Produção Nacional
Revisado por pares
Oral Semaglutide Versus Empagliflozin in Patients With Type 2 Diabetes Uncontrolled on Metformin: The PIONEER 2 Trial
2019; American Diabetes Association; Volume: 42; Issue: 12 Linguagem: Inglês
10.2337/dc19-0883
ISSN1935-5548
AutoresHelena W. Rodbard, Julio Rosenstock, Luís Henrique Santos Canani, Chaicharn Deerochanawong, Janusz Gumprecht, Søren Lindberg, Ildiko Lingvay, ANETTE L. SØNDERGAARD, Marianne Bach Treppendahl, Eduard Montanya, Pablo Jordão Alcântara Cruz, Luis De Loredo, Cecilia Luquez, Maria Alejandra Moisello, Gustavo Akerman Augusto, Marise Lazaretti Castro, Luís Henrique Santos Canani, Branko Akrap, Tomislav Bulum, Dario Rahelić, Ivana Sunic-Grcic, Srecko Tusek, Iakovos Avramidis, Marian Benroubi, Triantafyllos Didangelos, Gerasimos Karousos, Emmanouil Pagkalos, Christos Sampanis, Maria Somali, Zsolt Domboróczki, Péter Faludi, Zsolt Gaál, Piroska Kis-Gombos, Győző Kocsis, Zoltán Márton, Zsolt Sudár, Silvio Buscemi, Alberto Di Carlo, Francesco Dotta, Alessandra Gambineri, Davide Lauro, Marianna Maranghi, Małgorzata Arciszewska, Janusz Gumprecht, Krystyna Matuszewska, Ewa Skokowska, Teresa Stasinska, Svetlana Feofanova, Е. О. Филиппова, G. R. Galstyan, Leyla Gaysina, М. А. Куницына, Lyudmila Suplotova, Slobodan Antić, Aleksandar Djukić, Milena Mitrović, Milica Pešić, Edita Stokić, Esteban Jódar, Encarna Martínez, Pedro Mezquita Raya, Eduard Montanya, Cristóbal Morales, Mercè Pérez Vera, Margarita Fernández, Patricia San José, Manel Terns Riera, Apussanee Boonyavarakul, Chaicharn Deerochanawong, Apiradee Sriwijitkamol, Dilawar Ajani, Eddie Armas, Kim Barbel-Johnson, Darlene Bartilucci, Gholamreza Bonabi, Robert S. Busch, David Butuk, Kevin D. Cannon, Craig Chase, Louis Chaykin, Vasundhara Cheekati, Thomas R. A. Davis, Belkis Delgado, Neil Farris, Mark Graves, Chi Ha, Linda Harper, Sharon J. Herring, Mitzie Hewitt, Daniel S. Hsia, Richard A. Jackson, Michael Jardula, Mark Joyce, Mario Juarez, Anoop Kapoor, Dennis G. Karounos, David Kayne, Audrey Lacour, Gilbert Ledesma, Ildiko Lingvay, Robert Lipetz, Joseph Lomboy, Sean Lynd, Emily Morawski, Robert J. Morin, Richard Murphy, J. Scott Overcash, John Pullman, Helena W. Rodbard, Julio Rosenstock, Gary Ruoff, Devin Steenkamp, H Toro, David Trachtenbarg, B. Tulloch, Albert Weisbrot, Alison E. Wright,
Tópico(s)Pancreatic function and diabetes
ResumoEfficacy and safety of the glucagon-like peptide 1 (GLP-1) analog oral semaglutide and the sodium-glucose cotransporter 2 inhibitor empagliflozin were compared in patients with type 2 diabetes uncontrolled on metformin.Patients were randomized to once-daily open-label treatment with oral semaglutide 14 mg (n = 412) or empagliflozin 25 mg (n = 410) in a 52-week trial. Key end points were change from baseline to week 26 in HbA1c (primary) and body weight (confirmatory secondary). Two estimands addressed efficacy-related questions: treatment policy (regardless of trial product discontinuation or rescue medication) and trial product (on trial product without rescue medication) in all randomized patients.Four hundred (97.1%) patients in the oral semaglutide group and 387 (94.4%) in the empagliflozin group completed the trial. Oral semaglutide provided superior reductions in HbA1c versus empagliflozin at week 26 (treatment policy -1.3% vs. -0.9% [-14 vs. -9 mmol/mol], estimated treatment difference [ETD] -0.4% [95% CI -0.6, -0.3] [-5 mmol/mol (-6, -3)]; P < 0.0001). The treatment difference in HbA1c significantly favored oral semaglutide at week 26 for the trial product estimand (-1.4% vs. -0.9% [-15 vs. -9 mmol/mol], ETD -0.5% [95% CI -0.7, -0.4] [-6 mmol/mol (-7, -5)]; P < 0.0001) and at week 52 for both estimands (P < 0.0001). Superior weight loss was not confirmed at week 26 (treatment policy), but oral semaglutide was significantly better than empagliflozin at week 52 (trial product -4.7 vs. -3.8 kg; P = 0.0114). Gastrointestinal adverse events were more common with oral semaglutide.Oral semaglutide was superior to empagliflozin in reducing HbA1c but not body weight at 26 weeks in patients with type 2 diabetes uncontrolled on metformin. At week 52, HbA1c and body weight (trial product estimand) were significantly reduced versus empagliflozin. Oral semaglutide was well tolerated within the established safety profile of GLP-1 receptor agonists.
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