3 research outputs found
Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial
- Author
- Abbas Jalal
- Abraham Sybil
- Ackert Jessica
- Adams Patricia
- Aggarwala Gaurav
- Aher Nutan
- Ahlqvist Jørn
- Ahn Chul Woo
- Akers Teresa
- Akhras Ronald
- Akhter Faiq
- Aksentyev Sergey
- Al Kawas Firas
- Alexander Karen
- Althouse Denise
- Altobelli Desma
- Alvarisqueta Andres
- Ambrosy Andrew
- Andersen James
- Andersen Ulla
- Anderson Michelle
- Anglade Moise
- Arbañil Hugo
- Arciszewska Malgorzata
- Argoud Georges
- Ariani Mehrdad
- Ashdji Reswan
- Avogaro Angelo
- Avramidis Iakovos
- Axthelm Christoph
- Aye Myint
- Babi Charleen
- Bachus Erasmus
- Baik Sei-Hyun
- Bailey Matt
- Bakhtari Ladan
- Baksi Arun
- Balasubramani Mathangi
- Baldovino Jorge
- Banach Marek
- Banerjee Subhash
- Bartlett Andrew
- Bartone Susan
- Baum Howard
- Bays Harold
- Bazhan Larysa
- Beasley Richard
- Beaudry Yves
- Beaulieu Gail
- Beboso Ronnie
- Bedard Jacques
- Beijerbacht Hugo Peter
- Belfort de Aguiar Renata
- Benjamin Sabrina
- Berger Dirk
- Berlingieri Joseph
- Berndtsson Blom Katarina
- Besada Diego
- Bethel M Angelyn
- Bhagwat Ravi
- Bhargava Anuj
- Bhosale Archana
- Bieler Tasso
- Bijata-Bronisz Renata
- Birkeland Kare
- Birkenfeld Andreas
- Blagden Mark
- Bloomfield Gerald
- Bode Bruce
- Boemi Massimo
- Bonadonna Riccardo
- Bondar Irina
- Bott Jochen
- Bousboulas Stavros
- Boye Alain
- Bratcher Christina
- Breneman Jody
- Briskin Toby
- Bristianou Magdalini
- Brockmyre Andrew
- Broughton Raymond
- Brown Judith
- Brown Kim
- Brychta Tomas
- Brønnum-Schou Jens
- Budhraja Madhusudan
- Bull Georgina
- Bundy Charles
- Burgess Lesley
- Busch Klaus
- Caca Karel
- Cadinot Didier
- Calderon Jorge
- Calella Pedro
- Califf Robert M
- Calvo Gómez Carlos
- Camacho Luis
- Cannon Kevin
- Cano Rodríguez Isidoro
- Cantero Maria Cecilia
- Carr Jewell
- Casson Ed
- Castaño Patricia
- Castro Conde Almudena
- Cathcart Harold
- Cavale Arvind
- Cech Vladimir
- Cequier Fillat Angel
- Cervantes-Escárcega Jose-Luis
- Cha Bong-Soo
- Chau Tuan
- Chaykin Louis
- Chehayeb Raja
- Chen David
- Chen Jung-Fu
- Chertkoff Alejandro
- Cheung Deanna
- Cheung Stephen
- Chevts Julia
- Chiang Chern-En
- Childress Richard
- Christian Tamra
- Chung Choon-Hee
- Coetzee Kathleen
- Cohen Allan
- Coker Rebecca
- Cole Joanna
- Collier Jeannie
- Condit Jonathan
- Consoli Agostino
- Conway James
- Cooksey Erin
- Cookson Tobias
- Cooper John
- Cooper Lauren
- Copland Allan
- Cornel Jan
- Cornett George Mitchell
- Crenier Laurent
- Cuadrado Jesus
- Cuatrecasas Cambra Guillem
- Cusson Jean
- D'Agostino Ralph B
- D'Agostino Ralph B.
- Daga Shruti
- Damyanova Velichka
- Dauber Ira
- Davila William
- Dawood Saleem
- De Armas Luis
- De Cosmo Salvatore
- De Loredo Luis
- De Teresa Parreño Luis
- de Álvaro Moreno Fernando
- Dean Julius
- Debroye Corinne
- Del Prato Stefano
- Del Prato Stefano
- Delgado Lista Javier
- Della Siega Anthony
- DeMets David
- Demidova Irina
- Derezinski Tadeusz
- Deshpande Sameer
- Detweiler Robert
- Devore Adam
- Di Bartolo Paolo
- Di Giovanna Michael
- Diaz Ernesto
- Dimitriadis Georgios
- Dimitrov Stefan
- Distiller Larry
- Dombrowski Keith
- Dominguez Andrea
- Domínguez Escribano José Ramón
- Donaldson Jill
- Donaubauer Torsten
- Dor Isaac
- Dotta Francesco
- Dreval Alexander
- Drummond Waymon
- Dumas Richard
- Dumbre Snehal
- Dungan Kathleen
- Durán García Santiago
- Duyck Francis
- Dvorakova Eva
- Dzongowski Peter
- Eagerton Donald
- Eapen Zubin
- Earl John
- Eaton Charles
- Ebo Geraldine
- Edelsberger Tomas
- Eliasson Bjorn
- Eliasson Ken
- Elisaf Moses
- Ellison Howard
- Elvira González Javier
- Emslie-Smith Alistair
- Endsley Patricia
- Enns Robert
- Erlinger Rudolf
- Ershova Olga
- Español Maria Vanesa
- Espinoza Augusto Dextre
- Farris Neil
- Ferguson Murdo
- Fernandez-Salazar Eva
- Fernández Rodríguez José María
- Fiel Thomas
- Finkelstein Hernan
- Firek Anthony
- First Brian
- Fleming John
- Flota-Cervera Luis Fernando
- Forgosh Les
- Frechtel Gustavo
- French William
- Fretes Jose
- Friedman Daniel
- Frontoni Simona
- Funke Klaus
- Fushtey Ivan
- Gadzinski Waldemar
- Gajek Jacek
- Galatius Søren
- Galetta Marianna
- Galstyan Gagik
- Gambineri Alessandra
- Gandy Winston
- Garcia Ronald
- Garganeeva Alla
- Garrido Santos Natalia
- Garrido Elizabeth
- Garvey Louisa
- Gaudet Daniel
- Gazzaruso Carmine
- Gentry Tracy
- Giaccari Andrea
- Gill Santosh
- Giorgino Francesco
- Goday Arno Alberto
- Godse Rupali
- Gomez Huelgas Ricardo
- Gonzales Rolando Vargas
- Gonzalez Joaquin
- González Juanatey José Ramón
- González-González José Gerardo
- Goodman Shaun
- Gordon Murray
- Gouet Didier
- Grachova Mariya
- Granger Christopher B
- Granger Christopher B.
- Green Fiona
- Green Jennifer B
- Green Jennifer B
- Greene Deb
- Greene Stephen
- Grondin Francois
- Grosskopf Josef
- Groutars Reginald G.E.J.
- Guerci Bruno
- Guice Michael
- Guimaraes Patricia
- Gulseth Hanne
- Gummadi Siva
- Gunstone Anthony
- Gupta Anil
- Gupta Milan
- Gupta Nikita
- Guttormsen Gaute
- Ha JuYoung
- Hackenyos Jonathan
- Haddock Trevorlyn
- Hagenow Andreas
- Hairston Kristen
- Hajdú Csaba
- Halciakova Katarina
- Halperin Frank
- Haluzik Martin
- Hamann Monika
- Hanson Lenita
- Haque Ghazala
- Harcsa Eleonóra
- Harris Tara
- Harrison Lindsay
- Harrison Rob
- Hartard Manfred
- Hartman Israel
- Heitner John
- Hejeebu Srini
- Henry Patrick
- Hereghty Belinda
- Hermany Paul
- Hernandez Mijares Antonio
- Hernandez Adrian F
- Hernandez Adrian F.
- Hernandez-Cassis Carlos
- Heymer Peter
- Hidalgo Horacio
- Higgins Alexander
- Hoek Boudewijn A
- Holman Rury
- Hoogslag Pieter A.M.
- Houle Pierre-Alain
- Hove Jens
- Howell Christina
- Hramiak Irene
- Huppertz Wolfgang
- Hutayanon Pisit
- Ibrahim Hassan
- Illies Gabriele
- Issa Basil
- Izmozherova Nadezhda
- Jackson-Voyzey Ewart
- Jacob Stephan
- Jacobs Shahram
- James Kourtnei
- James Rachel
- Jang Hak Chul
- Janmohamed Salim
- Janmohamed Salim
- Jarosz Marie
- Jenkins Wendy
- Jensen Jan Skov
- Jerjes-Díaz Carlos Sánchez
- Jiménez Díaz Víctor Alfonso
- Jintapakorn Woravut
- Jodar Gimeno Esteban
- Johnson Andrew
- Johnson David
- Johnson Megan
- Jones Michael
- Jones Nigel P
- Jones Nigel P
- Jordan Dedrick
- Joshi Parag
- Jung Thomas
- Kadgaonkar Neha
- Kahrmann Gerd
- Karetnikova Victoria
- Karka Mounika
- Karmalkar Anisha
- Kast Petra
- Kaster Steven
- Katerenchuk Vitaliy
- Kellerer Monika
- Kellum Daniel
- Kelly Aoife
- Kempe Hans-Peter
- Kessler Laurence
- Khandelwal Chaitali
- Kharakhulakh Marina
- Khariouzov Andrei
- Khokhlov Aleksandr
- Kim Chong-Jin
- Kim Christopher
- Kim Ellen
- Kim Hye Soon
- Kim In Joo
- Kirby William
- Klausmann Gerhard
- Klein Christiane
- Kleinecke-Pohl Uwe
- Kleinertz Klaus
- Klodawska Katarzyna
- Knouse Albert
- Kobalava Zhanna
- Kober Lars
- Koch Thorsten
- Kocsis Gyozo
- Kolls Brad
- Kong David
- Konyves Laszlo
- Kooy Adriaan
- Korpachev Vadym
- Kosch Christine
- Koshelskaya Olga
- Kosiborod Mikhail
- Koskinen Pekka
- Kosmacheva Elena
- Kostin Vladimir
- Kotsa Kalliopi
- Kouz Simon
- Kovacheva Snezhina
- Kovacs Christopher
- Koziolova Natalia
- Kragten Johannes A.
- Kravchun Nonna
- Kristiansen Ole Peter
- Krizova Jarmila
- Krzyzagorska Ewa
- Kulback Steven
- Kulkarni Mangesh
- Kumar Mariananda
- Kumar Rakesh
- Kumar Somesh
- Kumari Aditi
- Kuruvanka Tulsidas
- Kuzin Anatoly
- Labroo Ajay
- Lalau Jean-Daniel
- Landry Daniel
- Larin Oleksandr
- Larnefeldt Hans
- Lasswell William
- Lastuvka Jiri
- Lauder Steven
- Lauro Davide
- Lee Eun Young
- Lee Hyoung Woo
- Lee Kwan-Woo
- Lee Moon Kyu
- Leiter Lawrence A
- Leiter Lawrence A.
- Lentz John
- Lenzmeier Thomas
- Lesnov Victor
- Lewis David
- Li Wenyan
- Li Zhaoping
- Lieverse Aloysius G.
- Lif-Tiberg Cornelia
- Lillestol Michael
- Linderfalk Carina
- Lindsay Alistair
- Little Raymond
- Litvak Marcos
- Llamas Edmundo-Alfredo Bayram
- Lokhngina Yuliya
- Lombard Landman
- Longley Troy
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- Loureyro Juan
- Lozanov Lachezar
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- Luedemann Joerg
- Luna Alejandro
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- Lund Per
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- Luttermann Matthias
- Lysenko Tatyana
- Maclean Malcolm
- Madej Andrzej
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- Manrique Helard
- Marazuela Monica
- Margaritov Viktor
- Markov Valentin
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- Martell Claros Nieves
- Mathews Robin
- Mathieu Chantal
- Mauricio Puente Didac
- Maxeiner Stephan
- Mayorov Alexander
- McGuire Darren
- McKeown-Biagas Cecilia
- McKnight John
- McLaughlin Patricia
- McMurray John J.V.
- McMurray John J.V.
- McNeill Robert
- Mehta Anand
- Mehta Rajendra
- Melchior Thomas
- Melidonis Andreas
- Melloni Chiara
- Mena Ribas Elena
- Merino Torres Juan Francisco
- Mezquita Raya Pedro
- Mhambrey Ankita
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- Migdalis Ilias
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- Milek Karsten
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- Moodley Rajendran
- Moon Keon-Woong
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- Myshanych Halyna
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- Nadar Venkatesh
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- Nischik Ruth
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- Olesinska-Mader Martyna
- Olsson Åke
- Oosthuysen Wessels
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- Ordoñez Sánchez Xavier
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- Orlenko Valeriia
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- Overton Robert
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- Pashkovska Nataliia
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- Patil Ashwini P
- Patil Suradnya
- Patterson Catherine
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- Pelayo-Orozco Emilia Susana
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- Perez Manghi Federico
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- Revoredo Frederick Massucco
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- Rosenberg Anne E
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- Siegel Anna
- Sigal Helena
- Sigmon Kristina
- Sigmon Kristina N
- Silhova Elena
- Sinay Isaac
- Singh Narendra
- Sivalingam Kanagaratnam
- Sjöberg Folke
- Skokowska Ewa
- Smirnov Ivan
- Smith Paul
- Smith Peter
- Soffer Joseph
- Sokolova Nadezhda
- Solanki Sheetal
- Somerville Matthew
- Somerville Matthew C
- Soto González Alfonso
- Sowell Margaret
- Sposetti Georgina
- Srimahachota Suphot
- St-Maurice Francois
- Stankiewicz Andrzej
- Stasinska Teresa
- Stead Janet
- Steindorf Joerg
- Stewart Murray
- Stockhausen Juergen
- Stone Allegra
- Stonesifer Larry
- Storey Daniel
- Stoyanova Zhasmina
- Stuebler Petra
- Suh David
- Sukumaran Usha
- Swart Hendrik P.
- Sándor Vangel
- Söderberg Stefan
- Taeschner Heidrun
- Taft Lin
- Tahir Mohammed
- Tan Anjanette
- Tan Choon Beng Kathryn
- Tan Marilyn
- Taylon Alain
- Tentolouris Nikolaos
- Tews Dietrich
- Thakkar Maitreya
- Thomas Betsy
- Thorpe Karl
- Thorpe Karl M
- Thuan Jean-Francois
- Tien Kai Jen
- Tinahones Madueno Francisco
- Tirador Louie
- Tonolo Giancarlo
- Torres-Colores Jose Juan
- Torstensson Ingemar
- Trescoli Serrano Carlos
- Trevisan Roberto
- Tricoci Pierluigi
- Tripathy Devjit
- Trznadel-Morawska Iwona
- Tsapas Apostolos
- Tschoepe Diethelm
- Tseng Shih-Ting
- Tu Shih-Te
- Tugwell Barna
- Tzatzagou Glykeria
- Ulied Armiñana Angels
- Ulla Maria
- Urbanek Robin
- Uwaifo Gabriel
- Van Gaal Luc
- Vandyne Beth
- Vaphare Ashok
- Vasilevskaya Olga
- Vass Viktor
- Vedere Amarnath
- Vemulapalli Sreekanth
- Venugopal Chandra
- Verbovaya Nelli
- Vercammen Chris
- Verra Fernando
- Vidrio-Velázquez Maricela
- Viergever Eric P.
- Villagordoa-Mesa Juan
- Vishneva Elena
- Vizel Saul
- Vlasenko Maryna
- Vo Anthony
- Voinot Christel
- Vorobyev Sergey
- Vorokhobina Natalya
- Vouillarmet Julien
- Vrkoc Jan
- Wang Chih-Yuan
- Wang Ji-Hung
- Watson Anthony
- Watson David
- Welch Michelle
- Welker James
- White Alexander
- Wilhelm Karl
- Willis John
- Wilson Matt
- Wilson Tim
- Witek Robert
- Wium Cecilie
- Womer Terese
- Woo Vincent
- Wraight Ella
- Wynne Alan
- Xing Weibing
- Yamwong Sukit
- Yazdani Shahram
- Ye June
- Yoo Soon Jib
- Yordanov Victor
- Yu Jaemyung
- Zabalua Silvina
- Zaidman Cesar
- Zang Eddie
- Zanozina Olga
- Zeller-Stefan Helga
- Zhdanova Elena
- Zlova Tetiana
- Zubiate Carlos
- Zykova Tatyana
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/01/2018
- Field of study
Background:
Glucagon-like peptide 1 receptor agonists differ in chemical structure, duration of action, and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. We aimed to determine the safety and efficacy of albiglutide in preventing cardiovascular death, myocardial infarction, or stroke.
Methods:
We did a double-blind, randomised, placebo-controlled trial in 610 sites across 28 countries. We randomly assigned patients aged 40 years and older with type 2 diabetes and cardiovascular disease (at a 1:1 ratio) to groups that either received a subcutaneous injection of albiglutide (30–50 mg, based on glycaemic response and tolerability) or of a matched volume of placebo once a week, in addition to their standard care. Investigators used an interactive voice or web response system to obtain treatment assignment, and patients and all study investigators were masked to their treatment allocation. We hypothesised that albiglutide would be non-inferior to placebo for the primary outcome of the first occurrence of cardiovascular death, myocardial infarction, or stroke, which was assessed in the intention-to-treat population. If non-inferiority was confirmed by an upper limit of the 95% CI for a hazard ratio of less than 1·30, closed testing for superiority was prespecified. This study is registered with ClinicalTrials.gov, number NCT02465515.
Findings:
Patients were screened between July 1, 2015, and Nov 24, 2016. 10 793 patients were screened and 9463 participants were enrolled and randomly assigned to groups: 4731 patients were assigned to receive albiglutide and 4732 patients to receive placebo. On Nov 8, 2017, it was determined that 611 primary endpoints and a median follow-up of at least 1·5 years had accrued, and participants returned for a final visit and discontinuation from study treatment; the last patient visit was on March 12, 2018. These 9463 patients, the intention-to-treat population, were evaluated for a median duration of 1·6 years and were assessed for the primary outcome. The primary composite outcome occurred in 338 (7%) of 4731 patients at an incidence rate of 4·6 events per 100 person-years in the albiglutide group and in 428 (9%) of 4732 patients at an incidence rate of 5·9 events per 100 person-years in the placebo group (hazard ratio 0·78, 95% CI 0·68–0·90), which indicated that albiglutide was superior to placebo (p<0·0001 for non-inferiority; p=0·0006 for superiority). The incidence of acute pancreatitis (ten patients in the albiglutide group and seven patients in the placebo group), pancreatic cancer (six patients in the albiglutide group and five patients in the placebo group), medullary thyroid carcinoma (zero patients in both groups), and other serious adverse events did not differ between the two groups. There were three (<1%) deaths in the placebo group that were assessed by investigators, who were masked to study drug assignment, to be treatment-related and two (<1%) deaths in the albiglutide group.
Interpretation:
In patients with type 2 diabetes and cardiovascular disease, albiglutide was superior to placebo with respect to major adverse cardiovascular events. Evidence-based glucagon-like peptide 1 receptor agonists should therefore be considered as part of a comprehensive strategy to reduce the risk of cardiovascular events in patients with type 2 diabetes.
Funding:
GlaxoSmithKline
Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo
- Author
- Abid Mohamed
- Accini Jose Luis
- Acuña Silvia
- Adawi Faiad
- Adenuga Babafemi
- Adina Pop-Moldovan
- Ageev Fail
- Aguilar David
- Aguilar-Orozco Raul
- Ahmad Zia
- Aimaretti Gianluca
- Aizenberg Diego
- Akahori Hiroshi
- Akhmedzhanov Nadir
- Akinboboye Olakunle
- Akright Laura
- Al Mahmeed Wael
- Alanko Juha
- Alappat Paul
- Alawad Mohamad
- Alfonso Teresa
- Alimard Ramin
- Allen Peter
- Alvarez Carlos
- Alvarisqueta Andres
- Alzohaili Opada
- Ambos Anu
- Amerena John
- Amolina Ildze
- Andjelic Jelic Marina
- Andrade Miguel
- Andrews Robert
- Antorrena Isabel
- Araneda Guillermo
- Arango Juan
- Ariani Mehrdad
- Arnold Susan
- Arora Chander
- Arteaga Juan Manuel
- Assaad Samir
- Atar Shaul
- Avram Rodica Ioana
- Azad Nasrin
- Azzam Samir
- Baccaro Claudia
- Bailey Gordon
- Bain Stephen
- Barbarash Olga
- Barbarich Vladimir
- Barkoudah Ebrahim
- Bartolacci Ines
- Bascil Tutuncu Neslihan
- Basu Ambar
- Bayram Edmundo
- Bednarski Janusz
- Belousov Yury
- Ben Abdallah Nejib
- Benjamin Sabrina
- Bentley-Lewis Rhonda
- Berns Svetlana
- Berra Cesare
- Bertrand Olivier
- Bhargava Rakesh
- Bhatnagar Deepak
- Bickerton Alex
- Bijata-Bronisz Renata
- Block Bradley
- Boberg Gunnar
- Bodi Vicent
- Bokarev Igor
- Bolshakova Olga
- Bordonava Anselmo
- Borzadek Eliza
- Botelho Roberto Vieira
- Botella Marta
- Botero Rodrigo
- Boyarkin Mikhail
- Bragança Nuno
- Brahimi Abdel
- Breisblatt Warren
- Bright Tamis
- Bronnum-Schou Jens
- Browne Duncan
- Bryniarski Leszek
- Bunster Lia
- Burgess Lesley
- Burton Jeffrey
- Bustamante Labarta Miguel
- Busz-Papiez Benita
- Byrd Leroy
- Caccavo Alberto
- Calderon Jorge
- Calella Pedro
- Campeau Jean
- Camsari Ahmet
- Cantero Maria
- Cardosa-Torres Francisco
- Cariou Bertrand
- Carranza-Madrigal Jaime
- Castillo Gilberto
- Castro Eholo
- Castro Maria Guadalupe
- Catargi Bogdan
- Cerqueira Maria Jose
- Chacra Antonio
- Charytan David
- Chaturvedi Nishi
- Chavez Carlos
- Chen Li
- Chiang Chern-En
- Chiou Choyen
- Chiu Yu-Wei
- Chochinov Ronald
- Chopda Manoj
- Chopra Vijay
- Christensen Tom
- Christofides Elena
- Chumakova Galina
- Chumburidze Vakhtang
- Chung Choon Hee
- Chung Wook Jin
- Ciardullo Anna Vittoria
- Cif Adriana
- Claggett Brian
- Cobos Leonardo
- Codutti Renzo
- Coetzee Kathleen
- Cohen Ohad
- Cohen Robert
- Commendatore Victor
- Consoli Agostino
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- Tsoukas George
- Tsuboko Yusuke
- Tsujimoto Mitsuru
- Tsujino Motoyoshi
- Tsuzuki Masahiro
- Tuan Weiming
- Tuomilehto Jaakko
- Turcios Erick
- Turgeman Yoav
- Turner Jeremy
- Twahirwa Marcel
- Tzekova Maria
- Ueng Kwo-Chang
- Ulla Maria
- Umpierrez Guillermo
- Urboniene Audrone
- Urdiales Pedro
- Uribe Marittza
- Vaid Brij
- Vallejos Julio
- Van Gaal William
- Van Zyl Louis
- Vance Carl
- Vasko Peter
- Vazir Ali
- Vazquez-Garcia Abraham
- Velasco-Sanchez Raul
- Venter Tjaart
- Vico Marisa
- Vida Manuel
- Vides Hella
- Vidrio Maricela
- Viktorova Inna
- Villalobos Renato
- Vinereanu Dragos
- Vinhas Margarida
- Vishnevsky Alexander
- Vorokhobina Natalia
- Wainstein Julio
- Waisman Florencia
- Wang Thomas
- Wang Tzung-Dau
- Warner Alberta
- Warnica James Wayne
- Watanabe Shuichi
- Watson Henry
- Weber Sandra
- Webster Brian
- Weindorff Kathleen
- Weinrauch Larry
- Welch Michelle
- Welker James
- Westerberg Bernhard
- White Anthony
- White Lindsey
- Whitelaw Donald
- Wilczewski Przemyslaw
- Wilding John
- Wiles Philip
- Williams Marcus
- Wu Wen-Chih
- Wu Yujun
- Wynne Alan
- Wyss Fernando
- Xu Biao
- Yakusevich Vladimir
- Yakushin Sergey
- Yamada Takahisa
- Yang Jiefu
- Yang Jinkui
- Yang Yanmin
- Yañez Mario
- Yeap Bu
- Yigit Zerrin
- Yocono Mark
- Yordanov Viktor
- Yuen Kevin
- Yupanqui Hernan
- Zadionchenko Vladimir
- Zalevskaya Alsu
- Zalevsky Grigory
- Zarankiene Rima
- Zateyshchikova Anna
- Zavala Alejandro
- Zhuravleva Larisa
- Zidi Borni
- Zorkun Cafer
- Zubiate Carlos
- Zuraw Bruce L.
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/01/2015
- Field of study
BACKGROUND:
Cardiovascular (CV) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Furthermore, patients with T2DM and acute coronary syndrome (ACS) have a particularly high risk of CV events. The glucagon-like peptide 1 receptor agonist, lixisenatide, improves glycemia, but its effects on CV events have not been thoroughly evaluated.
METHODS:
ELIXA (www.clinicaltrials.gov no. NCT01147250) is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study of lixisenatide in patients with T2DM and a recent ACS event. The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population at high CV risk. The primary efficacy end point is a composite of time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. Data are systematically collected for safety outcomes, including hypoglycemia, pancreatitis, and malignancy.
RESULTS:
Enrollment began in July 2010 and ended in August 2013; 6,068 patients from 49 countries were randomized. Of these, 69% are men and 75% are white; at baseline, the mean ± SD age was 60.3 ± 9.7 years, body mass index was 30.2 ± 5.7 kg/m(2), and duration of T2DM was 9.3 ± 8.2 years. The qualifying ACS was a myocardial infarction in 83% and unstable angina in 17%. The study will continue until the positive adjudication of the protocol-specified number of primary CV events.
CONCLUSION:
ELIXA will be the first trial to report the safety and efficacy of a glucagon-like peptide 1 receptor agonist in people with T2DM and high CV event risk
Angiotensin receptor neprilysin inhibition compared with enalapril on the risk of clinical progression in surviving patients with heart failure.
- Author
- Abhyankar A
- Accini J
- Adamson P
- Adelberger V
- Agarwal D K
- Ageev F
- Aggarwal R
- Aguilera M
- Ahlström P
- Ahmad W
- Ahmed F
- Akimov A
- Akinboboye O
- Aktoz M
- Akyea-Djamson A
- Al-Zoebi A
- Albisu J
- Albornoz F
- Alegre R
- Alexeeva-Kovalchuk A
- Almanzar A
- Almeida F
- Alvarez M
- Alvarisqueta A
- Amin A
- Amkieh A
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- Anand I
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- Andersen H
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- Andreka P
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- González-Bueno M
- Gordienko A
- Gosse P
- Gotchev D
- Goudev A
- Gould R
- Grazette L
- Greco O
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- Gudnason T
- Guerrero A
- Guetlin A
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- Hagege A A
- Hagenow A
- Hagerman I
- Hagège Albert A
- Haidar A
- Hajimirsadeghi A
- Hajko E
- Halpern S
- Hampf J
- Hansson A
- Hanustiakova A
- Hargrove J
- Harris J
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- Hergeldjieva V
- Hermes S
- Hernandes M
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- Himpel-Bönninghoff A
- Hiremath S
- Hoedemaker G
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- Horak A
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- Hotchkiss D
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- Jansen van Rensburg D
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- Jazwinska-Tarnawska E
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- Kabara A
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- Kamensky I
- Kaneshige A
- Kang D-H
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- Kania G
- Kaplan A
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- Kapp C
- Kardos A
- Karle C
- Karpov Y
- Kastanayan A
- Katova T
- Katz A
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- Kempe A
- Keren A
- Kerkar P
- Khan M
- Khromtsova O
- Kiatchoosakun S
- Kiilavuori K
- Kim B-J
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- Kim Kee-Sik
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- Kindermann I
- Kisliak O
- Klapholz M
- Klinke P
- Knapp M
- Kobalava Z
- Koehler I
- Kolaczyk P
- Kolar K
- Komajda M
- Konradi A
- Koolen J
- Koren M
- Kornder J
- Korolev M
- Kosmacheva E
- Kostenko V
- Kostis J
- Kotliar C
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- Kovács J
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- Kozan Ömer
- Koziolova N
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- Krosse B
- Krupicka J
- Kucharski W
- Kudat H
- Kuhrs M
- Kuimov A
- Kulibaba E
- Kumbla M
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- Køber L
- Kühne U
- Laane E
- Labeque J-N
- Labonte R
- Lanas F
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- Larrain G
- Lasala G
- Latiff G
- Laufer N
- Lauzon C
- Lazov P
- Leal S
- Lebedev P
- Lederballe O
- Lee C
- Lee K
- Lefkowitz Martin P
- Leicht M
- Lembo G
- Leon de la Fuente R
- Leon S
- Leonen M
- Lepage S
- Lerumo T
- Leslie S
- Lesnov V
- Levy T
- Lewis B
- Li L G
- Li S K
- Li W M
- Li X D
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- Liberato N L
- Liberman A
- Libis R
- Lieber I
- Liem L
- Lighezan D
- Lin L Y
- Lindovsky P
- Liniado G
- Liu M
- Liu S W
- Liu X H
- Livarek B
- Llamas E B
- Llamas Edmundo Bayram
- Llamas G
- Llanos J
- Lobo Marquez L
- Locnen S
- Logeart D
- Lombaard J
- Lombardi F
- Loos H
- Lopatin Y
- Lorenc Z
- Lu L
- Luis-Arias J
- Luiz Rech R
- Luksiene D
- Lupkovics G
- Luquez H
- Lvova T
- Lynch M
- László Z
- López E
- Löbe M
- Ma G S
- MacFadyen R
- Macias A
- Mackinnon I
- Magno J
- Magrini F
- Maher J
- Mahmood S
- Mainar L
- Maisel A
- Maislos F
- Majerčák I
- Mak S
- Makukhin V
- Maleckas T
- Malek F
- Malik J
- Malipeddi B
- Malkowski M
- Mallagray M
- Mallis G
- Mamas M
- Mandovec A
- Mandviwala M
- Manga P
- Mani C
- Manlutac B
- Mannarino E
- Manukov I
- Manzur F
- Marchese D
- Marchev S
- Marin I
- Mariscal C
- Markham D
- Marmol R
- Marmor A
- Marple R
- Martelet M
- Martin W
- Martinez F
- Martinez P
- Martingano R
- Martínez-Sellés M
- Marzal D
- María E
- Masterov I
- Mathan G
- Matoltsy A
- Maurer M
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- Mazúr J
- Maček V
- McKenzie W
- McMurray J
- Meaney A
- Megarry S
- Mehling H
- Mehrle A
- Mehta A
- Melchior K
- Mendez J
- Mendoza I
- Menzel F
- Mercado D
- Merkely B
- Mesquita E
- Mihalíková A
- Mihov L
- Milanova M
- Mileva-Manolova A
- Milhous J
- Militaru C
- Miliuniene R
- Miller A
- Miller R
- Miller V
- Mincheva-Kabakchieva V
- Minneci C
- Mirek-Bryniarska E
- Mishkin J
- Missault L
- Mitchell J
- Mkhwanazi M
- Modena M G
- Mody F
- Moe G
- Mohamed Z
- Mohan M
- Mohindra R
- Moiseeva Y
- Moises Azize G
- Montgomery B
- Moraes J
- More R
- Moriarty A
- Morozova T
- Mos L
- Mosterd A
- Motylev I
- Mpe M
- Mulleners T
- Murashkina S
- Murphy J
- Murray A
- Murray D
- Murthy D
- Murthy L
- Muthusamy R
- Muñoz B
- Muñoz R
- Müller G
- Münzel T
- Nagy A
- Naidoo D
- Naidu J
- Nair A
- Nanea T
- Napoli T
- Natour M
- Naudts I
- Naumann R
- Nazeyrollas P
- Nechita C
- Negrusz-Kawecka M
- Neto J
- Neuder Y
- Neuenschwander F
- Neutel J
- Neyses L
- Nguyen D
- Nieto R
- Nightingale A
- Nischik R
- Noori E
- Nosov V
- Nourredine M
- Nyolczas N
- Núñez J
- O'Brien T
- O'Toole L
- Oberoi M S
- Olbrich H-G
- Olexa P
- Oleynikov V
- Oliveira L
- Olsen S
- Ong H
- Ong T
- Ooi H
- Opasich C
- Orchard R
- Orihuela B
- Orihuela O
- Ovando A
- Pacherová J
- Packer M
- Padayachee T
- Padua F
- Pai P Y
- Pai V
- Paiva M
- Pajes G
- Palatkina T
- Palinský M
- Pandey A
- Pandey S
- Paniagua A
- Papp A
- Park D-G
- Parker J
- Parmon E
- Parody L
- Parrott C
- Parvanova Z
- Pascual D
- Paulino A
- Pavía A
- Pedersen O
- Pella D
- Pencheva G
- Perez Rey R
- Perticone F
- Petenian E
- Petersen J
- Petranov S
- Petrova I
- Petrulioniene Z
- Peuhkurinen K
- Peña G
- Piepiorka M
- Pijanowski Z
- Pileri P V
- Pimenov L
- Piyayotai D
- Pocock S
- Poddighe G
- Podzemska B
- Pohl W
- Poling T
- Poulard J-E
- Povolny P
- Prakash V
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- Privalov D
- Prodafikas J
- Prohaska M
- Pronk A
- Proskynitopoulus N
- Ptacin M
- Purvis J
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- Quinlan E
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- Rabelo A
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- Raev D
- Rafalsky V
- RaidRihani R
- Rajda M
- Rama B
- Ramanathan K
- Ramires F
- Ramshev K
- Rancane G
- Ranjith N
- Rassi S
- Rawitscher D
- Rebrov A
- Reddy N
- Refsgaard J
- Regner S
- Reimer D
- Reis G
- Reis H
- Remišová S
- Reyes A
- Reynales H
- Reznik I
- Richter M
- Rickers H
- Riha V
- Rizkala Adel R
- Robinson S
- Rodriguez A
- Rodriguez I
- Rodriguez M
- Rodriguez T
- Rodríguez D
- Rodríguez M
- Roeder S
- Rogelio G
- Rojas C
- Roldan Y
- Romano A
- Ronchi E
- Ronner E
- Rosado J
- Rosenthal A
- Rosenthal S
- Rosita R
- Rossi P
- Rouleau J
- Ruales A
- Ruda M
- Rummel R
- Rupka D
- Ryding A
- Saaiman J
- Saba P S
- Sabatier R
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- Sabl P
- Saifutdinov R
- Salamon C
- Salbach P
- Salcido E
- Salvatierra Ruiz A
- Samal A
- Sanchez A
- Sanguanwong S
- Sanmartín M
- Saporito W
- Sarjanovich R
- Sarma P
- Sarries A
- Sayganov S
- Schaefer S
- Schaum T
- Schenkenberger I
- Schiavi L
- Schichorová J
- Schindler A
- Schmalfuss C
- Schmidt A
- Schmidt E
- Schnabel A
- Schneider R
- Schneider W
- Schreckenberg A
- Schreibmüller F
- Schreiner M
- Schröder T
- Schumacher M
- Schwartz S
- Schäfer T
- Sciborski R
- Seals A
- Sebopa B
- Segner A
- Seibert H
- Selektor Y
- Senni M
- Sepulveda P
- Sessa H
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- Shamsudden K
- Shanes J
- Sharma K
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- Shochat M
- Shpagina L
- Shustov S
- Shutemova E
- Shvarts Y
- Siao G
- Siao K
- Sibulo A S
- Sibulo Antonio S
- Sicuro M
- Sigurdsson A
- Silva E
- Silva-Cardoso José
- Silvestre I
- Silvestri F
- Sime I
- Simoes M
- Sims J
- Singh S
- Sinha S
- Sirakova V
- Sitnikova M
- Sizova J
- Slaby J
- Slapikas R
- Smik R
- Smith D
- Smolders W
- Smolenskaya O
- Soares R
- Sobkowicz B
- Sobolewska J
- Sohn H-Y
- Sokolová B
- Solache G
- Soler J
- Solomon S
- Solovieva A
- Soo L
- Sooudi S
- Sotolongo R
- Sotomayor A
- Souza W
- Spagnuolo V
- Sprovieri M
- Squire I
- Srinivasa Rao M
- Srinivasa Rao N
- Staneva A
- Starling R
- Staroverov I
- Steffensen F
- Stockins B
- Strain D
- Struk R
- Stöhring R
- Suiter D
- Sun N L
- Sunderam S
- Svejda J
- Svistov A
- Swart H
- Swedberg K
- Szocs A
- Szpajer M
- Szántai G
- Taddei S
- Tangerding G
- Tarasov N
- Tarlovskaya E
- Taubert G
- Taurio J
- Tayob M
- Teerlink J
- Telekes P
- Tereschenko S
- Terhorst A
- Terrosu P
- Tesch C
- Tespili M
- Thadani U
- Thakkar B
- Thanvi S
- Theron H
- Thomas M
- Thongsri T
- Thorgeirsson G
- Thorsén C
- Thrasher J
- Tisheva-Gospodinova S
- Tjeerdsma G
- Todorov G
- Tokmakova M
- Tomcsányi J
- Tomescu M
- Torres F
- Torres P
- Toth D
- Toursarkissian N
- Tran N-T To
- Trelawny J
- Trevelyan J
- Trichon B
- Trivedi P
- Trofimov N
- Tsao H M
- Tse H F
- Tudoran M
- Tyler K
- Tyminski M
- Tzekova M
- Tzeng B H
- Uebel P
- Ulman J
- Ural D
- Uriarte A S
- Uriarte J
- Urina M
- Urquiaga J
- Uspensky Y
- Valchanova P
- Vally T
- van der Merwe N
- van Eck J
- van Zyl L
- Vandekerckhove H
- Vanhaecke J
- Varjú I
- Vasilieva E
- Velasco R
- Velasquez J
- Velasquez L
- Venter T
- Veress G
- Vergara G
- Vergoni W
- Vertes A
- Vesga B
- Vezikova N
- Vico M
- Vicuna R
- Vida M
- Vijan V
- Vilas Boas F
- Vilela G
- Vincent M
- Vinereanu D
- Vishnevsky A
- Viňanská D
- Volkov D
- Volterrani M
- Vomacka Z
- Vranian R
- Vélez S
- Wallach S
- Ward N
- Watkin R
- Weglarz P
- Weinstein D
- Wellmann H
- Wells T
- Weyland K
- Weytjens C
- Wickemeyer W
- Wight J
- Wilke A
- Willems F
- Williams C
- Witherow F
- Wojciechowska C
- Woldman S
- Wollaert B
- Wong R
- Wronska D
- Wu L
- Wyss F
- Xu G
- Yakhontov D
- Yakovlev A
- Yan B
- Yang K
- Yannick N
- Yao L
- Yavdosyuk A
- Yavuzgil O
- Yenigun M
- Yeo D
- Yigit Z
- Yilmaz A
- Yilmaz M B
- Yip G
- Yokusoglu M
- Yoo B-S
- Yotov Y
- Yousef Z
- Yovaniniz P
- Yuan Z Y
- Yugandhar B
- Zaidman C
- Zannad F
- Zateyshchikova A
- Zebrack J
- Zeh W
- Zemek S
- Zemmrich C
- Zethson-Halldén M
- Zhang J
- Zhao R P
- Zharkov O
- Zhelev V
- Zhilyaev E
- Zilahi Z
- Zile M
- Zo J-H
- Zotov D
- Zotz R
- Zrazhevsky K
- Zuraw B
- Zámolyi K
- Édes I
- Šuch S
- Publication venue
- 'Ovid Technologies (Wolters Kluwer Health)'
- Publication date
- 06/01/2015
- Field of study