Document Detail


Effect of aleglitazar on cardiovascular outcomes after acute coronary syndrome in patients with type 2 diabetes mellitus: the AleCardio randomized clinical trial.
MedLine Citation:
PMID:  24682069     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
IMPORTANCE: No therapy directed against diabetes has been shown to unequivocally reduce the excess risk of cardiovascular complications. Aleglitazar is a dual agonist of peroxisome proliferator-activated receptors with insulin-sensitizing and glucose-lowering actions and favorable effects on lipid profiles.
OBJECTIVE: To determine whether the addition of aleglitazar to standard medical therapy reduces cardiovascular morbidity and mortality among patients with type 2 diabetes mellitus and a recent acute coronary syndrome (ACS).
DESIGN, SETTING, AND PARTICIPANTS: AleCardio was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial conducted in 720 hospitals in 26 countries throughout North America, Latin America, Europe, and Asia-Pacific regions. The enrollment of 7226 patients hospitalized for ACS (myocardial infarction or unstable angina) with type 2 diabetes occurred between February 2010 and May 2012; treatment was planned to continue until patients were followed-up for at least 2.5 years and 950 primary end point events were positively adjudicated.
INTERVENTIONS: Randomized in a 1:1 ratio to receive aleglitazar 150 µg or placebo daily.
MAIN OUTCOMES AND MEASURES: The primary efficacy end point was time to cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Principal safety end points were hospitalization due to heart failure and changes in renal function.
RESULTS: The trial was terminated on July 2, 2013, after a median follow-up of 104 weeks, upon recommendation of the data and safety monitoring board due to futility for efficacy at an unplanned interim analysis and increased rates of safety end points. A total of 3.1% of patients were lost to follow-up and 3.2% of patients withdrew consent. The primary end point occurred in 344 patients (9.5%) in the aleglitazar group and 360 patients (10.0%) in the placebo group (hazard ratio, 0.96 [95% CI, 0.83-1.11]; P = .57). Rates of serious adverse events, including heart failure (3.4% for aleglitazar vs 2.8% for placebo, P = .14), gastrointestinal hemorrhages (2.4% for aleglitazar vs 1.7% for placebo, P = .03), and renal dysfunction (7.4% for aleglitazar vs 2.7% for placebo, P < .001) were increased.
CONCLUSIONS AND RELEVANCE: Among patients with type 2 diabetes and recent ACS, use of aleglitazar did not reduce the risk of cardiovascular outcomes. These findings do not support the use of aleglitazar in this setting with a goal of reducing cardiovascular risk.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01042769.
Authors:
A Michael Lincoff; Jean-Claude Tardif; Gregory G Schwartz; Stephen J Nicholls; Lars Rydén; Bruce Neal; Klas Malmberg; Hans Wedel; John B Buse; Robert R Henry; Arlette Weichert; Ruth Cannata; Anders Svensson; Dietmar Volz; Diederick E Grobbee;
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  JAMA     Volume:  311     ISSN:  1538-3598     ISO Abbreviation:  JAMA     Publication Date:  2014 Apr 
Date Detail:
Created Date:  2014-04-16     Completed Date:  2014-04-28     Revised Date:  2014-09-17    
Medline Journal Info:
Nlm Unique ID:  7501160     Medline TA:  JAMA     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1515-25     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT01042769
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MeSH Terms
Descriptor/Qualifier:
Acute Coronary Syndrome / complications*
Aged
Diabetes Mellitus, Type 2 / complications*,  drug therapy*
Double-Blind Method
Female
Humans
Hypoglycemic Agents / adverse effects,  therapeutic use*
Kidney / physiopathology
Male
Middle Aged
Myocardial Infarction
Oxazoles / therapeutic use*
Peroxisome Proliferator-Activated Receptors / agonists
Risk
Stroke
Survival Analysis
Thiophenes / therapeutic use*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Hypoglycemic Agents; 0/Oxazoles; 0/Peroxisome Proliferator-Activated Receptors; 0/Thiophenes; 41T4OAG59U/aleglitazar
Investigator
Investigator/Affiliation:
Marisa Liliana Vico / ; Diego Gabriel Conde / ; Cristian Edgardo Botta / ; Elizabeth Gelersztein / ; Hugo Ramos / ; Aldo Daniel Prado / ; Alfredo Piombo / ; Andrea Piredda / ; Carlos Lorente / ; Juan Pablo Cimbaro Canella / ; Pablo Guzman / ; Horacio Avaca / ; Laura Elena Maffei / ; Nestor Alejandro Vita / ; Vanina Gorosito / ; Claudio Cosman / ; Alberto Caccavo / ; Daniel Piskorz / ; Horacio Omar Jure / ; Ricardo Alcides Fernandez / ; Sebastian Saravia Toledo / ; Daniel Nul / ; Javier Claudio Marino / ; Jose Luis Navarro Estrada / ; Luis Sztejfman / ; John Amerena / ; Leonard Arnolda / ; Raibhan Yadav / ; Paul Garrahy / ; Sidney Lo / ; David Brieger / ; Gregory Nelson / ; Margaret Arstall / ; Matthew Worthley / ; David Colquhoun / ; Stephanie Wilson / ; Tuan Hoai Nguyen Dang / ; Ananth Prasan / ; Jens Kilian / ; Nicholas Collins / ; Ernesto Oqueli / ; Patrick Carroll / ; Frederico De Lima E Silva / ; Oscar Dutra / ; Marcelo Franken / ; Rogerio Tumelero / ; Pedro Pimentel / ; Artur Herdy / ; Maria Sanali Paiva / ; Costantino Roberto Costantini Frack / ; Fabio Rossi / ; Lilia Maia / ; Adriana Forti / ; Jose Francisco Saraiva / ; Luiz Bodanese / ; Jordan Oliveira / ; Paulo Rossi / ; Jorge Gross / ; Audes Feitosa / ; Marco Wainstein / ; Ricardo Silva / ; Delcio Silva / ; Roberto Botelho / ; Euler Manenti / ; Jose Airton de Arruda / ; Jose Augusto Ribas Fortes / ; Wilma Ardito / ; Raul Dos Santos Filho / ; Dalton Bertolim Precoma / ; Jamil Saad / ; Jose Antonio Jatene / ; Miguel Hissa / ; Alvaro Junior / ; Joao Borges / ; Celia Sampaio / ; Gilmar Reis / ; Aurora Issa / ; Paulo Ernesto Leaes / ; Sergio Emanuel Kaiser / ; Daniel Savard / ; Jean Claude Tardif / ; Manohara Sanaratne / ; Gurcharan Syan / ; Simon Kouz / ; Jan Kornder / ; Ariel Diaz / ; Ronald Bourgeois / ; Erick Schampaert / ; Eva Lonn / ; Frank Nigro / ; Michel Degrace / ; Guiseppe Mazza / ; Philippe Robichaud / ; Lawrence Title / ; Dennis Rupka / ; Jean-Francois Baril / ; Ron James Hatheway / ; Annie Roy / ; Jean Pierre Lavoie / ; Raymond Leung / ; Gerald Tremblay / ; Joel Pouliot / ; Laurie Hill / ; Roger Labonte / ; Shahar Lavi / ; Patrick Bergin / ; Yves Pesant / ; Denis Carl Phaneuf / ; Gustavo Nogareda / ; Stuart Smith / ; Thao Huynh / ; Anthony Rolfe / ; James Conway / ; Olivier Bertrand / ; Raja Chehayeb / ; Shekhar Pandey / ; Robert Petrella / ; Serge Lepage / ; Shah Nawaz / ; Amer Johri / ; Beth Abramson / ; Didier Fay / ; Gregory Searles / ; Guy Chouinard / ; Maynard Luterman / ; Remo Zadra / ; Robert Welsh / ; Saul Vizel / ; Christian Leduc / ; Patrice Nault / ; Philippe Beaudry / ; Asaad Bakbak / ; Faryala Shabani / ; Joseph Berlingieri / ; Xinchun Yang / ; Ruiping Zhao / ; Jianjun Peng / ; Hongde Hu / ; Ming Luo / ; Yuannan Ke / ; Zuyi Yuan / ; Yun Zhang / ; Xiaofeng Lv / ; Changsheng Ma / ; Genshan Ma / ; Jiyan Chen / ; Xiaodong Li / ; Zhanquan Li / ; Xiaowei Yan / ; Xuedong Gan / ; Junzhu Chen / ; Shuiping Zhao / ; Yundai Chen / ; Hui Li / ; Lang Li / ; Li Huimin / ; Ying Guo / ; Taohong Hu / ; Weiyi Fang / ; Xiaofei Wang / ; Kan Yang / ; Xiaomei Bao / ; Guosheng Fu / ; Hongwei Li / ; Jing Yan / ; Dongmei Wang / ; Ben He / ; Fang Zhang / ; Yaling Han / ; Jun Liu / ; Meng Wei / ; Hong Ma / ; Shiyao Wu / ; Weiming Li / ; Haiming Shi / ; Zdenek Monhart / ; Miroslav Solar / ; Jan Belohlavek / ; Richard Ferkl / ; Rostislav Kral / ; Martin Hutyra / ; Martin Novak / ; Jiri Kettner / ; Ivo Podpera / ; Jan Malik / ; Ole May / ; Thomas Gohr / ; Peter Clemmensen / ; Jens Lomholdt / ; Marine Verges / ; Benaissa Agraou / ; Gilles Montalescot / ; Vincent Probst / ; Michel Galinier / ; Raymond Roudaut / ; Anne Isabelle Tropeano / ; Michel Ovize / ; Simon Elhadad / ; Abdelkader Belhassane / ; Fabrice Dhoudain / ; Francois Schiele / ; Nicolas Danchin / ; Teodora Dutoiu / ; Christophe Caussin / ; Yves Cottin / ; Thomas Münzel / ; Heinz Voeller / ; Franz Josef Neumann / ; Klaus Edel / ; Wolfram Kamke / ; Juergen vom Dahl / ; Thomas Ali / ; Volker Schächinger / ; Mohammed Natour / ; Christoph Kadel / ; Anja Löw / ; Christian Hamm / ; Hans-Dirk Düngen / ; Siegfried Eckert / ; Ursula Hoffmann / ; Eberhards von Hodenberg / ; Nikos Werner / ; Ulrich Laufs / ; Hans-Friedrich Voehringer / ; Holger Reinecke / ; Andreas Mügge / ; Eckart Fleck / ; Hannes Reuter / ; Johannes Hensen / ; Martin Bergmann / ; Carsten Tschoepe / ; Ursula Kuehne / ; Nicolaos Proskynitopoulos / ; Peter Michalko / ; Malte Kelm / ; Istvan Edes / ; Laszlo Koranyi / ; Andras Papp / ; Andras Vertes / ; Ivan Horvath / ; Geza Lupkovics / ; Laszlo Deak / ; Bela Benczur / ; Erzsébet Sziliczei-Nemeth / ; Gabriella Hodi / ; Kalman Csapo / ; Mihaly Dudas / ; Aniko Somogyi / ; Istvan Czuriga / ; Lajos Nagy / ; Keyur Parikh / ; Bipin Kumar Sethi / ; Rakesh Kumar Sahay / ; Rajendra Premchand / ; Arpandev Bhattacharya / ; Jagdish Hiremath / ; Subir Ghosh / ; Anil Jawahirani / ; Kamal Sharma / ; Milind Gadkari / ; Ashok Dash / ; Sameer Dani / ; Sudeep Kumar / ; Purshottam Khanna / ; Neeta Deshpande / ; Harish Kumar / ; Jaspal Arneja / ; Selvamani Setthuraman / ; 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Thanakorn Laksomya / ; Piyamitr Sritara / ; Dallas Price / ; Rajesh Aggarwal / ; Ian Purcell / ; Ceri Davies / ; Iqbal Malik / ; Andonis Violaris / ; Frances Game / ; John Harvey / ; Douglas Robertson / ; Honer Kadr / ; Thomas Graham Trouton / ; Raffi Kaprielian / ; David Dutka / ; David Hildick-Smith / ; Robert Butler / ; Sandra MacRury / ; Beverley Ann Millward / ; John Purvis / ; John Reckless / ; Ramzi Ajjan / ; Diane Bruce / ; Dominic Cox / ; Iqbal Malik / ; Jaspal Kooner / ; Scott Muir / ; Simon Hutchinson / ; Dinesh Gupta / ; Debra Weinstein / ; Mark Bieniarz / ; Mahmoud Traina / ; Ira Lieber / ; John Mohart / ; John Prodafikas / ; Donald Laurion / ; Mandeep Oberoi / ; Eric Carlson / ; John Schmedtje / ; Ronald Mayfield / ; Gina Chandler / ; Kalgi Modi / ; Matthew Budoff / ; Richard Zelman / ; Robert Dalton / ; Kwan Lee / ; Paul Gordon / ; Woubeshet Ayenew / ; Charles Mathis / ; Robert Busch / ; Timothy Schuchard / ; Ajit Raisinghani / ; Alexander M Shepherd / ; Naseem Jaffrani / ; Peter Ver Lee / ; Yellapragada Chandrashekhar / ; Akber Mohammed / ; Giora Weisz / ; Hossein Almassi / ; Joseph Krantzler / ; Mark Quadrel / ; Scott Martin / ; Sorin Brener / ; Barry Harris / ; Charles Eaton / ; Chippy Nalluri / ; Gregory Schwartz / ; Harinder Gogia / ; Harry Colfer / ; John Doherty / ; Nguyen Dang / ; Ronald Blonder / ; Stuart Jacobson / ; William Rogers / ; Ellis Levin / ; George Isa / ; Harish Chandna / ; Jang Singh / ; Les Forgosh / ; Michael Melucci / ; Robert Chilton / ; Salah El Hafi / ; Brian Way / ; Charles Lambert / ; Elie Korban / ; Eric Auerbach / ; Keith Hickey / ; Marcus McKenzie / ; Neeraj Tandon / ; Sharan Mahal / ; Stephen Heitner / ; David O'Halloran / ; Irving Kent Loh / ; Jeffrey Harris / ; Joseph Gelormini / ; Leonardo Clavijo / ; Marc Klapholz / ; Mark Studeny / ; Rajiv Goswami / ; Robert Norris / ; Rodica Pop Busui / ; Sammy Lane Cox / ; Tahir Tak / ; Thomas Anan / ; Touraj Taghizadeh / ; Vincent Pompili / ; Alan Camp / ; Amit Khera / ; Anil Shah / ; 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Bassem Masri / ; Bruce Iteld / ; Cameron Gifford / ; Cranford Scott / ; Francisco Maislos / ; James Longo / ; James Rider / ; Jay Silverstein / ; Michael Miller / ; Michele Nanna / ; Misal Khan / ; Ricky Schneider / ; Riyaz Bashir / ; Robert Evans / ; Robert Fierer / ; Samuel Teniola / ; Stephen Welka / ; Vibhuti Singh / ; William Randall / ; William Rowe / ; Abraham Salacata / ; Ali Bazzi / ; Alon Steinberg / ; Aryan Mooss / ; Aylmer Tang / ; Brian Kahn / ; Bronell Chandler / ; Carlos Bayron / ; Carsten Schmalfuss / ; Cary Hirsch / ; Charles Thompson / ; Craig Thompson / ; Dinesh Singal / ; Eric Lo / ; Eric Spivack / ; Geetha Gopalakrishnan / ; James Lowe / ; James Talano / ; Jeanine Albu / ; John McClure / ; John McGettigan / ; Jonathan Hemphill / ; Kishor Vora / ; Maria Del Pilar Solano / ; Mohammad Shoukfeh / ; Patricia Best / ; Paul Thompson / ; Salvador Borromeo / ; Thomas Barringer / ; Thomas Hilton / ; Thomas Knickelbine / ; William Palmer /
Comments/Corrections
Comment In:
Nat Rev Cardiol. 2014 Jun;11(6):311   [PMID:  24736759 ]

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