2 research outputs found
Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial
- Author
- Abbas Jalal
- Abraham Sybil
- Ackert Jessica
- Adams Patricia
- Aggarwala Gaurav
- Aher Nutan
- Ahlqvist JĂžrn
- Ahn Chul Woo
- Akers Teresa
- Akhras Ronald
- Akhter Faiq
- Aksentyev Sergey
- Al Kawas Firas
- Alexander Karen
- Althouse Denise
- Altobelli Desma
- Alvarisqueta Andres
- Ambrosy Andrew
- Andersen James
- Andersen Ulla
- Anderson Michelle
- Anglade Moise
- Arbañil Hugo
- Arciszewska Malgorzata
- Argoud Georges
- Ariani Mehrdad
- Ashdji Reswan
- Avogaro Angelo
- Avramidis Iakovos
- Axthelm Christoph
- Aye Myint
- Babi Charleen
- Bachus Erasmus
- Baik Sei-Hyun
- Bailey Matt
- Bakhtari Ladan
- Baksi Arun
- Balasubramani Mathangi
- Baldovino Jorge
- Banach Marek
- Banerjee Subhash
- Bartlett Andrew
- Bartone Susan
- Baum Howard
- Bays Harold
- Bazhan Larysa
- Beasley Richard
- Beaudry Yves
- Beaulieu Gail
- Beboso Ronnie
- Bedard Jacques
- Beijerbacht Hugo Peter
- Belfort de Aguiar Renata
- Benjamin Sabrina
- Berger Dirk
- Berlingieri Joseph
- Berndtsson Blom Katarina
- Besada Diego
- Bethel M Angelyn
- Bhagwat Ravi
- Bhargava Anuj
- Bhosale Archana
- Bieler Tasso
- Bijata-Bronisz Renata
- Birkeland Kare
- Birkenfeld Andreas
- Blagden Mark
- Bloomfield Gerald
- Bode Bruce
- Boemi Massimo
- Bonadonna Riccardo
- Bondar Irina
- Bott Jochen
- Bousboulas Stavros
- Boye Alain
- Bratcher Christina
- Breneman Jody
- Briskin Toby
- Bristianou Magdalini
- Brockmyre Andrew
- Broughton Raymond
- Brown Judith
- Brown Kim
- Brychta Tomas
- BrĂžnnum-Schou Jens
- Budhraja Madhusudan
- Bull Georgina
- Bundy Charles
- Burgess Lesley
- Busch Klaus
- Caca Karel
- Cadinot Didier
- Calderon Jorge
- Calella Pedro
- Califf Robert M
- Calvo GĂłmez Carlos
- Camacho Luis
- Cannon Kevin
- Cano RodrĂguez Isidoro
- Cantero Maria Cecilia
- Carr Jewell
- Casson Ed
- Castaño Patricia
- Castro Conde Almudena
- Cathcart Harold
- Cavale Arvind
- Cech Vladimir
- Cequier Fillat Angel
- Cervantes-EscĂĄrcega Jose-Luis
- Cha Bong-Soo
- Chau Tuan
- Chaykin Louis
- Chehayeb Raja
- Chen David
- Chen Jung-Fu
- Chertkoff Alejandro
- Cheung Deanna
- Cheung Stephen
- Chevts Julia
- Chiang Chern-En
- Childress Richard
- Christian Tamra
- Chung Choon-Hee
- Coetzee Kathleen
- Cohen Allan
- Coker Rebecca
- Cole Joanna
- Collier Jeannie
- Condit Jonathan
- Consoli Agostino
- Conway James
- Cooksey Erin
- Cookson Tobias
- Cooper John
- Cooper Lauren
- Copland Allan
- Cornel Jan
- Cornett George Mitchell
- Crenier Laurent
- Cuadrado Jesus
- Cuatrecasas Cambra Guillem
- Cusson Jean
- D'Agostino Ralph B
- D'Agostino Ralph B.
- Daga Shruti
- Damyanova Velichka
- Dauber Ira
- Davila William
- Dawood Saleem
- De Armas Luis
- De Cosmo Salvatore
- De Loredo Luis
- De Teresa Parreño Luis
- de Ălvaro Moreno Fernando
- Dean Julius
- Debroye Corinne
- Del Prato Stefano
- Del Prato Stefano
- Delgado Lista Javier
- Della Siega Anthony
- DeMets David
- Demidova Irina
- Derezinski Tadeusz
- Deshpande Sameer
- Detweiler Robert
- Devore Adam
- Di Bartolo Paolo
- Di Giovanna Michael
- Diaz Ernesto
- Dimitriadis Georgios
- Dimitrov Stefan
- Distiller Larry
- Dombrowski Keith
- Dominguez Andrea
- DomĂnguez Escribano JosĂ© RamĂłn
- Donaldson Jill
- Donaubauer Torsten
- Dor Isaac
- Dotta Francesco
- Dreval Alexander
- Drummond Waymon
- Dumas Richard
- Dumbre Snehal
- Dungan Kathleen
- DurĂĄn GarcĂa Santiago
- Duyck Francis
- Dvorakova Eva
- Dzongowski Peter
- Eagerton Donald
- Eapen Zubin
- Earl John
- Eaton Charles
- Ebo Geraldine
- Edelsberger Tomas
- Eliasson Bjorn
- Eliasson Ken
- Elisaf Moses
- Ellison Howard
- Elvira GonzĂĄlez Javier
- Emslie-Smith Alistair
- Endsley Patricia
- Enns Robert
- Erlinger Rudolf
- Ershova Olga
- Español Maria Vanesa
- Espinoza Augusto Dextre
- Farris Neil
- Ferguson Murdo
- Fernandez-Salazar Eva
- FernĂĄndez RodrĂguez JosĂ© MarĂa
- Fiel Thomas
- Finkelstein Hernan
- Firek Anthony
- First Brian
- Fleming John
- Flota-Cervera Luis Fernando
- Forgosh Les
- Frechtel Gustavo
- French William
- Fretes Jose
- Friedman Daniel
- Frontoni Simona
- Funke Klaus
- Fushtey Ivan
- Gadzinski Waldemar
- Gajek Jacek
- Galatius SĂžren
- Galetta Marianna
- Galstyan Gagik
- Gambineri Alessandra
- Gandy Winston
- Garcia Ronald
- Garganeeva Alla
- Garrido Santos Natalia
- Garrido Elizabeth
- Garvey Louisa
- Gaudet Daniel
- Gazzaruso Carmine
- Gentry Tracy
- Giaccari Andrea
- Gill Santosh
- Giorgino Francesco
- Goday Arno Alberto
- Godse Rupali
- Gomez Huelgas Ricardo
- Gonzales Rolando Vargas
- Gonzalez Joaquin
- Gonzålez Juanatey José Ramón
- Gonzålez-Gonzålez José Gerardo
- Goodman Shaun
- Gordon Murray
- Gouet Didier
- Grachova Mariya
- Granger Christopher B
- Granger Christopher B.
- Green Fiona
- Green Jennifer B
- Green Jennifer B
- Greene Deb
- Greene Stephen
- Grondin Francois
- Grosskopf Josef
- Groutars Reginald G.E.J.
- Guerci Bruno
- Guice Michael
- Guimaraes Patricia
- Gulseth Hanne
- Gummadi Siva
- Gunstone Anthony
- Gupta Anil
- Gupta Milan
- Gupta Nikita
- Guttormsen Gaute
- Ha JuYoung
- Hackenyos Jonathan
- Haddock Trevorlyn
- Hagenow Andreas
- Hairston Kristen
- HajdĂș Csaba
- Halciakova Katarina
- Halperin Frank
- Haluzik Martin
- Hamann Monika
- Hanson Lenita
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- Hartard Manfred
- Hartman Israel
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- Hejeebu Srini
- Henry Patrick
- Hereghty Belinda
- Hermany Paul
- Hernandez Mijares Antonio
- Hernandez Adrian F
- Hernandez Adrian F.
- Hernandez-Cassis Carlos
- Heymer Peter
- Hidalgo Horacio
- Higgins Alexander
- Hoek Boudewijn A
- Holman Rury
- Hoogslag Pieter A.M.
- Houle Pierre-Alain
- Hove Jens
- Howell Christina
- Hramiak Irene
- Huppertz Wolfgang
- Hutayanon Pisit
- Ibrahim Hassan
- Illies Gabriele
- Issa Basil
- Izmozherova Nadezhda
- Jackson-Voyzey Ewart
- Jacob Stephan
- Jacobs Shahram
- James Kourtnei
- James Rachel
- Jang Hak Chul
- Janmohamed Salim
- Janmohamed Salim
- Jarosz Marie
- Jenkins Wendy
- Jensen Jan Skov
- Jerjes-DĂaz Carlos SĂĄnchez
- JimĂ©nez DĂaz VĂctor Alfonso
- Jintapakorn Woravut
- Jodar Gimeno Esteban
- Johnson Andrew
- Johnson David
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- Khandelwal Chaitali
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- Khariouzov Andrei
- Khokhlov Aleksandr
- Kim Chong-Jin
- Kim Christopher
- Kim Ellen
- Kim Hye Soon
- Kim In Joo
- Kirby William
- Klausmann Gerhard
- Klein Christiane
- Kleinecke-Pohl Uwe
- Kleinertz Klaus
- Klodawska Katarzyna
- Knouse Albert
- Kobalava Zhanna
- Kober Lars
- Koch Thorsten
- Kocsis Gyozo
- Kolls Brad
- Kong David
- Konyves Laszlo
- Kooy Adriaan
- Korpachev Vadym
- Kosch Christine
- Koshelskaya Olga
- Kosiborod Mikhail
- Koskinen Pekka
- Kosmacheva Elena
- Kostin Vladimir
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- Kovacs Christopher
- Koziolova Natalia
- Kragten Johannes A.
- Kravchun Nonna
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- Lastuvka Jiri
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- Leiter Lawrence A
- Leiter Lawrence A.
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- Lenzmeier Thomas
- Lesnov Victor
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- Taft Lin
- Tahir Mohammed
- Tan Anjanette
- Tan Choon Beng Kathryn
- Tan Marilyn
- Taylon Alain
- Tentolouris Nikolaos
- Tews Dietrich
- Thakkar Maitreya
- Thomas Betsy
- Thorpe Karl
- Thorpe Karl M
- Thuan Jean-Francois
- Tien Kai Jen
- Tinahones Madueno Francisco
- Tirador Louie
- Tonolo Giancarlo
- Torres-Colores Jose Juan
- Torstensson Ingemar
- Trescoli Serrano Carlos
- Trevisan Roberto
- Tricoci Pierluigi
- Tripathy Devjit
- Trznadel-Morawska Iwona
- Tsapas Apostolos
- Tschoepe Diethelm
- Tseng Shih-Ting
- Tu Shih-Te
- Tugwell Barna
- Tzatzagou Glykeria
- Ulied Armiñana Angels
- Ulla Maria
- Urbanek Robin
- Uwaifo Gabriel
- Van Gaal Luc
- Vandyne Beth
- Vaphare Ashok
- Vasilevskaya Olga
- Vass Viktor
- Vedere Amarnath
- Vemulapalli Sreekanth
- Venugopal Chandra
- Verbovaya Nelli
- Vercammen Chris
- Verra Fernando
- Vidrio-VelĂĄzquez Maricela
- Viergever Eric P.
- Villagordoa-Mesa Juan
- Vishneva Elena
- Vizel Saul
- Vlasenko Maryna
- Vo Anthony
- Voinot Christel
- Vorobyev Sergey
- Vorokhobina Natalya
- Vouillarmet Julien
- Vrkoc Jan
- Wang Chih-Yuan
- Wang Ji-Hung
- Watson Anthony
- Watson David
- Welch Michelle
- Welker James
- White Alexander
- Wilhelm Karl
- Willis John
- Wilson Matt
- Wilson Tim
- Witek Robert
- Wium Cecilie
- Womer Terese
- Woo Vincent
- Wraight Ella
- Wynne Alan
- Xing Weibing
- Yamwong Sukit
- Yazdani Shahram
- Ye June
- Yoo Soon Jib
- Yordanov Victor
- Yu Jaemyung
- Zabalua Silvina
- Zaidman Cesar
- Zang Eddie
- Zanozina Olga
- Zeller-Stefan Helga
- Zhdanova Elena
- Zlova Tetiana
- Zubiate Carlos
- Zykova Tatyana
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/01/2018
- Field of study
Background:
Glucagon-like peptide 1 receptor agonists differ in chemical structure, duration of action, and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. We aimed to determine the safety and efficacy of albiglutide in preventing cardiovascular death, myocardial infarction, or stroke.
Methods:
We did a double-blind, randomised, placebo-controlled trial in 610 sites across 28 countries. We randomly assigned patients aged 40 years and older with type 2 diabetes and cardiovascular disease (at a 1:1 ratio) to groups that either received a subcutaneous injection of albiglutide (30â50 mg, based on glycaemic response and tolerability) or of a matched volume of placebo once a week, in addition to their standard care. Investigators used an interactive voice or web response system to obtain treatment assignment, and patients and all study investigators were masked to their treatment allocation. We hypothesised that albiglutide would be non-inferior to placebo for the primary outcome of the first occurrence of cardiovascular death, myocardial infarction, or stroke, which was assessed in the intention-to-treat population. If non-inferiority was confirmed by an upper limit of the 95% CI for a hazard ratio of less than 1·30, closed testing for superiority was prespecified. This study is registered with ClinicalTrials.gov, number NCT02465515.
Findings:
Patients were screened between July 1, 2015, and Nov 24, 2016. 10â793 patients were screened and 9463 participants were enrolled and randomly assigned to groups: 4731 patients were assigned to receive albiglutide and 4732 patients to receive placebo. On Nov 8, 2017, it was determined that 611 primary endpoints and a median follow-up of at least 1·5 years had accrued, and participants returned for a final visit and discontinuation from study treatment; the last patient visit was on March 12, 2018. These 9463 patients, the intention-to-treat population, were evaluated for a median duration of 1·6 years and were assessed for the primary outcome. The primary composite outcome occurred in 338 (7%) of 4731 patients at an incidence rate of 4·6 events per 100 person-years in the albiglutide group and in 428 (9%) of 4732 patients at an incidence rate of 5·9 events per 100 person-years in the placebo group (hazard ratio 0·78, 95% CI 0·68â0·90), which indicated that albiglutide was superior to placebo (p<0·0001 for non-inferiority; p=0·0006 for superiority). The incidence of acute pancreatitis (ten patients in the albiglutide group and seven patients in the placebo group), pancreatic cancer (six patients in the albiglutide group and five patients in the placebo group), medullary thyroid carcinoma (zero patients in both groups), and other serious adverse events did not differ between the two groups. There were three (<1%) deaths in the placebo group that were assessed by investigators, who were masked to study drug assignment, to be treatment-related and two (<1%) deaths in the albiglutide group.
Interpretation:
In patients with type 2 diabetes and cardiovascular disease, albiglutide was superior to placebo with respect to major adverse cardiovascular events. Evidence-based glucagon-like peptide 1 receptor agonists should therefore be considered as part of a comprehensive strategy to reduce the risk of cardiovascular events in patients with type 2 diabetes.
Funding:
GlaxoSmithKline
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 CarĂ 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
- Bacon Gina
- Badalamenti Salvatore
- Badie Julio
- Bagavathy Kavitha
- Bagot Catherine
- Bagshaw Sean
- Baig Nadia
- Baikady Ravishankar
- Bailey Lucy
- Baillie Kenneth
- Bain William
- Baker Alice
- Baker Evelyn
- Baker Stuart
- Bakthavatsalam Dhanalakshmi
- Balaie Morteza
- Balls-Burgess Sam
- Bamford Amy
- Bamford Peter
- Banach Dorota
- Bannard-Smith Jonathan
- Barbash Ian
- Barber Russell
- Barbier François
- Barge Deborah
- Bariola Ryan
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- de Courcy-Golder Kim
- de Groot Klaas
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- Derde Lennie P. G.
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- Detry Michelle A.
- Deye Nicolas
- de la Fuente Carmen
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- Godoy Lucas C.
- Goebeler M.E.
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- Hall Alistair S
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- Harris Celia
- Harris Jade
- Harris John
- Harrison David A.
- Harrison Susan
- Harrow Kath
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- Harvala-Simmonds Heli
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- Hey Samuel
- Hickey John
- Hierons Sarah
- Higgins Alisa M.
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- Hornsby James
- Horton Michelle
- Horvat Christopher M.
- Howcroft Clare
- Howell Alice
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- Howie Lucy
- Howle Ryan
- Hoxha Elvira
- Huang David T.
- Hughes Debbie
- Hugill Keith
- Huijbens Danique
- Hullegie Sebastiaan
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- Kremling Julius
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- Krishnamurthy Vinodh
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- Le Basnier Elliot
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- Lewis Sarah
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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 nonâcritically 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 (nâ=â257), ARB (nâ=â248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; nâ=â10), or no RAS inhibitor (control; nâ=â264) for up to 10 days.
MAIN OUTCOMES AND MEASURES The primary outcome was organ supportâfree 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 supportâfree days among critically ill patients was 10 (â1 to 16) in the ACE inhibitor group (nâ=â231), 8 (â1 to 17) in the ARB group (nâ=â217), and 12 (0 to 17) in the control group (nâ=â231) (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 supportâfree 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