11 research outputs found
Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes.
- Author
- 6hman P
- Abbott L
- Acheatel R
- Adamkova V
- Adawi F
- Adler A
- Aguliera D
- Aizenberg D
- Akerblom A
- Akinboboye O
- Akpunonu B
- Al-Khatib S
- Alcocer Gamba MA
- Alexander K
- Alfonso L
- Almeida CA
- Alvarez L
- Alvarisqueta A
- Ambrish M
- Ambrosio G
- Amerena J
- Anastasi L
- Anderson H
- Andersone I
- Anekwe A
- Ang E
- Angelescu LM
- Angustias Quesada M
- Anoop M
- Aomar I
- Appel KF
- Arauz-Pacheco C
- Argoud G
- Arguelles I
- Armaganijan L
- Aron G
- Aronoff S
- Asamoah-Owusu NJ
- Athwal R
- Augusteniene A
- Azad N
- Azizad M
- Badat A
- Bain C
- Bajaj M
- Baldauf C
- Bandeira e Farias F
- Barbarash O
- Barber T
- Barkai L
- Baron M
- Barrientos Perez M
- Barros e Silva P
- Barros P
- Barsiene L
- Bartkowiak A Jr
- Bartolacci I
- Bashkin A
- Batit M
- Batra P
- Becker B
- Bell A
- Bellary S
- Bellido D
- Benjasuratwong Y
- Benson M
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- Berenfus V
- Bergenstal R
- Berk M
- Bernacki G
- Bernandez S
- Bestermann W Jr
- Bethel MA
- Bezzegh K
- Bhargava A
- Bhatt B
- Bickel L
- Bieler T
- Biscoveanu M
- Bland V
- Blignaut S
- Bloomfield G
- Blumberg E
- Bobeva R
- Boenninghoff AH
- Boggs B
- Bondar I
- Borges J
- Botella Serrano M
- Botero Lopes R
- Botsyurko V
- Bourgeois R
- Braun M
- Bressler P
- Brychta T
- Buganova I
- Bundy C
- Busch K
- Busch R
- Buse JB
- Butnaru A
- Bybee K
- Cabrera Jardines R
- Calella P
- Calvert J
- Campbell C
- Canadas R
- Caponis J
- Carim-Ganey N
- Carr K
- Caterson I
- Catindig EA
- Cavale A
- Cavarape A
- Chacra A
- Chadha C
- Chan JC
- Chane M
- Chang A
- Chang A
- Chang M
- Chatterjee S
- Chaudhri O
- Cheah WK
- Chen JF
- Cheung BM
- Cheung S
- Cheung-Wong MM
- Choi J
- Choi KM
- Choi SH
- Chu DW
- Cignarelli M
- Clark J
- Clausen E
- Claxton E Jr
- Coetzee K
- Coetzer T
- Cohen J
- Coleman R
- Collier T
- Colman P
- Colquhoun D
- Constantinescu S
- Contreras Gilbert J
- Conway R
- Corder C
- Coronel Arroyo J
- Costa e Forti A
- Cox K
- Crawford V
- Crimmins D
- Cruciani A
- Cuddihy R
- Culman MI
- Cure Cure CA
- Custodio M
- Cutfield R
- Cylkowska B
- Czegany Z
- D\u2019Agostino R
- Damyanova V
- Dang C
- Danyte E
- Darbyshire J
- Dauber I
- Dauksiene D
- Davies M
- Davis C
- Dawson A
- Dayamani P
- De La Fuente RL
- De La Garza Hernandez NE
- de Salvo M
- De Souza Brito F
- de Valk HW
- Dean J
- del Prato S
- Delcourt C
- Deng H
- Denham D
- Denopol M
- Detweiler R
- DeVore A
- Dezso E
- Diamant M
- Diaz R
- DiGiovanna M
- Dimitropoulos I
- Distiller L
- Dixon P
- Dogadin S
- Dombrowski K
- Dong Y
- Donovan D
- Dreval A
- Dreval AV
- Drexel H
- Du Y
- Dube F
- Duengen HD
- Dugano-Daphnis P
- Dulin M
- Dumas R
- Dungan K
- Dunn P
- Durborow L
- Dushkin H
- Dziemidok P
- Dzupina A
- Eapen Z
- Earl J
- Eaton C
- Ebenbichler C
- Ebo G
- Ebrahim I
- Eckel R
- Eglite R
- Eisen H
- El Shahawy M
- Elias N
- Eliaschewitz F
- Elkins M
- Elliott T
- Ellis G
- Erickson B
- Estevez R
- EXSCEL Study Group : Califf RM
- Farago K
- Farnsworth K
- Fasching P
- Fedacko J
- Feinglos M
- Felicio J
- Feng Y
- Ferch A
- Fern\ue1ndez Balsells M
- Ferrier N
- Field B
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- Force R
- Forker A
- Forst T
- Fox D
- Francesconi C
- Frechtel G
- Fulat M
- Fulop T
- Fushtey I
- Futo L
- G\uf3mez Cerezo F
- G\uf3mez Marcos MA
- Gaal Z
- Gagel R
- Gallegos JA
- Gandy W
- Gani M
- Garbelini B
- Garcia Ortiz L
- Garcia Puig J
- Garvey T
- Gaudiani L
- Gelersztein E
- Gellad Z
- Genovese S
- George D
- George J
- Ghani RA
- Giep S
- Gilbert J
- Gillies J
- Godbole N
- Godoy J
- Golden G
- Gonzaga C
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- Gorelick F
- Gosselin G
- Gottlieb P
- Govender T
- Grabowska A
- Graur M
- Graves M
- Green JB
- Green S
- Greenspoon A
- Grishyna O
- Grueneberg M
- Grunberger G
- Gu W
- Guimaraes P
- Guo X
- Gushterova V
- Gustavson SM
- Gyrina O
- Hage-Korban E
- Halim S
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- Hamer A
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- Hanefeld M
- Hannan K
- Haque I
- Hargrove J
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- Hatheway R
- Havelkova J
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- Hess C
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- Holman RR
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- Hsieh IC
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- Ivanov V
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- Jaramilo Gomez CJ
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- Jimenez A
- Jimeno C
- Johnson A
- Jones S
- Jordan D
- Julius U
- Junbo G
- Juskiene R
- K\uf6se V
- Kaczmarek G
- Kakariekiene V
- Kalen V
- Kamke W
- Kaplan H
- Karounos D
- Katona B
- Katz M
- Kayne D
- Kelfkens Y
- Kellinerova I
- Keltai M
- Kennedy I
- Kentgens S
- Kerenyi Z
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- Kilvert A
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- Kleinertz K
- Klonoff D
- Klyver MI
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- Korzeniak R
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- Laferrere B
- Lagzdina L
- Lai WT
- Lakey W
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- Ledesma G
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- Leese G
- Lefterov IN
- Lehrke M
- Leitane I
- Leiter L
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- Lenhard J
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- Levinger A
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- Lottering H
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- Luger A
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- Luo N
- Luttrell L
- Lyubenova L
- M\ue1rquez-Rodriguez E
- M\uf6lle A
- Ma C
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- Madu I
- Maffei L
- Maggioni AP
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- Milward A
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- Mindrescu NM
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- Molina de Salazar DI
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- Oh BH
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- Oldenburg-Ligtenberg PC
- Olexa P
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- Oroszan T
- Orozco Linares A
- Osunkoya A
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- Overcash J
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- Pagidipati NJ
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- Pastare S
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- Strautina I
- Strongin L
- Strotmann HJ
- Struble R
- Su SL
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- Sugimoto D
- Sulskiene M
- Suplotova L
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- Suresh D
- Swart H
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- Szakal I
- Szentpeteri I
- Szilagyi I
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- Tamez Perez HE
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- Torello AL
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- Velickiene D
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- Veresiu IA
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- Villeda Espinosa E
- Vinanska D
- Vincent J
- Vishlitsky V
- Vizir V
- Vlasenko M
- Vo A
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- Voors-Pette C
- Voros P
- Wade T
- Wainstein J
- Wakefield P
- Wang CY
- Wang J
- Wang Y
- Webster B
- Weiss D
- Weiss R
- Weng J
- White A
- White J
- Whitehouse F
- Widimsky P
- Wiles P
- Wilhase A
- Wilson J
- Wilson M.
- Wilson S
- Wine A
- Wing J
- Wittert G
- Wittman I
- Wong SYS
- Wong YW
- Wong YW
- Woo V
- Woodall A
- Woodford T
- Wright A
- Wyne K
- Wysham C
- Yakov A
- Yale JF
- Yale JF
- Yan BPY
- Yang CY
- Yang T
- Yeung VT
- Yong H
- Yoon KH
- Yuan Z
- Zabuliene L
- Zaharie DG
- Zaharieva S
- Zaidman C
- Zaluska R
- Zannad F
- Zazula A
- Zeitler E
- Zhang L
- Zhou S
- Zilahi Z
- Zimering M
- Zimmerman R
- Zinman B
- Zrahevskiy K
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
Abstract
BACKGROUND:
The cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown.
METHODS:
We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly. The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The coprimary hypotheses were that exenatide, administered once weekly, would be noninferior to placebo with respect to safety and superior to placebo with respect to efficacy.
RESULTS:
In all, 14,752 patients (of whom 10,782 [73.1%] had previous cardiovascular disease) were followed for a median of 3.2 years (interquartile range, 2.2 to 4.4). A primary composite outcome event occurred in 839 of 7356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group and in 905 of 7396 patients (12.2%; 4.0 events per 100 person-years) in the placebo group (hazard ratio, 0.91; 95% confidence interval [CI], 0.83 to 1.00), with the intention-to-treat analysis indicating that exenatide, administered once weekly, was noninferior to placebo with respect to safety (P<0.001 for noninferiority) but was not superior to placebo with respect to efficacy (P=0.06 for superiority). The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome, and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly between the two groups.
CONCLUSIONS:
Among patients with type 2 diabetes with or without previous cardiovascular disease, the incidence of major adverse cardiovascular events did not differ significantly between patients who received exenatide and those who received placebo. (Funded by Amylin Pharmaceuticals; EXSCEL ClinicalTrials.gov number, NCT01144338 .)
Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: 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
- Abo‐Auda 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
- Arias‐Mendoza 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
- Biering‐Sørensen 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
- Constance Christian
- Contreras Johanna
- Corbalan Ramon
- Corbalan Ramon
- Correa Luis Eduardo Echeverria
- Corredor Miguel Alfredo Moncada
- Cosansu Kahraman
- Costa‐Vitali Atilio
- Cotarlan Vladimir
- Coufal Zdenek
- Cox Jeremy
- Crespo‐Leiro 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
- Dib Nabil
- Diez Mirta
- Dimov Bojidar
- Doblas Juan Jose Gomez
- Doi Masayuki
- Domae Hiroshi
- Donal Erwan
- Dong Yugang
- Donnelly Patrick
- Dorobantu Maria
- Dovgolis Svetlana
- Doyle Timothy
- Drexel Heinz
- Dronov Dmitry
- Droogne Walter
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- Teerlink John R.
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- Terasawa Akihiro
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- Timofeev Alexander
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- Tocchetti Carlo Gabriele
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- Tognon Alexandre
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- Tomcsanyi Janos
- Toth Kalman
- Treasure Charles
- Trebacz Jaroslaw
- Trevelyan Jasper
- Triana Miguel Urina
- Trichon Benjamin
- Trochu Jean Noel
- Tsabedze Nqoba
- Tsao Lana
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- Tsioufis Konstantinos
- Tsujimoto Mitsuru
- Tuncer Mustafa
- Turgut Okan Onur
- Tyl Petr
- Tzekova Maria
- Tziakas Dimitrios
- Ueda Yasunori
- Ueno Hideki
- Uhliar Rudolf
- Ujino Keiji
- Uretsky Barry
- Usui Makoto
- Utsu Noriaki
- Vaccari Christopher
- Vakaliuk Igor
- Van Eck Jacob
- Van Kesteren Henricus
- Van Zyl Louis
- Vandekerckhove Hans
- Vandekerckhove Hans
- Vanhecke Thomas
- Varin Claire
- Vasallo Javier
- Vasilev Ivaylo
- Vasilyeva Larysa
- Vaz Garth
- Vazquez Eduardo Salcido
- Vega Mario
- Velikov Chavdar
- 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 Olga‐Cristina
- 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
- Wozakowska‐Kaplon 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 (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials.
Methods and Results:
Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤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 (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF 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 pressure < 100 mmHg (n = 1127), estimated glomerular filtration rate < 30 mL/min/1.73 m2 (n = 528), and treated with sacubitril‐valsartan at baseline (n = 1594).
Conclusions:
GALACTIC‐HF enrolled a well‐treated, high‐risk 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
NT-proBNP Response to Sacubitril/Valsartan in Hospitalized Heart Failure Patients With Reduced Ejection Fraction: TRANSITION Study
- Author
- A. Baglikov
- A. El Sayed
- A. Heyse
- A. Moriarty
- A. Noe
- A. Oshurkov
- A. Ryding
- A. Schee
- A. Schmeisser
- A. Tokarcikova
- A. Vishnevsky
- A. Wong
- A.-. Pouleur
- A.A. Cohen
- A.A. Fernandez
- A.G. Quintana
- A.J. Castro Fernandez
- A.O. Soares
- A.R. Dominguez
- B. Demirkan
- B. Huegl
- B. Hulkoova
- C. Davies
- C. Fonseca
- C. Hayes
- C. Kadel
- C. Tribouilloy
- C.E. Mueller
- D. Brito
- D. Butylin
- D. Endemann
- D. Ferreira
- D. Logeart
- D. Pascual
- D. Pascual-Figal
- D. Westermann
- D.C. Alasia
- D.F. Zivano
- E. Bollano
- E. Bulut
- E. Decoulx
- E. Garcia del Rio
- E. Goncalvesova
- E. Hasbani
- E. Lenner
- E. Lonn
- E. Straburzynska-Migaj
- E.G. Basilio
- F. Almeida
- F. Frioes
- G. Arbolishvili
- G. De Geeter
- G. Di Tano
- G. Hoegalmen
- G. Pulignano
- G.P. Perez
- H. Kaya
- H. Lapp
- H. Schwende
- H.-. Olbrich
- I. Akin
- I. Marques
- I. Moreira
- I. Squire
- I. Voigt
- I.T. Ozcan
- J. Al-Buraiki
- J. Belohlavek
- J. Glover
- J. Gniot
- J. Nessler
- J. Spinar
- J. Stevlik
- J. Thambyrajah
- J. Vegsundvaag
- J. vom Dahl
- J. Weil
- J.A. Da Silva Antunes
- J.C. Trullas Vila
- J.M. Garcia Pinilla
- J.N. Villota
- K. Abdelbaki
- K. Bailey
- K. Loboz-Grudzien
- K. Sochor
- K. Witte
- K. Wong
- L. Ermoshkina
- L. Oliveira
- L. Spinarova
- L.A. Bonet
- L.B. Schiavi
- L.F. Rubio
- L.M. Santos
- M. Belicova
- M. Delforge
- M. Galinier
- M. Houra
- M. Kaislerova
- M. Lelonek
- M. Mozheiko
- M. Noutsias
- M. Peterka
- M. Radvan
- M. Refaat
- M. Senni
- M. Slanina
- M. Taborsky
- M.B. Lisik
- M.B. Robles
- M.C. Bott
- M.C. Leiro
- M.F. Prescott
- M.F. Seronde
- M.G. Aguado
- M.G. Bueno
- M.R. Barrionuevo
- O.B. Vasilevna
- P. Foley
- P. Karlstrom
- P. Kycina
- P. Letavay
- P. Meyer
- P. Monteiro
- P. Mota
- P. Schwimmbeck
- R. Al-Ani
- R. Kryza
- R. Polasek
- R. Sankaranarayanan
- R. Sheppard
- R. Wachter
- S. Al-Saif
- S. Carugo
- S. Chaaban
- S. Filali zaatari
- S. Hojerova
- S. Karabsheh
- S. Meyer
- S. Virani
- S.J. Sunderland
- T. Exequiel
- T. Horacek
- T. Muenzel
- T. Nageh
- T. Nitschke
- T. Sahin
- T.A. Massih
- T.H. McGill
- U. Landmesser
- W. Bao
- W. Droogne
- W. Fehske
- W. Mullens
- W. Musial
- Y. Cavusoglu
- Z. Klimsa
- Z. Kobalava
- Z. Motovska
- Z. Yigit
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/10/2020
- Field of study
Objectives: This study examined the effects of sacubitril/valsartan on N-terminal pro\u2013B-type natriuretic peptide (NT-proBNP) levels and determined patient characteristics associated with favorable NT-proBNP reduction response. Background: NT-proBNP levels reflect cardiac wall stress and predict event risk in patients with acute decompensated heart failure (ADHF). Methods: Post-hoc analysis of the TRANSITION (Comparison of Pre- and Post-discharge Initiation of Sacubitril/Valsartan Therapy in HFrEF Patients After an Acute Decompensation Event) study, including stabilized ADHF patients with reduced ejection fraction, randomized to open-label sacubitril/valsartan initiation in-hospital (pre-discharge) versus post-discharge. NT-proBNP was measured at randomization (baseline), discharge, and 4 and 10 weeks post-randomization. A favorable NT-proBNP response was defined as reduction to 641,000 pg/ml or >30% from baseline. Results: In patients receiving sacubitril/valsartan in-hospital, NT-proBNP was reduced by 28% at discharge, with 46% of patients obtaining favorable NT-proBNP reduction response compared with a 4% reduction and 18% favorable response rate in patients initiated post-discharge (p < 0.001). NT-proBNP was reduced similarly in patients initiating sacubitril/valsartan pre- and post-discharge (reduction at 4 weeks: 25%/22%; 10 weeks: 38%/34%) with comparable favorable response rates (46%/42% and 51%/48% at 4 and 10 weeks, respectively). NT-proBNP favorable response at 4 weeks was associated with lower risk of first heart failure (HF) rehospitalization or cardiovascular death through 26 weeks (hazard ratio: 0.57; 95% confidence interval [CI]: 0.38 to 0.86; p = 0.007). Predictors of a favorable response at 4 weeks were starting dose 6549/51 mg twice daily, higher baseline NT-proBNP, lower baseline serum creatinine, de novo HF, no atrial fibrillation, angiotensin-converting enzyme inhibitor\u2013naive or angiotensin receptor blocker\u2013naive, and no prior myocardial infarction. Conclusions: In-hospital initiation of sacubitril/valsartan produced rapid reductions in NT-proBNP, statistically significant at discharge. A favorable NT-proBNP response over time was associated with a better prognosis and predicted by higher starting dose and predisposing clinical profile. (Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event [TRANSITION]; NCT02661217
Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients
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- Abdullah S.
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- Vinanska D.
- Vincent John
- Vincent S.
- Vinyoles Bargallo E.
- Violante Ortiz R.
- Vishlitzky V.
- Vishneva E.
- Visser Rieuwk P.
- Visseren F. L.
- Vivekananthan K.
- Vizel S.
- Vlach J. J.
- Vodnansky P.
- Voehringer H-F
- Vogel D. R.
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- Volkova A.
- Voller H.
- von Engelhardt C. B.
- von Hodenberg E. F.
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- Wainstein J.
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- Walczewska J.
- Walukiewica P.
- Wang D.
- Wang Ellen
- Wang G.
- Wang Y.
- Wasserburger B.
- Waxler A. R.
- Wayne J. D.
- Weber D.
- Weber K.
- Wegner John
- Wei Caimiao
- Weigmann I.
- Weinstein D. L.
- Weiss R.
- Welker J. A.
- Welty Francine
- Wenetz L. M. M.
- Wermuth S.
- Wesson T.
- West S. H.
- Westerndorp I.
- Wetzel T.
- White H.
- Whitlock L.
- Whitney R. T.
- Wiggers H.
- William M.
- Williams D. G.
- Williams M.
- Willis J. G.
- Willits V. L.
- Winkelmann B.
- Witt N.
- Wittmann I.
- Woehrle J.
- Worner Diz F.
- Wozniak I.
- Wright R. S.
- Wronska D.
- Wuerzner G.
- Wychota K.
- Xu P.
- Xue L.
- Yakusevich V. V.
- Yang P.
- Yang X.
- Yao L. C.
- Yared Z.
- Yarows S. A.
- Yigit Z.
- Yoon J.
- Yunis C.
- Zadra R.
- Zaidman C. J.
- Zamorano Gomez J. L.
- Zannad Faiez
- Zarandon R. B. S.
- Zarich S. W.
- Zateyshchikov D.
- Zavaro S. H.
- Zebrack J. S.
- Zeig S.
- Zemek S.
- Zemour G.
- Zeng X.
- Zeno M. L.
- Zhang L.
- Zhang X.
- Zhang Y.
- Zhao Y.
- Zhou C.
- Zhou Y.
- Zhu Y.
- Zidkova E.
- Zieba B.
- Zilahi Z.
- Zoet-Nugteren S. K.
- Zrazhevskiy K.
- Zubek V.
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
BACKGROUN
Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study
- Author
- A.L. Buraiki J.
- Abdelbaki K.
- Aguado M.G.
- Akin I.
- Al-Ani R.
- Al-Buraiki J.
- Al-Saif S.
- Alasia D.C.
- Alexandre Da Silva Antunes J.
- Almeida F.
- Arbolishvili G.
- Baglikov A.
- Bailey K.
- Bao W.
- Barrionuevo M.R.
- Basilio E.G.
- Belicova M.
- Belohlavek J.
- Belohlavek J.
- Bollano E.
- Bonet L.A.
- Bott M.C.
- Brito D.
- Bueno M.G.
- Bulut E.
- Butylin D.
- Bøhmer E.
- Carles Trullas Vila J.
- Carugo S.
- Cavusoglu Y.
- Cavusoglu Y.
- Chaaban S.
- Chaaban S.
- Davies C.
- De Geeter G.
- Decoulx E.
- Del Rio E.G.
- Delforge M.
- Demirkan B.
- Di Tano G.
- Dominguez A.R.
- Droogne W.
- Endemann D.
- Ermoshkina L.
- Exequiel T.
- Fehske W.
- Fernandez A.
- Fernandez A.A.
- Ferreira D.
- Filali Zaatari S.
- Foley P.
- Fonseca C.
- Fonseca C.
- Frioes F.
- Galinier M.
- Glover J.
- Gniot J.
- Gniot J.
- Goncalvesova E.
- Goncalvesova E.
- Hasbani E.
- Hayes C.
- Heyse A.
- Hoegalmen G.
- Hojerova S.
- Horacek T.
- Houra M.
- Huegl B.
- Hulkoova B.
- Juan Castro Fernandez A.
- Kadel C.
- Kaislerova M.
- Karabsheh S.
- Karlstrom P.
- Kaya H.
- Klimsa Z.
- Kobalava Z.
- Kobalava Z.
- Kryza R.
- Kycina P.
- Landmesser U.
- Lapp H.
- Leiro M.C.
- Lelonek M.
- Lelonek M.
- Lenner E.
- Letavay P.
- Lisik M.B.
- Loboz-Grudzien K.
- Logeart D.
- Lonn E.
- Lonn E.
- Manuel Garcia Pinilla J.
- Marques I.
- Massih T.A.
- McGill T.H.
- Meyer P.
- Meyer S.
- Monteiro P.
- Moreira I.
- Moriarty A.
- Mota P.
- Motovska Z.
- Mozheiko M.
- Mozheiko M.
- Mueller C.
- Mueller C.E.
- Muenzel T.
- Mullens W.
- Musial W.
- Nageh T.
- Nessler J.
- Nitschke T.
- Noutsias M.
- Noè A.
- Olbrich H.-G.
- Oliveira L.
- On Behalf of the TRANSITION Investigators
- Oshurkov A.
- Ozcan I.T.
- Pascual D.
- Pascual-Figal D.
- Perez G.P.
- Peterka M.
- Polasek R.
- Pouleur A.-C.
- Pouleur A.-C.
- Praha
- Pulignano G.
- Quintana A.G.
- Radvan M.
- Refaat M.
- Robles M.B.
- Rubio L.F.
- Ryding A.
- Sahin T.
- Sankaranarayanan R.
- Santos L.M.
- Sayed A.E.
- Schee A.
- Schiavi L.B.
- Schmeisser A.
- Schwende H.
- Schwimmbeck P.
- Senni M.
- Senni M.
- Seronde M.F.
- Sheppard R.
- Slanina M.
- Soares A.O.
- Sochor K.
- Spinar J.
- Spinarova L.
- Squire I.
- Stevlik J.
- Straburzynska-Migaj E.
- Straburzynska-Migaj E.
- Sunderland S.J.
- Taborsky M.
- Thambyrajah J.
- Tokarcikova A.
- Tribouilloy C.
- Tribouilloy C.
- Vasilevna O.B.
- Vegsundvaag J.
- Villota J.N.
- Virani S.
- Vishnevsky A.
- Voigt I.
- Vom Dahl J.
- Wachter R.
- Wachter R.
- Weil J.
- Westermann D.
- Witte K.
- Witte K.K.
- Wong A.
- Wong K.
- Yigit Z.
- Zivano D.F.
- Publication venue
- 'Wiley'
- Publication date
- Field of study
Aims: To assess tolerability and optimal time point for initiation of sacubitril/valsartan in patients stabilised after acute heart failure (AHF). Methods and results: TRANSITION was a randomised, multicentre, open-label study comparing two treatment initiation modalities of sacubitril/valsartan. Patients aged ≥ 18 years, hospitalised for AHF were stratified according to pre-admission use of renin–angiotensin–aldosterone system inhibitors and randomised (n = 1002) after stabilisation to initiate sacubitril/valsartan either ≥ 12-h pre-discharge or between Days 1–14 post-discharge. Starting dose (as per label) was 24/26 mg or 49/51 mg bid with up- or down-titration based on tolerability. The primary endpoint was the proportion of patients attaining 97/103 mg bid target dose after 10 weeks. Median time of first dose of sacubitril/valsartan from. the day of discharge was Day –1 and Day +1 in the pre-discharge group and the post-discharge group, respectively. Comparable proportions of patients in the pre- and post-discharge initiation groups met the primary endpoint [45.4% vs. 50.7%; risk ratio (RR) 0.90; 95% confidence interval (CI) 0.79–1.02]. The proportion of patients who achieved and maintained for ≥ 2 weeks leading to Week 10, either 49/51 or 97/103 mg bid was 62.1% vs. 68.5% (RR 0.91; 95% CI 0.83–0.99); or any dose was 86.0% vs. 89.6% (RR 0.96; 95% CI 0.92–1.01). Discontinuation due to adverse events occurred in 7.3% vs. 4.9% of patients (RR 1.49; 95% CI 0.90–2.46). Conclusions: Initiation of sacubitril/valsartan in a wide range of heart failure with reduced ejection fraction patients stabilised after an AHF event, either in hospital or shortly after discharge, is feasible with about half of the patients achieving target dose within 10 weeks. Clinical Trial Registration: ClinicalTrials.gov ID: NCT02661217. © 2019 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology
Ezetimibe added to statin therapy after acute coronary syndromes
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- Vertes G
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- Viergever EP
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- Voyles W
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- Vértes A
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- Waalewijn RA
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- Witzling V
- Wiviott Stephen D.
- Wohns D
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- Worthley S
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- Yildiz Z
- Yoon J
- Yoon M
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- Zakhary B
- Zaluska R
- Zambahari R
- Zanini R
- Zanini R
- Zanolin D
- Zapata M
- Zarandon R
- Zeiher A
- Zeltser D
- Zeman K
- Zemberova A
- Zemour G
- Zender H
- Zeymer U
- Zhukova Y
- Ziegler B
- Zimlichman R
- Zimmerman T
- Zimmermann R
- Zingarelli A
- Zirkle J
- Zucchetti C
- Zughaib M
- Zuidgeest JA
- Zuppiroli A
- Zwart PA
- Zweiker R
- Ångman K
- Édes I
- Östberg S
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2015
- Field of study
BACKGROUND: Statin therapy reduces low-density lipoprotein (LDL) cholesterol levels and the risk of cardiovascular events, but whether the addition of ezetimibe, a nonstatin drug that reduces intestinal cholesterol absorption, can reduce the rate of cardiovascular events further is not known. METHODS: We conducted a double-blind, randomized trial involving 18,144 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and had LDL cholesterol levels of 50 to 100 mg per deciliter (1.3 to 2.6 mmol per liter) if they were receiving lipid-lowering therapy or 50 to 125 mg per deciliter (1.3 to 3.2 mmol per liter) if they were not receiving lipid-lowering therapy. The combination of simvastatin (40 mg) and ezetimibe (10 mg) (simvastatin-ezetimibe) was compared with simvastatin (40 mg) and placebo (simvastatin monotherapy). The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, unstable angina requiring rehospitalization, coronary revascularization ( 6530 days after randomization), or nonfatal stroke. The median follow-up was 6 years. RESULTS: The median time-weighted average LDL cholesterol level during the study was 53.7 mg per deciliter (1.4 mmol per liter) in the simvastatin-ezetimibe group, as compared with 69.5 mg per deciliter (1.8 mmol per liter) in the simvastatin-monotherapy group (P<0.001). The Kaplan-Meier event rate for the primary end point at 7 years was 32.7% in the simvastatin-ezetimibe group, as compared with 34.7% in the simvastatin-monotherapy group (absolute risk difference, 2.0 percentage points; hazard ratio, 0.936; 95% confidence interval, 0.89 to 0.99; P = 0.016). Rates of pre-specified muscle, gallbladder, and hepatic adverse effects and cancer were similar in the two groups. CONCLUSIONS: When added to statin therapy, ezetimibe resulted in incremental lowering of LDL cholesterol levels and improved cardiovascular outcomes. Moreover, lowering LDL cholesterol to levels below previous targets provided additional benefit
Cardiorenal end points in a trial of aliskiren for type 2 diabetes.
- Author
- 3rd Allison J.
- Abe N
- Abedini S
- Abraham G
- Acker Kv
- Adelberger V
- Adhikari P
- Agarwal N
- Ahmed F
- Aiello A
- Aizemberg D
- Aldigier Jc
- Allemann Y
- Almeida F
- Altes U
- Altschuller A
- Amod A
- Anderson J
- Andre I
- Aniko S
- Antepara N
- Aoki S
- Arakaki R
- Aranda P
- Arango Jl
- Araz M
- Arez L
- Arici M
- Armario P
- Arnouts P
- Aronson R
- Ates K
- Aucello G
- Azize Gm
- Bacariza M
- Badariene J
- Baggen Mg
- Bajaj M
- Bakker Rc
- Bako B
- Banerjee D
- Bantwal G
- Barima Yt
- Barranco E
- Barrera C
- Barrett B
- Barrios V
- Bartolacci I
- Batt R
- Bazzi A
- Beacom M
- Behnke T
- Belobradkova J
- Benacka J
- Berg J
- Berlingieri Jc
- Berrizbeitia M
- Bevilacqua Mt
- Bhana Sa
- Bhattacharyya A
- Bianda T
- Bieler T
- Biernacki W
- Bilazarian S
- Bilous R
- Birne R
- Blacher J
- Blakney E
- Blanco D
- Boermans T
- Bonora E
- Botero R
- Botero R
- Bowden R
- Bowering K
- Branco P
- Brandao A
- Brandstetter R
- Brath H
- Braun Rk
- Brenner Bm
- Bressler P
- Brotons C
- Brown C
- Browne D
- Brunel P
- Bulliard C
- Burkhardt F
- Burnier M
- Burstein D
- Busch R
- Busick E
- Cabrera W
- Calatola P
- Calle A
- Calvert J
- Calviñ
- Calvo C
- Capuano V
- Carillo E
- Carrillo E
- Carugo S
- Carvalho D
- Casalla F
- Casas L
- Catelao Am
- Catena C
- Cerasola G
- Cha D
- Cha J
- Chae D
- Chanchairujira T
- Charles H
- Charpentier G
- Chaturvedi N
- Chen Hc
- Chen J
- Chen Sc
- Chen X
- Cho W
- Chou Cw
- Chouinard G
- Chowdhury S
- Christiansen Js
- Christiansen Js
- Chua T
- Cifkova R
- Cifkova R
- Cocchi R
- Comas A
- Comlekci A
- Comlekci A
- Connery L
- Constam En
- Cooperman M
- Corona V
- Corsi A
- Coucke F
- Cournoyer S
- Cozzolino D
- Craig W
- Culak J
- Cunha R
- Cusachs Ar
- Dö
- D&apos
- D&apos
- da Costa AG
- da Silva GF
- da Silva PM
- Dani S
- Darko D
- Dattani D
- David S
- de Jong A
- de Paula RB
- De Pellegrin A
- de Roa ER
- De Teresa E
- de Zeeuw D
- Deak L
- Del Prato S
- dell Valle MH
- Dellanna F
- Demetry K
- Demirbas B
- Dendale P
- Desai As
- Desai V
- Dharmalingam M
- Diaz M
- Dohnalova L
- Dong J
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- Dudas M
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- Dunselman Ph
- Duprez D
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- East C
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- Egstrup K
- Eiam Ong S
- Eickhoff F
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- Klaff L
- Klausmann G
- Klepzig C
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- Mateos C
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- Matsubayashi S
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- Mediavilla Jd
- Medina B
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- Merke J
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- Middleton A
- Migdalis I
- Miglinas M
- Milesi R
- Minehart C
- Mion D. Jr
- Moccetti T
- Modi Kk
- Mohan V
- Montañ
- Monterroso V
- Morosetti M
- Mos L
- Mostard G
- Moustafa M
- Mueller G
- Muirhead N
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- Naicker P
- Nanclares Ms
- Narayan P
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- Nickenig G
- Nickenig G
- Nicolaides M
- Niepen Pv
- Nierop Pr
- Nolen T
- Nour K
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- Nyirati G
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- Oerter E
- Oestergaard O
- Ogawa Y
- Oh H
- Oigman W
- Okamoto H
- Olivan J
- Olsen H
- Onishi Y
- Ontiveros C
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- Oroszlan T
- Ott P
- Ovize M
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- Pan C
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- Papadakis I
- Pappas S
- Paragh G
- Parra J
- Parreñ
- Parving Hh
- Pascual J
- Pastrnakova E
- Paulweber B
- Pedersen Tr
- Pedrinelli R
- Pella D
- Pencz I
- Penfornis A
- Peral Jl
- Perez Js
- Pernalete N
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- Persson F
- Persu A
- Perticone F
- Petrillo A
- Petrulioniene Z
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- Phillips A
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- Piskorz D
- Podgorski G
- Pollock J
- Polonia Dj
- Polonia J
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- Poteliuniene V
- Povedano St
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- Rheeder P
- Ricart W
- Richard A
- Rickli H
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- Risberg K
- Roberts J
- Robertson D
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- Rosenblit P
- Rossing P
- Ruddy M
- Rudofsky G
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- Yalouris A
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- Yamada T
- Yan J
- Yan L
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- Yang Tc
- Yang W
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- Yuan Z
- Zabuliene L
- Zamora B
- Zamorano Jl
- Zanella M
- Zanella Mt
- Zanette G
- Zangroniz P
- Zaoui P
- Zhan X
- Zhang H
- Zhang J
- Zhang M
- Zhong H
- Zhong L
- Zhou Z
- Zhu D
- Zigrang W
- Zimmermann U
- Zinman B
- Zushi S
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2012
- Field of study
Background
This study was undertaken to determine whether use of the direct renin inhibitor aliskiren would reduce cardiovascular and renal events in patients with type 2 dia- betes and chronic kidney disease, cardiovascular disease, or both.
Methods
In a double-blind fashion, we randomly assigned 8561 patients to aliskiren (300 mg daily) or placebo as an adjunct to an angiotensin-converting\u2013enzyme inhibitor or an angiotensin-receptor blocker. The primary end point was a composite of the time to cardiovascular death or a first occurrence of cardiac arrest with resuscitation; nonfatal myocardial infarction; nonfatal stroke; unplanned hospitalization for heart failure; end-stage renal disease, death attributable to kidney failure, or the need for renal-replacement therapy with no dialysis or transplantation available or initiated; or doubling of the baseline serum creatinine level.
Results
The trial was stopped prematurely after the second interim efficacy analysis. After a median follow-up of 32.9 months, the primary end point had occurred in 783 patients (18.3%) assigned to aliskiren as compared with 732 (17.1%) assigned to placebo (hazard ratio, 1.08; 95% confidence interval [CI], 0.98 to 1.20; P=0.12). Effects on secondary renal end points were similar. Systolic and diastolic blood pres- sures were lower with aliskiren (between-group differences, 1.3 and 0.6 mm Hg, respectively) and the mean reduction in the urinary albumin-to-creatinine ratio was greater (between-group difference, 14 percentage points; 95% CI, 11 to 17). The proportion of patients with hyperkalemia (serum potassium level, 656 mmol per liter) was significantly higher in the aliskiren group than in the placebo group (11.2% vs. 7.2%), as was the proportion with reported hypotension (12.1% vs. 8.3%) (P<0.001 for both comparisons).
Conclusions
The addition of aliskiren to standard therapy with renin\u2013angiotensin system block- ade in patients with type 2 diabetes who are at high risk for cardiovascular and renal events is not supported by these data and may even be harmful
Cardiorenal end points in a trial of aliskiren for type 2 diabetes.
- Author
- Abe N
- Abedini S
- Abraham G
- Acker KV
- Adelberger V
- Adhikari P
- Agarwal N
- Ahmed F
- Aiello A
- Aizemberg D
- Aldigier JC
- Allemann Y
- Allison J 3rd
- Almeida F
- Altes U
- Altschuller A
- Amod A
- Anderson J
- Andre I
- Aniko S
- Antepara N
- Aoki S
- Arakaki R
- Aranda P
- Arango JL
- Araz M
- Arez L
- Arici M
- Armario P
- Arnouts P
- Aronson R
- Ates K
- Aucello G
- Azize GM
- Bacariza M
- Badariene J
- Baggen MG
- Bajaj M
- Bakker RC
- Bako B
- Banerjee D
- Bantwal G
- Barima YT
- Barranco E
- Barrera C
- Barrett B
- Barrios V
- Bartolacci I
- Batt R
- Bazzi A
- Beacom M
- Behnke T
- Belobradkova J
- Benacka J
- Berg J
- Berlingieri JC
- Berrizbeitia M
- Bevilacqua MT
- Bhana SA
- Bhattacharyya A
- Bianda T
- Bieler T
- Biernacki W
- Bilazarian S
- Bilous R
- Birne R
- Blacher J
- Blakney E
- Blanco D
- Boermans T
- Bonora E
- Botero R
- Botero R
- Bowden R
- Bowering K
- Branco P
- Brandao A
- Brandstetter R
- Brath H
- Braun RK
- Brenner BM
- Bressler P
- Brotons C
- Brown C
- Browne D
- Brunel P
- Bulliard C
- Burkhardt F
- Burnier M
- Burstein D
- Busch R
- Busick E
- Cabrera W
- Calatola P
- Calle A
- Calvert J
- Calvi\uf1o J
- Calvo C
- Capuano V
- Carillo E
- Carrillo E
- Carugo S
- Carvalho D
- Casalla F
- Casas L
- Catelao AM
- Catena C
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- Zimmermann U
- Zinman B
- Zushi S
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2012
- Field of study
BACKGROUND: This study was undertaken to determine whether use of the direct renin inhibitor aliskiren would reduce cardiovascular and renal events in patients with type 2 diabetes and chronic kidney disease, cardiovascular disease, or both.
METHODS: In a double-blind fashion, we randomly assigned 8561 patients to aliskiren (300 mg daily) or placebo as an adjunct to an angiotensin-converting-enzyme inhibitor or an angiotensin-receptor blocker. The primary end point was a composite of the time to cardiovascular death or a first occurrence of cardiac arrest with resuscitation; nonfatal myocardial infarction; nonfatal stroke; unplanned hospitalization for heart failure; end-stage renal disease, death attributable to kidney failure, or the need for renal-replacement therapy with no dialysis or transplantation available or initiated; or doubling of the baseline serum creatinine level.
RESULTS: The trial was stopped prematurely after the second interim efficacy analysis. After a median follow-up of 32.9 months, the primary end point had occurred in 783 patients (18.3%) assigned to aliskiren as compared with 732 (17.1%) assigned to placebo (hazard ratio, 1.08; 95% confidence interval [CI], 0.98 to 1.20; P=0.12). Effects on secondary renal end points were similar. Systolic and diastolic blood pressures were lower with aliskiren (between-group differences, 1.3 and 0.6 mm Hg, respectively) and the mean reduction in the urinary albumin-to-creatinine ratio was greater (between-group difference, 14 percentage points; 95% CI, 11 to 17). The proportion of patients with hyperkalemia (serum potassium level, 656 mmol per liter) was significantly higher in the aliskiren group than in the placebo group (11.2% vs. 7.2%), as was the proportion with reported hypotension (12.1% vs. 8.3%) (P<0.001 for both comparisons).
CONCLUSIONS: The addition of aliskiren to standard therapy with renin-angiotensin system blockade in patients with type 2 diabetes who are at high risk for cardiovascular and renal events is not supported by these data and may even be harmful
Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients
- Author
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- Yang P
- Yang X
- Yao Lc
- Yared Z
- Yarows Sa
- Yigit Z
- Yoon J
- Yunis C.
- Zadra R
- Zaidman Cj
- Zamorano Gomez Jl
- Zannad F
- Zarandon Rb
- Zarich Sw
- Zateyshchikov D
- Zavaro Sh
- Zebrack Js
- Zeig S
- Zemek S
- Zemour G
- Zeng X
- Zeno Ml
- Zhang L
- Zhang X
- Zhang Y
- Zhao Y
- Zhou C
- Zhou Y
- Zhu Y
- Zidkova E
- Zieba B
- Zilahi Z
- Zoet-Nugteren Sk
- Zrazhevskiy K
- Zubek V
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
Bococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin- kexin type 9 (PCSK9) and reduces levels of low-density lipoprotein (LDL) cholesterol. We sought to evaluate the efficacy of bococizumab in patients at high cardiovascular risk. METHODS In two parallel, multinational trials with different entry criteria for LDL cholesterol levels, we randomly assigned the 27,438 patients in the combined trials to receive bococizumab (at a dose of 150 mg) subcutaneously every 2 weeks or placebo. The primary end point was nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina requiring urgent revascularization, or cardiovascular death; 93% of the patients were receiving statin therapy at baseline. The trials were stopped early after the sponsor elected to discontinue the development of bococizumab owing in part to the development of high rates of antidrug antibodies, as seen in data from other studies in the program. The median follow-up was 10 months. RESULTS At 14 weeks, patients in the combined trials had a mean change from baseline in LDL cholesterol levels of -56.0% in the bococizumab group and +2.9% in the placebo group, for a between-group difference of -59.0 percentage points (P<0.001) and a median reduction from baseline of 64.2% (P<0.001). In the lower-risk, shorter-duration trial (in which the patients had a baseline LDL cholesterol level of ≥70 mg per deciliter [1.8 mmol per liter] and the median follow-up was 7 months), major cardiovascular events occurred in 173 patients each in the bococizumab group and the placebo group (hazard ratio, 0.99; 95% confidence interval [CI], 0.80 to 1.22; P = 0.94). In the higher-risk, longer-duration trial (in which the patients had a baseline LDL cholesterol level of ≥100 mg per deciliter [2.6 mmol per liter] and the median follow-up was 12 months), major cardiovascular events occurred in 179 and 224 patients, respectively (hazard ratio, 0.79; 95% CI, 0.65 to 0.97; P = 0.02). The hazard ratio for the primary end point in the combined trials was 0.88 (95% CI, 0.76 to 1.02; P = 0.08). Injection-site reactions were more common in the bococizumab group than in the placebo group (10.4% vs. 1.3%, P<0.001). CONCLUSIONS In two randomized trials comparing the PCSK9 inhibitor bococizumab with placebo, bococizumab had no benefit with respect to major adverse cardiovascular events in the trial involving lower-risk patients but did have a significant benefit in the trial involving higher-risk patients
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
- Daniel Vogel
- Daniela Garcia Brasca
- Daniela Pini
- Daniela Vinanska
- Dariusz Korczyk
- David Chang
- David F Kong
- David Henderson
- David Lanfear
- David Murray
- David Rawitscher
- David Schultz
- David Stepek
- 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
- Dmitry Dronov
- Dmytro Reshotko
- Domenico Bonaduce
- Domingo Andres Pascual Figal
- Dongye Li
- Donna Mancini
- Dora Ines Molina de Salazar
- Douglas Brinkley
- Douglas Martel
- Douglas Sawyer
- Dragos Vinereanu
- Driek Beelen
- Dulce Brito
- Dumitru Zdrenghea
- Echeverria L. E.
- Edmundo Alfredo Bayram Llamas
- Edo Kaluski
- Eduardo Perna
- Eduardo Salcido Vazquez
- Edward Geltman
- Edward Portnay
- Egon Lenner
- Eileen O'Meara
- Einas Elmahi
- Eiran Gorodeski
- Elena Cowan
- Elena Kosmacheva
- Elena Kulibaba
- Elena Shutemova
- Ellis Lader
- Elvin Kedhi
- Erberto Carluccio
- Eric Decoulx
- Eric Klug
- Erik Hajko
- Ersel Onrat
- Ertugrul Okuyan
- Erwan Donal
- Eugene Chung
- Eugene Joseph Bauerlein
- Euler Roberto Fernandes Manenti
- Eva Goncalvesova
- Eva Peterfai
- Ewa Kalecinska-Krystkiewicz
- Ewa Straburzynska-Migaj
- Fabiana Rollini
- Fabio Silveira
- Fady I Malik
- Faiez Zannad
- Faisal Wahid
- Fang J. C.
- Farid Jadbabaie
- Felice Achilli
- Felix Ramires
- Feng Liu
- Ferenc Lakatos
- Fernando Bacal
- Fernando Boccalandro
- Fernando Colombo Berra
- Fernando Manzur Jattin
- Fernando Soto Loureiro
- Fernando Tomas Lanas Zanetti
- Filipa Almeida
- Filippatos G.
- Flavio Brito
- Flavio Eduardo Giorgeto
- 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
- Gabriel Arturo Ramos Lopez
- Gabriela Stanciulescu
- Gabriele Jakl-Kotauschek
- Gaetano Maria De Ferrari
- Garth Vaz
- Gary Yeoman
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- Gerhard Poelzl
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- Gilmar Reis
- Gintare Sakalyte
- Giovanni Geronilla
- Giovanni Quinto Villani
- Giuseppe Ambrosio
- Giuseppe Musumeci
- Glenn Hamroff
- Goncalvesova E.
- Gordon Moe
- Gordon Reeves
- Goudev A. R.
- Gregorio Sanchez Vallejo
- Gregory Sampognaro
- Gregory Szto
- Gregory Thomas
- Grigorios Giamouzis
- Grzegorz Kania
- Grzegorz Skonieczny
- Guillaume De Geeter
- Guillaume Jondeau
- Guillermo Antonio Llamas Esperon
- Guoqin Chen
- Gurinder Grewal
- Gurusher Panjrath
- Gustavo Francisco Mendez Machado
- Guy Proulx
- Gyula Szasz
- Hakima Bourhaial
- Hal Skopicki
- Hamish Hart
- Hanbin Cui
- Hans Vandekerckhove
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- Haralambos Karvounis
- Harinder Gogia
- Harukazu Iseki
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- He Huang
- Heinz Drexel
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- Hideo Izawa
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- Hiroshi Ito
- Hiroshi Meno
- Hiroshi Sugino
- 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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- Inder Anand
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- Ioannis Barbetseas
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- Ira Dauber
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- Iurii Rudyk
- Ivan Goncharov
- Ivan Majercak
- Ivana Kellnerova
- Ivaylo Vasilev
- Ivo Petrov
- Ivo Podpera
- J Dedrick Jordan
- J Russell Strader
- Jacob Eifer Moller
- Jacob Van Eck
- Jadwiga Nessler
- Jagadeesh Ganji
- James Elliott
- James Fang
- James L Januzzi
- James Rider
- James Watts
- Jan Belohlavek
- Jan Stevlik
- Jana Lukacova
- Janka Skrobakova
- Janos Tomcsanyi
- Janusz Spyra
- Jaroslaw Drozdz
- Jaroslaw Trebacz
- Jason C Legg
- Jason Glover
- Jasper Trevelyan
- Javed Butler
- Javier Segovia Cubero
- Javier Vasallo
- Jean Etienne Ricci
- Jean-Louis Georges
- Jean-Marie Lefebvre
- Jean-Michel Tartiere
- Jean-Noel Trochu
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- Jeffrey Martindale
- Jelena Celutkiene
- Jenica N Upshaw
- Jennifer Cook
- Jens Taggeselle
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- Jianjun Li
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- Jose Luis Lambert Rodriguez
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- Jozef Gonsorcik
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- Ladislav Busak
- Lana Tsao
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- Lars Videbaek
- Larysa Mishchenko
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- Leonardo Novaretto
- Leonid Pimenov
- Leonid Rudenko
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- Lesley Burgess
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- Li J.
- Libor Nechvatal
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- Luis Oliveira
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- Lund M.
- Lutfu Bekar
- Lutz Frankenstein
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- Malik F. I.
- Mamoru Manita
- Manoel Canesin
- Manohara Senaratne
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- Manuel Martinez-Selles D Oliveira Soares
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- Masaki Yoshikawa
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- Masayoshi Ajioka
- Masayuki Doi
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- Matthias Dupont
- Maurizio Volterrani
- Mayanna Lund
- McMurray J. J. V.
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- Mehmet Birhan Yilmaz
- Mehmet Duzenli
- Mehrdad Ariani
- Melchor Alpizar Salazar
- Melvin Martinez-Castrillon
- Mesut Demir
- Metra M.
- Michael Boehm
- Michael Böhm
- Michael Felker G.
- Michael Hartleib
- Michael Koren
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- Michael Magro
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- Michael Pham
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- Michal Cepelak
- Michel Galinier
- Michel Ovize
- Michele Hamilton
- Michele Senni
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- Mirta Diez
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- Mitsuru Tsujimoto
- Mitsutaka Yamamoto
- Mohammad Abuannadi
- Mohan Babapulle
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- Roman Pfister
- Roman Stets
- Ronald Bourgeois
- Ronald Fernando
- Ronald Zolty
- Rosario Santa Fe
- Rostislav Polasek
- Ruben Omar Garcia Duran
- Rudolf Smik
- Rudolf Spacek
- Rudolf Uhliar
- Russell Scott
- Ruud van de Wal
- Ryszard Sciborski
- Rémi Sabatier
- Saad Ahmad
- Sabine Genth-Zotz
- Salvador Leon Gonzalez
- Salvador Rassi
- Sana M Al-Khatib
- Sandra Chaparro
- Sanem Nalbantgil
- Sanjay Malhotra
- Sanjeev Saxena
- Sara Llerena
- Sara Soares Goncalves
- Satoru Sakagami
- Scott D Solomon
- Scott Feitell
- Scott Franczek
- Scott McKenzie
- Sebastian Velez Pelaez
- Seigo Masuda
- Seiichiro Gohara
- Sergey Boytsov
- Sergey Tereschenko
- Sergio Leonardi
- Sergio Potthoff
- Serpytis P.
- Shafiq Mamdani
- Shahid Mahmood
- Shamaila Aslam
- Sharpsten L.
- Shaumik Adhya
- Shawn Robinson
- Shelley Zieroth
- Sherryn Roth
- Shigeru Fujii
- Shigeru Fukuzawa
- Shin-Ichi Momomura
- Shinichiro Miura
- Shitoshi Hiroi
- Shogo Oishi
- Shouyan Zhang
- Shreyansh Shah
- Shuaib Abdullah
- Shuichi Taguchi
- Shumei Ma
- Shunsuke Tatebe
- Shuntaro Kagiyama
- Siddique Abbasi
- Silvia Lopez Fernandez
- Sliwa K.
- Snezhanka Tisheva-Gospodinova
- Solomon S. D.
- Sonia Mirabet Perez
- Sonia Sassone
- Soren Vraa
- Sorin Stamate
- Sotirios Patsilinakos
- Sourin Banerji
- Spinar J.
- Stavros Drakos
- Stefan Berglund
- Stefan Störk
- Stephan von Haehling
- Stephanie Olsen
- Stephen Gottlieb
- Stephen Halpern
- Stephen Rennyson
- Steven Forman
- Steven Hearne
- Steven Krueger
- Steven Lupovitch
- Steven Shayani
- Sunder Rao
- Sunil Pauwaa
- Susan Joseph
- Suter T. M.
- Svetlana Dovgolis
- Svetlana Villevalde
- Syed Hasni
- Takaaki Isshiki
- Takahiro Okumura
- Takahiro Tanaka
- Takashi Matsumoto
- Takashi Takenaka
- Takayuki Hidaka
- Takayuki Inomata
- Takeshi Serikawa
- Takeshi Yoshida
- Tamas Forster
- Tariq Haddad
- Tatiana Duarte
- Tayfun Sahin
- Teerlink J. R.
- Terence Hart
- Terrence O'Brien
- Tetsuo Sakai
- Tetsuro Miyazaki
- Tetsuya Amano
- Thao Huynh
- Theodore Frank
- Theodore Takata
- Thibaud Damy
- Thierry Laperche
- Thomas Ashcom
- Thomas Duythuc To
- Thomas Horacek
- Thomas Hucko
- Thomas J Povsic
- Thomas Suter
- Thomas Vanhecke
- Tianfa Li
- Tienush Rassaf
- Timothy Doyle
- Tina Sichrovsky
- Tiziano Moccetti
- Tjeerd Römer
- Tokushi Koga
- Tom Smilde
- Tomas Brabec
- Tomasz Blicharski
- Tomasz Borkowski
- Tomcsanyi J.
- Tomohiro Kawasaki
- Tomohiro Ogawa
- Tomohiro Sakamoto
- Tomomi Koizumi
- Tonny Nielsen
- Tor Biering-Sørensen
- Toru Kubota
- Toshiaki Kadokami
- Toshio Kasai
- Toshiro Terasaki
- Ulf Dahlstrom
- Umit Guray
- Uwe Zeymer
- Valentina Mincheva
- Valerio Zaca
- Valery Popov
- Vandekerckhove H.
- Varin C.
- Vasilios Papademetriou
- Vedampattu Ganeshram
- Venkatesh Nadar
- Vernon Hunter
- Veselin Mitrovic
- Viacheslav Mareev
- Vicente Eduardo Climent Paya
- Victor Aboyans
- Victor Alfonso Jimenez Diaz
- Victor Areli Saavedra Gajardo
- Viktor Kostenko
- Vilma Machova
- Vinay Malhotra
- Vinay Thohan
- Vinereanu D.
- Viorel Florea
- Vira Tseluyko
- Vittorio Giudici
- Viviane Nguyen
- Vladimir Cech
- Vladimir Cotarlan
- Vladimir Nosov
- Vladimir Rafalskiy
- Vladimir Salukhov
- Vladislav Mitrokhin
- Voors A. A.
- Vyacheslav Mareev
- Vyacheslav Ryabov
- W Schuyler Jones
- Wael AboAuda
- Wakaya Fujiwara
- Walter Abhayaratna
- Walter Droogne
- Walter Hermans
- Wataru Shimizu
- Wayne Gray
- 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.)