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Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus

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期刊论文
作者:
Scirica, Benjamin M.;Bhatt, Deepak L.;Braunwald, Eugene;Steg, P. Gabriel;Davidson, Jaime;Hirshberg, Boaz;Ohman, Peter;Frederich, Robert;Wiviott, Stephen D.;Hoffman, Elaine B.;Cavender, Matthew A.;Udell, Jacob A.;Desai, Nihar R.;Mosenzon, Ofri;McGuire, Darren K.;Ray, Kausik K.;Leiter, Lawrence A.;Raz, Itamar;Braunwald, Eugene;Bhatt, Deepak L.;Scirica, Benjamin M.;Udell, Jacob A.;Cavender, Matthew A.;Desai, Nihar;Abrahamsen, Timothy;Grossman, Michelle;Morin, Suzanne;Im, Kyungah;Hoffman, Elaine;Gabovitch, Daniel;Pricken, Alexandra;Mosenzon, Ofri;Buskila, Alona;Ohman, Peter;Hirshberg, Boaz;Stahre, Christina;Price, Deborah;Billing-Clason, Solveig;Sabel, Karin;Monyak, John;Sjostrand, Mikalea;Wei, Cheryl;Lu, Jane;Miller, Elinor;Raichlen, Joel;Fitt, Sandy;Frederich, Robert;Iqbal, Nayyar;Donovan, Mark;Davidson, Jaime A.;Steg, Ph. Gabriel;Aguilar-Salinas, Carlos;Alvarsson, Michael;Amerena, John;Ardissino, Diego;Averkov, Oleg;Avogaro, Angelo;Barnett, Anthony;Bretzel, Reinhard;Chiang, Chern-En;Codoceo, Verner;Corbalan, Ramon;Dalby, Anthony;Darius, Harald;Deerochanawong, Chaicharn;Dellborg, Mikael;Eliaschewitz, Freddy;Garcia-Castillo, Armando;Gomis, Ramon;Henry, Patrick;Hoekstra, Joost;Jermendy, Gyorgy;Kastelein, John;Keech, Anthony;Kiss, Robert;Krempf, Michel;Laakso, Markku;Leiter, Lawrence;Leitersdorf, Eran;Lewis, Basil;Litwak, Leon;Lopez-Sendon, Jose;Ma, Ronald;McGuire, Darren;Medina, Felix;Moses, Robert;Nicolau, Jose C.;Opolski, Grzegorz;Ophuis, Ton Oude;Paolasso, Ernesto;Ray, Kausik K.;Ruda, Mikhail;Kumar, K. M. Prasanna;Shestakova, Marina;Sheu, Wayne H-H;Smahelova, Alena;Bhupathiraju, B. Soma Raju;Spinar, Jindrich;Sritata, Piyamitr;Strojeck, Krysztof;Villena-Chavez, Jaime E.;Jia, Weiping;Huo, Young;Wiviott, Stephen D.;Lowe, Cheryl;Awtry, Eric;Berger, Clifford;Desai, Akshay S.;Gelfand, Eli;Leeman, David;Link, Mark;Ruberg, Frederick;Vita, Joseph;Rost, Natalia;Silverman, Scott;Greenberger, Norton J.;Lerch, Markus M.;Gersh, Bernard;Nesto, Richard;Del Prato, Stefano;Tuomilehto, Jaakko;Kelsey, Sheryl;Alvarisqueta, A.;Cuadrado, J.;Rista, L.;Hermida, S.;Baccaro, C.;Luquez, C.;Lagrutta, M.;Maffei, L.;Bartolacci, I.;Montana, O.;Cutuli, H.;Berli, M.;Lorenzatti, A.;Frechtel, G.;La Greca, R.;Fretes, O.;Diaz, M.;Rodriguez Papini, N.;Farias, E.;Issa, C.;Elbert, A.;Lehman, R.;Arya, M.;Singh, B.;Colquhoun, D.;Jayasinghe, R.;de Looze, F.;Blombery, P.;Ward, G.;Szto, G.;Abhayaratna, W.;Borges, J.;Russo, L.;Felicio, J.;Santos, F.;Guimaraes Filho, F.;Lazaretti Castro, M.;Rossi, P.;Armaganijan, D.;Leaes, P.;Bandeira, F.;Franken, M.;Rassi, N.;Rea, R.;Zanella, M.;Amodeo, C.;Cesar, L.;Betti, R.;Chacra, A.;Schmid, H.;Bell, A.;Syan, G.;Zadra, R.;Conter, H.;Dumas, R.;Borts, D.;Dattani, I.;Poirier, P.;Cha, J.;Dzongowski, P.;Labonte, R.;St Pierre, B.;Gaudet, D.;Kouz, S.;Lamy, A.;Tishler, S.;Chehayeb, R.;Bedard, J.;Hramiak, I.;Teitelbaum, I.;Fortin, C.;Woo, V.;Conway, J.;Mehta, P.;Robinson, S.;Sussex, B.;Chiasson, J.;Muirhead, N.;Bose, S.;Ouellet, A.;Yale, J.;Bhargava, R.;Lau, D.;Tobe, S.;Perron, P.;Sigalas, J.;Bilodeau, L.;Tytus, R.;Achyuthan, G.;Pearce, M.;Steele, A.;Bailey, G.;Ma, P.;St-Maurice, F.;Rupka, D.;Houlden, R.;Bailey, A.;Rewa, G.;Sohal, P.;Ting, R.;Prieto, J.;Rodriguez, M.;Godoy, G.;Larenas, G.;Pincetti, C.;Cobos, L.;Saavedra, V.;Varleta, P.;Lucero, F.;Kuzmanic, O.;Acevedo, M.;Aguirre, M.;Florenzano, F.;Ma, J.;Bao, Y.;Jiang, M.;Xu, W.;Shi, Y.;Zheng, M.;Li, Y.;Dong, Y.;Zhao, W.;Sun, M.;Lei, M.;Wang, J.;Pistek, Z.;Rihacek, I.;Kucera, D.;Brada, M.;Naplava, R.;Karasova, J.;Vlasicova, H.;Skopecek, J.;Spinarova, L.;Raclavska, L.;Sarbochova, R.;Okenka, L.;Racicka, E.;Urbancova, K.;Oznerova, M.;Lorenc, Z.;Wasserburger, B.;Zahumensky, E.;Gruenfeldova, H.;Hradec, J.;Lukac, M.;Svacina, S.;Podzimek, J.;Hemzsky, L.;Mikulkova, I.;Pavlickova, J.;Brychta, T.;Chochola, J.;Couffinhal, T.;Elbaz, M.;Petit, C.;Faller, B.;Marechaud, R.;Moulin, P.;Fendri, S.;Nazeyrollas, P.;Wendisch, U.;Busch, K.;Klausmann, G.;Duengen, H.;Appel, K.;Toursarkissian, N.;Jung, T.;Ott, P.;Schenkenberger, I.;Kuesters, D.;Landers, B.;Nischik, R.;Fischer, H.;Tschoepe, D.;Paschen, B.;Krause, K.;Derwahl, K.;Wenzl-Bauer, V.;Hamann, A.;Strotmann, H.;Milek, K.;Mueller, S.;Chu, D.;Tan, K.;Kung, K.;Chu, D.;Tsang, C.;Chu, D.;Tomlinson, B.;Kung, K.;Koranyi, L.;Kerenyi, Z.;Benczur, B.;Illyes, L.;Hidvegi, T.;Somogyi, A.;Valco, J.;Ferenczi, S.;Rapi, J.;Voeroes, P.;Winkler, G.;Sydo, T.;Hetey, M.;Simon, K.;Penzes, J.;Kempler, P.;Bako, B.;Lengyel, Z.;Witmann, I.;Dudas, M.;Vandorfi, G.;Takacs, J.;Matoltsy, A.;Ladanyi, E.;Gyimesi, A.;Sadikot, S.;Parikh, K.;Jain, S.;Yajnik, C.;Sosale, A.;Shamanna, P.;Srikanta, S.;Shah, S.;Srinivas, A.;Banker, D.;Shah, P.;Sharda, A.;Makkar, B.;Desai, N.;Rais, N.;Mardikar, H.;Mishra, A.;Bhupati, S.;Menon, J.;Sathe, S.;Gupta, R.;Sharma, V.;Darawsha, M.;Herskovits, T.;Hamoud, S.;Nikolsky, E.;Adawi, F.;Zimlichman, R.;Tsalihin, D.;Wainstein, J.;Klainman, E.;Mosseri, M.;Yerushalmi, Y.;Karnieli, E.;Knobler, H.;Zimlichman, R.;Benchetrit, S.;Tsur, A.;Yagil, Y.;Atar, S.;Beberashvili, I.;Fuchs, S.;Stern, N.;Pollak, A.;Chajek-Shaul, T.;Rozenman, Y.;Biton, A.;Bramucci, E.;Fiscella, A.;Grassia, V.;Piatti, P.;De Cosmo, S.;Di Lorenzo, L.;Merlini, P.;Mannucci, E.;Frontoni, S.;Trevisan, R.;Zenari, L.;Lambiase, C.;Salvioni, A.;Silvestri, O.;Ambrosio, G.;Di Bartolo, P.;Fattore, L.;Presbitero, P.;Calabrese, M.;Evola, R.;Alcocer Gamba, M.;de los Rios Ibarra, M. Odin;Cardona Munoz, E.;Reyes Sanchez, D.;Hernandez Herrera, C.;Perez Rios, J.;Bayram Llamas, E.;Llamas Esperon, G.;Garcia Cantu, E.;Nunez Fragoso, J.;Gonzalez Gonzalez, J.;Rivera Martinez, G.;Padilla Padilla, F.;Melendez Mier, G.;Herrera Marmolejo, D.;Garza Ruiz, J.;Caracas Portilla, N.;Lopez Rosas, E.;Mendez Machado, G.;Chevaile Ramos, J.;Rodriguez Briones, I.;van Hessen, M. W. J.;Strikwerda, S.;The, S. H. K.;Kooy, A.;Ronner, E.;Nierop, P. R.;Remmen, J. J.;Groenemeijer, B. E.;Hamer, B. J. B.;Basart, D. C. G.;van Lennep, H. W. O. Roeters;Nieuwdorp, M.;van Dijk, M. P. M.;Kentgens, S.;van Kempen, W. W.;Hoogendijk, J.;Spiering, W.;Voors-Pette, C.;Kose, V.;de Waard, D. E. P.;Gonkel, F.;Kaasjager, H. A. H.;Lingan, G. M. Rojas;Agous, I.;Kruik, H. J.;Imholz, B. P. M.;Pieterse, M.;Manrique, H.;Villena, J.;Leon, L.;Kundert, K.;Minchola, J.;Pinto, M.;Heredia, J.;Rodriguez, A.;Guerreros, C.;Berrospi, P.;Zubiate, C.;Allemant, A.;Arbanil, H.;Ponciano, W.;Calderon, J.;Lisson, R.;Segura, L.;Sidorowicz-Bialynicka, A.;Sciborski, R.;Fares, I.;Mader, P.;Skierkowska, J.;Stasinska, T.;Pomiecko, W.;Skorski, M.;Krzyzagorska, E.;Polaszewska-Muszynska, M.;Sowinski, D.;Strojek, K.;Rosinska-Migda, J.;Romanczuk, P.;Golebiowski, G.;Kubica, J.;Mazurek, T.;Wojnowski, L.;Pasternak, D.;Stachlewski, P.;Trzepla, E.;Bogdanowicz, G.;Uzunow, A.;Potakowska, I.;Miszczyszyn, Z.;Waszyrowski, T.;Smolenskaya, O.;Lukyanov, Y.;Vorokhobina, N.;Khalimov, Y.;Orlikova, O.;Rebrov, A.;Kukharchuk, V.;Boldueva, S.;Arkhipov, M.;Zhelninova, T.;Pavlysh, E.;Antsiferov, M.;Panov, A.;Pavlova, M.;Shustov, S.;Demchenko, E.;Galyavich, A.;Malakhina, E.;Semenova, O.;Kobalava, Z.;Kotova, S.;Gavrisheva, I.;Oschepkova, E.;Karpov, Y.;Sidorenko, B.;Kislyak, O.;Ametov, A.;Dreval, A.;Grineva, E.;Mkrtumyan, A.;Tyurina, T.;Sazonova, O.;Bonnici, F.;Ranjith, N.;Burgess, L.;Nortje, H.;Distiller, L.;Mitha, I.;Moore, R.;Conradie, M.;Horak, A.;Pillay, S.;Wellmann, H.;Berg, E.;Pillai, P.;Padayachee, T.;Corbett, C.;Makan, H.;Wing, J.;Vawda, Z.;Ebrahim, I.;Dalby, A.;Mitha, E.;Bhorat, A.;Cruz Fernandez, J.;Munoz, C.;Bruguera Cortada, J.;Castro Conde, A.;Calvo, C.;Gil Extremera, B.;Delgado, E.;Masmiquel, L.;Garcia Puig, J.;de Teresa Parreno, L.;Mauricio, D.;Redon, J.;Brito, M.;Lopez, C.;Segura de la Morera, J.;Linderfalk, C.;Larnefeldt, H.;Olsson, A.;Lonneborg, L.;Ekelund, M.;Samad, B.;Borgencrantz, B.;Nilsson, J.;Berglund, O.;Svensson, M.;Mooe, T.;Curiac, D.;Albin, J.;Angesjo, E.;Lannemyr, O.;Chiang, C.;Sheu, W.;Chen, J.;Tien, K.;Ueng, K.;Lai, W.;Yin, W.;Hung, Y.;Shyu, K.;Hou, J.;Lam, H.;Laothavorn, P.;Kuanprasert, S.;Khovidhunkit, W.;Benjasuratwong, Y.;Chotinaiwattarakul, C.;Mamanasiri, S.;Suraamornkul, S.;Pratipanawatr, T.;Nitiyanant, W.;Heller, S.;Ray, K.;Pieters, R.;Strang, C.;Bodalia, B.;Middleton, A.;Hall, T.;Chapman, G.;Calvert, J.;Reed, R.;Tam, D.;Butcher, G.;Jones, N.;Takhar, A.;Turner, W.;McNally, D.;Corey, O.;Chapman, J.;Mohr, S.;Edwards, S.;Bhatt, D.;Davidson, J.;Ocampo, A.;Kandath, D.;Aude, Y.;Ervin, W.;Savin, V.;Anderson, R.;Littlefield, R.;Oberoi, M.;Platt, George E.;Yazdani, S.;Mangoo-Karim, R.;Walder, J.;Gogia, H.;Chandrashekhar, Y.;Boccalandro, F.;Rogers, W., Jr.;Bilazarian, S.;Zieve, F.;Siage, Y.;O'Connor, T.;Mudaliar, S.;Nikas, A.;Giusti, R.;Glover, R.;Chilka, S.;French, W.;Roth, E.;Singh, N.;Christofferson, R.;Stich, M.;Dagogo-Jack, S.;Allison, J., III;Zengotita, G. Arroyo;Ison, R.;Iteld, B.;Sulistio, M.;Gonzalez, E.;Gorman, T.;Hage-Korban, E.;Reddy, R.;Byars, W.;Antonishen, M.;Benjamin, S.;First, B.;Rosado, J.;Bruschetta, H.;Mehta, P.;Poling, T.;Rosendorff, C.;Kerstein, Howard J.;Saba, F.;Willis, J.;Adams, K.;Vazquez, E. Camilo;Ellison, H.;Kahn, B.;Kereiakes, D.;Powell, S.;Raskin, P.;Smith, K.;Varma, S.;Whittier, F.;Casanova, R.;Isserman, S.;Kaye, W.;McGuinn, W., II;Bartkowiak, A., Jr.;Dworkin, L.;Labrador, Carlos A.;Podlecki, D.;Popovtzer, M.;Aronoff, S.;Ballantyne, C.;Gonzalez-Ortiz, Elena;Mora, A., III;Pitts, T.;Reinhardt, S.;Soucie, G.;Wainwright, W.;Henson, B.;Sklaver, N.;Arakaki, R.;Brown, J.;Chalavarya, G.;Chochinov, R.;Dixon, T.;Kutner, M.;Perlman, R.;Raisinghani, A.;Salacata, A.;Awasty, V.;Elinoff, V.;George, W.;LaRochelle-Gryseels, A.;Mercado, A.;Miller, G.;Qureshi, M.;Steljes, A.;Wefald, F.;Wilson, J.;Chinn, J.;Chuang, Rita B.;Comulada-Rivera, A.;Hartman, I.;Narayan, P.;Pacheco, T.;Weiss, R.;Beavins, J.;Creevy, J.;Hamroff, G.;Hodson, R.;Kosinski, E.;Krichmar, P.;Patel, R.;Schneider, R.;Shapiro, J.;Sharp, D.;Speer, J.;Stegemoller, R.;Waxman, F.;Chang, F. Young;Braun, E.;Eder, F.;Minor, S.;Albert, M.;Carr, Kenneth W.;Diaczok, B.;Gastman, I.;Gupta, V.;Longshaw, K.;Gonzalez-Campoy, J. M.;Raikhel, M.;Thomas, J.;Wood, K.;Diab, I.;Furda, J.;Gelernt, M.;Halter, M.;House, B.;Kaster, S.;Raad, G.;Stamatin, R.;Barker, B.;Blonder, R.;Bloomberg, Robert J.;Calderon, R. Burgos;Carrol, A.;Comerota, A.;Feinglos, M.;Henderson, D.;Kastelic, R.;Stonesifer, Larry D.;Talano, J.;Lee, P. Ver;Brosseau, J.;Clark, W.;Cohen, E.;Fialkow, J.;Horton, K.;Kozman, H.;McGill, J.;Mihills, C.;Poonawala, R.;Shore, K.;Tejada, L.;Torres, R.;Wright, W.;Calatayud, G.;Chandna, H.;Drozdiak, R.;Fink, R.;Gill, R.;Glandt, M.;Gottlieb, Daniel W.;Hack, T.;Kay, J.;Mansouri, V.;McKnight, T.;Mostel, E.;Schmidt, L.;Seide, H.;Sonel, E.;Taylor, R.;Velasquez, M.;Bretton, E.;Feldman, R.;Hartman, A.;Hershon, K.;Leach, Charles R.;Martin, E.;Mohiuddin, F.;Naygandhi, Y.;Riske, T.;Schima, S.;Uzoaga, E. R.;Ward, H.;Weinstock, R.;Williams, T.;Altschuller, A.;Aoki, T.;Blumenthal, S.;Cash, A.;Eisner, Gilbert;Gutmann, J.;Hagan, M.;Kabour, A.;Markus, T.;McKenzie, W.;Moursi, M.;Mystkowski, P.;Ovalle, F.;Perkins, R.;Popeil, L.;Saniuk, R.;Sierra, Y.;Alvarado, O.;Anderson, J.;Bajaj, M.;Blank, R.;Chu, A.;Levinsky, L.;Levy, P.;Osborne, J.;Pavon, H.;Sanderlin, D.;Schaer, G.;Zarich, S.;Atassi, K.;Bayron, C.;Casagrande, M.;Das, D.;Gimness, M.;Handel, F.;Kinstrey, T.;Leu, S.;Osei, K.;Nouel, J. Soba;Soltani, Z.;Sussman, H.;Chiu, K.;Duda, R., Jr.;Farnsworth, K.;Lano, M.;Lee, F.;Levin, P.;Pratt, S.;Richwine, R.;Ruiz-Rivera, L.;Turner, J.;Wood, J.;Zigrang, William D.;Baquerizo, Hernan R.;Colon, Carlos Benitez;Demattia, J.;Desai, V.;Fitz-Patrick, D.;Goral, S.;Odhav, A.;Prentiss, A.;Ruff, C.;Wu, W.;Wyne, K.;Abbott, Lisa G.;Applegate, R.;Cabral, J.;Kotha, P.;Ortega, P.;Simmons, D.
通讯作者:
Bhatt, DL
作者机构:
[Zieve, F.] McGuire VA Med Ctr, Richmond, VA USA.
[Scirica, Benjamin M.; Desai, Nihar R.; Bhatt, Deepak L.; Braunwald, Eugene; Udell, Jacob A.; Wiviott, Stephen D.; Cavender, Matthew A.; Hoffman, Elaine B.] Brigham & Womens Hosp, TIMI Study Grp, Cardiovasc Div, Boston, MA 02115 USA.
[Scirica, Benjamin M.; Desai, Nihar R.; Bhatt, Deepak L.; Braunwald, Eugene; Udell, Jacob A.; Wiviott, Stephen D.; Cavender, Matthew A.; Hoffman, Elaine B.] Harvard Univ, Sch Med, Boston, MA USA.
[van Lennep, H. W. O. Roeters] Admiraal Ruyterziekenhuis, Goes, Netherlands.
[Silvestri, O.] AO Cardarelli, Naples, Italy.
通讯机构:
[Bhatt, DL] VA Boston Healthcare Syst, 1400 VFW Pkwy, Boston, MA 02132 USA.
语种:
英文
期刊:
NEW ENGLAND JOURNAL OF MEDICINE
ISSN:
0028-4793
年:
2013
卷:
369
期:
14
页码:
1317-1326
文献类别:
WOS:Article
所属学科:
ESI学科类别:临床医学;WOS学科类别:Medicine, General & Internal
入藏号:
基金类别:
AstraZeneca; Bristol-Myers Squibb
机构署名:
本校为其他机构
院系归属:
基础医学院
湘雅医院(第一临床学院)
湘雅二医院(第二临床学院)
湘雅三医院(第三临床学院)
摘要:
BackgroundThe cardiovascular safety and efficacy of many current antihyperglycemic agents, including saxagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, are unclear. MethodsWe randomly assigned 16,492 patients with type 2 diabetes who had a history of, or were at risk for, cardiovascular events to receive saxagliptin or placebo and followed them for a median of 2.1 years. Physicians were permitted to adjust other medications, including antihyperglycemic agents. The primary end point was a composite of cardiovascular death, myocardial infarction, or ischemic stroke. ResultsA primary end-point event occurred in 613 patients in the saxagliptin group and in 609 patients in the placebo group (7.3% and 7.2%, respectively, according to 2-year Kaplan-Meier estimates; hazard ratio with saxagliptin, 1.00; 95% confidence interval [CI], 0.89 to 1.12; P=0.99 for superiority; P<0.001 for noninferiority); the results were similar in the on-treatment analysis (hazard ratio, 1.03; 95% CI, 0.91 to 1.17). The major secondary end point of a composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or heart failure occurred in 1059 patients in the saxagliptin group and in 1034 patients in the placebo group (12.8% and 12.4%, respectively, according to 2-year Kaplan-Meier estimates; hazard ratio, 1.02; 95% CI, 0.94 to 1.11; P=0.66). More patients in the saxagliptin group than in the placebo group were hospitalized for heart failure (3.5% vs. 2.8%; hazard ratio, 1.27; 95% CI, 1.07 to 1.51; P=0.007). Rates of adjudicated cases of acute and chronic pancreatitis were similar in the two groups (acute pancreatitis, 0.3% in the saxagliptin group and 0.2% in the placebo group; chronic pancreatitis, <0.1% and 0.1% in the two groups, respectively). ConclusionsDPP-4 inhibition with saxagliptin did not increase or decrease the rate of ischemic events, though the rate of hospitalization for heart failure was increased. Although saxagliptin improves glycemic control, other approaches are necessary to reduce cardiovascular risk in patients with diabetes.
参考文献:
American Diabetes Association, 2013, DIABETES CARE S1, V36, pS11, DOI DOI 10.2337/DC13-S011
Ray KK, 2009, LANCET, V373, P1765, DOI 10.1016/S0140-6736(09)60697-8
Inzucchi SE, 2008, CIRCULATION, V117, P574, DOI 10.1161/CIRCULATIONAHA.107.735795
Preis SR, 2009, CIRCULATION, V119, P1728, DOI 10.1161/CIRCULATIONAHA.108.829176
Mosenzon O, 2013, DIABETES-METAB RES, V29, P417, DOI 10.1002/dmrr.2413

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