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Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes
Authors :
Green JB Bethel MA Armstrong PW Buse JB Engel SS Garg J Josse R Kaufman KD Koglin J Korn S Lachin JM McGuire DK Pencina MJ Standl E Stein PP Suryawanshi S Van de Werf F Peterson ED Holman RR Josse RG Califf RM Goldstein BJ Shapiro DR Silverman R Bethel A Green J Hayden S Hannan K Quintero K Rorick T Berdan L Leloudis D Califf S Wilson M McFarron D Trollinger K Pesarchick J Eskenazi L Campbell C Townes O Tolsma D Keenan J Milton J Athwal R Darbyshire J Doran Z Kennedy I Gregory V Lokhnygina Y Prather K Wolfley A Usman M Tajjar A Gray R Pfeffer MA Gerstein HC Groop L McMurray JJ Pocock SJ Clayton T Sinay I Brieger D Stranks S Scheen A Lopes R Tankova T Hramiak I Grado CR Wenying Y Ge J Aschner P Skrha J Ambos A Strandberg T Travert F Hanefeld M Riefflin A Chan JC Ofner P Reddy NK Christopher J Mathur A Arambam P Mittal S Manchanda M Wainstein J Ambrosio G Pirags V Jakuboniene N Mohamed M Scott R White H Cornel J Halvorsen S Tykarski A Veresiu IA Dreval AV Misinkova I Tai E Krahulec B Distiller L Park Y Rovira A Alversson M Chuang LM Delibasi T Adler A Rodbard HW Marre M Goff D Chacra A DeVore A Beaven A Shah B Hirsch B Batch B Bushnell C Patel C Melloni C Henshaw C Kong D Bernecki G Tillman H Kang HJ Hawes J Strickler J Piccini J Wilder J Alexander K Mahaffey K Patel K Hyland K Newby K Jackson L Cooper L Armaganijan L Szczeh L Koshizaka M Roe M Morse M Guimaraes P Hess P Tricoci P Mehta R Mathews R Kociol R Harrison R Mentz R Pokorney S Leblanc T Lazzarini V Eapen Z Truffa A Fosbol E Brito F Katz M Bahit M Santos M Barros P Bernardez S Alvarisqueta AF Arias P Cagide AL Calella PR Cantero MC Canella JP Cipullo MA de Loredo L Gelersztein ES Gorban de Lapertosa SB Klyver MI Maffei LE Maldonado N Oviedo AI Piskorz DL Ridruejo MC Saavedra SS Sessa HA Sinay IR Sposetti GD Ulla MR Vico ML Waitman JN Binnekamp M Carroll P Cheung W Colman P Davis T De Looze F dEmden M Fulcher G Gerstman M Hamilton A Lehman S Moses R Proietto J Roberts A Shaw J Simpson R Sinha A Tan Y Topliss D Vora P Waites J Crenier L Descamps O Keymeulen B Mathieu C Nobels F Van den Bruel A Van Gaal L Borges JL Costa e Forti A Eliaschewitz FG Felício JS Griz LH Hissa MN Leite S Panarotto D Pimentel Filho P Rassi N Saraiva JK Sgarbi JA Silva RP Tambascia M Weber Silva DM Bobeva R Bostandzhieva R Cinlikov I Georgieva M Iliev D Ilieva E Kovacheva S Liubenova L Nikitov Z SHeinikova G Slavcheva A Spasova V Temelkova-Kurktschiev T Velichka D Yakov A Carpentier A Chiasson JL Constance C Dumas R Filteau P Garceau C Huynh T Kaiser S Kornder J Leiter L Mereu L Miller D Pandey S Punthakee Z Rabasa-Lhoret R Robitaille Y Saunders K Sigal R Sigalas J Vizel S Weisnagel S Woo V Yale JF Yared K Zinman B Bunster Balocchi LB Escobar Cerda EE Garces Flores EE Lanas Zanetti FT Larrazabal Miranda Adel P Morales Alvarado JM Olivares Cañon CM Potthoff Cárdenas SH Raffo Grado CA Rodriguez Venegas ME Saavedra Gajardo VA Westerberg Maldonado BH Chen LL Dong J Guo X Li QM Shi B Tang XL Yang T Yang WY Zheng SX Aschner Montoya P Botero Lopez R Coronel Arroyo JA Cure CA Gómez Medina AM Molina DI Perez Amador GA Reyes Rincon A Urina Triana MA Valenzuela Rincon A Vélez Pelaez S Yupanqui Lozno H Brabec T Brychta T Hasalova Zapletalova J Havelkova J Hejnicova K Hola O Hornackova M Hrdina T Kafkova D Kellnerova I Krystl T Kutejova V Mikulkova I Nevrla J Pantlikova C Petr M Racicka E Sarbochova R Smolenakova K Turcinek R Urbancova K Vejvodova J Vondrakova M Zachoval R Alt I Kaasik Ü Kiiroja K Lanno R Märtsin K Past M Vides H Viitas L Kantola I Nieminen S Perhonen M Strand J Valle T Clergeot A Couffinhal T Courreges JP Gouet D Moulin P Ziegler O Badenhoop K Behnke T Bender G Braun M Dshabrailov J Hamann A Himpel-Boenninghoff A Kamke W Kasperk C Luedemann J Mayr P Merkel M Oerter EM Ohlow MA Ott P Overhoff U Paschen B Remppis R Rose L Schumm-Draeger PM Segiet T Strotmann HJ Stuchlik G Stürmer W Thinesse-Mallwitz M Tytko A Wendisch U Wurziger J Ho AY Kam G Kong AP Lam YY Lau EY Lee S Siu SC Tomlinson B Tsang CC Yeung VT Dezső E Dudás M Földesi I Fülöp T Késmárki N Koranyi L Nagy K Oroszlán T Pécsvárady Z Ples Z Taller A Agarwal P Ambulkar S Aravind S Balaji V Kalra S Kesavadev J Kudalkar H Kumar A Misra A Mithal A Mohan V Pitale S Ramu M Reddy N Shah S Shamanna P Sharda A Sharma A Shunmugavelu M Srikanta S Suryaprakash G Abramov G Adawi F Bashkin A Darawsha M Fuchs S Harman-Boehm I Hayek T Jaffe A Knobler H Minuchin O Mosseri M Shechter M Shimon I Stern N Tsur A Vishlitzky V Alfonsi F Cavalot F Del Vecchio L Frisinghelli A Gambardella S Lauro D Lembo G Leotta S Mondillo S Novo S Pedrinelli R Piatti P Salvioni A Tritto I Zavaroni DZ Ahn KJ Choi KM Chung C Han SJ Kim DM Kim IJ Kim MH Lee IK Nam M Park IeB Park KS Park TS Rhee EJ Yoo SJ Andersone I Balode A Eglite R Gersamija A Kakurina N Jegere B Leitane I Pastare S Stalte V Teterovska D Baltramonaitiene K Barsiene L Ceponis J Lasiene J Levinger A Sirutaviciene A Sulskiene M Urbanaviciene L Valius L Varanauskiene E Velickiene D Mahendran KA Abu Hassan MR Aziz NA Hussein Z Ismail IS Kamaruddin NA Nordin Z Nayar SK Ramanathan GR Sothiratnam R Beijerbacht H Breedveld R Cornel JH Den Hartog F Hermans W Kietselaer B Kooy A Lenderink T Nierop P Remmen J Rojas Lingan G Ronner E Van der Heijden R Van Hessen M van Kempen W Voors-Pette C Westendorp I Baker J Benatar J Cutfield R Krebs J Leikis R Lunt H Manning P Williams M Birkeland K Claudi T Istad H Karlsson T Ossum Gronert J Arciszewska M Artemiuk E Blach E Blicharski T Cypryk K Dabrowska M Górny G Górska M Jakubowska I Jazwinska-Tarnawska E Karczmarczyk A Kitowska-Koterla J Koltowski L Krzyzagorska E Pasternak D Pentela-Nowicka J Piesiewicz W Przekwas-Jaruchowska M Rajzer M Salamon-Ferenc A Sawicki A Skowron T Śmiałowski A Albota A Alexandru C Crisan C Dumitrescu A Ferariu IE Lupusoru DA Munteanu M Negru D Nicolau A Pintiliei E Popescu A Serban G Voitec M Babenko A Barbarash O Bondar I Chizhov P Demin A Dora S Dreval A Ershova O Gratsiansky N Ketova G Kotelnikov M Levashov S Morugova T Mustafina S Pekarskiy S Raskina T Rechkova E Samoylova Y Sazonova O Sherenkov A Shilkina N Stetsyuk O Tretyakova T Turova E Valeeva F Zadionchenko V Dalan R Tan RS Tay L Buganova I Fabry J Jan C Toserova E Zak R Zimanova J Badat A Bester F Burgess L De Jong D Ellis G Fouche L Govender P Govind U Naidoo V Nieuwoudt G Nortje H Rheeder P Robertson L Siddique N Stapelberg AM Trinder Y Van Der Merwe A Van Zyl L Viljoen M Wilhase A Botella M Civeira Murillo F de Teresa L Del Cañizo FJ Extremera BG Gimeno EJ Martin-Hidalgo A Morales C Nubiola A Tinahones Madueño F Tranche S Trescolí Serrano C Alvarsson M Eizyk E Gillblad A Johansson P Löndahl M Ohlsson-Önerud Å Rautio A Sundström U Torstensson I Chen JF Chou CW Ho LT Hsieh IC Huang BH Huang CL Huang CN Lai WT Lo PH Pei D Sheu WH Wang SY Araz M Bakiner O Comlekci A Guler S Sahin I Sarac F Tarkun I Ukinc K Yilmaz M Abdulhakim E Abraham P Adamson K Blagden M Bundy C Daly M Davies M Deshpande M Gillings S Harvey P Horvathova V Hristova D Jaap A Johnson A Jones H Kerrane J Kilvert A Ko T Kumar J Lindsay R Litchfield J McCrimmon R McKnight J Millward B Oyesile B Purewal T Ravikumar C Robinson A Sathyapalan T Simpson H Thomas H Turner W Weaver J Wilding J Wiles P Adkins K Akpunonu B Albu J Anagnostis G Anastasi L Argoud G Aroda V Azizad M Banerji MA Bartkowiak A Jr Bays H Behn P Bergenstal R Bhargava A Bias D Bolster E Buchanan P Busch R Chadha C Chang M Cheng C Cohen A Cohen J Cole B Connery L Cooperman M Cushman W DAgostino R Dayamani P De Lemos J De Meireles M Dean J DeHart D Detweiler R Donovan D Dugano-Daphnis P Dulin M Dunn F Eaton C Erickson B Estevez R Feinglos M Fonseca V Force R Forker A Fox D Gabriel J Garcia R Garvey T Gaudiani L Getaneh A Goldberg A Goldman S Hairston K Harris R Haught W Hidalgo H Jr Higgins A Houchin V Ison R Jacobs G Jaffrani N Jafry B Kapsner P Kaye W Labroo A Levinson L Lewis S Lillestol M Luttrell L Madu I McNeill R Merrick B Metzger F Nadar V Nagelberg S Nash S Oparil S Osei K Papademetriou V Patel N Pedley C Prentiss A Radbill M Raisinghani A Rassouli N Reddy R Rees P Rendell M Robbins D Rodbard H Rohlf J Roseman H Rudolph L Sadler L Schnall A Schramm R Schubart U Seneviratne T Shanik M Snyder H Sorli C Stich M Sweeney ME Tsao J Ukwade P Viswanath D Vo A Vogel C Voyce S Weintraub H White J Wood M Wu P Wysham C Zimmerman R Pathology/molecular and cellular medicine Diabetes Pathology & Therapy Green JB, Bethel MA, Armstrong PW, Buse JB, Engel SS, Garg J, Josse R, Kaufman KD, Koglin J, Korn S, Lachin JM, McGuire DK, Pencina MJ, Standl E, Stein PP, Suryawanshi S, Van de Werf F, Peterson ED, Holman RR, Holman RR, Peterson ED, Holman RR, Peterson ED, Armstrong PW, Buse JB, Josse RG, Kaufman KD, Koglin J, Korn S, Lachin JM, McGuire DK, Standl E, Stein PP, Suryawanshi S, Van de Werf F, Engel SS, Califf RM, Goldstein BJ, Shapiro DR, Silverman R, Bethel A, Green J, Hayden S, Hannan K, Quintero K, Rorick T, Berdan L, Leloudis D, Califf S, Wilson M, McFarron D, Trollinger K, Pesarchick J, Eskenazi L, Campbell C, Townes O, Tolsma D, Keenan J, Milton J, Athwal R, Darbyshire J, Doran Z, Kennedy I, Gregory V, Garg J, Lokhnygina Y, Prather K, Wolfley A, Usman M, Tajjar A, Gray R, Pfeffer MA, Gerstein HC, Groop L, McMurray JJ, Pocock SJ, Clayton T, Sinay I, Brieger D, Stranks S, Scheen A, Lopes R, Tankova T, Hramiak I, Grado CR, Wenying Y, Ge J, Aschner P, Skrha J, Ambos A, Strandberg T, Travert F, Hanefeld M, Riefflin A, Chan JC, Ofner P, Reddy NK, Christopher J, Mathur A, Arambam P, Mittal S, Manchanda M, Wainstein J, Ambrosio G, Pirags V, Jakuboniene N, Mohamed M, Scott R, White H, Cornel J, Halvorsen S, Tykarski A, Veresiu IA, Dreval AV, Misinkova I, Tai E, Krahulec B, Distiller L, Park Y, Rovira A, Alversson M, Chuang LM, Delibasi T, Adler A, Rodbard HW, Marre M, Goff D, Chacra A, DeVore A, Beaven A, Shah B, Hirsch B, Batch B, Bushnell C, Patel C, Melloni C, Henshaw C, Kong D, McFarron D, Bernecki G, Tillman H, Kang HJ, Green J, Hawes J, Strickler J, Piccini J, Wilder J, Alexander K, Mahaffey K, Patel K, Hyland K, Newby K, Jackson L, Cooper L, Armaganijan L, Szczeh L, Koshizaka M, Roe M, Morse M, Guimaraes P, Hess P, Tricoci P, Mehta R, Lopes R, Mathews R, Kociol R, Harrison R, Mentz R, Pokorney S, Leblanc T, Lazzarini V, Eapen Z, Truffa A, Fosbol E, Brito F, Katz M, Bahit M, Santos M, Barros P, Bernardez S, Alvarisqueta AF, Arias P, Cagide AL, Calella PR, Cantero MC, Canella JP, Cipullo MA, de Loredo L, Gelersztein ES, Gorban de Lapertosa SB, Klyver MI, Maffei LE, Maldonado N, Oviedo AI, Piskorz DL, Ridruejo MC, Saavedra SS, Sessa HA, Sinay IR, Sposetti GD, Ulla MR, Vico ML, Waitman JN, Binnekamp M, Carroll P, Cheung W, Colman P, Davis T, De Looze F, dEmden M, Fulcher G, Gerstman M, Hamilton A, Lehman S, Moses R, Proietto J, Roberts A, Shaw J, Simpson R, Sinha A, Stranks S, Tan Y, Topliss D, Vora P, Waites J, Crenier L, Descamps O, Keymeulen B, Mathieu C, Nobels F, Scheen A, Van den Bruel A, Van Gaal L, Borges JL, Costa e Forti A, Eliaschewitz FG, Felício JS, Griz LH, Hissa MN, Leite S, Panarotto D, Pimentel Filho P, Rassi N, Saraiva JK, Sgarbi JA, Silva RP, Tambascia M, Weber Silva DM, Bobeva R, Bostandzhieva R, Cinlikov I, Georgieva M, Iliev D, Ilieva E, Kovacheva S, Liubenova L, Nikitov Z, SHeinikova G, Slavcheva A, Spasova V, Tankova T, Temelkova-Kurktschiev T, Velichka D, Yakov A, Carpentier A, Chiasson JL, Constance C, Dumas R, Filteau P, Garceau C, Hramiak I, Huynh T, Kaiser S, Kornder J, Leiter L, Mereu L, Miller D, Pandey S, Punthakee Z, Rabasa-Lhoret R, Robitaille Y, Saunders K, Sigal R, Sigalas J, Vizel S, Weisnagel S, Woo V, Yale JF, Yared K, Zinman B, Bunster Balocchi LB, Escobar Cerda EE, Garces Flores EE, Lanas Zanetti FT, Larrazabal Miranda Adel P, Morales Alvarado JM, Olivares Cañon CM, Potthoff Cárdenas SH, Raffo Grado CA, Rodriguez Venegas ME, Saavedra Gajardo VA, Westerberg Maldonado BH, Chen LL, Dong J, Guo X, Li QM, Shi B, Tang XL, Yang T, Yang WY, Zheng SX, 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TS, Park Y, Rhee EJ, Yoo SJ, Andersone I, Balode A, Eglite R, Gersamija A, Kakurina N, Jegere B, Leitane I, Pastare S, Pirags V, Stalte V, Teterovska D, Baltramonaitiene K, Barsiene L, Ceponis J, Jakuboniene N, Lasiene J, Levinger A, Sirutaviciene A, Sulskiene M, Urbanaviciene L, Valius L, Varanauskiene E, Velickiene D, Mahendran KA, Abu Hassan MR, Aziz NA, Hussein Z, Ismail IS, Kamaruddin NA, Mohamed M, Nordin Z, Nayar SK, Ramanathan GR, Sothiratnam R, Beijerbacht H, Breedveld R, Cornel JH, Den Hartog F, Hermans W, Kietselaer B, Kooy A, Lenderink T, Nierop P, Remmen J, Rojas Lingan G, Ronner E, Van der Heijden R, Van Hessen M, van Kempen W, Voors-Pette C, Westendorp I, Baker J, Benatar J, Cutfield R, Krebs J, Leikis R, Lunt H, Manning P, Scott R, Williams M, Birkeland K, Claudi T, Halvorsen S, Istad H, Karlsson T, Ossum Gronert J, Arciszewska M, Artemiuk E, Blach E, Blicharski T, Cypryk K, Dabrowska M, Górny G, Górska M, Jakubowska I, Jazwinska-Tarnawska E, Karczmarczyk A, 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Seneviratne T, Shanik M, Snyder H, Sorli C, Stich M, Sweeney ME, Tsao J, Ukwade P, Viswanath D, Vo A, Vogel C, Voyce S, Weintraub H, White J, Wood M, Wu P, Wysham C, Zimmerman R
Source :
New England Journal of Medicine . 373:232-242
Publication Year :
2015
Abstract
BACKGROUND: Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin, a dipeptidyl peptidase 4 inhibitor, to usual care in patients with type 2 diabetes and cardiovascular disease. METHODS: In this randomized, double-blind study, we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy. Open-label use of antihyperglycemic therapy was encouraged as required, aimed at reaching individually appropriate glycemic targets in all patients. To determine whether sitagliptin was noninferior to placebo, we used a relative risk of 1.3 as the marginal upper boundary. The primary cardiovascular outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. RESULTS: During a median follow-up of 3.0 years, there was a small difference in glycated hemoglobin levels (least-squares mean difference for sitagliptin vs. placebo, -0.29 percentage points; 95% confidence interval [CI], -0.32 to-0.27). Overall, the primary outcome occurred in 839 patients in the sitagliptin group (11.4%; 4.06 per 100 person-years) and 851 patients in the placebo group (11.6%; 4.17 per 100 person-years). Sitagliptin was noninferior to placebo for the primary composite cardiovascular outcome (hazard ratio, 0.98; 95% CI, 0.88 to 1.09; P
Details
Language :
English
ISSN :
00284793
Volume :
373
Database :
OpenAIRE
Journal :
New England Journal of Medicine
Accession number :
edsair.doi.dedup.....0115f94b4333945408cd9a9c7dea2963
Full Text :
https://doi.org/10.1056/NEJMoa1501352