5 research outputs found
Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTICâHF: baseline characteristics and comparison with contemporary clinical trials
- Author
- Aaronson Keith
- Abadier Rafik
- Abbasi Siddique A.
- Abdullah Shuaib
- Abelson Mark
- Abhayaratna Walter
- Ablasser Klemens
- Aboyans Victor
- AboâAuda Wael
- Abuannadi Mohammad
- Adams Kirkwood
- Adams Kirkwood F.
- Adhya Shaumik
- Adler Alexander
- Aggarwala Gaurav
- Agostoni Piergiuseppe
- Ahmad Saad
- Aiub Jorge Roberto
- Al Mohammad Abdallah
- Alharethi Rami
- Alieksieieva Liudmyla
- Almeida Filipa
- Almousalli Omar
- Amano Tetsuya
- Amanullah Aman
- Ambardekar Amrut
- Amerena John
- Anand Inder
- Anderson William
- Ando Kenji
- Andreka Peter
- Antalik Lubomir
- Aradi Daniel
- Araiza Raul Reyes
- Arbolishvili Georgy
- Ariani Mehrdad
- AriasâMendoza Alexandra
- Arora Raveen
- Arroyo Julian Alonso Coronel
- Artis Andre
- Asakura Masanori
- Asano Hiroshi
- Ashcom Thomas
- Aslam Shamaila
- Asubiaro Joshua
- Atherton John
- Avaca Horacio Alberto
- Babapulle Mohan
- Bacal Fernando
- Badak Ozer
- Badariene Jolita
- Badat Aysha
- Baker Mathue
- Balsam Pawel
- Banerji Sourin
- Barbarash Olga
- Barbetseas Ioannis
- Barr Craig
- Barros e Silva Pedro Gabriel Melo
- Barua Rajat
- Bauerlein Eugene Joseph
- Baweja Paramdeep
- Bednarkiewicz Zbigniew
- Beelen Driek
- Begg Alistair
- Bekar Lutfu
- Belenkiy Dmitriy
- Belohlavek Jan
- Beltrame John
- Berdague Philippe
- Berglund Stefan
- Berk Martin
- Berkowski Piotr
- Berra Fernando Colombo
- Bertolet Barry
- Besada Diego Alejandro
- Beug Daniel
- Bezzegh Katalin
- Bhagwat Ravi
- Bhargava Rakesh
- BieringâSĂžrensen Tor
- Bilato Claudio
- Blicharski Tomasz
- Boccalandro Fernando
- Boehm Michael
- Boehmer John
- Bogaev Roberta
- Bolshakova Olga
- Boman Kurt
- Bonderman Diana
- Bonet Luis Almenar
- Bonfanti Alberto Cadena
- Bordonava Anselmo Paulino
- Bostick Brian
- Boswijk Dirk
- Bourgeois Ronald
- Bourhaial Hakima
- Bouza Manuel
- Braga Joao Carlos
- Brasca Daniela Garcia
- Brinkley Douglas
- Brito Dulce
- Brunetti Natale Daniele
- Bruno Marco Raul Litvak
- Bu Peili
- Burgess Lesley
- Busak Ladislav
- Buynak Robert
- Buysschaert Ian
- Bykov Alexander
- Böhm Michael
- Caccavo Alberto
- Canesin Manoel
- Cardona Jose
- Cardoso Juliano
- Carluccio Erberto
- Carrasco Jose Alfredo Pagola
- Carson Peter
- Castillo Armando Garcia
- Cavallini Claudio
- Cavusoglu Yuksel
- Cech Vladimir
- Celik Ahmet
- Celutkiene Jelena
- Cepelak Michal
- Cerci Rodrigo Julio
- Chandra Lokesh
- Chandrasekaran Badrinathan
- Chang David
- Chaves Renato
- Chehayeb Raja
- Cheirif Jorge
- Chen Guoqin
- Chen Jiyan
- Chmielak Zbigniew
- Chouchane Iman
- Chung Eugene
- Cid Maria Cristina Schnettler
- Civitello Andrew
- Clark Andrew
- Cleland John G.F.
- Clifford Piers
- Coletti Andrew
- Collins John
- Colque Roberto
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- Contreras Johanna
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- Corbalan Ramon
- Correa Luis Eduardo Echeverria
- Corredor Miguel Alfredo Moncada
- Cosansu Kahraman
- CostaâVitali Atilio
- Cotarlan Vladimir
- Coufal Zdenek
- Cox Jeremy
- CrespoâLeiro Maria G.
- Cruz Kimberly
- Cubero Javier Segovia
- Cui Hanbin
- Cymerman Krzysztof
- Dahlström Ulf
- Damy Thibaud
- Dauber Ira
- De Geeter Guillaume
- De los Rios Ibarra Manuel Odin
- De Pasquale Carmine
- Decoulx Eric
- Demir Mesut
- Desai Pratik
- Diaz Rafael
- Diaz Rafael
- Diaz Victor Alfonso Jimenez
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- Diez Mirta
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- Doblas Juan Jose Gomez
- Doi Masayuki
- Domae Hiroshi
- Donal Erwan
- Dong Yugang
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- Dorobantu Maria
- Dovgolis Svetlana
- Doyle Timothy
- Drexel Heinz
- Dronov Dmitry
- Droogne Walter
- Drozdz Jaroslaw
- Duarte Tatiana
- Duengen HansâDirk
- Dujardin Karl
- Dupont Matthias
- Duran Ruben Omar Garcia
- Duzenli Mehmet
- Dzupina Andrej
- Eaton Charles
- Ebato Mio
- Ebelt Henning
- Eberly Arthur
- Ebner Christian
- Echeverria Correa Luis E.
- Elliott James
- Elmahi Einas
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- Fang James C.
- Farris Neil
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- Fu Xin
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- Vandekerckhove Hans
- Vanhecke Thomas
- Varin Claire
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- Vasilev Ivaylo
- Vasilyeva Larysa
- Vaz Garth
- Vazquez Eduardo Salcido
- Vega Mario
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- Venegas Manuel Eduardo Rodriguez
- Videbaek Lars
- Vidotti Maria Helena
- Vijay Nampalli
- Vilamajo Oscar Alberto Gomez
- Vilchez Francisco Gonzalez
- Villani Giovanni Quinto
- Villoch Mario
- Villota Julio Eduardo Nuñez
- Vinanska Daniela
- Vincenzi Antonella
- Vinereanu Dragos
- Vinereanu Dragos
- Vishnevsky Alexander
- Voevoda Mikhail
- Vogel Daniel
- Voicu OlgaâCristina
- Volterrani Maurizio
- Voors Adriaan
- Voors Adriaan A.
- Voronkov Leonid
- Vraa Soren
- Wada Atsuyuki
- Wahid Faisal
- Wal Ruud
- Wang Yi
- Wang Zhifang
- Watanabe Naoki
- Wei Yu
- Weir Robin
- Westenfeld Ralf
- Wheeler Matthew
- Whellan David
- Wiggers Henrik
- Wilkett Matt
- Willems Frank
- Williams Celeste
- Wlodarczyk Aleksander
- Wodlin Peter
- Wong Kenneth
- WozakowskaâKaplon Beata
- Wu Weiheng
- Yagensky Andriy
- Yamamoto Mitsutaka
- Yan Jing
- Yang Ping
- Yang Xuming
- Yang Zhenyu
- Yeoman Gary
- Yigit Zerrin
- Yilmaz Mehmet B.
- Yoshida Takeshi
- Yoshikawa Masaki
- Yousuf Kabir
- Yuan Zuyi
- Yuge Masaru
- Zabowka Maciej
- Zaca Valerio
- Zaidman Cesar
- Zanetti Fernando Tomas Lanas
- Zannad Faiez
- Zapata Gerardo
- Zdrenghea Dumitru
- Zeman Kamil
- Zeymer Uwe
- Zhang Jinguo
- Zhang Lily
- Zhang Shouyan
- Zhang Xuelian
- Zhang Yuhui
- Zhang Yuqing
- Zheng Yang
- Zheng Zhe
- Zhou Changyong
- Zieroth Shelley
- Zilahi Zsolt
- Zimmet Hendrik
- Zolty Ronald
- Zrazhevskiy Konstantin
- Zwaan Coenraad
- Publication venue
- 'Wiley'
- Publication date
- 01/11/2020
- Field of study
Aims:
The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTICâHF) trial. Here we describe the baseline characteristics of participants in GALACTICâHF and how these compare with other contemporary trials.
Methods and Results:
Adults with established HFrEF, New York Heart Association functional class (NYHA)ââ„âII, EF â€35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokineticâguided dosing: 25, 37.5 or 50âmg bid). 8256 patients [male (79%), nonâwhite (22%), mean age 65âyears] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NTâproBNP 1971âpg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTICâHF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressureâ<â100âmmHg (n = 1127), estimated glomerular filtration rate <â30âmL/min/1.73 m2 (n = 528), and treated with sacubitrilâvalsartan at baseline (n = 1594).
Conclusions:
GALACTICâHF enrolled a wellâtreated, highârisk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation
Emergence and spread of a new community-genotype methicillin-resistant Staphylococcus aureus clone in Colombia
- Author
- A Loytynoja
- A Stamatakis
- AJ Page
- BA Diep
- BC Portillo
- Betsy Esperanza Castro
- C Milheirico
- CA Alvarez
- CA Alvarez
- CA Arias
- Catalina Tovar
- DJ Diekema
- EA Rodriguez
- FC Tenover
- G Talavera
- GR Nimmo
- GW Coombs
- Hernando PinzĂłn
- J Reyes
- JA Escobar
- JA Otter
- Jaime Moreno-Castañeda
- Javier Escobar-Perez
- JN Jimenez
- Juan Rebollo
- M David
- M Deghorain
- M Otto
- MA Machuca
- Maria Victoria Moncada
- MC Enright
- MI Alvarez-Olmos
- Natasha Vanegas
- NF Alikhan
- Niradiz Reyes
- PJ Planet
- R Blanco
- RA Marquez-Ortiz
- Ricaurte Alejandro Marquez-Ortiz
- RK Aziz
- S Jarraud
- SH Park
- T Seemann
- Y Chen
- Zayda Lorena Corredor
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- Field of study
Evolocumab and clinical outcomes in patients with cardiovascular disease
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- Yao Z
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- Yataco A
- Yeh H
- Yena L
- Yeoman G
- Yigit Z
- Yilmaz Mb
- Yokoya K
- Yoshimichi G
- Yotov Y
- Youngman D
- Younis L
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- Zabowka M
- Zahn L
- Zamorano Gomez Jl
- Zarich S
- Zateyshchikov D
- Zdrenghea D
- Zechowicz T
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- Zemanek J
- Zeng X
- Zhang L
- Zhang X
- Zhao S
- Zheng Y
- Zheng Z
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- Zhurba S
- Zidkova E
- Zieba B
- Ziegler O
- Zilahi Z
- Zrazhevskiy K
- Ăstergren J
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
BACKGROUND Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol levels by approximately 60%. Whether it prevents cardiovascular events is uncertain. METHODS We conducted a randomized, double-blind, placebo-controlled trial involving 27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or higher who were receiving statin therapy. Patients were randomly assigned to receive evolocumab (either 140 mg every 2 weeks or 420 mg monthly) or matching placebo as subcutaneous injections. The primary efficacy end point was the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary efficacy end point was the composite of cardiovascular death, myocardial infarction, or stroke. The median duration of follow-up was 2.2 years. RESULTS At 48 weeks, the least-squares mean percentage reduction in LDL cholesterol levels with evolocumab, as compared with placebo, was 59%, from a median baseline value of 92 mg per deciliter (2.4 mmol per liter) to 30 mg per deciliter (0.78 mmol per liter) (P<0.001). Relative to placebo, evolocumab treatment significantly reduced the risk of the primary end point (1344 patients [9.8%] vs. 1563 patients [11.3%]; hazard ratio, 0.85; 95% confidence interval [CI], 0.79 to 0.92; P<0.001) and the key secondary end point (816 [5.9%] vs. 1013 [7.4%]; hazard ratio, 0.80; 95% CI, 0.73 to 0.88; P<0.001). The results were consistent across key subgroups, including the subgroup of patients in the lowest quartile for baseline LDL cholesterol levels (median, 74 mg per deciliter [1.9 mmol per liter]). There was no significant difference between the study groups with regard to adverse events (including new-onset diabetes and neurocognitive events), with the exception of injection-site reactions, which were more common with evolocumab (2.1% vs. 1.6%). CONCLUSIONS In our trial, inhibition of PCSK9 with evolocumab on a background of statin therapy lowered LDL cholesterol levels to a median of 30 mg per deciliter (0.78 mmol per liter) and reduced the risk of cardiovascular events. These findings show that patients with atherosclerotic cardiovascular disease benefit from lowering of LDL cholesterol levels below current targets
Cardiac myosin activation with omecamtiv mecarbil in systolic heart failure
- Author
- A Alan Chu
- A Shekhar Pandey
- Aaron Sverdlov
- Abbasi S. A.
- Abdallah Al Mohammad
- Abdul Al-Hesayen
- Adams K. F.
- Adnan Malik
- Adriaan Voors
- Adrian Shandling
- Agata Marina Floresta
- Ahmet Celik
- Ailiman Mahemuti
- Aize van der Sluis
- Akihiro Koike
- Akihiro Nakamura
- Akihiro Terasawa
- Alan Gass
- Alan Kono
- Alan Meholick
- Alberto Caccavo
- Alberto Cadena Bonfanti
- Alberto Esteban Bazzoni Ruiz
- Alberto Fernandez
- Alberto Margonato
- Aldo Prado
- Alejandro Recio Mayoral
- Aleksander Wlodarczyk
- Aleksandra Manolova
- Alessandro Fucili
- Alex Mauricio Villablanca Sepulveda
- Alexander Adler
- Alexander Bykov
- Alexander Parkhomenko
- Alexander Sherenkov
- Alexander Timofeev
- Alexander Vishnevsky
- Alexandr Schee
- Alexandra Arias Mendoza
- Alexandre Tognon
- Alexey Repin
- Alicia Contreras Rodriguez
- Alina Giuca
- Alisdair Ryding
- Alistair Begg
- Almir Ferraz
- Alonzo Jones
- Amal Muthumala
- Aman Amanullah
- Amarinder Bindra
- Amin Karim
- Amin Yehya
- Amit Shah
- Amrut Ambardekar
- Ana Maria De Leon Flores
- Anand I.
- Anays Santana Izquierdo
- Andras Papp
- Andre Artis
- Andrea Mortara
- Andrej Dzupina
- Andres Iñiguez Romo
- Andrew Boyle
- Andrew Civitello
- Andrew Clark
- Andrew Coletti
- Andrew Hamilton
- Andrew Ludman
- Andrew Sauer
- Andrew Sindone
- Andriy Yagensky
- Andrzej Rynkiewicz
- Aniko Papp
- Anil Shah
- Anna Paszczuk
- Anna Stankiewicz
- Anselmo Paulino Bordonava
- Anthony Gemignani
- Anthony King
- Antonella Vincenzi
- Antonio Juan Castro Fernandez
- Antonio Lara Padron
- Apostolos Karavidas
- Arias-Mendoza A.
- Arif Elvan
- Arman Postadzhiyan
- Armando Garcia Castillo
- Arnold Seto
- Arthur Eberly 3rd
- Arun Krishnamoorthy
- Arunima Misra
- Assad Mouhaffel
- Assen Goudev
- Athanasios Manolis
- Atilio Costa-Vitali
- Atsushi Hirayama
- Atsutoshi Takagi
- Atsuyuki Wada
- Attila Mohacsi
- Aurelio Ortiz
- Aysha Badat
- Badrinathan Chandrasekaran
- Balgit Chhokar
- Barbara Pisani
- Barna Szabo
- Barry Bertolet
- Barry H Greenberg
- Barry Uretsky
- Batlagundu Lakshminarayanan
- Beat Knusel
- Beata Wozakowska-Kaplon
- Beatriz Diaz Molina
- Bela Herczeg
- Bela Merkely
- Benjamin Trichon
- Bhola Rama
- Biering-Sorensen T.
- Binoy Skaria
- Binu Jacob
- Bohm M.
- Bojidar Dimov
- Bonderman D.
- Boris Goloshchekin
- Bozena Sobkowicz
- Brack Hattler
- Bradley Weinberg
- Brenda Lemus
- Brenda Peart
- Brian Bostick
- Brian Claggett
- Brian Gordon
- Brian Houston
- Bruce Jackson
- Bruce Sussex
- Bruno Paolino
- Candida Fonseca
- Carl-Johan Lindholm
- Carlo Gabriele Tocchetti
- Carlos Alberto Luengas
- Carlos Arrieta Garcia
- Carlos Conejeros Kindel
- Carlos Poy
- Carmine De Pasquale
- Carol Davila
- Carsten Schmalfuss
- Celeste Williams
- Cesar Zaidman
- Cevat Kirma
- CezarEugen Macarie
- Changyong Zhou
- Charles Eaton
- Charles Koo
- Charles Lovell
- Charles Treasure
- Chavdar Velikov
- Chester Hedgepeth
- Chiara Melloni
- Chim Lang
- Christian Constance
- Christian Ebner
- Christian Mueller
- Christian Paolo Pincetti Jofre
- Christoph Kadel
- Christopher E Kurtz
- Christopher Judkins
- Christopher Lang
- Christopher Pickett
- Christopher Rowan
- Christopher Vaccari
- Christos Kassiotis
- Ciro Indolfi
- Claire Varin
- Clara Ines Saldarriaga Giraldo
- Claudia Raineri
- Claudio Bilato
- Claudio Cavallini
- Claudio Rodolfo Majul
- Cleland J. G. F.
- Coenraad van der Zwaan
- Constantin Militaru
- Corbalan R.
- Craig Barr
- Craig Hametz
- Crespo-Leiro M. G.
- Cristian Gheorghe Podoleanu
- Cristiano Pederneiras Jaeger
- Cristina Danila
- Csaba Salamon
- Dahlstrom U.
- Dalia Jarasuniene
- Dallas Price
- Dalton McLean
- Daniel Aradi
- Daniel Beug
- Daniel Fisher
- Daniel Gaudet
- Daniel Lenihan
- Daniel Lighezan
- Daniel Pauly
- Daniel Savard
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- Dariusz Korczyk
- David Chang
- David F Kong
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- David Murray
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- David Whellan
- Debashis Roy
- Deddo Moertl
- Denis-Carl Phaneuf
- Dennis Rupka
- Deovrat Singh
- Devesh Patel
- Diana Bonderman
- Diaz R.
- Diego Alejandro Besada
- Diego Felipe Martinez
- Dimitrios Tziakas
- Dinesh Gupta
- Dipti Itchhaporia
- Dirk Boswijk
- Dirk Lok
- Dirk Schellings
- Dmitriy Belenkiy
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- Dmytro Reshotko
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- Domingo Andres Pascual Figal
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- Donna Mancini
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- Echeverria L. E.
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- Ersel Onrat
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- Erwan Donal
- Eugene Chung
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- Euler Roberto Fernandes Manenti
- Eva Goncalvesova
- Eva Peterfai
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- Filipa Almeida
- Filippatos G.
- Flavio Brito
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- Florence Rothenberg
- Florin Mitu
- Fonseca C.
- Fragkiskos Parthenakis
- Francesco Franchi
- Francisco Gonzalez Vilchez
- Francois Roubille
- Frank McGrew
- Frank Smart
- Frank Willems
- Franklin Handel
- François Picard
- Freny Mody
- Friedrich Fruhwald
- Fumi Yamamoto
- G Michael Felker
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- Giovanni Geronilla
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- Giuseppe Ambrosio
- Giuseppe Musumeci
- Glenn Hamroff
- Goncalvesova E.
- Gordon Moe
- Gordon Reeves
- Goudev A. R.
- Gregorio Sanchez Vallejo
- Gregory Sampognaro
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- Guillaume De Geeter
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- Guoqin Chen
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- Gurusher Panjrath
- Gustavo Francisco Mendez Machado
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- Hakima Bourhaial
- Hal Skopicki
- Hamish Hart
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- Hans Vandekerckhove
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- He Huang
- Heinz Drexel
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- Hiroshi Takaishi
- Hiroyuki Kawata
- Hisao Hara
- Hisashi Kai
- Holger Killat
- Honarpour N.
- Horacio Alberto Avaca
- Howlett J. G.
- Hugo Luquez
- Huifang Tang
- Ian Buysschaert
- Ibrahim Haldun Muderrisoglu
- Ichiro Michishita
- Ignacio Mackinnon
- Igor Kraiz
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- Ivan Goncharov
- Ivan Majercak
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- J Dedrick Jordan
- J Russell Strader
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- Jacob Van Eck
- Jadwiga Nessler
- Jagadeesh Ganji
- James Elliott
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- Jaroslaw Drozdz
- Jaroslaw Trebacz
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- Jasper Trevelyan
- Javed Butler
- Javier Segovia Cubero
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- Jean-Marie Lefebvre
- Jean-Michel Tartiere
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- Maurizio Volterrani
- Mayanna Lund
- McMurray J. J. V.
- Mehmet Birhan Yilmaz
- Mehmet Birhan Yilmaz
- Mehmet Duzenli
- Mehrdad Ariani
- Melchor Alpizar Salazar
- Melvin Martinez-Castrillon
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- Michael Felker G.
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- Mitsuru Tsujimoto
- Mitsutaka Yamamoto
- Mohammad Abuannadi
- Mohan Babapulle
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- Monica Lopez Pareja
- Mori Krantz
- Mukesh Sharma
- Munir Janmohamed
- Muriel Salvat
- Mustafa Tuncer
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- Mykola Rishko
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- Voors A. A.
- Vyacheslav Mareev
- Vyacheslav Ryabov
- W Schuyler Jones
- Wael AboAuda
- Wakaya Fujiwara
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- Weiheng Wu
- Weimar Kunz Barroso de Souza
- Weimin Li
- Wentang Niu
- Wilder Castaño Osorio
- William Anderson
- William Herzog
- William Nelson
- William Randall
- Wissam Khalife
- Xin Fu
- Xuelian Zhang
- Xuming Yang
- Yafei Mi
- Yajun Han
- Yang Zheng
- Yanling Qu
- Yann Rosamel
- Yasuchika Takeishi
- Yasuhiro Maejima
- Yasuki Kihara
- Yasunori Ueda
- Yasuo Okumura
- Yasushi Sakata
- Yevgeniya Svishchenko
- Yi Wang
- Yilmaz M. B.
- Yinjun Li
- Yorihiko Higashino
- Yoshihiko Saito
- Yoshiki Hata
- Yoshinori Yasaka
- Yoshitoshi Urabe
- Yu Wei
- Yuemin Sun
- Yugang Dong
- Yuhui Zhang
- Yuji Nakazato
- Yukihiko Momiyama
- Yukihito Sato
- Yukiko Morita
- Yuksel Cavusoglu
- Yuqing Zhang
- Yurii Lymar
- Yuriy Mostovoy
- Yury Lukyanov
- Yury Shvarts
- Yutaka Akatsuka
- Yves Pesant
- Zannad F.
- Zbigniew Bednarkiewicz
- Zbigniew Chmielak
- Zbigniew Gola
- Zbigniew Kalarus
- Zbigniew Pijanowski
- Zbynek Pozdisek
- Zdenek Coufal
- Zdenek Klimsa
- Zdenek Monhart
- Zehra Lale Koldas
- Zerrin Yigit
- Zhanna Kobalava
- Zhanquan Li
- Zhaoping Li
- Zhe Zheng
- Zhenyu Yang
- Zhifang Wang
- Zoltan Laszlo
- Zsolt Zilahi
- Zuyi Yuan
- Zuzana Motovska
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2021
- Field of study
BACKGROUND The selective cardiac myosin activator omecamtiv mecarbil has been shown to improve cardiac function in patients with heart failure with a reduced ejection fraction. Its effect on cardiovascular outcomes is unknown. METHODS We randomly assigned 8256 patients (inpatients and outpatients) with symptomatic chronic heart failure and an ejection fraction of 35% or less to receive omecamtiv mecarbil (using pharmacokinetic-guided doses of 25 mg, 37.5 mg, or 50 mg twice daily) or placebo, in addition to standard heart-failure therapy. The primary outcome was a composite of a first heart-failure event (hospitalization or urgent visit for heart failure) or death from cardiovascular causes. RESULTS During a median of 21.8 months, a primary-outcome event occurred in 1523 of 4120 patients (37.0%) in the omecamtiv mecarbil group and in 1607 of 4112 patients (39.1%) in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.86 to 0.99; P = 0.03). A total of 808 patients (19.6%) and 798 patients (19.4%), respectively, died from cardiovascular causes (hazard ratio, 1.01; 95% CI, 0.92 to 1.11). There was no significant difference between groups in the change from baseline on the Kansas City Cardiomyopathy Questionnaire total symptom score. At week 24, the change from baseline for the median N-terminal pro-B-type natriuretic peptide level was 10% lower in the omecamtiv mecarbil group than in the placebo group; the median cardiac troponin I level was 4 ng per liter higher. The frequency of cardiac ischemic and ventricular arrhythmia events was similar in the two groups. CONCLUSIONS Among patients with heart failure and a reduced ejection, those who received omecamtiv mecarbil had a lower incidence of a composite of a heart-failure event or death from cardiovascular causes than those who received placebo. (Funded by Amgen and others; GALACTIC-HF ClinicalTrials.gov number, NCT02929329; EudraCT number, 2016 -002299-28.)
Edoxaban versus warfarin in patients with atrial fibrillation
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- Zamlynskyy M
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- Zateyshchikova A
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- Zubeeva G
- Zyatenkova E
- Ă kerberg A
- Ăstberg S
- Ćpinar J
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2013
- Field of study
Contains fulltext :
125374.pdf (publisher's version ) (Open Access)BACKGROUND: Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects. The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known. METHODS: We conducted a randomized, double-blind, double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation (median follow-up, 2.8 years). The primary efficacy end point was stroke or systemic embolism. Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period. The principal safety end point was major bleeding. RESULTS: The annualized rate of the primary end point during treatment was 1.50% with warfarin (median time in the therapeutic range, 68.4%), as compared with 1.18% with high-dose edoxaban (hazard ratio, 0.79; 97.5% confidence interval [CI], 0.63 to 0.99; P<0.001 for noninferiority) and 1.61% with low-dose edoxaban (hazard ratio, 1.07; 97.5% CI, 0.87 to 1.31; P=0.005 for noninferiority). In the intention-to-treat analysis, there was a trend favoring high-dose edoxaban versus warfarin (hazard ratio, 0.87; 97.5% CI, 0.73 to 1.04; P=0.08) and an unfavorable trend with low-dose edoxaban versus warfarin (hazard ratio, 1.13; 97.5% CI, 0.96 to 1.34; P=0.10). The annualized rate of major bleeding was 3.43% with warfarin versus 2.75% with high-dose edoxaban (hazard ratio, 0.80; 95% CI, 0.71 to 0.91; P<0.001) and 1.61% with low-dose edoxaban (hazard ratio, 0.47; 95% CI, 0.41 to 0.55; P<0.001). The corresponding annualized rates of death from cardiovascular causes were 3.17% versus 2.74% (hazard ratio, 0.86; 95% CI, 0.77 to 0.97; P=0.01), and 2.71% (hazard ratio, 0.85; 95% CI, 0.76 to 0.96; P=0.008), and the corresponding rates of the key secondary end point (a composite of stroke, systemic embolism, or death from cardiovascular causes) were 4.43% versus 3.85% (hazard ratio, 0.87; 95% CI, 0.78 to 0.96; P=0.005), and 4.23% (hazard ratio, 0.95; 95% CI, 0.86 to 1.05; P=0.32). CONCLUSIONS: Both once-daily regimens of edoxaban were noninferior to warfarin with respect to the prevention of stroke or systemic embolism and were associated with significantly lower rates of bleeding and death from cardiovascular causes. (Funded by Daiichi Sankyo Pharma Development; ENGAGE AF-TIMI 48 ClinicalTrials.gov number, NCT00781391.)