Data di Pubblicazione:
2017
Abstract:
BACKGROUND: The cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown. METHODS: We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly. The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The coprimary hypotheses were that exenatide, administered once weekly, would be noninferior to placebo with respect to safety and superior to placebo with respect to efficacy. RESULTS: In all, 14,752 patients (of whom 10,782 [73.1%] had previous cardiovascular disease) were followed for a median of 3.2 years (interquartile range, 2.2 to 4.4). A primary composite outcome event occurred in 839 of 7356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group and in 905 of 7396 patients (12.2%; 4.0 events per 100 person-years) in the placebo group (hazard ratio, 0.91; 95% confidence interval [CI], 0.83 to 1.00), with the intention-to-treat analysis indicating that exenatide, administered once weekly, was noninferior to placebo with respect to safety (P<0.001 for noninferiority) but was not superior to placebo with respect to efficacy (P=0.06 for superiority). The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome, and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly between the two groups. CONCLUSIONS: Among patients with type 2 diabetes with or without previous cardiovascular disease, the incidence of major adverse cardiovascular events did not differ significantly between patients who received exenatide and those who received placebo.
Tipologia CRIS:
1.1 Articolo in rivista
Keywords:
Aged; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Administration Schedule; Exenatide; Female; Humans; Hypoglycemic Agents; Incidence; Injections, Subcutaneous; Kaplan-Meier Estimate; Least-Squares Analysis; Male; Middle Aged; Peptides; Venoms
Elenco autori:
R. R., Holman; M. A., Bethel; R. J., Mentz; V. P., Thompson; Y., Lokhnygina; J. B., Buse; J. C., Chan; J., Choi; S. M., Gustavson; N., Iqbal; A. P., Maggioni; S. P., Marso; P., Ohman; N. J., Pagidipati; N., Poulter; A., Ramachandran; B., Zinman; EXSCEL Study Group: Robert M Califf, Hernandez A. F.; Patel, Rishi; George, Jyothis; Sourij, Harald; Weng Wong, Yee; Hannan, Karen; Ann Sellers, Mary; Gottlieb, Pat; Lavender, Paula; Leloudis, Dianne; Meadows, Yolanda; Larson, Dan; Anderson, Heidi; Elkins, Mary; Stone, Allegra; Tisch, Andrea; Perkins, Lynn; Sanders, Kesi; Campbell, Curtis; Kennedy, Irene; Heal, Paul; Masterson, Michelle; Darbyshire, Julie; Mumtaz, Lorraine; Athwal, Rajbir; Ferch, Andrea; Batra, Priyanka; Durborow, Lynne; Vincent, Jennifer; Woodall, Andrew; Flanagan, Terry; Katona, Brian; Reicher, Barry; Pozzi, Emanuela; Oulhaj, Abderrahim; Coleman, Ruth; Lucien Rouleau, Jean; J Pocock, Stuart; Gorelick, Fred; Mcmurray, John; Riddle, Matt; Gagel, Robert; Collier, Tim; Markovic, Tania; Pik Shan Kong, Alice; Kui Hian, Sim; Scott, Russell; Panelo, Araceli; Yoon, Kun-Ho; Sheu, Wayne; Sritara, Piyamitr; Linong, Ji; Pan, Chanyu; Yong, Huo; Schernthaner, Guntram; Mathieu, Chantal; Tankova, Tsvetalina; Widimsky, Petr; Hanefeld, Markolf; Keltai, Matyas; Wainstein, Julio; del Prato, Stefano; Pirags, Valdis; Jakuboniene, Neli; Kooy, Adriaan; Dziemidok, Piotr; Andrei Veresiu, Ioan; V Dreval, Alexander; Murin, Jan; LeCube Torello, Albert; Sattar, Naveed; Parkhomenko, Olexander; Omar, Mohamed; Diaz, Rafael; Lopes, Renato; Lanas, Fernando; Urina Triana, Miguel; Luis Leiva-Pons, Jose; Aguliera, David; Bergenstal, Richard; Goodman, Shaun; Francois Yale, Jean; Caterson, Ian; Weng, Jianping; Hu, Dayi; Junbo, Ge; Zannad, Faiez; Anoop, Misra; Ambrish, Mithal; Adaly Gallegos, John; B Green, Jennifer; Akerblom, Axel; Alexander, Karen; Al-Khatib, Sana; Armaganijan, Luciana; Barros, Pedro; Batit, Maria; Bernacki, Gwen; Bernandez, Sabrina; Bloomfield, Gerald; Clausen, Emily; De Souza Brito, Flavio; Devore, Adam; Dombrowski, Keith; Eapen, Zubin; Gellad, Ziad; George, Daniel; Guimaraes, Patricia; Halim, Sharif; Harrison, Rob; Hawes, Jodi; Hess, Connie; Hyland, Kristen; Jackson, Larry; Jones, Schuyler; Jordan, Dedrick; Katz, Marcelo; Kong, David; Koshizaka, Masaya; Lakey, Wanda; Leblanc, Thomas; Leonardi, Sergio; Luo, Nancy; Mahaffey, Ken; Mandawat, Aditya; Mehta, Rajendra; Melloni, Chiara; Morse, Michael; Pagidpati, Neha; Patel, Chetan; Patel, Keyur; Pokorney, Sean; Posvic, Tom; Rao, Meena; Roe, Matthew; Shah, Bimal; Tillmann, Hans; Truffa, Adriano; Wong, Yee-Weng; Zazula, Ana; Zeitler, Emily; Sicer, Maximiliano; Rosa Ulla, Maria; Maffei, Laura; Isabel Klyver, Maria; Calella, Pedro; Alvarisqueta, Andrés; Leon De La Fuente, Ricardo; Aizenberg, Diego; Roque, Fernando; Cruciani, Adrian; Frechtel, Gustavo; Gelersztein, Elizabeth; Villarino, Adriana; Mallagray, Marcelo; Nardone, Lucrecia; Zaidman, Cesar; Novaretto, Leonardo; Bartolacci, Ines; de Salvo, Maria; Delcourt, Candice; Crimmins, Denis; Jackson, Richard; O’Neal, David; Colman, Peter; Jeffries, William; Mann Mah, Peak; Wittert, Gary; Proietto, Joseph; Amerena, John; Marks, Sharon; Tan, Ren; Colquhoun, David; Pieber, Thomas; Drexel, Heinz; Prager, Rudolf; Schnack, Christoph; Hoppichler, Fredrich; Fasching, Peter; Francesconi, Claudia; Luger, Anton; Schoenherr, Hans-Robert; Ebenbichler, Christoph; Paulweber, Bernhard; Shernthaner, Guntram; Verhaegen, Ann; Vanuytsel, Johan; Thissen, Jean-Paul; e Silva, Pedro Barros; Gonzaga, Carolina; Borges, Joao; Hissa, Miguel; Rea, Rosangela; Rossi, Paulo; Chacra, Antonio; Eliaschewitz, Freddy; Garbelini, Benito; Felicio, Joao; Rassi, Nelson; Rossi, Fabio; Nunes dos Santos, Mayler; e Farias, Francisco Bandeira; Lisboa, Hugo; e Forti, Adriana Costa; Kerr Saraiva, José; Kovacheva, Snejina; Levterov, Georgi; Sheinkova, Galina; Ilieva, Elena; Lyubenova, Lyudmila; Damyanova, Velichka; Gushterova, Valentina; Mincheva,
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