9 research outputs found
Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial
- Author
- Abdel-Rahman Emaad
- Abhayaratna Walter
- Abramof Ness Rosane
- Acosta Idalia
- Adams Atoya
- Adawi Faiad
- Adler Sharon
- Ahmed Fayzal
- Aizenberg Diego
- Ajani Dilawar
- Al-Karadsheh Amer
- Albota Adrian
- Alferi Dino
- Alicic Radica
- Alla Sreedhara
- Allison D
- Almeida Edgar
- Alpizar Salazar Melchor
- Amer Joseph
- Amod Aslam
- Andrawis Nabil
- Antonio Bossi Carlo
- Antsiferov Mikhail
- Antunes Daniela
- Araki Hideo
- Arango Clara
- Arcos Edgar
- Arif Ahmed
- Arif Imrozia
- Arkhipov Mikhail
- Armaly Zaher
- Aroca Gustavo
- Asprusten Emil
- Atar Shaul
- Avila Pardo Sandro
- Awad Ahmed
- Axthelm Christoph
- Azizad Masoud
- Azizah Aziz Nor
- B Brouwer C
- Babikova Jana
- Babkin Andrey
- Badak Ozer
- Bahrami Michael
- Bajcsi Dora
- Baker John
- Bala Cornelia
- Ballesteros Rosa
- Bansal Shweta
- Barag Steven
- Barakzoy Ahmad
- Baranov Vitaliy
- Barbarash Olga
- Barbonta Hortensia
- Barney Mark
- Barre Paul
- Barrera Sandra
- Barreto Carlos
- Barreto Germ\ue1n
- Bartolacci In\ue9s
- Bashir Khalid
- Bashkin Amir
- Bastidas Adrian Miriam
- Bautista Albert
- Bautista Jose
- Bech Jesper
- Beddhu Srinivasan
- Beltr\ue1n L\uf3pez Nelly
- Ben Chetrit Sydney
- Benitez Diego
- Benjamin Sabrina
- Berar Yanay Noa
- Berenji Ramin
- Bertram Pitt
- Bertsch John
- Besada Diego
- Bhana Sindeep
- Bhargava Anuj
- Bilz Stefan
- Birkenfeld Andreas
- Birriel Jose
- Bittar Julio
- Blanco Guillermo
- Bleich David
- Boletis Ioannis
- Bondarets Iryna
- Bonora Enzo
- Bornfreund Jonathan
- Boshnyashka Radostina
- Botelho Roberto
- Botero Rodrigo
- Botsyurko Volodymyr
- Bouarich Hanane
- Brada Michal
- Brandao Ilidio
- Brar Harjeet
- Braun Hermann
- Brezina Jiri
- Brian Susan
- Brietzke Stephen
- Brito Claudia
- Bruchfeld Annette
- Bruno Giorda Carlo
- Brusco Osvaldo
- Bu Ruifang
- Bucek Petr
- Buganova Ingrid
- Burgner Anna
- Busch Klaus
- Busch Robert
- Butrymowicz Patrycja
- C Bakker R
- C\ue1rdenas Tatiana
- Caceaune Elena
- Cai Hanqing
- Calabr\uf2 Paolo
- Calero Francesca
- Canadas Rafael
- Canani Luis
- Caramori Maria
- Cardona Jose
- Cariou Bertrand
- Carlo Maggi Davide
- Carlos Palma Juan
- Carlos Prieto Juan
- Carlson Brian
- Carpio Jose
- Carvalho Rui
- Case Christopher
- Castro Cristina
- Catindig Elizabeth
- Catrinoiu Doina
- Cayli Murat
- Cereto Castro Fernando
- Cerqueira Maria
- Chahin Mariano
- Chang Chiz-Tzung
- Chantrel Fran\ue7ois
- Chen Dejun
- Chen Nan
- Chen Qinkai
- Cheng Jinluo
- Chernikova Viktoriia
- Chernin Gil
- Chernyavskaya Elena
- Chew Wong Alfredo
- Christina Nowack
- Chuang Lee-Ming
- Chung ChoonHee
- Ciechanowski Kazimierz
- Cieslik Grazyna
- Cigarr\ue1n Guldris Secundino
- Cimino Roberto
- Clavel Sylvaine
- Clodi Martin
- Cobos Jorge
- Colman Peter
- Colquhoun David
- Constantin Ciprian
- Contzen Christel
- Conway James
- Coronel Julian
- Cortes-Maisonet Gregorio
- Cortes-Maisonet Gregorio
- Cournoyer Serge
- Crawford Veronica
- Cristina Gregorini Maria
- Cruz Humberto
- Cruzado Garrit Josep
- Cure Carlos
- Curiac Dan
- Cutfield Rick
- Dandillaya Ramprasad
- Dang Cuong
- Danos Peter
- Darawsha Mahmud
- de \uc1lvaro Fernando
- de Paula Rogerio
- Deerochanawong Chaicharn
- Degenhardt Stefan
- Demko Arkadiy
- Derwahl Karl
- Dhanireddy Soni
- Din Zia
- Distiller Larry
- Dixon Bradley
- Dolores Mart\uednez Esteban M\uaa
- Donath Marc
- Donets Oleksandra
- Dong Junwu
- Dong Youping
- Doshi Ankur
- Doubel Peter
- Dreval Alexander
- Drexel Heinz
- Du Yuming
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- Dumitrescu Adriana
- Dunn Peter
- Dur\ue1n Carlos
- Duyck Francis
- Dzupina Andrej
- E Costa Fernando Teixeira
- Ebenbichler Christoph
- Ebisui Osamu
- Edelsberger Tomas
- Edin Anton
- Eduardo Figueiredo Carlos
- Eduardo Salles Joao
- Efrati Shai
- Ekinci Elif
- El Shahawy Mahfouz
- El-Shahawy Mohammed
- Elbert Alicia
- Elias Mazen
- Eliaschewitz Freddy
- Eliasson Ken
- Emdin Michele
- Engelen Wendy
- Eren Necmi
- Eriksen Erik
- Ermakova Polina
- Escalada San Mart\uedn Javier
- Escobedo de la Pe\uf1a Jorge
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- Eugenia Canziani Maria
- Eustace Joe
- Evans John
- Faber Jens
- Fadda George
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- Fang Yi
- Fangh\ue4nel Salm\uf3n Guillermo
- Farah Ghassan
- Farber Evgeny
- Farooq Umar
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- Fernando Roland
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- Fikry Sameh
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- Fiorina Paolo
- First Brian
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- Forti Adriana
- Franek Edward
- Frank Malin
- Frias Juan
- Fujita Naruhiro
- Furuya Ryuichi
- Fushtey Ivan
- G Lieverse A
- Galcer\ue1n Josep
- Gallouj Karim
- Galphin Claude
- Galyavich Albert
- Gansevoort Ron
- Garc\ueda Hern\ue1ndez Pedro
- Garc\ueda Luis
- Garcia-Mayol Luis
- Gaysina Leyla
- Gelersztein Elizabeth
- George L Bakris
- Georgiev Dimitar
- Gerasimos Filippatos
- Giebel Thomas
- Gillard Pieter
- Giorgio Battaglia Giovanni
- Gislason Gunnar
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- Gonz\ue1lez Albarr\ue1n Olga
- Gonz\ue1lez G\ue1lvez Guillermo
- Gonz\ue1lez Gonz\ue1lez Jos\ue9
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- Gore Ashwini
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- Guo Weiying
- Guron Gregor
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- Guti\ue9rrez Ochoa Ramiro
- Guzm\ue1n Gustavo
- H Boonstra A
- H\uf8ivik Hans
- Habwe Violet
- Hagemeier Robert
- Hagenow Andreas
- Halabi Majdi
- Haller Hermann
- Halpern Stephen
- Hamamoto Yoshiyuki
- Hamasaki Akihiro
- Hamet Pavel
- Hamilton Maxine
- Hammoud Jamal
- Handelsman Stuart
- Hangaard J\uf8rgen
- Hanna Fahmy
- Hanusch Ursula
- Hao Chuanming
- Harcsa Eleonora
- Hart Randolph
- Hartman Israel
- Hasalova Zapletalova Jitka
- Hasnul Halimi Bin Wan Hasan Wan
- Hasslacher Christoph
- Hatazaki Masahiro
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- Hatziagelaki Erifili
- Hayashi Terumasa
- Heigerick Glenn
- Heitor Susana
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- Hougardy Jean-Michel
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- Humaloja Kari
- Hung Cheng-Chieh
- Hwang YouCheol
- Ibarra Jaime
- Ibern\uf3n Meritxell
- Imoto Hirofumi
- Inagaki Akemi
- Inagaki Masayuki
- Ioannidis Ioannis
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- Ishiko Tamayo
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- Jansen van Rensburg Dirkie
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- Wu Mai-Szu
- Wu Ming-Ju
- Wu Tianfeng
- Wudi Krisztina
- Wuerzner Gregoire
- Wynne Katie-Jane
- Xing Changying
- Xiong Fei
- Xu Ning
- Xu Xudong
- Yagil Yoram
- Yajima Ken
- Yakhontov Davyd
- Yale Jean-Francois
- Yamada Daishiro
- Yamada Masayo
- Yamagata Kazuo
- Yamakawa Fumiko
- Yamakawa Ken
- Yamasaki Yoshimitsu
- Yambe Yuko
- Yanai Hidekatsu
- Yang Jinkui
- Yasuda Tetsuyuki
- Yenicerioglu Yavuz
- Yeung Vincent
- Yilmaz Huseyin
- Yin Aiping
- Yoncheva-Mihaylova Mariana
- Young Park Cheol
- Yuan Lee Li
- Yupanqui Hern\ue1n
- Yuryev Michael
- Zakharova Elena
- Zalevskaya Alsu
- Zanozina Olga
- Zaoui Philippe
- Zeig Steven
- Zeng Longyi
- Zhang Hao
- Zhang Yanlin
- Zhang Ying
- Zhao Zhiquan
- Zhdanova Elena
- Zheng Hongguang
- Zhong Ling
- Zhong Liyong
- Zhu Dalong
- Zhukova Larisa
- Zilahi Zsolt
- Zsom Marianna
- Zukermann Robert
- Zykova Tatyana
- Publication venue
- 'S. Karger AG'
- Publication date
- 01/01/2019
- Field of study
Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials.
Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate >= 25 mL/min/1.73 m(2) and albuminuria (urinary albumin-to-creatinine ratio >= 30 to <= 5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure.
Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen.
Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049
Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease
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- A Gorog D
- Abadier R
- Acheatel R
- Al-Joundi B
- Albert M
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- Albisu Di Gennaro J
- Alcocer Gamba M
- Alexandersen P
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- Apostolova E
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- Arif I
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- Benatar J
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- Betteridge J
- Bhagwat R
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- Bhatia P
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- Brewer H. Bryan
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- Brown K
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- Brønnum-Schou J
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- Chandrika Parameswaran A
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- Claudio J
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- Colombo H
- Colombo T
- Colquhoun D
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- Conde Diego
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- Maixing A
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- Mason Denise
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- Momiyama Y
- Montalescot Gilles
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- Nicholls Stephen J.
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- Nortje H
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- Okopien B
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- Pagel-Langenickel I
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- Suryanarayana P
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- Syan R
- Szakal I
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- Szántai G
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- Taguchi S
- Tahirkheli Naeem
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- Teklinski A
- Tengmark Bo
- Theron H
- Tishler S
- Tong Yc
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- Toursarkissian N
- Traboulssi M
- Tran D
- Treasure C
- Trenk D
- Troquay R
- Tsujita K
- Tyden P
- Tzekova M
- Uchino K
- Ueda O
- Ueng K
- Uhliar R
- Valter I
- van Cleeff M
- van Eck J
- Van Leendert R
- Van-Zyl L
- Vangel S
- Vangerow Burkhard
- Vanwelden J
- Vazquez-Tanus J
- Velimsky T
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- Verhave G
- Vinanska D
- Violante Ortiz R
- Visona A
- Vo A
- Vodnansky P
- Vogel C
- vom Dahl J
- Vora N
- Wali A
- Weerakkody Govinda
- Weinstein D
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- Weisz G
- West S
- Westendorp I
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- Wolski Kathy
- Wong B
- Xu D
- Yagensky A
- Yamagishi M
- Yasuda S
- Yeo W
- Yeoman G
- Yeung V
- Young C
- Younis L
- Yu C
- Z Jafar M
- Zakhary B
- Zayas-Torres C
- Zebrack J
- Zelman R
- Zhu J
- Ziada K
- Zrazhevsky K
- Zólyomi S
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
BACKGROUND:
The cholesteryl ester transfer protein inhibitor evacetrapib substantially raises the high-density lipoprotein (HDL) cholesterol level, reduces the low-density lipoprotein (LDL) cholesterol level, and enhances cellular cholesterol efflux capacity. We sought to determine the effect of evacetrapib on major adverse cardiovascular outcomes in patients with high-risk vascular disease.
METHODS:
In a multicenter, randomized, double-blind, placebo-controlled phase 3 trial, we enrolled 12,092 patients who had at least one of the following conditions: an acute coronary syndrome within the previous 30 to 365 days, cerebrovascular atherosclerotic disease, peripheral vascular arterial disease, or diabetes mellitus with coronary artery disease. Patients were randomly assigned to receive either evacetrapib at a dose of 130 mg or matching placebo, administered daily, in addition to standard medical therapy. The primary efficacy end point was the first occurrence of any component of the composite of death from cardiovascular causes, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina.
RESULTS:
At 3 months, a 31.1% decrease in the mean LDL cholesterol level was observed with evacetrapib versus a 6.0% increase with placebo, and a 133.2% increase in the mean HDL cholesterol level was seen with evacetrapib versus a 1.6% increase with placebo. After 1363 of the planned 1670 primary end-point events had occurred, the data and safety monitoring board recommended that the trial be terminated early because of a lack of efficacy. After a median of 26 months of evacetrapib or placebo, a primary end-point event occurred in 12.9% of the patients in the evacetrapib group and in 12.8% of those in the placebo group (hazard ratio, 1.01; 95% confidence interval, 0.91 to 1.11; P=0.91).
CONCLUSIONS:
Although the cholesteryl ester transfer protein inhibitor evacetrapib had favorable effects on established lipid biomarkers, treatment with evacetrapib did not result in a lower rate of cardiovascular events than placebo among patients with high-risk vascular disease. (Funded by Eli Lilly; ACCELERATE ClinicalTrials.gov number, NCT01687998 .)
Primary neuroendocrine neoplasm of the esophagus – Report of 14 cases from a single institute and review of the literature
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- Adachi K
- Akagi I
- Ando T
- Asayama M
- Atsumi K
- Atsumi K
- Babich JP
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- Bennouna J
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- Briggs JC
- Brown Jr RS
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- Chong FK
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- Cox PM
- Craig SR
- Deepak P
- del Valle Ruiz SR
- Doherty MA
- Eccles DM
- Einspanier GR
- Enzinger PC
- Fattahi Masoum SH
- Feng JF
- Feng W
- Fenlon HM
- Flavio Roberto TAKEDA
- Francisco TUSTUMI
- Fukuchi M
- Funakoshi S
- Gao R
- Gollard R
- González LM
- Goscinski MA
- Goto T
- Guilherme Luiz Stelko PEREIRA
- Gumprich T
- Gupta NM
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- Rubens Antonio Aissar SALLUM
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- Publication venue
- 'FapUNIFESP (SciELO)'
- Publication date
- Field of study
Misinterpreting School Reform: The Dissolution of a Dual-Immersion Bilingual Program in an Urban New England Elementary School
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- Anysia Mayer
- August D.
- August D.
- Batalova J.
- Byrd S. P.
- Celce-Murcia M.
- Crawford J.
- Crawford J.
- Darling-Hammond L.
- De Jong E.
- De Jong E. J.
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- Fishman J. A.
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- García-Nevarez A. G.
- Genesee F.
- González J. M.
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- Haas E.
- Heath S. B.
- Hornberger N. H.
- Hornberger N. H.
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- Johnson D.
- Karathanos K.
- Larisa Warhol
- Leibowitz A. H.
- Lomawaima K. T.
- Martínez-Roldán C. M.
- Maxwell L.
- Mayer A. P.
- Menken K.
- Miles M.
- Moore S. C.
- Ovando C.
- Palmer D.
- Rolstad K.
- Ruiz R.
- Schiffman H.
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- Stritikus T.
- Stritikus T.
- Tollefson J.
- Walker A.
- Warhol L.
- Wiley T. G.
- Wiley T. G.
- Woolard K.
- Wright S.
- Yanow D.
- Publication venue
- 'Informa UK Limited'
- Publication date
- Field of study
Situating Practice in Schools and Communities: Case Studies of Teacher Candidates in Diverse Clinical Experiences with English Language Learners
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- American Association of Colleges of Teacher Education
- Ann J.
- Baldwin S. C.
- Ball D. L.
- Ball D. L.
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- Barry N. H.
- Berk L. E.
- Bollin G. G
- Boyle-Baise M.
- Buchanan A.
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- Cochran-Smith M.
- Cochran-Smith M.
- Erickson F
- Ericsson K. A
- Finnigan K.
- Flores B. B.
- García E.
- González V
- Goodwin A. L
- Gottlieb M
- Grossman P.
- Grossman P.
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- Krashen S.D
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- Lucas T.
- Lucas T.
- Maxwell J. A
- McDonald M.
- McIntyre D.J.
- Mercado C. I.
- Merriam S. B
- Moll L. C.
- Murrell P. C
- National Clearinghouse for English Language Acquisition
- National Council for Accreditation of Teacher Education
- Nevarez-LaToree A. A.
- Onore C.
- Onosko J
- O’Malley J. M.
- Rogoff B.
- Ruiz J. H.
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- Shin H. B.
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- Solano-Flores G.
- Tinajero J. V.
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- Wade R. C
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- Publication venue
- 'Informa UK Limited'
- Publication date
- Field of study
Evolocumab and clinical outcomes in patients with cardiovascular disease
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- Abelson M.
- Aboufakher R.
- Abrahamsen T. E.
- Accini Mendoza J. L.
- Acheatel R.
- Ackermann D.
- Adamkova V.
- Adams M.
- Adlam D.
- Aggarwal R.
- Aggarwal S.
- Ahsan A.
- Ainsworth P.
- Airody Govinda R.
- Akai A.
- Ako J.
- Al-Bahrani A.
- Al-Joundi T.
- Aldegather J.
- Aldrete Velasco J. A.
- Alfieri A.
- Alt I.
- Alzohaili O.
- Amerena J.
- Amin J.
- Amoedo R.
- Amuchastegui M.
- Anderson T.
- Andreka P.
- Andreotti F.
- Angoulvant D.
- Ansell B.
- Antalik L.
- Antkowiak-Piatyszek K.
- Appel K.
- Arakawa T.
- Arana Londoño C.
- Ardissino D.
- Ardito W. R.
- Arkhipov M.
- Arsenescu-Georgescu C.
- Asamoah N.
- Ascaso Gimilio J. F.
- Atar S.
- Atassi K.
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- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
peer reviewedBACKGROUND Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol levels by approximately 60%. Whether it prevents cardiovascular events is uncertain. METHODS We conducted a randomized, double-blind, placebo-controlled trial involving 27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or higher who were receiving statin therapy. Patients were randomly assigned to receive evolocumab (either 140 mg every 2 weeks or 420 mg monthly) or matching placebo as subcutaneous injections. The primary efficacy end point was the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary efficacy end point was the composite of cardiovascular death, myocardial infarction, or stroke. The median duration of follow-up was 2.2 years. RESULTS At 48 weeks, the least-squares mean percentage reduction in LDL cholesterol levels with evolocumab, as compared with placebo, was 59%, from a median baseline value of 92 mg per deciliter (2.4 mmol per liter) to 30 mg per deciliter (0.78 mmol per liter) (P<0.001). Relative to placebo, evolocumab treatment significantly reduced the risk of the primary end point (1344 patients [9.8%] vs. 1563 patients [11.3%]; hazard ratio, 0.85; 95% confidence interval [CI], 0.79 to 0.92; P<0.001) and the key secondary end point (816 [5.9%] vs. 1013 [7.4%]; hazard ratio, 0.80; 95% CI, 0.73 to 0.88; P<0.001). The results were consistent across key subgroups, including the subgroup of patients in the lowest quartile for baseline LDL cholesterol levels (median, 74 mg per deciliter [1.9 mmol per liter]). There was no significant difference between the study groups with regard to adverse events (including new-onset diabetes and neurocognitive events), with the exception of injection-site reactions, which were more common with evolocumab (2.1% vs. 1.6%). CONCLUSIONS In our trial, inhibition of PCSK9 with evolocumab on a background of statin therapy lowered LDL cholesterol levels to a median of 30 mg per deciliter (0.78 mmol per liter) and reduced the risk of cardiovascular events. These findings show that patients with atherosclerotic cardiovascular disease benefit from lowering of LDL cholesterol levels below current targets. © 2017 Massachusetts Medical Society
Evolocumab and clinical outcomes in patients with cardiovascular disease
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- Yeh H
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- Zarich S
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- Zieba B
- Ziegler O
- Zilahi Z
- Zrazhevskiy K
- Östergren J
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
BACKGROUND Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol levels by approximately 60%. Whether it prevents cardiovascular events is uncertain. METHODS We conducted a randomized, double-blind, placebo-controlled trial involving 27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or higher who were receiving statin therapy. Patients were randomly assigned to receive evolocumab (either 140 mg every 2 weeks or 420 mg monthly) or matching placebo as subcutaneous injections. The primary efficacy end point was the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary efficacy end point was the composite of cardiovascular death, myocardial infarction, or stroke. The median duration of follow-up was 2.2 years. RESULTS At 48 weeks, the least-squares mean percentage reduction in LDL cholesterol levels with evolocumab, as compared with placebo, was 59%, from a median baseline value of 92 mg per deciliter (2.4 mmol per liter) to 30 mg per deciliter (0.78 mmol per liter) (P<0.001). Relative to placebo, evolocumab treatment significantly reduced the risk of the primary end point (1344 patients [9.8%] vs. 1563 patients [11.3%]; hazard ratio, 0.85; 95% confidence interval [CI], 0.79 to 0.92; P<0.001) and the key secondary end point (816 [5.9%] vs. 1013 [7.4%]; hazard ratio, 0.80; 95% CI, 0.73 to 0.88; P<0.001). The results were consistent across key subgroups, including the subgroup of patients in the lowest quartile for baseline LDL cholesterol levels (median, 74 mg per deciliter [1.9 mmol per liter]). There was no significant difference between the study groups with regard to adverse events (including new-onset diabetes and neurocognitive events), with the exception of injection-site reactions, which were more common with evolocumab (2.1% vs. 1.6%). CONCLUSIONS In our trial, inhibition of PCSK9 with evolocumab on a background of statin therapy lowered LDL cholesterol levels to a median of 30 mg per deciliter (0.78 mmol per liter) and reduced the risk of cardiovascular events. These findings show that patients with atherosclerotic cardiovascular disease benefit from lowering of LDL cholesterol levels below current targets
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- Author
- Abad Vanessa
- Abate Getahun
- Abbas Anum
- Ackerman Jamie
- Ackerman Ronald
- Ackermann Jeremy
- Adams Atoya
- Adams Mark S.
- Adams Michael R.
- Adelglass Jeffrey
- Afework Sarah
- Ahmad Nina
- Akamine Christine
- Ake Julie A.
- Al-Ibrahim Mohamed S.
- Albert Gary
- Alcaide Maria L.
- Alderson Nathan
- Aleman Lily
- Alemán José O.
- Allaw Mohammed
- Alva E. Javier Pretell
- Alvarado Hilario
- Amador Carmen
- Andersen James
- Anderson Corey G.
- Anderson Evan J.
- Anderson Victoria R.
- Andes David R.
- Andrasik Michele P.
- Andree Stephanie
- Andrews Jeb
- Andriesen Jessica G.
- Andriulis Victoria
- Ansel Jessica L.
- Anthony Codi M.
- Antwi Mohammed
- Arduino Roberto C.
- Aristy Florida
- Arnold Valerie K.
- Arrazcaeta Alicia
- Atmar Robert L.
- Avworo Ayoade
- Bacher Christina
- Baden Lindsey R.
- Badillo Diana
- Bainbridge Emma
- Baka Michele
- Baker Sherrie
- Balani Bindu
- Ball Brandy
- Bances Karla Beatriz Tafur
- Baron Mira
- Barranco-Santana Elizabeth
- Bartilucci Darlene
- Bashour Jennifer
- Batteiger Teresa A.
- Baudelaire Clarisse
- Bazan Jose A.
- Becerra Maria G.
- Becker Teresa
- Beckmann David
- Bedimo Roger J.
- Belhorn Linda R.
- Benavides Alfredo Gilberto Guerreros
- Beninati Genevieve
- Benitez Jorge A.
- Bennett Annette R.
- Bennett Elizabeth
- Beresnev Tatiana
- Berman Megan
- Bermudez Maria I.
- Bernard Marcia
- Bernstein David I.
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- Berry Jennifer
- Berthaud Vladimir
- Bialobok Kristin
- Billings Joanne L.
- Bittner Zachary
- Blevins Jeanne
- Blumenthal Jill
- Boas Rebecca
- Bocchini Joseph
- Bold Tyler D.
- Bondell Alison
- Bondy Paul
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- Borgetti Scott
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- Hendriks Jenny
- Hennekes Gayle D.
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- Irani Farah
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- Wakefield Paul H.
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- Walker James
- Walker Shannon
- Walsh Edward E.
- Walsh Mary C.
- Walsh Stephen R.
- Walsh Stephen R.
- Walter Emmanuel B.
- Walters Ayanna
- Wang Tina
- Warden Ashley
- Waters Michael
- Watkins Breanz
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- Webster Hala
- Weidler Jessica L.
- Weiss Thomas
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- Wendell Lewis III
- Wendrow Andrea
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- Whatley Jordan L.
- Whitaker Jennifer A.
- White Jewel J.
- White Julie
- White Toni
- Wijewardane Priyantha N.
- Wilkin Timothy
- Wilkinson Bethanie
- William S. Davis Jr
- Williams Barton G.
- Williams Hayes
- Williams Samantha
- Wilson Christine
- Wilson Clint
- Wilson Greg
- Wilson Natasha
- Winbigler Jennifer
- Winkle Peter J.
- Winokur Patricia L.
- Witbeck John
- Wohl David
- Woo Wayne
- Woodside Leana
- Wortman Glenn
- Wu Yi H.
- Wylie Paul E.
- Yang Fan
- Yang Kinara S.
- Yoon Anelgine C.
- York Jill
- Young Cheryl
- Yu Chenchen
- Yusin Joseph
- Zapata Luz
- Zash Rebecca
- Zegarra Eneyda Giuvanela Llerena
- Zemanek Arthur L.
- Zenlea Kate
- Zepeda Karla
- Zervos Marcus J.
- Zhai Nan
- Zhang Kevin
- Zhou James
- Zimmer Andrea
- Zingman Barry S.
- Zorrilla Carmen D.
- Áñez Germán
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/10/2023
- Field of study
Background: While vaccines have established utility against COVID-19, phase 3 efficacy studies have generally not comprehensively evaluated protection provided by previous infection or hybrid immunity (previous infection plus vaccination). Individual patient data from US government-supported harmonized vaccine trials provide an unprecedented sample population to address this issue. We characterized the protective efficacy of previous SARS-CoV-2 infection and hybrid immunity against COVID-19 early in the pandemic over three-to six-month follow-up and compared with vaccine-associated protection. Methods: In this post-hoc cross-protocol analysis of the Moderna, AstraZeneca, Janssen, and Novavax COVID-19 vaccine clinical trials, we allocated participants into four groups based on previous-infection status at enrolment and treatment: no previous infection/placebo; previous infection/placebo; no previous infection/vaccine; and previous infection/vaccine. The main outcome was RT-PCR-confirmed COVID-19 >7–15 days (per original protocols) after final study injection. We calculated crude and adjusted efficacy measures. Findings: Previous infection/placebo participants had a 92% decreased risk of future COVID-19 compared to no previous infection/placebo participants (overall hazard ratio [HR] ratio: 0.08; 95% CI: 0.05–0.13). Among single-dose Janssen participants, hybrid immunity conferred greater protection than vaccine alone (HR: 0.03; 95% CI: 0.01–0.10). Too few infections were observed to draw statistical inferences comparing hybrid immunity to vaccine alone for other trials. Vaccination, previous infection, and hybrid immunity all provided near-complete protection against severe disease. Interpretation: Previous infection, any hybrid immunity, and two-dose vaccination all provided substantial protection against symptomatic and severe COVID-19 through the early Delta period. Thus, as a surrogate for natural infection, vaccination remains the safest approach to protection. Funding: National Institutes of Health
Risk of COVID-19 after natural infection or vaccinationResearch in context
- Author
- A. Lina Rosengren
- Abram Burgher
- Adam B. Brosz
- Adam Rosen
- Adam Schwartz
- Adriana Sordo Duran
- Adrienna Marquez
- Adrienne E. Shapiro
- Aeiress Duhart
- Afsoon Roberts
- Albert Liu
- Alejandro Hoberman
- Alejandro Quintín Barrat Hernández
- Alex Greninger
- Alexander Clark
- Alfredo Gilberto Guerreros Benavides
- Alice McGarry
- Alicia Arrazcaeta
- Alisha Lutat
- Alison Bondell
- Alison Pellecchia
- Allie Oplinger
- Allison Green
- Allison O'Brien
- Alpa Patel
- Alyssa-Kay Peay
- Amanda Horn
- Amanda Lilienthal
- Amanda Occhino
- Amanda Philyaw
- Amaran Moodley
- Amber Grant
- Amber Stanford
- Amesika Nyaku
- Amie Shannon
- Amina Z. Haggag
- Amit Paliwal
- Amy Caldwell
- Amy Chamberlain
- Amy Dye
- Amy Falk
- Amy Kelley
- Amy Medina
- Amy Potts
- Amy Salzl
- Amy Sherman
- Amy Starr
- Amy Thompson
- Andrea Berry
- Andrea Clement
- Andrea Wendrow
- Andrea Zimmer
- Andres Bran
- Andres Camacho-Gonzalez
- Andrew Lauria
- Andrew McConnell
- Andrew McWilliams
- Anelgine C. Yoon
- Angela Lee
- Angela R. Branche
- Angelica Kottkamp
- Angella Webb
- Ann M. Milliken
- Ann R. Falsey
- Anna S. Lok
- Anna Wald
- Anne Marit de Groot
- Anne-Marie Rick
- Annette R. Bennett
- Annie Ciambruschini
- Annie Luetkemeyer
- Anthony Kim
- Anum Abbas
- Anyela Lara
- April Pixler
- Ariana C. Stanton
- Arthur L. Zemanek
- Asha Inniss
- Ashley Kennedy
- Ashley Perez
- Ashley Warden
- Asif Noor
- Atoya Adams
- Aurelio Cruz-Valdez
- Austin Chan
- Austin Swanson
- Ayanna Walters
- Ayoade Avworo
- Bailey Jordan
- Barbara Corral
- Barbara Rizzardi
- Barbara Rizzardi
- Barbara S. Taylor
- Barry S. Zingman
- Barton G. Williams
- Beatriz Grinsztejn
- Becky Martinez
- Ben Ladner
- Benjamin Eckhardt
- Benjamin J. Luft
- Bernard Grunstra
- Beth Safirstein
- Bethanie Wilkinson
- Beverly E. Sha
- Beverly Ewing
- Bindu Balani
- Blanca Gomez
- Bo Shopsin
- Boerries Brandenburg
- Brandie Taylor
- Brandon J. Essink
- Brandy Ball
- Breanz Watkins
- Brenda Dorcely
- Brendan Levy
- Brett Gray
- Brett Leav
- Brian D.W. Chow
- Brit Sovic
- Brittany Feijoo
- Brittany Stewart
- Bruce C. Gebhardt
- Bruce G. Rankin
- Bruce McClenathan
- Bruno Valenti
- Bryan Gordon
- C. Mary Healy
- Caitlin J. Guiney
- Caitlin Moran
- Candace Smith
- Candice Montros
- Carina A. Rodriguez
- Carl Fichtenbaum
- Carl P. Griffin
- Carlos A. Fierro
- Carlos del Rio
- Carlos Lopez
- Carlos Malvestutto
- Carmel B. Dyer
- Carmen A. Paez
- Carmen Amador
- Carmen D. Zorrilla
- Carmen Medina
- Carol Ann Linebarger
- Carol Kauffman
- Carol L. Mitchell
- Carolene Stephenson
- Caroline Greene
- Carolyn Scatamacchia
- Carolyn Tran
- Carrie Johnston
- Carrie Sopher
- Catherine A. Bunce
- Catherine Mary Healy
- Catherine Q. Gular
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- Cecilia McKeown-Bragas
- Celia Gonzalez
- Celia Maxwell
- Charles Harper
- Charles M. Fogarty
- Charlotte-Paige Rolle
- Charnell Cromer
- Chelsea Miles
- Chelsie Nutsch
- Chelsie Nutsch
- Chen S. Tan
- Chenchen Yu
- Cheryl Nuss
- Cheryl Young
- Chimeremma Nnadi
- Chinar Desai
- Christian Tomaszewski
- Christina A. Rostad
- Christina Bacher
- Christina Kennelly
- Christine Akamine
- Christine B. Turley
- Christine Hull
- Christine Wilson
- Christopher Carpenter
- Christopher Dedon
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- Christopher Matich
- Christy Schmeck
- Christy Sweet
- Clarence B. Creech II
- Clarisse Baudelaire
- Claudia De La Matta Rodriguez
- Claudia Espinosa
- Claudio Nuñez Lagos
- Clint C. Guillory
- Clint Wilson
- Codi M. Anthony
- Colleen F. Kelley
- Colleen Jacobsen
- Connie Moya
- Cora Sonnier
- Corey G. Anderson
- Corey M. Chen
- Cornell Calinescu
- Corrina Pavetto
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- Craig Dietz
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- Crystal Rowell
- Cynthia Becher Strout
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- Cynthia Bueno
- Cynthia L. Gay
- Cynthia L. Monaco
- Cynthia Montano-Pereira
- Cyrus Hoseyni
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- Dalia Tovar
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- Daniel Hoft
- Daniel Kaul
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- Daniel T. Lawler
- Daniela Pineda Méndez
- Danielle Raley
- Danny Sugimoto
- Danyel Johnson
- Darlene Bartilucci
- David B. Musante
- David Beckmann
- David Browder
- David Dellaero
- David Fitz-Patrick
- David Halpert
- David I. Bernstein
- David J. Diemert
- David J. Ensz
- David Kline
- David L. Fried
- David Metzger
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- Dawn Furey
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- Deanna Cooper
- Debora Dunbar
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- Derek Lewis
- Derek M. Smith
- Destiny S. Heinzig-Cartwright
- Diana Badillo
- Diana F. Florescu
- Diana Vegas
- Dianca Sierra
- Diane H. Johnson
- Dilek Ince
- Dima Dandachi
- Dirk Heerwegh
- Dolores Rijos
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- E. Javier Pretell Alva
- Edgar Garcia
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- Filip Dubovsky
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- Fred E. Newton
- Frederick Raiser III
- Fredric Santiago
- Gail Broder
- Gary Albert
- Gary Headden
- Gary Horwith
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- Gary Simon
- Gayle D. Hennekes
- Genevieve Beninati
- Genevieve Iwuala
- George H. Bauer Jr.
- George H. Freeman
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- Georgettea Geuss
- Gerald Kelty
- Germán Áñez
- Getahun Abate
- Gina Rivero
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- Glenn Wortman
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- Jaleh Ostovar
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- M. Juliana McElrath
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- Maggie Lewis
- Mai Pham
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- Maria Johnson
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- Maria Mileno
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- Marianela Carvajal
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- Marina Lee
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- Mark E. Kutner
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- Mark S. Adams
- Marshall A. Cross
- Marshall Nash
- Martha Carmen Medina
- Martha Cecilia Gómora Madrid
- Martha Nason
- Martha Sanchez
- Martín Bäcker
- Marvin Castellon
- Mary A. Marovich
- Mary Beth Manning
- Mary C. Walsh
- Mary Easley
- Mary Hussain
- Mary Smith
- Mary Vogler
- Maryam Jahromi
- Maryrose Laguio-Vila
- Marysol Villegas
- María E. Santolaya
- María I. Rivera
- María José Reyes Fentanes
- Masaru Oshita
- Mashrur Islam Majumder
- Matthew B. Laurens
- Matthew D. Sims
- Matthew G. Davis
- Matthew Hepburn
- Matthew Hong
- Matthew Hong
- Matthew Miles
- Matthew W. Doust
- Maureen Cooney
- May-Yin Suen
- Mayur Ramesh
- Meagan Miller
- Meagan Thomas
- Megan Berman
- Meghan Teherani
- Mehdi Mirsaeidi
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- Melissa Gottschlich
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- Melody Werne
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- Merlin Robb
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- Michael C. Keefer
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- Michael Cancilla
- Michael Chung
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- Michael E. Dever
- Michael Fay
- Michael J. Cotugno
- Michael J. Koren
- Michael J. McCartney
- Michael J. Smith
- Michael Jacobs
- Michael L. Levin
- Michael Lewis
- Michael P. Dube
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- Michael Sciaudone
- Michael Waters
- Michele Baka
- Michele D. Reynolds
- Michele P. Andrasik
- Michele Vertucci
- Michelle DallaPiazza
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- Michelle Haynes
- Michelle King
- Michelle L. Burgett
- Michelle Maxwell
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- Mike Delgado
- Milagritos Tapia
- Mildred Stull
- Millie Manalo
- Milton Haber
- Mimi Van Der Leden
- Mira Baron
- Mitul Shah
- Mohamed S. Al-Ibrahim
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- Nga Le
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- Nicole L. Nollen
- Niles Eaton
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- Surisday Mederos
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- Susan L. Koletar
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- Sybil G. Hosek
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- Tameika Scott
- Tami Wahlin
- Tammi L. Shlotzhauer
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- Tanya Hutchins
- Taryn Petty
- Tatiana Beresnev
- Tavane Harrison
- Taylor Nelson
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- Teresa Becker
- Teresa Deese
- Teresa S. Sligh
- Teri Thompson-Seim
- Terri Moye
- Terry D. Klein
- Terry L. Poling
- Terry Piedra
- Theresa Hegmann
- Thomas B. Campbell
- Thomas C. Klein
- Thomas C.S. Martin
- Thomas Mellman
- Thomas Patterson
- Thomas Weiss
- Tiffany Esinhart
- Tiffany Nemecek
- Tiffany Schwasinger-Schmidt
- Tilly Varughese
- Timothy J. Hatlen
- Timothy P. Vachris
- Timothy Shope
- Timothy W. Schacker
- Timothy Wilkin
- Tina Tong
- Tina Wang
- Toby Briskin
- Todd Simmons
- Tom Fiel
- Toni Robinson
- Toni White
- Tracy Okonya
- Tracy R. Klein
- Trina L. Reynolds
- Troy Holdeman
- Tyler D. Bold
- Uriel R. Felsen
- Valentine M. Ebuh
- Valeria D. Cantos
- Valerie K. Arnold
- Vanessa Abad
- Vanessa Raabe
- Veronica G. Fragoso
- Veronica Garcia-Fragoso
- Veronica Procasky
- Veronica Viar
- Vicki E. Miller
- Vickie Leathers
- Victoria Andriulis
- Victoria Engler
- Victoria Mosteller
- Victoria R. Anderson
- Vida Veronica Ruiz Herrera
- Vincent Huynh
- Vincent Mirkil
- Vivek Rajasekhar
- Viviana Gonzalez
- Vladimir Berthaud
- Walter Patton
- Wanda Ramon
- Waseem Chughtai
- Wayne L. Harper
- Wayne Woo
- Wendell Lewis
- Wendell Lewis III
- Wendy A. Keitel
- Wesley Campbell
- Wesley Van Ever
- Westly Keating
- Whitney West
- Will Hernandez
- William B. Davis
- William B. Smith
- William H. Jones
- William Jennings
- William Kirby
- William P. Silver
- William R. Hartman
- William S. Davis Jr.
- William Schnitz
- William Seger
- Winniberg Stephany Alvarez León
- Winston Cavert
- Xiaomi Tong
- Yaa D. Oppong
- Yi H. Wu
- Ying Huang
- Yogesh K. Paliwal
- Youyi Fong
- Yunda Huang
- Yunda Huang
- Yvonne Davis
- Zachary Bittner
- Zainab Rizvi
- Zindy Yazmín Zárate Hinojosa
- Zudi-Mwak Takizala
- Publication venue
- Elsevier
- Publication date
- 01/10/2023
- Field of study
Summary: Background: While vaccines have established utility against COVID-19, phase 3 efficacy studies have generally not comprehensively evaluated protection provided by previous infection or hybrid immunity (previous infection plus vaccination). Individual patient data from US government-supported harmonized vaccine trials provide an unprecedented sample population to address this issue. We characterized the protective efficacy of previous SARS-CoV-2 infection and hybrid immunity against COVID-19 early in the pandemic over three-to six-month follow-up and compared with vaccine-associated protection. Methods: In this post-hoc cross-protocol analysis of the Moderna, AstraZeneca, Janssen, and Novavax COVID-19 vaccine clinical trials, we allocated participants into four groups based on previous-infection status at enrolment and treatment: no previous infection/placebo; previous infection/placebo; no previous infection/vaccine; and previous infection/vaccine. The main outcome was RT-PCR-confirmed COVID-19 >7–15 days (per original protocols) after final study injection. We calculated crude and adjusted efficacy measures. Findings: Previous infection/placebo participants had a 92% decreased risk of future COVID-19 compared to no previous infection/placebo participants (overall hazard ratio [HR] ratio: 0.08; 95% CI: 0.05–0.13). Among single-dose Janssen participants, hybrid immunity conferred greater protection than vaccine alone (HR: 0.03; 95% CI: 0.01–0.10). Too few infections were observed to draw statistical inferences comparing hybrid immunity to vaccine alone for other trials. Vaccination, previous infection, and hybrid immunity all provided near-complete protection against severe disease. Interpretation: Previous infection, any hybrid immunity, and two-dose vaccination all provided substantial protection against symptomatic and severe COVID-19 through the early Delta period. Thus, as a surrogate for natural infection, vaccination remains the safest approach to protection. Funding: National Institutes of Health