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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Alogliptin after acute coronary syndrome in patients with type 2 diabetes
New England Journal of Medicine, Volume 369, No. 14, Year 2013
Notification
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Description
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. Copyright © 2013 Massachusetts Medical Society.
Authors & Co-Authors
White, William B.
United States, Farmington
Uconn Health
Cannon, Christopher Paul
United States, Boston
Harvard Medical School
Heller, Simon R.
United Kingdom, Sheffield
The University of Sheffield
Nissen, Steven E.
United States, Cleveland
Cleveland Clinic Foundation
Bergenstal, Richard M.
United States, Minneapolis
Park Nicollet Clinic
Bakris, George L.
United States, Chicago
The University of Chicago Medicine
Fleck, Penny R.
United States, Deerfield
Takeda Development Center Americas, Inc.
Kupfer, Stuart F.
United States, Deerfield
Takeda Development Center Americas, Inc.
Wilson, Craig A.
United States, Deerfield
Takeda Development Center Americas, Inc.
Cushman, William C.
United States, Memphis
Memphis va Medical Center
Zannad, Faïez Mohamed
France, Nancy
Chu de Nancy
Astesiano, Alfredo
Unknown Affiliation
Barcudi, Raúl J.
Unknown Affiliation
Bendersky, Mario A.
Unknown Affiliation
Bono, Julio Oscar Emilio
Unknown Affiliation
Bustos, Betina
Unknown Affiliation
Cartasegna, Luis Rodolfo
Unknown Affiliation
Castro, Rita C.
Unknown Affiliation
Cuneo, Carlos Alberto
Unknown Affiliation
Dran, Ricardo Dario
Unknown Affiliation
Fernández, Huberth
Unknown Affiliation
Hrabar, Adrián D.
Unknown Affiliation
Lúquez, Hugo A.
Unknown Affiliation
MacKinnon, Ignacio J.
Unknown Affiliation
Maffei, Laura Elena
Unknown Affiliation
Majul, Claudio Rodolfo
Unknown Affiliation
Parody, Maria Leonor
Unknown Affiliation
Prado, Aldo
Unknown Affiliation
Rodríguez, Monica J.
Unknown Affiliation
Sarjanovich, Rodolfo Juan
Unknown Affiliation
Vita, Néstor Alejandro
Unknown Affiliation
Vogel, Daniel R.
Unknown Affiliation
Zaidman, Cesar Javier
Unknown Affiliation
Colquhoun, David M.
Unknown Affiliation
Drexel, Heinz
Unknown Affiliation
Luger, Aanton F.
Unknown Affiliation
Pieber, Thomas Rudolf
Unknown Affiliation
Cools, Frank Johan C.
Unknown Affiliation
Ruige, Johannes B.
Unknown Affiliation
Amodeo, Celso
Unknown Affiliation
Borges, João Lindolfo Cunha
Unknown Affiliation
Botelho, Roberto Vieira
Unknown Affiliation
Faria-Neto, José Rocha
Unknown Affiliation
Fraige-Filho, Fadlo
Unknown Affiliation
Hernandes, Mauro Esteves
Unknown Affiliation
Kormann, Adrian Paulo Morales
Unknown Affiliation
Maia, Lília Nigro
Unknown Affiliation
Précoma, Dalton Bertolim
Unknown Affiliation
Reis, Gilmar
Unknown Affiliation
Reis, Heleno
Unknown Affiliation
Rossi, Paulo R.F.
Unknown Affiliation
Daskalova, Ivona Kirilova
Unknown Affiliation
Hristozov, Kiril Hristov
Unknown Affiliation
Carpentier, André C. C.
Unknown Affiliation
Chan, Yih Kai
Unknown Affiliation
Cheema, Asim N.
Unknown Affiliation
Ma, Patrick T.S.
Unknown Affiliation
Mehta, Shamir R.
Unknown Affiliation
Saavedra, Víctor Villarroel
Unknown Affiliation
Accini, José Luis
Unknown Affiliation
Havelková, Jana
Unknown Affiliation
El Badry, Mahmoud E.
Unknown Affiliation
Airaksinen, Juhani K.E.
Unknown Affiliation
Bonnet, Jean Louis
Unknown Affiliation
Elbaz, Meyer
Unknown Affiliation
Henry, Patrick
Unknown Affiliation
Tropéano, Anne Isabelle
Unknown Affiliation
Bornstein, Stefan R.
Unknown Affiliation
Poerner, Tudor C.
Unknown Affiliation
Bellary, Srikanth
Unknown Affiliation
Fisher, Miles B.
Unknown Affiliation
Nagi, Dinesh K.
Unknown Affiliation
Saravanan, Ponnusamy
Unknown Affiliation
Viljoen, Adie
Unknown Affiliation
Wilding, Prof John
Unknown Affiliation
Arango, Juan Luis
Unknown Affiliation
Chow, Felicia C.
Unknown Affiliation
Édes, István Ferenc
Unknown Affiliation
Merkely, Béla D.Signla
Unknown Affiliation
Tabák, Ádám Gy
Unknown Affiliation
Tomcsányi, Jànos
Unknown Affiliation
Bantwal, Ganapathi
Unknown Affiliation
Dani, Sameer Indravadan
Unknown Affiliation
Deshpande, Neeta Rohit
Unknown Affiliation
Goyal, Naresh Kumar
Unknown Affiliation
Srinivas, Arun
Unknown Affiliation
Harman-Boehm, Ilana
Unknown Affiliation
Iakobishvili, Zaza
Unknown Affiliation
Calabrò, Paolo
Unknown Affiliation
Novo, Salvatore
Unknown Affiliation
Volpe, Massimo
Unknown Affiliation
Daida, Hiroyuki
Unknown Affiliation
Morimoto, Takeshi
Unknown Affiliation
Kim, Chonghwa
Unknown Affiliation
Kim, W. S.
Unknown Affiliation
Pyun, Wookbum
Unknown Affiliation
Rha, Seungwoon
Unknown Affiliation
Bennakhi, Abdullah
Unknown Affiliation
Žilaitiené, Birute
Unknown Affiliation
Yusoff, Khalid
Unknown Affiliation
Carrillo-Calvillo, Jorge
Unknown Affiliation
Ramos López, Gabriel Arturo
Unknown Affiliation
Dixon, Paul
Unknown Affiliation
Scott, R. S.
Unknown Affiliation
Mirasol, Roberto C.
Unknown Affiliation
Czajkowska-Kaczmarek, Eugenia
Unknown Affiliation
Gil, Robert Julian
Unknown Affiliation
Gniot, Jacek R.
Unknown Affiliation
Kawecka-Jaszcz, Kalina
Unknown Affiliation
Krzeminśka-Pakuła, Maria
Unknown Affiliation
Nessler, Jadwiga Maria
Unknown Affiliation
Rajzer, Marek W.
Unknown Affiliation
Mimoso, Jorge M.Vieira
Unknown Affiliation
Barbarash, Olga Leonidovna
Unknown Affiliation
Vishnevsky, Alexander Yu
Unknown Affiliation
Ristić, Arsen D.
Unknown Affiliation
Stojkovic, S. M.
Unknown Affiliation
Tasić, Nebojša M.
Unknown Affiliation
Džupina, Andrej
Unknown Affiliation
Burgess, Lesley Jean
Unknown Affiliation
Coetzee, Kathleen
Unknown Affiliation
Joshi, Pankaj H.
Unknown Affiliation
Nortje, Hendrik F.M.
Unknown Affiliation
Seeber, Mary Elizabeth
Unknown Affiliation
van Zyl, Louis T.
Unknown Affiliation
Wellmann, Holger
Unknown Affiliation
Calvo, Carlos A.
Unknown Affiliation
Tengmark, Bengt Olov
Unknown Affiliation
Hsieh, I. Chang
Unknown Affiliation
Wu, Chiung Jung (Jo)
Unknown Affiliation
Kaidashev, I. P.
Unknown Affiliation
Korzh, Oleksii M.
Unknown Affiliation
Mankovsky, Boris N.
Unknown Affiliation
Sirenko, Yu M.
Unknown Affiliation
Al-Mahmeed, Wael Abdulrahman R.
Unknown Affiliation
Barzilay, Joshua I.
Unknown Affiliation
Bisognano, John D.
Unknown Affiliation
Budoff, M. Jay
Unknown Affiliation
Cheung, Deanna G.
Unknown Affiliation
Coats, Paul
Unknown Affiliation
Collins, Jennifer A.
Unknown Affiliation
Graf, Ronald J.
Unknown Affiliation
Graves, Morgan
Unknown Affiliation
Kereiakes, Dean J.
Unknown Affiliation
Kozinn, Marc J.
Unknown Affiliation
Lader, Ellis W.
Unknown Affiliation
Lewis, David A.
Unknown Affiliation
Miller, Michael B.
Unknown Affiliation
Rosenblit, Paul David
Unknown Affiliation
Rosenstock, Julio
Unknown Affiliation
Scott, Charlie
Unknown Affiliation
Warner, Alberta L.
Unknown Affiliation
Fonseca, Vivian A.
Unknown Affiliation
McCullough, Peter A.
Unknown Affiliation
Janssens, A. Cecile J.W.
Unknown Affiliation
Sila, Cathy A.
Unknown Affiliation
Al Solaiman, Firas
Unknown Affiliation
Cavender, Matthew A.
Unknown Affiliation
Uchino, Ken
Unknown Affiliation
Hoang, Mai P.
Unknown Affiliation
Statistics
Citations: 2,147
Authors: 160
Affiliations: 10
Identifiers
Doi:
10.1056/NEJMoa1305889
ISSN:
00284793
Research Areas
Cancer
Disability
Environmental
Noncommunicable Diseases
Study Design
Randomised Control Trial