10 research outputs found
Baseline characteristics of patients in the reduction of events with darbepoetin alfa in heart failure trial (RED-HF)
- Author
- Adams K.
- Adamson P.
- Adler A.
- Admon D.
- Agarwal D.
- Aggarwal A.
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- Aguilar-Romero R.
- Albanese M.
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- Andreou C.
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- Aroutiounov G.
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- Coman I.
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- Dickstein K.
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- Lopez Alvarado A.
- Luksiene D.
- Lupkovics G.
- Lupon J.
- Lycksell M.
- Ma P.
- Mabin T.
- Machado C.
- Mackinnon I.
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- Manitiu I.
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- Miller A.
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- Moccetti T.4
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- Xu Z.
- Yan B.
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- Zateyshchikov D.
- Zimlichman R.
- Zolty R.
- Publication venue
- 'Oxford University Press (OUP)'
- Publication date
- 01/01/2013
- Field of study
<p>Aims: This report describes the baseline characteristics of patients in the Reduction of Events with Darbepoetin alfa in Heart Failure trial (RED-HF) which is testing the hypothesis that anaemia correction with darbepoetin alfa will reduce the composite endpoint of death from any cause or hospital admission for worsening heart failure, and improve other outcomes.</p>
<p>Methods and results: Key demographic, clinical, and laboratory findings, along with baseline treatment, are reported and compared with those of patients in other recent clinical trials in heart failure. Compared with other recent trials, RED-HF enrolled more elderly [mean age 70 (SD 11.4) years], female (41%), and black (9%) patients. RED-HF patients more often had diabetes (46%) and renal impairment (72% had an estimated glomerular filtration rate <60 mL/min/1.73 m2). Patients in RED-HF had heart failure of longer duration [5.3 (5.4) years], worse NYHA class (35% II, 63% III, and 2% IV), and more signs of congestion. Mean EF was 30% (6.8%). RED-HF patients were well treated at randomization, and pharmacological therapy at baseline was broadly similar to that of other recent trials, taking account of study-specific inclusion/exclusion criteria. Median (interquartile range) haemoglobin at baseline was 112 (106–117) g/L.</p>
<p>Conclusion: The anaemic patients enrolled in RED-HF were older, moderately to markedly symptomatic, and had extensive co-morbidity.</p>
Zymogen activation peptides and their relationship to disease severity in acute pancreatitis.
- Author
- Publication venue
- Publication date
- 01/01/1993
- Field of study
Abstract not available
Dysregulation of T cell-macrophage network in severe acute pancreatitis
- Publication venue
- 'Portland Press Ltd.'
- Publication date
- Field of study
Bariatric Support Line: A Prospective Study of Support Line Activity
- Author
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- Field of study
Laparoscopic Insertion of a Gastric Band for Weight Gain Following Laparoscopic Roux-en-Y Gastric Bypass: Description of the Technique
- Author
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- Field of study
The Role of Compartmentation in the Control of Glycolysis
- Author
- Agren
- Allfrey
- Amberson
- Amberson
- Andersson-Cedergren
- Annau
- Annau
- Antony
- Appleman
- Arese
- Aris
- Arnold
- Arnold
- Arnold
- Astrachan
- Atkinson
- Baba
- Bakker
- Baranowski
- Barber
- Barker
- Barrett
- Baskin
- Bass
- Batschelet
- Beames
- Beamish
- Beauchamp
- Beis
- Belton
- Benesch
- Berg
- Berger
- Berry
- Besenfelder
- Black
- Black
- Black
- Blaedel
- Bloch
- Bohnensack
- Bone
- Braekkan
- Brandau
- Brdiczka
- Brosemer
- Brouwer
- Brown
- Bryant
- Bueding
- Bueding
- Busby
- Butterfield
- Bücher
- Bücher
- Bücher
- Bücher
- Bücher
- Carraway
- Chance
- Chance
- Chappell
- Cheah
- Cheng
- Christie
- Clark
- Clarke
- Clarke
- Clarke
- Clarke
- Clarke
- Cohen
- Cohen
- Colomb
- Cooke
- Cope
- Cori
- Cori
- Cori
- Coty
- Crane
- Craven
- Dagher
- Das
- Davies
- de Duve
- de Zwaan
- de Zwaan
- de Zwaan
- de Zwaan
- Diamant
- Dick
- DiMauro
- Dixon
- Dugal
- Dugal
- Dully
- Dölken
- Eaton
- Edzes
- Emmart
- Emmart
- Emmelot
- Engel
- Fahimi
- Fahimi
- Fairbairn
- Fairlamb
- Farlow
- Fawcett
- Fenichel
- Fenselau
- Fonnum
- Franzini-Armstrong
- Franzini-Armstrong
- Frenkel
- Fuller
- Garber
- Garfinkel
- Gatt
- Gear
- Ghosh
- Gibbs
- Giddings
- Giles
- Gilles
- Gimpel
- Gosselin-Rey
- Gosselin-Rey
- Granholm
- Green
- Greenbaum
- Greville
- Gumaa
- Gumaa
- Güttler
- Haft
- Halestrap
- Halestrap
- Halestrap
- Hamilton
- Hamm
- Hanson
- Harris
- Harris
- Harris
- Harris
- Harris
- Heath
- Heath
- Heber
- Heber
- Helmreich
- Henderson
- Hess
- Hess
- Hess
- Hess
- Hess
- Hill
- Hill
- Hillarp
- Hober
- Hochachka
- Hofer
- Hohorst
- Holbrook
- Holzer
- Houstek
- Huckabee
- Huckabee
- Huckabee
- Hultin
- Hultin
- Hultin
- Hultin
- Hübscher
- Illingworth
- Jacobs
- Jacobus
- Jarvie
- Kaback
- Kacser
- Kalant
- Kant
- Karpatkin
- Kato
- Keitt
- Keller
- Kilejan
- Kirk
- Kiyasu
- Klingenberg
- Klingenberg
- Klingenberg
- Klingenberg
- Klouwen
- Knull
- Knull
- Koch
- Kohen
- Kohen
- Korkes
- Krebs
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- Krebs
- Krebs
- Krebs
- Krietsch
- Kubista
- Kuehl
- Kushmerick
- Kuylenstierna
- Lai
- Lamartiniere
- Land
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- Landau
- Lange
- LaNoue
- Laris
- Lee
- Lee
- Leeflano-de-Pijper
- Leenders
- Lehninger
- Leive
- Lev
- Levinthal
- Ling
- Loewenstein
- Love
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- Lowry
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- Lynen
- Macnab
- Mansour
- Marco
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- Mersmann
- Meyer
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- Miller
- Minikami
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- Mowbray
- Mowbray
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- Nag
- Nelson
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- Nimmo
- Nineham
- Nisselbaum
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- O'Doherty
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- Oldendorf
- Onishi
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- Ostwald
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- Ottaway
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- Page
- Paglia
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- Palmieri
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- Parr
- Pastan
- Pepe
- Perry
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- Pette
- Pette
- Pette
- Pette
- Pette
- Pietrzyk
- Pletscher
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- Pocchiari
- Pollard
- Poon
- Portenhauser
- Porter
- Prankerd
- Preiss
- Prichard
- Purich
- Purich
- Racker
- Racker
- Rakusan
- Ray
- Ray
- Rayner
- Read
- Read
- Reed
- Reeves
- Reeves
- Ressler
- Rew
- Reynolds
- Robinson
- Robinson
- Roodyn
- Roodyn
- Roodyn
- Rosell
- Rutter
- Sacks
- Sacks
- Sacks
- Sacktor
- Sacktor
- Safer
- Saito
- Sarkar
- Saz
- Saz
- Saz
- Saz
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- Schneider
- Schnitger
- Scholz
- Schumacher
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- Scopes
- Scott
- Scrutton
- Seeley
- Seidman
- Seligman
- Shank
- Shaw
- Shaw
- Shin
- Shoemaker
- Shrago
- Siebert
- Siess
- Sigel
- Simpson
- Sims
- Singer
- Singer
- Skilleter
- Slater
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- Smith
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- Srere
- Srere
- Srere
- Starlinger
- Steck
- Stetten
- Stokes
- Strapazon
- Sugden
- Szent-Gyorgyi
- Szent-Gyorgyi
- Talesara
- Tanaka
- Tanner
- Tarui
- Tata
- Taylor
- Thomas
- Threlfall
- Thunberg
- Till
- Tinberg
- Touster
- Trentham
- Tsubai
- Turner
- Tygstrup
- Ullrich
- Utter
- Uyeda
- Vallejo
- Vardanis
- Veech
- Velick
- Venrooij
- von Brand
- von Jagow
- Wachsmuth
- Waddell
- Walker
- Walli
- Walli
- Wanson
- Warburg
- Warchol
- Watts
- Watts
- Weber
- Whelan
- Williamson
- Williamson
- Williamson
- Williamson
- Wilson
- Wilson
- Wilson
- Wins
- Wittenberger
- Wojtczak
- Wood
- Woods
- Yunis
- Zahlten
- Zelitch
- Ziegler
- Zierler
- Zierler
- Zorkoczy
- Zurcher
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/01/1977
- Field of study
Treatment of Anemia with Darbepoetin Alfa in Systolic Heart Failure
- Author
- Adams K
- Adams K
- Adamson P
- Adler A
- Admon D
- Agarwal D
- Aggarwal A
- Agostoni P
- Aguilar-Romero R
- Akshay S. Desai
- Albanese M
- Albizem M
- Albuquerque D
- Aldo P. Maggioni
- Almeida D
- Altenberger J
- Altschul L
- Altschuller A
- Alunni G
- Amerena J
- Amirani H
- Amuchastegui M
- Anand I
- Anand I
- Andreou C
- Angelo GD
- Anguita M
- Anker SD
- Anker SD
- Ansari M
- Antezana G
- Antonishen M
- Apetrei E
- Apetrei E
- Aroutiounov G
- Ashok J
- Aspe y Rosas J
- Aspe y Rosas J
- Badat A
- Bagdonas A
- Bahl V
- Ballyuzek M
- Banchs H
- Banerjee P
- Banerjee S
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- Barbagelata A
- Barkoudah E
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- Benn A
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- Berrazueta J
- Berry B
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- Bethala V
- Bilazarian S
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- Bisognano J
- Bleyer F
- Bluguermann J
- Blum M
- Boccanelli A
- Bocchi E
- Boehmer J
- Bolognese L
- Bordignon S
- Bordoloi A
- Bouchard A
- Boyle A
- Bozkurt B
- Bronnum-Schou J
- Brown C
- Bruckner I
- Bruguera i Cortada J
- Bugueno C
- Buijs E
- Burlew B
- Burnham K
- Butler J
- Butler J
- Caccavo M
- Call J
- Camacho A
- Cambier P
- Campana C
- Campbell P
- Cappola T
- Carasca E
- Carbonieri E
- Cardona Munoz E
- Cardona-Muñoz E
- Carlson R
- Carpino C
- Carr-White G
- Carson P
- Cartasegna L
- Castro P
- Castro-Jimenez J
- Celutkiene J
- Chandler B
- Chandra R
- Chandraratna P
- Charlier F
- Chavez-Herrera J
- Checco L
- Cheng S
- Chernick R
- Chockalingam K
- Chompalova B
- Chopda M
- Chopra V
- Chopra V
- Chou W
- Christopher O'Connor
- Chuquiure Valenzuela E
- Churina S
- Clausell N
- Cleland J
- Cleland J
- Clemmensen K
- Cohen Solal A
- Cohen-Solal A
- Cohn J
- Coisne D
- Colan D
- Colfer H
- Colque R
- Colucci W
- Coman I
- Conejeros C
- Connelly T
- Connolly E
- Corbalan R
- Cornel J
- Cosmi F
- Costantini O
- Csikasz J
- Cuneo C
- Czarnecki W
- Dabrowski M
- Dadkhah S
- Dalby A
- Dambrauskaite A
- Datcu M
- Dauber I
- Davis J
- Davis S
- Davy J
- Dawood S
- de Ceuninck M
- De Cristofaro M
- De Groote P
- De Keulenaer G
- De la Pena G
- de Leeuw M
- De Looze F
- de Teresa E
- Deegenaars M
- Delport E
- Dendale P
- Denning S
- Denny S
- Desai A
- Dezsi C
- Dickstein K
- Dickstein K
- Dijkgraaf R
- Dirk J. van Veldhuisen
- Donova T
- Dos Santos P
- Dougherty M
- Dragulescu S
- Drazner M
- Drexler H
- Dreykluft T
- Dugal J
- Dunlap M
- Dunlap S
- Dunselman P
- Dunselman P
- Dzupina A
- Ebner C
- Edes I
- Egbujiobi L
- Egstrup K
- Eha J
- El-Shahawy M
- Elkayam U
- Elliott J
- Ellis G
- Erglis A
- Erglis A
- Essandoh L
- Ewald G
- Fang J
- Farhoud H
- Felker G
- Felker M
- Fernandez A
- Fernandez J
- Festin R
- Finn PV
- Fishbane S
- Fishbein G
- Flesch M
- Fletcher P
- Florea V
- Flores E
- Floresta A
- Floro J
- Fonseca C
- Forster T
- Fouqueray B
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- Freericks M
- Froissart M
- Froment A
- Fucili A
- Funck F
- Gabito A
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- Gadd S
- Galinier M
- Galvani M
- Garda R
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- Gatewood R
- Geller M
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- Ghali J
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- Ghumman W
- Giannetti N
- Gibbs G
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- Gillespie E
- Gilmore R
- Glezer M
- Gogia H
- Goicochea R
- Goldberg L
- Goloshchekin B
- Gonzalez M
- Gonzalez-Maqueda I
- González Juanatey J
- Gorosito V
- Gorski J
- Gotchev D
- Goudev A
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- Gradus-Pizlo I
- Grainger T
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- Grigorov M
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- Guenova D
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- Gulabani D
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- Gómez Sánchez M
- Hack T
- Haddad H
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- Hall S
- Hambrecht R
- Hamraoui K
- Hamroff G
- Hankins S
- Hanna M
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- Hargrove J
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- Harris C
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- Hazelrigg M
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- Herold M
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- Herzog C
- Heywood J
- Hill T
- Hilton T
- Hiremath S
- Hirsch H
- Hole T
- Hominal M
- Howlett J
- Hradec J
- Hranai M
- Hunter J
- Huynh T
- Ibrahim H
- Imburgia M
- Inder S. Anand
- Ionescu P
- Iordachescu-Petica D
- Ireland M
- Isnard R
- Iteld B
- Ivanov D
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- Ivleva A
- Ivleva A
- Iyengar S
- Jackson B
- Jaffer A
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- Jagadeesa Subramania B
- Jain A
- Jain D
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- James B. Young
- James M
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- Jasinkevica I
- Jensen G
- Jerabek O
- Jeserich M
- Jimenez J
- Jirmar R
- John J.V. McMurray
- John M
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- Jordana R
- Joshi A
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- Karl Swedberg
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- Katz A
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- Kerekes C
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- Khan A
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- Klainman E
- Klapholz M
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- Kmec J
- Knussel B
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- Kober L
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- Korewicki J
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- Kotila M
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- Kreider-Stempfle H
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- Krum H
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- Law H
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- Light-McGroary K
- Lindsay S
- Linhart A
- Linssen G
- Litvak Bruno M
- Liu P
- Llanos J
- Lodewick P
- Lodewijks C
- Loh I
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- Lombardi W
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- Lopez Alvarado A
- Lopez-Sendon J
- Luksiene D
- Lupkovics G
- Lupon J
- Lycksell M
- Ma P
- Mabin T
- Machado C
- Mackinnon I
- Maislos F
- Mancini D
- Manitiu I
- Manolova A
- Manriquez L
- Manuale O
- Manyari D
- Manzano L
- Marc A. Pfeffer
- Marchev S
- Mareev V
- Markenvard J
- Markus T
- Marmor A
- Marra S
- Martinez D
- Martins Alves S
- Martynov A
- Marwick T
- Marzetti E
- Maréchal P
- Mather P
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- McCants K
- McGrew F
- McLaurin B
- McMillan E
- McMurray J
- McNamara D
- Megarry S
- Memon A
- Mendez Machado G
- Meyer T
- Meymandi S
- Michal Tendera
- Micko K
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- Minami E
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- Modi M
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- Muellerleile K
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- Scott D. Solomon
- Seabra Gomes R
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- Smith E
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- Sunfa Cheng
- Sussex B
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- Talibov O
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- Toblli J
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- Ujda M
- Vahala P
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- Van Bakel A
- van Dantzig J
- van der Burgh P
- van Kempen L
- van Vlies B
- Van Zyl L
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- Vanhaecke J
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- Vicari R
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- Vijayaraghavan K
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- Vita I
- Vittorio T
- Vizel S
- Vodnansky P
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- von Hodenberg E
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- Westheim A
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- Wikstrom G
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- Willenheimer R
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- Winkelmann B
- Witte K
- Wittmer B
- Wojciechowski D
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- Wong M
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- Wysokinski A
- Xu Z
- Yan Sun
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- Zadionchenko V
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- Zateyshchikov D
- Zhang Y
- Zimlichman R
- Zolty R.
- Publication venue
- Publication date
- 01/01/2013
- Field of study
<p>BACKGROUND</p><p>Patients with systolic heart failure and anemia have worse symptoms, functional capacity, and outcomes than those without anemia. We evaluated the effects of darbepoetin alfa on clinical outcomes in patients with systolic heart failure and anemia.</p><p>METHODS</p><p>In this randomized, double-blind trial, we assigned 2278 patients with systolic heart failure and mild-to-moderate anemia (hemoglobin level, 9.0 to 12.0 g per deciliter) to receive either darbepoetin alfa (to achieve a hemoglobin target of 13 g per deciliter) or placebo. The primary outcome was a composite of death from any cause or hospitalization for worsening heart failure.</p><p>RESULTS</p><p>The primary outcome occurred in 576 of 1136 patients (50.7%) in the darbepoetin alfa group and 565 of 1142 patients (49.5%) in the placebo group (hazard ratio in the darbepoetin alfa group, 1.01; 95% confidence interval, 0.90 to 1.13; P = 0.87). There was no significant between-group difference in any of the secondary outcomes. The neutral effect of darbepoetin alfa was consistent across all prespecified subgroups. Fatal or nonfatal stroke occurred in 42 patients (3.7%) in the darbepoetin alfa group and 31 patients (2.7%) in the placebo group (P = 0.23). Thromboembolic adverse events were reported in 153 patients (13.5%) in the darbepoetin alfa group and 114 patients (10.0%) in the placebo group (P = 0.01). Cancer-related adverse events were similar in the two study groups.</p><p>CONCLUSIONS</p><p>Treatment with darbepoetin alfa did not improve clinical outcomes in patients with systolic heart failure and mild-to-moderate anemia. Our findings do not support the use of darbepoetin alfa in these patients. (Funded by Amgen; RED-HF ClinicalTrials.gov number, NCT00358215.)</p>
Edoxaban versus warfarin in patients with atrial fibrillation
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- Abdullakutty J
- Abi-Mansour P
- Abril SB
- Accini J
- Accini M
- Acikel M
- Acikel M
- Adachi C
- Adams K
- Adams K
- Adamus J
- Adler J
- Adler P
- Agarwal D
- Aggarwal R
- Aggarwal R
- Agirov M
- Agraou B
- Ahmad A
- Ahmadpour H
- Ahuad Guerrero R
- Ajioka M
- Akhter F
- Akihisa U
- Akilli H
- Al-Maliky T
- Al-Zoebi A
- Albert L. Waldo
- Albisu J
- Albulescu P
- Alexander J
- Alexandrova L
- Alexopoulos D
- Alexopoulos D
- Alhakim M
- Aliyar P
- Allall O
- Allison J
- Allman J
- Almaraz SP
- Almeida A
- Almeida M
- Almquist A
- Aloni I
- Alsheikh T
- Altonen D
- Alvarez C
- Alvarez M
- Alvarez RF
- Amarenco P
- Amato Vincenzo de Paola A
- Ambrovic I
- Ambrovicova V
- Ameriso P
- Ameriso S
- Amin K
- Amin M
- Amuchastegui M
- Anciu M
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- Anderson J
- Anderson J
- Andersson R
- Andor M
- Andrade Lotufo P
- Andresen T
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- Angel J
- Anscombe R
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- Antle S
- Antman EM
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- Antonino M
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- Apostolovic S
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- Yahata A
- Yakusevich V
- Yakushin S
- Yalcin R
- Yalcin R
- Yamabe H
- Yamada T
- Yamagishi K
- Yamagishi T
- Yamaguchi A
- Yamamoto Y
- Yamano R
- Yamashina A
- Yamashita T
- Yamashita T
- Yanac Chavez P
- Yang K
- Yang Y
- Yang YJ
- Yang ZY
- Yarows S
- Yasin M
- Yasumoto S
- Yeh HI
- Yeh TC
- Yena L
- Yi J
- Yigit F
- Yigit F
- Yigit Z
- Yigit Z
- Yin YH
- Yonehara T
- York T
- Yoshida K
- Yoshida K
- Yoshino H
- Yoshioka K
- You ZG
- Young C
- Young C
- Young G
- Young K
- Yousuf K
- Yovaniniz P
- Yu B
- Yu WC
- Yuan ZY
- Yukhno E
- Yukihiro Koretsune
- Yumoto I
- Zachar A
- Zacà V
- Zajac E
- Zakhary B
- Zamlynskyy M
- Zamorano JL
- Zanotti A
- Zanwar I
- Zapanta M
- Zarandon RS
- Zarebinski M
- Zareczky P
- Zarpentin C
- Zateyshchikov D
- Zateyshchikova A
- Zeig S
- Zellner C
- Zeltser D
- Zenin S
- Zhang HQ
- Zhang P
- Zhang X
- Zhang YL
- Zhang Z
- Zhao RP
- Zhao XL
- Zharinov O
- Zheng X
- Zheng Y
- Zheng ZQ
- Zhou SX
- Zhukova N
- Zhurba S
- Zidkova E
- Zidkova E
- Ziegler K
- Zielinski M
- Zienciuk-Krajka A
- Zimmermann EB
- Zimmermann S
- Zoghi M
- Zoghi M
- Zondag M
- Zotova I
- Zubeeva G
- Zyatenkova E
- Åkerberg A
- Östberg S
- Ŝpinar 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.)