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N Engl J Med. 2013 Oct 3;369(14):1327-35. doi: 10.1056/NEJMoa1305889. Epub 2013 Sep 2.

Alogliptin after acute coronary syndrome in patients with type 2 diabetes.

Collaborators (987)

Aiub J, Albisu J, Alvarez C, Astesiano A, Barcudi R, Bendersky M, Bono J, Bustos B, Cartasegna L, Caruso O, Casabe H, Castro R, Colombo H, Cuneo C, Cura F, De Loredo L, Dran R, Fernandez H, Garcia Pinna J, Hrabar A, Klyver de Saleme M, Luquez H, Mackinnon I, Maffei L, Majul C, Mallagray M, Marino J, Martinez D, Martingano R, Nul D, Parody ML, Petrucci J, Pieroni M, Piskorz D, Prado A, Ramos H, Resk J, Rodriguez M, Rojas C, Sarjanovich R, Sarries A, Sessa H, Silveiro S, Sosa Liprandi MI, Tartaglione J, Tonin H, Vallejos J, Vigo S, Visco V, Vita N, Vogel D, Vogelmann O, Zaidman C, Zangroniz P, Colquhoun D, Coverdale S, Flecknoe-Brown S, Hii CS, Roberts-Thomson P, Drexel H, Luger A, Pieber T, Cools F, Ruige J, Schoors D, Vercammen C, Wollaert B, Alves da Costa F, Amodeo C, Baggenstoss R, Barbosa E, Barroso de Souza WK, Bassan R, Borges JL, Botelho R, Braile MC, Castello H Jr, Chrisman C, dos Santos F, Faria Neto J, Farsky P, Fernandes Da Costa A, Fraige Filho F, Garbelini B Jr, Garcia MF, Garzon P, Guimaraes AE, Herdy A, Hernandes M, Hilgemberg S, Hissa M, Jatene JA, Kormann A, Leaes P, Lima F, Lisboa HR, Maia L, Maia da Silva F, Maldonado Franco D, Martin JF, Medeiros A, Michalaros Y, Miguel Leitao A, Montenegro S, Moraes Junior J, Mota Gomes M, Paiva MS, Precoma D, Rabelo A, Reis G, Reis H, Rossi P, Saporito W, Sarmento Leite R, Silva RP, Silva Junior D, Sousa L, Sousa AC, Ueda R, Vilas-Boas F, Wainstein M, Zago A, Angelova M, Apostolova E, Daskalova I, Delchev A, Hristozov K, Ilieva M, Kovacheva S, Lucheva M, Temelkova M, Toneva A, Videva V, Vuchkova E, Bakbak A, Carpentier A, Chan YK, Cheema A, Chouinard G, Conway J, Dery JP, Dowell A, Frechette A, Jakubowski M, Kelly A, Ma P, Maung TZ, Mehta S, Parker D, Pesant Y, Polasek P, Ransom T, Syan G, Vizel S, Albornoz F, Castro Galvez P, Cobos JL, Conejeros C, D'Acuña Apablaza M, Fajardo G, Illanes Brochet G, Lazcano MO, Pincetti C, Potthoff S, Raffo C, Saavedra V, Schnettler M, Sepulveda P, Stockins B, Vejar M, Accini JL, Cotes Aroca CH, Fernandez Ruiz RL, Orozco Linares LA, Vesga Angarita BE, Aganovic I, Bagatin J, Canecki-Varzic S, Erzen DJ, Knezevic A, Maric A, Milicevic G, Popovic Z, Rubes J, Weiss SS, Dresslerova I, Havelkova J, Kucera D, Machacek J, Pumprla J, May O, Perrild H, Aziz MA, El Badry M, Hasanein M, Airaksinen J, Laine M, Nyman K, Vikman S, Bonnet J, Elbaz M, Henry P, Paillard F, Petit C, Tropeano AI, Behnke T, Bornstein S, Busch K, Ebelt H, Faghih M, Fischer H, Heuer H, Paschke R, Porner TC, Tangerding G, Vöhringer HF, Adamson K, Beatt K, Bellary S, Chapman J, Cooke A, Fisher M, Gnudi L, Jones H, Kumar S, Nagi D, Oldroyd K, Richardson T, Robertson D, Robinson A, Saravanan P, Viljoen A, Wilding J, Wilkinson P, Wong YK, Zoupas C, Arango J, Castellanos J, Ceren Flores C, Corona V, Granados-Fuentes A, Haase F, Montenegro P, Prado JH, Villalobos R, Chow F, Li SK, Li J, Yan PY, Yeung V, Abel T, Benedek A, Dezso E, Dudas M, Édes I, Fulop G, Kovács A, Lupkovics G, Merkely B, Nagy A, Nagy A, Oroszlan T, Palinkas A, Papp A, Patkay J, Simon E, Sitkei E, Tabak A, Tomcsányi J, Abdullakutty J, Abhyankar A, Akalkotkar U, Alexander T, Arneja J, Aslam N, Babu PR, Babu BR, Banker D, Bantwal G, Bhimashankar PR, Calton RK, Chopda M, Dande A, Dani S, Deshpande N, Deshpande N, Dhanwal D, Dharmadhikari A, Gadkari M, Garg N, Ghaisas N, Goyal NK, Gupta JB, Jawahirani A, Joseph S, Kumar R, Kumble M, Mathavan A, Mathur A, Mohanan PP, Nair A, Nair T, Namjoshi D, Pinto R, Prakash G, Purushotham R, Raju S, Ramachandran P, Ramesh SS, Rao B, Ravikishore A, Reddy GR, Roy S, Sadhu N, Sastry BK, Singh P, Srinivas A, Thacker H, Thanvi S, Thomas J, Adawi F, Bashkin A, Cohen J, Harman-Boehm I, Hasin Y, Hayek T, Iakobishvili Z, Katz A, Kracoff O, Minuchin O, Moriel M, Mosseri M, Omary M, Wainstein J, Weiss A, Zeltser D, Calabro P, Derosa G, Genovese S, Novo S, Olivieri C, Piatti P, Violini R, Volpe M, Ajioka M, Amano T, Arasaki O, Daida H, Fujimoto K, Fujinaga H, Higashiue S, Hirohata A, Hosokawa S, Ikefuji H, Inagaki M, Iseki H, Iwabuchi M, Iwasaki T, Kakishita M, Katsuda Y, Kawada K, Kawajiri K, Kawamitsu K, Kobayashi K, Komada F, Komura Y, Machida M, Maemura K, Matsubara T, Matsubayashi S, Matsumoto T, Matsumoto N, Mima T, Miyamoto N, Momiyama Y, Morimoto T, Murakami M, Nakashima E, Niijima Y, Noda T, Node K, Nozaki A, Nunohiro T, Ogawa T, Ono Y, Saeki T, Sakota S, Sakuragi S, Sasaki T, Sato Y, Sueyoshi A, Suzuki M, Takagi G, Tanabe J, Tanaka S, Tei I, Yamamoto M, Yanagihara K, Hong TJ, Jeon HK, Kang DH, Kim CH, Kim DS, Kim HS, Kim JH, Kim SK, Kim WS, Kim YK, Lee SR, Lee KW, Park HS, Pyun WB, Rha SW, Yoon J, Yoon KH, Bennakhi A, Geldnere K, Sokolova J, Teterovska D, Dautaraite V, Kakariekiene V, Kavaliauskiene R, Kucinskiene A, Lasiene J, Mickuviene N, Palinauskas A, Urboniene A, Zilaitiene B, Abdul Manap H, Abidin IZ, Isa SH, Khir AM, Ng KH, Tan F, Yusof Z, Yusoff K, Zambahari R, Aguila-Marin J, Aguilera Real M, Alvarado-Ruiz R, Alvarez Lopez H, Arenas Leon J, Bayram Llamas EA, Calvo Vargas C, Carrillo Calvillo J, De los Rios Ibarra M, Dominguez-Reyes CA, Duarte M, Elizondo E, Fajardo Campos P, Fanghanel-Salmon G, Figueroa Sauceda S, Gallegos Martinez J, Garcia-Cantu E, Garza Ruiz JA, Gonzalez Gonzalez JG, Guerrero Garza M, Hernandez Herrera C, Hernandez Herrera C, Hernandez Munuzuri J, Hernandez-Garcia H, Jimenez Ramos S, Laviada Molina H, Lopez Villezca D, Montano-Gonzalez E, Nevarez Ruiz L, Ramos Lopez G, Reyes Araiza R, Salazar-Gaytan A, Salcido Vazquez E, Sanchez Mijangos H, Solis Morales L, Benatar J, Dixon P, Nirmalaraj K, Rosen I, Scott R, Young S, Araoz Tarco O, Barreda Cáceres L, Benites Lopez C, Camacho Cosavalente L, Chavez Huapalla E, Chois Malaga A, Copaja Flores A, Farfan Aspilcueta J, Gallardo Rojas W, Gallegos Cazorla A, Galvez Caballero D, Garcia Matheus J, Garrido Carrasco E, Gomez Sanchez J, Hernandez Zuniga J, Lu Galarreta L, Luna A, Manrique Hurtado H, Orihuela Pastor B, Pando Alvarez RM, Sanchez Povis J, Torres Eguiluz P, Valdivia Portugal A, Vargas Gonzales R, Zapata Rincon L, Aquitania G, Fortinez JT, Go A, Gomez MH, Habaluyas R, Jasul G, Magno M, Manalo CJ, Mirasol R, Morales-Palomares E, Salvador DR, Sy RA, Tirador L, Yao C, Arciszewska M, Bartkowiak R, Czajkowska-Kaczmarek E, Gil R, Gniot J, Janik K, Janion M, Jaworska K, Jozwa R, Kawecka-Jaszcz K, Kawka-Urbanek T, Kondys M, Korecki J, Korzeniak R, Kowalisko A, Krzeminska-Pakula M, Kwiecien J, Nessler J, Odrowaz-Pieniazek P, Piepiorka M, Rajzer M, Skokowska E, Spyra J, Sroka M, Stasinska T, Szymczyk I, Trznadel-Morawska I, Wysokinski A, Mateus P, Matos P, Mimoso J, Monteiro P, Caballero B, Garcia-Rinaldi R, Gonzalez E, Ortiz-Carrasquillo R, Roman A, Sierra Y, Unger N, Vazquez-Tanus J, Alexandru T, Busegeanu M, Cozman DC, Fica S, Minescu B, Morosanu M, Negrisanu GD, Pintilei E, Pop L, Szilagyi I, Teodorescu I, Tomescu M, Barbarash O, Chumakova G, Churina S, Dogadin S, Dvoryashina I, Esip V, Glezer M, Gordeev I, Gordienko A, Gratsiansky N, Grineva E, Khasanov N, Kostenko V, Meleshkevich T, Mikhin V, Morugova T, Motylev I, Nikolaev K, Ponomareva A, Repin M, Reshetko O, Shustov S, Shutemova E, Shvarts Y, Simanenkov V, Sobolev K, Sukmanova I, Timofeev A, Tsyba L, Varvarina G, Vertkin A, Vishnevsky A, Volkov D, Vorobiev S, Vorokhobina N, Yakhontov D, Zonova E, Zrazhevskiy K, Damjanovic S, Djordjevic D, Pavlovic M, Perunicic J, Ristic A, Stojkovic S, Tasic N, Bolvanska N, Buganova I, Dulkova K, Dzupina A, Fulop P, Gergel V, Kokles M, Micko K, Svoren P, Urban M, Vadinova S, Vargova A, Burgess L, Coetzee K, Du Toit J, Gani M, Joshi P, Naiker P, Nortje H, Sarvan M, Seeber M, Siebert M, van Zyl L, Wellmann H, Calvo C, De la Hera J, De Teresa L, Melero-Pita A, Mesa J, Parra Barona J, Serrano P, Soto A, Tofe S, Hornestam B, Kempe A, Rosenqvist U, Rydberg E, Tengmark BO, Torstensson I, Chang CT, Hsia TL, Hsieh IC, Lai WT, Wu CJ, Hutayanon P, Kosachunhanun N, Marapracertsak M, Piamsomboon C, Seekaew S, Srimahachota S, Sukhum P, Suraamornkul S, Tantiwong P, Wongvipaporn C, Amosova K, Barna O, Bazylevych A, Berenfus V, Dyadyk A, Fushtey I, Gyrina O, Iabluchanskyi M, Karpenko O, Kaydashev I, Korzh O, Kulynych R, Legkonogov O, Mankovsky B, Mostovoy Y, Parkhomenko O, Popik G, Rudenko L, Rudyk I, Shevchuk S, Sirenko Y, Suprun Y, Tryshchuk N, Tseluyko V, Vakaliuk I, Al Mahmeed W, Acheatel R, Ahmad A, Akbar S, Akhter F, Albirini A, Alexander A, Al-Joundi B, Al-Joundi T, Allen G, Aloi J, Alvarado O, Alzohaili O, Anderson C, Arastu A, Arena C, Argoud G, Ariani M, Arora C, Awasty V, Barker B, Barnum O, Bartkowiak AJ, Barzilay J, Behrens P, Belledonne M, Bergman B, Bilnoski W, Bisognano J, Bissette S, Blumberg E, Bonabi N, Bradley A, Breton C, Britos M, Broadstone V, Budoff M, Burge M, Butman S, Carroll M, Challappa K, Chepuri V, Cherlin R, Cheung D, Coats P, Collins J, Cruz H, Daboul N, Damberg G, David W, Dean J, Dedeke E, Deeb W, DeHaven J, Dobs A, Donelan T, Dy J, Dykstra G, Eisen H, Farris N, Fattal P, Fishman N, Foster M, Fredrickson S, Gabra N, Gabriel J, Gatien L, Giddings S, Ginsberg B, Gips S, Glandt M, Goldfein A, Gordon M, Gould R, Graf R, Graham B, Graves M, Grena P, Hahn R, Hamilton D, Hamroff G, Hanke F, Haque I, Harper J Jr, Harris A, Harris S, Henson B, Hermanns D, Herndon W, Hershberger V, Hyman D, Isserman S, Iteld B, Jacob M, Jaffrani N, Jamal A, Johnson D, Johnson G, Kaluski E, Keller R, Kereiakes D, Khan M, Khan S, Khan M, Klein M, Knutson T, Korban E, Kozinn M, Kraft P, Kroeze J, Kukuy E, Lader E, Laliotis A, Lambert C Jr, Landau C, Latif K, Lee K, Lester F, Levenson D, Levinson D, Lewis D, Litt M, Littlefield R, Lo E, Lovell C, Mahal S, Makam S, Mandviwala M, Marar I, Masri B, Mattson S, Mays M, McGrew F, Meengs M, Mikell F, Miller M, Miranda F, Moll D, Multani P, Munuswamy K, Nallasivan M, Nayles L, Ong S, Pacheco T, Paez H, Patel S, Phillips R, Pierpont B, Prasad J, Quinlan E, Quion J, Qureshi M, Rahman A, Raikhel M, Ramanathan K, Randhawa P, Ravi R, Reddy R, Rendell M, Rickner K, Rictor K, Rivas 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J, Koshy-Hunt S, Beers B, Black S, Buckley M, Ephrem M, Riley B, West N, Harre M, Hsieh R, Oshinyemi K, Oka Y, Matsui N, Hoang M, Doyle C, Koziol M, Lam H, Edmonds A, Azooz W, Cao C, Kim D, Boeshaar A, Dewindt A, Nicholson K, Smith N, Hisada M, Harding S, Cannon C, Yoshioka N, Gujral-Sandhu K, Gans J, Gresk C, Kujawski MR, Villinski A, Cosner S, Johannsen C, Barchha N, Knapp B.

Abstract

BACKGROUND:

To assess potentially elevated cardiovascular risk related to new antihyperglycemic drugs in patients with type 2 diabetes, regulatory agencies require a comprehensive evaluation of the cardiovascular safety profile of new antidiabetic therapies. We assessed cardiovascular outcomes with alogliptin, a new inhibitor of dipeptidyl peptidase 4 (DPP-4), as compared with placebo in patients with type 2 diabetes who had had a recent acute coronary syndrome.

METHODS:

We randomly assigned patients with type 2 diabetes and either an acute myocardial infarction or unstable angina requiring hospitalization within the previous 15 to 90 days to receive alogliptin or placebo in addition to existing antihyperglycemic and cardiovascular drug therapy. The study design was a double-blind, noninferiority trial with a prespecified noninferiority margin of 1.3 for the hazard ratio for the primary end point of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.

RESULTS:

A total of 5380 patients underwent randomization and were followed for up to 40 months (median, 18 months). A primary end-point event occurred in 305 patients assigned to alogliptin (11.3%) and in 316 patients assigned to placebo (11.8%) (hazard ratio, 0.96; upper boundary of the one-sided repeated confidence interval, 1.16; P<0.001 for noninferiority). Glycated hemoglobin levels were significantly lower with alogliptin than with placebo (mean difference, -0.36 percentage points; P<0.001). Incidences of hypoglycemia, cancer, pancreatitis, and initiation of dialysis were similar with alogliptin and placebo.

CONCLUSIONS:

Among patients with type 2 diabetes who had had a recent acute coronary syndrome, the rates of major adverse cardiovascular events were not increased with the DPP-4 inhibitor alogliptin as compared with placebo. (Funded by Takeda Development Center Americas; EXAMINE ClinicalTrials.gov number, NCT00968708.).

PMID:
23992602
DOI:
10.1056/NEJMoa1305889
[Indexed for MEDLINE]
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