalova M Shehadeh N Shlesinger Y Silver R Snyder B Soufer J Strand J Sulosaari S Tirosh A Traylor H Uhlenius N Vagapova G Yanovskaya M Zarutskaya L Zhdanova E Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment (PIONEER 5): a placebo-controlled, randomised, phase 3a trial The Lancet Diabetes & Endocrinology 2019 06 515 527 7 7 10.1016/s2213-8587(19)30192-5Pratley Richard Amod Aslam Hoff Søren Tetens Kadowaki Takashi Lingvay Ildiko Nauck Michael Pedersen Karen Boje Saugstrup Trine Meier Juris J Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial The Lancet 2019 06 39 50 394 10192 10.1016/s0140-6736(19)31271-1Yamada Yuichiro Katagiri Hideki Hamamoto Yoshiyuki Deenadayalan Srikanth Navarria Andrea Nishijima Keiji Seino Yutaka Fukushima Y Hamamoto Y Hisatomi A Ide Y Inoue S Kawada T Kim H Kiyosue A Matoba K Matsuoka O Nishimura H Noguchi M Osonoi T Sawada S Shibasaki Y Shin K Yamada Y Dose-response, efficacy, and safety of oral semaglutide monotherapy in Japanese patients with type 2 diabetes (PIONEER 9): a 52-week, phase 2/3a, randomised, controlled trial The Lancet Diabetes & Endocrinology 2020 04 377 391 8 5 10.1016/s2213-8587(20)30075-9Zinman Bernard Aroda Vanita R. Buse John B. Cariou Bertrand Harris Stewart B. Hoff Søren Tetens Pedersen Karen Boje Tarp-Johansen Mads Jeppe Araki Eiichi Zinman Bernard Fikry Sameh Bajaj Harpreet Landry Daniel Caplan David Woo Vincent Harris Stewart Thuan Jean-Francois Serusclat Pierre Cariou Bertrand Gourdy Pierre Fradet Gerard Monier Arnaud Borot Sophie Monguillon Pascal Gouet Didier Doupis John Tentolouris Nikolaos Tsimichodimos Vasileios Melidonis Andreas Bekiari Eleni Bargiota Alexandra Agarwal Sanjay Saboo Banshi Chatterjee Sanjay Mohan Viswanathan Shaikh Shehla Gupta Yashdeep Bhattacharyya Arpandev Manikath Neeraj Jain Sunil Sasaki Takashi Osonoi Takeshi Fukuda Shuichi Wada Seiki Kiyosue Arihiro Ide Yumiko Onishi Yukiko Matoba Kiyokazu Takai Kuninobu Yamauchi Akira Inoue Satoshi Kaneko Shizuka Ikeda Hiroki Ohta Yasuharu Hisatomi Akitaka Senokuchi Takafumi Jinnouchi Hideaki Nakamura Shuji Soto José Roberto Lazcano Briones Ignacio Rodriguez Bogdanski Pawel Szyprowska Ewa Modzelewska Anna Wozniak Iwona Zyangirova Svetlana Sergeeva-Kondrachenko Marina Davis Thomas Thomson Stephen Frias Juan Gandy Winston Lingvay Ildiko Pounds Kevin Bowman-Stroud Cynthia Dempsey Michael Huffman David Ahmed Azazuddin Fraser Neil Ortiz-Carrasquillo Ramon Bolster D. Eric Adams Michael Hummel Matthew Free Almena Houser Patricia Shockey Gerald Barnum Otis Bhasker Kala Cornett George Streja Dan Kirby William Lynd Sean Folkerth Steven Nakhle Samer Norwood Paul Perez Rodolfo Snyder Brian Farris Neil Litchfield Willian Hamdy Osama Park Jean Aroda Vanita Buse Joh Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial Diabetes Care 2019 09 2262 2271 42 12 10.2337/dc19-0898Pieber Thomas R Bode Bruce Mertens Ann Cho Young Min Christiansen Erik Hertz Christin L Wallenstein Signe O R Buse John B Akın S Aladağ N Arif A A Aronne L J Aronoff S Ataoglu E Baik S H Bays H Beckett P L Berker D Bilz S Bode B Braun E W Buse J B Canani L H S Cho Y M Chung C H Colin I Condit J Cooper J Delgado B Eagerton D C El Ebrashy I N El Hefnawy M H M F Eliaschewitz F G Finneran M P Fischli S Fließer-Görzer E Geohas J Godbole N A Golay A Gorban de Lapertosa S Gross J L Gulseth H L Helland F Høivik H O Issa C Kang E S Keller C Khalil S H A Kim N H Kim I J Klaff L J Laimer M LaRocque J C Lederman S N Lee K-W Litchfield W R Manning M B Mertens A Morawski E J Murray A V Nicol P R O'Connor T M Oğuz A Ong S Özdemir A Palace E M Palchick B A Pereles-Ortiz J Pieber T Prager R Preumont V Riffer E Rista L Rudofsky G Sarı R Scheen A Schultes B Seo J A Shelbaya S A Sivalingam K Sorli C H Stäuble S Streja D A T'Sjoen G Tetiker T Van Gaal L Vercammen C Warren M L Weinstein D L Weiss D White A Winnie M Wium C Yavuz D Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes (PIONEER 7): a multicentre, open-label, randomised, phase 3a trial The Lancet Diabetes & Endocrinology 2019 06 528 539 7 7 10.1016/s2213-8587(19)30194-9Yabe Daisuke Nakamura Jiro Kaneto Hideaki Deenadayalan Srikanth Navarria Andrea Gislum Mette Inagaki Nobuya Arisaka T Asakura T Azuma N Fukuda S Fukushima Y Harada N Inoue S Ishida H Ishii H Ishikawa S Jinnouchi H Kaneko S Kanno K Kato M Kato Y Kawada T Kim H Kiyosue A Matsuoka O Miho O Nakamoto S Nakamura S Nakanishi S Nishimura H Numata A Ohama T Okabe T Okuguchi F Osonoi T Sasaki T Seino H Shin K Shiraiwa T Sugiura T Wada S Yamauchi A Safety and efficacy of oral semaglutide versus dulaglutide in Japanese patients with type 2 diabetes (PIONEER 10): an open-label, randomised, active-controlled, phase 3a trial The Lancet Diabetes & Endocrinology 2020 04 392 406 8 5 10.1016/s2213-8587(20)30074-7Husain Mansoor Birkenfeld Andreas L. Donsmark Morten Dungan Kathleen Eliaschewitz Freddy G. Franco Denise R. Jeppesen Ole K. Lingvay Ildiko Mosenzon Ofri Pedersen Sue D. Tack Cees J. Thomsen Mette Vilsbøll Tina Warren Mark L. Bain Stephen C. Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes New England Journal of Medicine 2019 06 841 851 381 9 10.1056/nejmoa1901118DeVries J. Hans Desouza Cyrus Bellary Srikanth Unger Jeffrey Hansen Oluf K. H. Zacho Jeppe Woo Vincent Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme Diabetes, Obesity and Metabolism 2018 06 2426 2434 20 10 10.1111/dom.13396Quante M. Thate-Waschke I. Schofer M. Was sind die Gründe der Patientenpräferenz? Vergleich von oraler und subkutaner Darreichungsform Zeitschrift für Orthopädie und Unfallchirurgie 2012 03 397 403 150 04 10.1055/s-0031-1298347Center for Drug Evaluation and Research. Guidance for industry developing products for weight management, 2007 [cited 21.05.2023]. Available from: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm071612.pdfKhera Rohan Murad Mohammad Hassan Chandar Apoorva K. Dulai Parambir S. Wang Zhen Prokop Larry J. Loomba Rohit Camilleri Michael Singh Siddharth Association of Pharmacological Treatments for Obesity With Weight Loss and Adverse Events JAMA 2016 06 2424 315 22 10.1001/jama.2016.7602Apovian Caroline M. Aronne Louis Rubino Domenica Still Christopher Wyatt Holly Burns Colleen Kim Dennis Dunayevich Eduardo A randomized, phase 3 trial of naltrexone SR/bupropion SR on weight and obesity‐related risk factors (COR‐II) Obesity 2013 02 935 943 21 5 10.1002/oby.20309Finer N James WPT Kopelman PG Lean MEJ Williams G One-year treatment of obesity: a randomized, double-blind, placebo-controlled, multicentre study of orlistat, a gastrointestinal lipase inhibitor International Journal of Obesity 2002 09 306 313 24 3 10.1038/sj.ijo.0801128Allison David B. Gadde Kishore M. Garvey William Timothy Peterson Craig A. Schwiers Michael L. Najarian Thomas Tam Peter Y. Troupin Barbara Day Wesley W. Controlled-Release Phentermine/Topiramate in Severely Obese Adults: A Randomized Controlled Trial (EQUIP) Obesity 2011 11 330 342 20 2 10.1038/oby.2011.330Fidler Meredith C. Sanchez Matilde Raether Brian Weissman Neil J. Smith Steven R. Shanahan William R. Anderson Christen M. A One-Year Randomized Trial of Lorcaserin for Weight Loss in Obese and Overweight Adults: The BLOSSOM Trial The Journal of Clinical Endocrinology & Metabolism 2011 07 3067 3077 96 10 10.1210/jc.2011-1256Strizheletsky V. V. Gomon Yu. М. Spichakova Е. А. Kolbin А. S. Kalyapin А. А. Makarov S. А. Lomiya А. B. Sultanova F. М. Drug therapy for obesity in the Russian Federation: pharmacoepidemiological study FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology 2022 09 320 331 15 3 10.17749/2070-4909/farmakoekonomika.2022.149Hansen Gitte Jelsing Jacob Vrang Niels Effects of liraglutide and sibutramine on food intake, palatability, body weight and glucose tolerance in the gubra DIO-rats Acta Pharmacologica Sinica 2012 02 194 200 33 2 10.1038/aps.2011.168Matveev G. A. Golikova T. I. Vasileva A. A. Vasilieva E. V. Babenko A. Y. Shlyakhto E. V. Comparison of the effects of liraglutide and sibutramine in obese patients Obesity and metabolism 2021 07 218 228 18 2 10.14341/omet12498Shamkhalova M. Sh. Shestakova M. V. Efficacy and safety of oral semaglutide in Russian patients with type 2 diabetes: subgroup analysis of PIONEER 1, 2, 3 trials Diabetes mellitus 2022 07 204 214 25 3 10.14341/dm12941

The authors declare that there are no conflicts of interest present.