8 research outputs found
Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19
- Author
- ?ivko Iris
- Abbass Hakam
- Abdeladim Lilia
- Abdelhady Hesham
- Abdelkharim Hussam
- Abdelrazik Marwa
- Abdi Zakee
- Abdukahil Sheryl Ann
- Abel Lynn
- Abraham Jacinta
- Abrahamson Gail
- Abusamra Yousuf
- Aceto Romina
- Adams Nick
- Adams Peter
- Adebambo Olumide
- Adhikari Neill
- Adhikari Sheetal
- Affleck Julia
- Agha Gloria
- Aghemo Alessio
- Agno Ronan
- Ahmad Norfaizan
- Ain Quratul
- Ainscough Kate
- Ainsworth James
- Aitken Lindianne
- Akamp Ceren
- Al Enezi Farhan
- Al-Bassam Wisam
- Al-Beidh Farah
- Albert Martin
- Albrett Jonathan
- Alderman Meera
- Aldo Bonizzoni Matteo
- Alegria Ana
- Alessandro Carà Gianmarco
- Alexander Brian
- Alexander Peter
- Alfonso Jordan
- Ali Maryam
- Ali Murtaza
- Allam Hayat
- Allen Barbara
- Allen Louise
- Allibone Suzanne
- Almeshhedani Hasham
- AlQahtani Samah
- Alswaidan Lolowa
- Altomy Mohammed
- Al Amri Ali
- Al Qasim Eman
- Amatya Sameena
- Ambrosino Richard
- Anderson Thomas
- Andreae Mark
- Aneman Anders
- Angus Derek C.
- Anjum Aisha
- Ankert Juliane
- Annane Djillali
- Anne-Laure Fedou
- Anstey Matthew
- Antcliffe David
- Anthony Alpha
- Antoine Marchalot
- Antoine Pierre
- Antoine Studer
- Anumakonda Vikram
- Aparicio Christelle
- Aquino Maia
- Arabi Yaseen M.
- Arachchige Malka
- Aravindan Latha
- Arbane Gill
- Archambault Patrick
- Archer Simon
- Aref Noah
- Arias Ana-Marie
- Arias Sonia
- Arishi Hatim
- Arnold Donald
- Arnold John
- Arnott Andrew
- Arora Anand
- Aryal Diptesh
- Asghar Adeeba
- Asif Namra
- Aspinwall Angelique
- Attokaran Antony
- Attwood Ben
- Au Carly
- Audry Mathilde
- Austin Karen
- Austin Pauline
- Auvet Adrien
- Avard Bronwyn
- Awan Sidra
- Ayee Robert
- Azaiz Amine
- Azzaui Harun
- Babu Suresh
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- Badie Julio
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- Bagot Catherine
- Bagshaw Sean
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- Baillie Kenneth
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- Barker Stephanie
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- Baron Rebecca M.
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- Bartley Shauna
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- Basile Kim
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- Wright Kim
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- Xavier Kugan
- Yamagishi Yoshiaki
- Yamashita Chizuru
- Yang Yang
- Yarad Elizabeth
- Yates Bryan
- Yates David
- Yealy Donald
- Young Ian
- Young Meredith
- Young Paul
- Youngstein Taryn
- Yu Haili
- Yusuff Hakeem
- Zaharia Mihaela
- Zaidi Abbas
- Zaki Ahmed
- Zaman Mohsin
- Zarychanski Ryan
- Zdanavidiene Ausra
- Zhao Xiao
- Zinzoni Vanessa
- Zitter Letizia
- Zouita Louisa
- Publication venue
- 'American Medical Association (AMA)'
- Publication date
- 11/04/2023
- Field of study
IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19.
Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19.
DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022).
INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days.
MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes.
RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively).
CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes.
TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570
Ansiedade em Provas: um Estudo na Obtenção da Licença para Dirigir
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- Field of study
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- Enrique Alvarez
- Erik Strauss
- Eugen Schlegel
- Eva Meluzinova
- Eva-Maria Maida
- Evanthia Bernitsas
- Faria Amjad
- Farit Axatovich Khabirov
- Filipe Correia
- Florian Then Bergh
- Francesco Sacca
- Francois Emond
- Francois Grandmaison
- Francois Jacques
- Fredrik Piehl
- Fritz Leutmezer
- Gabriel Pardo
- Garry R Cutter
- Gemma Reig Rosello
- Geoffrey Eubank
- Georgi Krastev
- Gerald Mcintosh
- Gereon Nelles
- Giacomo Lus
- Giancarlo Comi
- Giles F Crowell
- Gilles Edan
- Giovanni Castelnovo
- Girolama Alessandra Marfia
- Goodyear A.
- Guntis Karelis
- Guy Laureys
- Halina Bartosik Psujek
- Hana Bokun
- Hans-Peter Hartung
- Haring D. A.
- Hauser S. L.
- Hayrettin Tumani
- Heinz Wiendl
- Helle Hvilsted Nielsen
- Hemanth Rao
- Husnu Efendi
- Igor Antoncic
- Igor Stolyarov
- Igor Vyacheslavovich Litvinenko
- Irina Aleksandrovna Sokolova
- Israel Steiner
- Ivan Milanov
- Ivana Stetkarova
- Ivaylo Tarnev
- Iwona Jastrzebska
- J Michael Hemphill
- Jack H Florin
- Jacqueline Nicholas
- James Napier
- James Overell
- James Scott
- Jan Lycke
- Jan Mares
- Jaroslaw Slawek
- Jason M Silversteen
- Javier Vasallo
- Jean-Raphael Schneider
- Jeanette Wendt
- Jeannette Lechner-Scott
- Jeffrey A Cohen
- Jeffrey Cohen
- Jeffrey Gross
- Jeffrey Groves
- Jeffrey Kaplan
- Jerome de Seze
- Jerry S Wolinsky
- Jessica Stulc
- Jeyaraj Durai Pandian
- Jo Caekebeke
- Joanna A Cooper
- Joao Cerqueira
- Joao De Sa
- John Foley
- John Parratt
- John Scagnelli
- Jolana Markova
- Jolanta Kalnina
- Jonathan C Calkwood
- Jorge Correale
- Jorge Gustavo Jose
- Jose Carlos Alvarez Cermeño
- Jose Martinez Rodriguez
- Jose Meca Lallana
- Jose Pizarro Otero
- Jose Rafecas
- Joshua Katz
- Joy Dev Mukherji
- Juan Antonio Garcia Merino
- Juan Jose Lopez Prieto
- Juha Pekka Eralinna
- Juliette S Saad
- Julio Perez
- Kakarieka A.
- Kappos L.
- Karine Geens
- Karl-Otto Sigel
- Katherine Standley
- Katrin Gross-Paju
- Keith Edwards
- Kenneth Sharlin
- Kerloeguen C.
- Khurram Bashir
- Kimberly Wagner
- Konstantinos Kilidireas
- Konstantinos Voumvourakis
- Kore Liow
- Kristina Svendsen
- Krisztina Kovacs
- Krzysztof Selmaj
- Larisa Ivanovna Volkova
- Larry Lee Blankenship Jr
- Laszlo Mate
- Laszlo Vecsei
- Laura Brambilla
- Lekha Pandit
- Leppert D.
- Li B.
- Liesly Lee
- Liliana Montoya
- Livia De Sousa
- Lluis Ramio Torrenta
- Lon D Lynn
- Lucia Forero Diaz
- Lucienne Costa Frossard Franca
- Ludo Vanopdenbosch
- Ludwig Kappos
- Luis Querol Gutierrez
- Lyubomir Haralanov
- M Mateo Paz Soldan
- Maciej Maciejowski
- Mads Ravnborg
- Marc Debouverie
- Marco Salvetti
- Maria Manova Slavova
- Maria Nikolaevna Zaharova
- Maria Vafaevna Davydovskaya
- Marie Sarah Gagne Brosseau
- Marija Bosnjak Pasic
- Mario Habek
- Marja-Liisa Sumelahti
- Mark Agius
- Mark Allan Goldstein
- Mark Cascione
- Mark Freedman
- Mark Janicki
- Marta Vachova
- Martin Cloutier
- Martin Gavidia
- Martin R Bialow
- Martin Stangel
- Martin Valis
- Mary Denise Hughes
- Massimo Filippi
- Matthew Craner
- Matthew J Baker
- Matthias Boehringer
- Mauro Zaffaroni
- Meena Angamuthu Kanikannan
- Merschhemke M.
- Michael Isaacs
- Michaela Tyblova
- Michal Dufek
- Michelle Apperson
- Michelle B Kuczma
- Mirela Cerghet
- Miroslav Brozman
- Miroslaw Dziki
- Monika Adamczyk Sowa
- Montalban X.
- Murat Terzi
- Nadezhda Alekseevna Malkova
- Natalia Agafonovna Totolyan
- Nathaniel Robb Whaley
- Nikolaos Fakas
- Nikolaos Grigoriadis
- Nikolay Vasilievich Dorogov
- Norma Haydee Deri
- Olaf Martin Hoffmann
- Olivier Deryck
- Ondrej Skoda
- Pahari Ghosh
- Paolo Gallo
- Patricia K Coyle
- Patrick Oschmann
- Patrick Vermersch
- Paul K Winner
- Pavel Hradilek
- Pavle Repovic
- Pedro Serrano Castro
- Penko Shotekov
- Per Soelberg Sørensen
- Peter Koleda
- Peter Turcani
- Peter Valkovic
- Peter Van Domburg
- Peter Vestergaard Rasmussen
- Pierre Clavelou
- Pierre Labauge
- Pingili R.
- Praful Kelkar
- Radi Shahien
- Rafael Arroyo Gonzalez
- Rahul Chakor
- Rahul Kulkarni
- Ramanathan K.
- Randall Trudell
- Raquel Gouveia
- Rasa Kizlaitiene
- Raymond Hupperts
- Reinhard Hohlfeld
- Ricardo Ayala
- Richard Sater
- Robert Bonek
- Robert Carruthers
- Robert Fairborn Armstrong
- Robert Naismith
- Robert Thomas Nahouraii
- Rogier Q Hintzen
- Romero Rekha Pillai
- Ron Milo
- Ronald S Murray
- Roopkumar Gursahani
- Samuel Hunter
- Sangeeta Ravat
- Sara Eichau Madueño
- Sara Qureshi
- Sarah Morrow
- Satori Maria
- Selmaj K.
- Sergio Martinez Yelamos
- Serhan Sevim
- Serkan Ozakbas
- Sharon Lynch
- Sibyl Wray
- Silke Walter
- Silva Butkovic Soldo
- Silvia R Delgado
- Silvia Rossi
- Simona Bonavita
- Somsak Tiamkao
- Srinivasa Rangasetty
- Stacy Donlon
- Stanley Cohan
- Stanya Smith
- Stella Anatolievna Sivertseva
- Stephen C Reingold
- Stephen L Hauser
- Stuart James Shafer
- Sulev Haldre
- Suresh Kumar
- Susan Azalone
- Susan Hibbs
- Susana Liwacki
- Suzanne Hodgkinson
- Sylvia Menck
- Tamara A Miller
- Tamara Castillo Trivino
- Thomas Doerner
- Thomas Giancarlo
- Thy-Sheng Lin
- Till Sprenger
- Tjalf Ziemssen
- Tobias Derfuss
- Tomic D.
- Troy Desai
- Valeria Studer
- Valerie Delvaux
- Varun K Saxena
- Veit Ulrich Becker
- Vera Straeten
- Viera Hancinova
- Vincent Van Pesch
- Virgina Meca Lallana
- Virginia Simnad
- Vladimir Donath
- Vladimira Vuletic
- Waldemar Fryze
- Wiendl H.
- Willi R.
- William David Honeycutt
- William E McElveen
- William Logan
- William Wagner
- Xavier Montalban
- Xaviere Montalban Gairin
- Yves Lapierre
- Zita Biro
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2020
- Field of study
BACKGROUND: Ofatumumab, a subcutaneous anti-CD20 monoclonal antibody, selectively depletes B cells. Teriflunomide, an oral inhibitor of pyrimidine synthesis, reduces T-cell and B-cell activation. The relative effects of these two drugs in patients with multiple sclerosis are not known. METHODS: In two double-blind, double-dummy, phase 3 trials, we randomly assigned patients with relapsing multiple sclerosis to receive subcutaneous ofatumumab (20 mg every 4 weeks after 20-mg loading doses at days 1, 7, and 14) or oral teriflunomide (14 mg daily) for up to 30 months. The primary end point was the annualized relapse rate. Secondary end points included disability worsening confirmed at 3 months or 6 months, disability improvement confirmed at 6 months, the number of gadolinium-enhancing lesions per T1-weighted magnetic resonance imaging (MRI) scan, the annualized rate of new or enlarging lesions on T2-weighted MRI, serum neurofilament light chain levels at month 3, and change in brain volume. RESULTS: Overall, 946 patients were assigned to receive ofatumumab and 936 to receive teriflunomide; the median follow-up was 1.6 years. The annualized relapse rates in the ofatumumab and teriflunomide groups were 0.11 and 0.22, respectively, in trial 1 (difference, -0.11; 95% confidence interval [CI], -0.16 to -0.06; P<0.001) and 0.10 and 0.25 in trial 2 (difference, -0.15; 95% CI, -0.20 to -0.09; P<0.001). In the pooled trials, the percentage of patients with disability worsening confirmed at 3 months was 10.9% with ofatumumab and 15.0% with teriflunomide (hazard ratio, 0.66; P = 0.002); the percentage with disability worsening confirmed at 6 months was 8.1% and 12.0%, respectively (hazard ratio, 0.68; P = 0.01); and the percentage with disability improvement confirmed at 6 months was 11.0% and 8.1% (hazard ratio, 1.35; P = 0.09). The number of gadolinium-enhancing lesions per T1-weighted MRI scan, the annualized rate of lesions on T2-weighted MRI, and serum neurofilament light chain levels, but not the change in brain volume, were in the same direction as the primary end point. Injection-related reactions occurred in 20.2% in the ofatumumab group and in 15.0% in the teriflunomide group (placebo injections). Serious infections occurred in 2.5% and 1.8% of the patients in the respective groups. CONCLUSIONS: Among patients with multiple sclerosis, ofatumumab was associated with lower annualized relapse rates than teriflunomide. (Funded by Novartis; ASCLEPIOS I and II ClinicalTrials.gov numbers, NCT02792218 and NCT02792231.)