33 research outputs found
Effect of SGLT2 inhibitors on stroke and atrial fibrillation in diabetic kidney disease: Results from the CREDENCE trial and meta-analysis
- Author
- Abdallah J.
- Abdullah R.
- Abejuela Z.
- Abouglila K.
- Abramowitz M.
- Abusnana S.
- Acosta I.
- Agafyina A.
- Aggarwal N.
- Agra J.
- Ahmad N. N. F. N.
- Ahmed F.
- Aiello J.
- Ainsworth P.
- Aizenberg D.
- Akiyama H.
- Akright L.
- Akyea-Djamson A.
- Al-Karadsheh A.
- Alamartine E.
- Alappan R.
- Albisu J. P.
- Ali N.
- Ali Z.
- Alicic R.
- Allison D. C.
- Alonso R. D. V.
- Alva H.
- Alvarisqueta A.
- Amodeo C.
- Andreeva V.
- Angelescu L. M.
- Angelova A.
- Anghel V.
- Antic S.
- Aoki H.
- Aquitania G.
- Arauz-Pacheco C.
- Arcos E.
- Arenales J. A. S.
- Arfeen S.
- Arif A.
- Aronson R.
- Arutchelvam V.
- Arvind M.
- Asano A.
- Atray N.
- Avendano J.
- Avram R. -I.
- Awad A.
- Babikova J.
- Badat A.
- Bajaj H.
- Baker J.
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- Zaniewski-Singh M.
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- Publication venue
- 'Ovid Technologies (Wolters Kluwer Health)'
- Publication date
- 01/01/2021
- Field of study
BACKGROUND AND PURPOSE: Chronic kidney disease with reduced estimated glomerular filtration rate or elevated albuminuria increases risk for ischemic and hemorrhagic stroke. This study assessed the effects of sodium glucose cotransporter 2 inhibitors (SGLT2i) on stroke and atrial fibrillation/flutter (AF/AFL) from CREDENCE (Canagliflozin and Renal Events in Diabetes With Established Nephropathy Clinical Evaluation) and a meta-Analysis of large cardiovascular outcome trials (CVOTs) of SGLT2i in type 2 diabetes mellitus. METHODS: CREDENCE randomized 4401 participants with type 2 diabetes mellitus and chronic kidney disease to canagliflozin or placebo. Post hoc, we estimated effects on fatal or nonfatal stroke, stroke subtypes, and intermediate markers of stroke risk including AF/AFL. Stroke and AF/AFL data from 3 other completed large CVOTs and CREDENCE were pooled using random-effects meta-Analysis. RESULTS: In CREDENCE, 142 participants experienced a stroke during follow-up (10.9/1000 patient-years with canagliflozin, 14.2/1000 patient-years with placebo; hazard ratio [HR], 0.77 [95% CI, 0.55-1.08]). Effects by stroke subtypes were: ischemic (HR, 0.88 [95% CI, 0.61-1.28]; n=111), hemorrhagic (HR, 0.50 [95% CI, 0.19-1.32]; n=18), and undetermined (HR, 0.54 [95% CI, 0.20-1.46]; n=17). There was no clear effect on AF/AFL (HR, 0.76 [95% CI, 0.53-1.10]; n=115). The overall effects in the 4 CVOTs combined were: Total stroke (HRpooled, 0.96 [95% CI, 0.82-1.12]), ischemic stroke (HRpooled, 1.01 [95% CI, 0.89-1.14]), hemorrhagic stroke (HRpooled, 0.50 [95% CI, 0.30-0.83]), undetermined stroke (HRpooled, 0.86 [95% CI, 0.49-1.51]), and AF/AFL (HRpooled, 0.81 [95% CI, 0.71-0.93]). There was evidence that SGLT2i effects on total stroke varied by baseline estimated glomerular filtration rate (P=0.01), with protection in the lowest estimated glomerular filtration rate (45 mL/min/1.73 m2]) subgroup (HRpooled, 0.50 [95% CI, 0.31-0.79]). CONCLUSIONS: Although we found no clear effect of SGLT2i on total stroke in CREDENCE or across trials combined, there was some evidence of benefit in preventing hemorrhagic stroke and AF/AFL, as well as total stroke for those with lowest estimated glomerular filtration rate. Future research should focus on confirming these data and exploring potential mechanisms
Improved functionalization of oleic acid-coated iron oxide nanoparticles for biomedical applications
- Author
- Abid M
- Accini JL
- Acuña S
- Adawi F
- Adenuga B
- Adina PM
- Ageev F
- Aguilar-Orozco R
- Ahmad Z
- Aimaretti G
- Aizenberg D
- Akahori H
- Akhmedzhanov N
- Akinboboye O
- Akright L
- Al Mahmeed W
- Alanko J
- Alappat P
- Alawad M
- Alfonso T
- Alimard R
- Alvarez C
- Alvarisqueta A
- Alzohaili O
- Ambos A
- Amerena J
- Amolina I
- Andjelic Jelic M
- Andrade M
- Andrews R
- Antorrena I
- Arana C
- Araneda G
- Arango J
- Ariani M
- Arnold S
- Arora C
- Arteaga JM
- Assaad S
- Atar S
- Avram RI
- Azad N
- Azzam S
- Baccaro C
- Bailey G
- Bain S
- Barbarash O
- Barbarich V
- Bartolacci I
- Bascil Tutuncu N
- Basu A
- Bayram E
- Bednarski J
- Belousov Y
- Ben Abdallah N
- Benjamin S
- Berns S
- Berra C
- Bertrand O
- Bhargava R
- Bhatnagar D
- Bickerton A
- Bijata-Bronisz R
- Block B
- Boberg G
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- Publication venue
- Springer Nature
- Publication date
- 01/01/2012
- Field of study
Superparamagnetic iron oxide nanoparticles
can providemultiple benefits for biomedical applications
in aqueous environments such asmagnetic separation or
magnetic resonance imaging. To increase the colloidal
stability and allow subsequent reactions, the introduction
of hydrophilic functional groups onto the particles’
surface is essential. During this process, the original
coating is exchanged by preferably covalently bonded
ligands such as trialkoxysilanes. The duration of the
silane exchange reaction, which commonly takes more
than 24 h, is an important drawback for this approach. In
this paper, we present a novel method, which introduces
ultrasonication as an energy source to dramatically
accelerate this process, resulting in high-quality waterdispersible nanoparticles around 10 nmin size. To prove
the generic character, different functional groups were
introduced on the surface including polyethylene glycol
chains, carboxylic acid, amine, and thiol groups. Their
colloidal stability in various aqueous buffer solutions as
well as human plasma and serum was investigated to
allow implementation in biomedical and sensing
applications.status: publishe
Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy
- Author
- Abdallah J
- Abdul Ghani R
- Abdul Kadir K
- Abdullah R
- Abejuela Z
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- Yumita W
- Yupanqui H
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- Zalunardo N
- Zamarripa Escobedo R
- Zanata Petry Tb
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- Zaniewski-Singh M.
- Zanoli L
- Zaoui P
- Zateyshchikova A
- Zateyshshikov D
- Zaviriukha V
- Zemek S
- Zhang H
- Zhang Hong
- Zhao M
- Zheng H
- Zinman B
- Zinman Bernard
- Zlova T
- Zsom M
- Zub L
- Zykova T
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2019
- Field of study
BACKGROUND Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available. In cardiovascular trials of inhibitors of sodium–glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes. METHODS In this double-blind, randomized trial, we assigned patients with type 2 diabetes and albuminuric chronic kidney disease to receive canagliflozin, an oral SGLT2 inhibitor, at a dose of 100 mg daily or placebo. All the patients had an estimated glomerular filtration rate (GFR) of 30 to 300 to 5000) and were treated with renin–angiotensin system blockade. The primary outcome was a composite of end-stage kidney disease (dialysis, transplantation, or a sustained estimated GFR of <15 ml per minute per 1.73 m 2), a doubling of the serum creatinine level, or death from renal or cardiovascular causes. Prespecified secondary outcomes were tested hierarchically. RESULTS The trial was stopped early after a planned interim analysis on the recommendation of the data and safety monitoring committee. At that time, 4401 patients had undergone randomization, with a median follow-up of 2.62 years. The relative risk of the primary outcome was 30% lower in the canagliflozin group than in the placebo group, with event rates of 43.2 and 61.2 per 1000 patient-years, respectively (hazard ratio, 0.70; 95% confidence interval [CI], 0.59 to 0.82; P=0.00001). The relative risk of the renal-specific composite of end-stage kidney disease, a doubling of the creatinine level, or death from renal causes was lower by 34% (hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P<0.001), and the relative risk of end-stage kidney disease was lower by 32% (hazard ratio, 0.68; 95% CI, 0.54 to 0.86; P=0.002). The canagliflozin group also had a lower risk of cardiovascular death, myocardial infarction, or stroke (hazard ratio, 0.80; 95% CI, 0.67 to 0.95; P=0.01) and hospitalization for heart failure (hazard ratio, 0.61; 95% CI, 0.47 to 0.80; P<0.001). There were no significant differences in rates of amputation or fracture. CONCLUSIONS In patients with type 2 diabetes and kidney disease, the risk of kidney failure and cardiovascular events was lower in the canagliflozin group than in the placebo group at a median follow-up of 2.62 years
Effects of alirocumab on types of myocardial infarction: insights from the ODYSSEY OUTCOMES trial
- Author
- Abbas J
- Abbate A
- Abdullakutty J
- Abhyanakar AD
- Aboyans V
- Abrantes JAM
- Abu-Fadel M
- Acevedo M
- Adamkova V
- Adhyapak S
- Agarwal H
- Aggarwal R
- Aggarwal RK
- Aguirre A
- Ahmed H
- Ahremark U
- Ahuad Guerrero RA
- Aidar Ayoub JC
- Airaksinen JK
- Aitken D
- Akatova E
- Akhter F
- Ako J
- Akright L
- Akyea-Djamson A
- Al Joundi T
- Al-Windy NYY
- Alan D
- Alcocer Gamba MA
- Alexander JH
- Alexander K
- Alexandru TM
- Alings M
- Alonso Martin JJ
- Alvarisqueta AF
- Alves De Lima AE
- Amarasekera S
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- Amir O
- Amlani M
- Amosova E
- Amuchastegui M
- Andersen K
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- Ando K
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- Annam S
- Anscombe R
- Apostolovic SR
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- Auguadro C
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- II TC
- III DG
- III KG
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- Iqbal SMR
- Irimpen A
- Istratoaie O
- Ito K
- Ivanov IG
- Ivanova R
- Ivanovic N
- Iyengar SS
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- Jukema JW
- Juonala M
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- Yagensky A
- Yakushin S
- Yan AT-K
- Yan BPY
- Yanez M
- Yang E
- Yang X
- Yang X
- Yao Z
- Yazdani S
- Yerra SK
- Yin W-H
- Yong H
- Yoon JH
- Younis L
- Yu Y
- Yuan Z
- Yusoff K
- Zahger D
- Zaidman CJ
- Zainea M
- Zaman A
- Zeiher AM
- Zhang W
- Zhang X
- Zhang Z
- Zhao X
- Zheng Y
- Zheng Z
- Zhou Y
- Zhu H
- Zirlik A
- Zizka J
- Zong W
- Zrazhevsky K
- Zuniga JDH
- Zurakowski A
- Zuran I
- Zweiker R
- Publication venue
- 'Oxford University Press (OUP)'
- Publication date
- 01/01/2019
- Field of study
Aims The third Universal Definition of Myocardial Infarction (MI) Task Force classified MIs into five types: Type 1, spontaneous; Type 2, related to oxygen supply/demand imbalance; Type 3, fatal without ascertainment of cardiac biomarkers; Type 4, related to percutaneous coronary intervention; and Type 5, related to coronary artery bypass surgery. Low-density lipoprotein cholesterol (LDL-C) reduction with statins and proprotein convertase subtilisin–kexin Type 9 (PCSK9) inhibitors reduces risk of MI, but less is known about effects on types of MI. ODYSSEY OUTCOMES compared the PCSK9 inhibitor alirocumab with placebo in 18 924 patients with recent acute coronary syndrome (ACS) and elevated LDL-C (≥1.8 mmol/L) despite intensive statin therapy. In a pre-specified analysis, we assessed the effects of alirocumab on types of MI. Methods and results Median follow-up was 2.8 years. Myocardial infarction types were prospectively adjudicated and classified. Of 1860 total MIs, 1223 (65.8%) were adjudicated as Type 1, 386 (20.8%) as Type 2, and 244 (13.1%) as Type 4. Few events were Type 3 (n = 2) or Type 5 (n = 5). Alirocumab reduced first MIs [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.77–0.95; P = 0.003], with reductions in both Type 1 (HR 0.87, 95% CI 0.77–0.99; P = 0.032) and Type 2 (0.77, 0.61–0.97; P = 0.025), but not Type 4 MI. Conclusion After ACS, alirocumab added to intensive statin therapy favourably impacted on Type 1 and 2 MIs. The data indicate for the first time that a lipid-lowering therapy can attenuate the risk of Type 2 MI. Low-density lipoprotein cholesterol reduction below levels achievable with statins is an effective preventive strategy for both MI types.For complete list of authors see http://dx.doi.org/10.1093/eurheartj/ehz299</p
Canagliflozin and renal outcomes in type 2 diabetes and nephropathy
- Author
- A Kaldun Nossuli
- Aamir Jamal
- Adalbert Schiller
- Adam Cheifetz
- Adarsh Daswani
- Adeera Levin
- Adline Ghazi
- Adrian Guinsburg
- Adriana Cif
- Adriana Gabriela Onaca
- Adriana Ilavska
- Adriana Villarino
- Agarwal R.
- Agnieszka Starzec
- Ahmed Arif
- Ahmed Awad
- Aiping Yin
- Akimichi Asano
- Alan Jackson
- Alan McMahon
- Alan Perlman
- Alberto Di Carlo
- Alberto Esquenazi
- Alejandra Oviedo
- Alejandro Valdes Depeda
- Aleksandra Kendereski
- Alex Valenzuela
- Alexander Dreval
- Alexander Gonzalez
- Alexander Shinkov
- Alexander Turchin
- Alexandre Klein
- Alfonso Soto Gonzalez
- Alfred Penfornis
- Alfredo Chew Wong
- Alfredo Wassermann
- Ali Torshizi
- Alicia Chilito
- Alina Agafyina
- Alison Dawson
- Alva Hansraj
- Amer Al-Karadsheh
- Amorin Remus Popa
- Amrendra Kumar
- Amy Sprague
- Ana Limos
- Ana Maria Cusumano
- Ana Maria Elosegui
- Anabella Amigo
- Anatoliy Kazmirchuk
- Andrea Phillips
- Andrea Stella
- Andreas Maddux
- Andrej Dzupina
- Andres Alvarisqueta
- Andrew Johnson
- Andrew O'Shaughnessy
- Andrew Steele
- Andrian Yakov
- Andrzej Januszewicz
- Andrzej Madej
- Angelina Angelova
- Anibal Gastaldi
- Anil Gupta
- Anita Bhajan Manocha
- Anjanette Tan
- Anna Kaminska
- Anna Maria Veronelli
- Anna Strzelecka
- Anna Zateyshchikova
- Anselmo Bordonava
- Antanas Navickas
- Anthony Gunstone
- Anthony Roberts
- Antonio Ceriello
- Antonio Galan Serrano
- Antonio Scafuto Scotton
- Antonio Terrelonge
- Antônio Roberto Chacra
- Anupama Gowda
- Arjun D Sinha
- Armando Perez
- Ashot Mkrtumyan
- Atanas Koundurdjiev
- Augusto Vallejos
- Aurelian-Emil Ranetti
- Ayim Akyea-Djamson
- Aysha Badat
- Bakris G.
- Baldev Singh
- Barbara Greco
- Barbara Kaczmarek
- Barbara Rewerska
- Barry M Brenner
- Belia Martin Del Camp Blanco
- Bernard Zinman
- Bertrand Cariou
- Bertrand Dussol
- Bhasker Mehta
- Bhimavarapu Sudhakar
- Björn Paschen
- Bompoint S.
- Borys Mankovskyy
- Botond Csiky
- Boyan Nonchev
- Brenner B. M.
- Brett Kissela
- Brian Nichol
- Bruce Neal
- Bruce Trippe
- Bruno Geloneze Neto
- Bull S.
- Byung-Wan Lee
- C B Keshavamurthy
- Cannon C. P.
- Capuano G.
- Carlo Giorda
- Carlos Alberto Cuneo
- Carlos Arauz-Pacheco
- Carlos Barrera
- Carlos Perez
- Carmel Hawley
- Carmen Crisan
- Carol Pollock
- Carolyn Droste
- Caroucel Chuateco
- Caryl David
- Cecilia Garcia Ballesteros
- Cecilia Jimeno
- Celso Amodeo
- Cesar Javier Zaidman
- Cesar Yoiti Hayashida
- Chamberlain Obialo
- Chang-Hsun Hsieh
- Charles Cook
- Charles Kaupke
- Charytan D. M.
- Chek Loong Loh
- Chen Leia
- Cheol-Young Park
- Chih-Ching Lin
- Christopher P Cannon
- Christy Yao
- Chu P. -L.
- Chwen-Tzuei Chang
- Chye Lee Gan
- Clara Barrios
- Claude Galphin
- Claudia Goycoa
- Claudia Moreira de Brito
- Clodoaido Caringal
- Cristian Serafinceanu
- Cristina Toarba
- Cristobal Morales Portillo
- Csaba Kovesdy
- Cynthia Bowman-Stroud
- Cynthia Christiano
- Cynthia Mustieles Rocha
- Cyrus Desouza
- Cássio Slompo Ramos
- Dagmar Bartaskova
- Dale Crawford Allison
- Dalia Kozloviene
- Dan Scharfstein
- Dana Cosma
- Daniel Coyne
- Daniel Hiser
- Daniel Kolansky
- Daniel Panarotto
- Daniel Pella
- Daniel Weiner
- Daniil Chizhov
- Dariusz Sowinski
- Darren K McGuire
- Davesh Sennik
- David C Wheeler
- David Cherney 3rd
- David Gorson
- David Johnson
- David M Charytan
- David Packham
- David Scott
- David Wheeler
- De Zeeuw D.
- Debbie Cohen-Stein
- Debbie Mascaro
- Deepak Koppolu
- Dennis Levinson
- Derek Lewis
- Detian Li
- Devasmita Dev
- Devesh Patel
- Dewan Deepak
- Dick de Zeeuw
- Diego Aizenberg
- Dinesh Jain
- Dinesh Khullar
- Diogo Belo
- Dmitry Zateyshshikov
- Domenico Santoro
- Domingos d'Avila
- Donald Brandon
- Donald Fraser
- Dong-Wan Chae
- Dora Inés Molina de Salazar
- Dorota Mlodawska-Choluj
- Doru Negru
- Edgar Arcos
- Edoardo Mannucci
- Eduardo Farias
- Edward Watson
- Edwards R.
- Egle Gaupsiene
- Egle Urbanaviciene
- Ekaterina Velichkova
- Elena Christofides
- Elena Grineva
- Elena Kolmakova
- Elena Shutemova
- Eleonora Harcsa
- Elizabeth Barranco
- Elizabeth Gelersztein
- Elizabeth Kern
- Elizete Keitel
- Eloisa Tellez Chavez
- Emanuela Orsi
- Emil Martinka
- Emyr Davies
- Enrique Gonzalez
- Eric Alamartine
- Eric Hernandez Triana
- Eric Thervet
- Erick Turcios Juarez
- Esteban Cercos
- Eugenia Galindo-Ramos
- Eva Peterfai
- Evaly Chen
- Evandro de Souza Portes
- Evgueniy Vazelov
- Fabian Otreras
- Fabiana Loss de Carvalho Contieri
- Fabio Malberti
- Fadi Saba
- Fadlo Fraige Filho
- Favio Edmundo Enriquez Sosa
- Fayzal Ahmed
- Ferdinando Carlo Sasso
- Fernanco Augusto Alves da Costa
- Fernanda Cristina Camelo Sanches
- Fernando Cereto Castro
- Fernando Flores Lozano
- Fernando Jimenez Florez
- Fernando Krynski
- Fernando M Edwin
- Fernando Thomé
- Fernando Trespalacios
- Florence Santos
- Florencia Kraft
- Fracisco Javier Gonzalez Martinez
- Fran Morren
- Franciso Jose Tinahones Madueno
- Frank Eder
- Franklin Joseph
- Franklin Paul Haase
- Frantisek Saudek
- François Dubé
- François Madore
- Freemu Varghese
- Gabriela Cecilia Coloma
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- Souhila Ounadjela
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- Srikanth Bellary
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- Stephan Maxeiner
- Stephen Grubb
- Stephen Smith
- Steven Fishbane
- Stuart Handelsman
- Suely Keiko Kohara
- Sun Kim
- Sun-Hee Park
- Sunil Sheth
- Susumu Kashine
- Svetlana Goykhman
- Svitlana D Bilyk
- Swee Win Lam
- Sylvia Rosas
- Sylvia Shaw
- Szilard Vasas
- Sérgio Alberto Cunha Vêncio
- Sérgio Yamada
- Tadashi Iitsuka
- Takamoto Kodera
- Takashi Wada
- Takayuki Watanabe
- Tamara Malek Marin
- Tamas Oroszlan
- Tara Chang
- Tareq Nassar
- Tarissa Beatrice Zanata Petry
- Tatiana Koroleva
- Tatiana Morugova
- Tatiana Raskina
- Tatyana Zykova
- Te-Lin Hsia
- Terue Sakakibara
- Tetiana Zlova
- Tetsuji Niiya
- Tetyana Pertseva
- Tiago Schuch
- Timothy Hall
- Tom Christensen
- Tom Greene
- Tomas Drasnar
- Tomas Smith Casabella
- Tonatiu Diaz Escalante
- Toshihiko Yanase
- Toshio Kawada
- Vadym Vizir
- Vanassa Ratnasingam
- Venessa Tsang
- Venkata Behara
- Vera Klokocnikova
- Vera Krane
- Veronica Anghel
- Veselka Genadieva
- Vesna Popovic-Radinovic
- Viacheslav Marasaev
- Victor Commendatore
- Victor Saavedra Gajardo
- Vijayaraman Arutchelvam
- Viktor Margaritov
- Viktor Zaviriukha
- Viktoria Andreeva
- Vimladhevi Govender
- Vincent Pichette
- Vincent Woo
- Vira Tseluyko
- Virginia Esther Visco
- Vivek Sood
- Vivekan Jha
- Vladimir Dobronravov
- Vladimir Khirmanov
- Vladimir Tesar
- Vlado Perkovic
- Volker Burst
- Volodymyr Botsyurko
- Walter Guillermo Douthat
- Walter Pharr
- Wasim Hanif
- Wataru Yumita
- Wayne H-H Sheu
- Wayne Turner
- Wei Yen Kong
- Weihong Song
- Weiping Lu
- Wendy Lane
- Wenge Li
- Wheeler D. C.
- Wladmir Saporito
- Xuemei Li
- Xueqing Yu
- Yamil Canaan
- Yan Ren
- Yannick Le Meur
- Yaozhong Kong
- Yasuro Kumeda
- Yasushi Wakida
- Yavin Y.
- Yeong Hoon Kim
- Yevgeniya Svyshchenko
- Young Min Cho
- Yulia Samoylova
- Yung-Chuan Lu
- Yuriy Mostovoy
- Yuriy Shwartz
- Yvette Ethel Yap
- Zaynab Abejuela
- Zdravko Kamenov
- Zeid Khitan
- Zhang H.
- Zinman B.
- Zishan Ali
- Zuzana Ochodnicka
- Ângela Regina Nazario Sabbag
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2019
- Field of study
BACKGROUND Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available. In cardiovascular trials of inhibitors of sodium–glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes. METHODS In this double-blind, randomized trial, we assigned patients with type 2 diabetes and albuminuric chronic kidney disease to receive canagliflozin, an oral SGLT2 inhibitor, at a dose of 100 mg daily or placebo. All the patients had an estimated glomerular filtration rate (GFR) of 30 to <90 ml per minute per 1.73 m2 of body-surface area and albuminuria (ratio of albumin [mg] to creatinine [g], >300 to 5000) and were treated with renin–angiotensin system blockade. The primary outcome was a composite of end-stage kidney disease (dialysis, transplantation, or a sustained estimated GFR of <15 ml per minute per 1.73 m2), a doubling of the serum creatinine level, or death from renal or cardiovascular causes. Prespecified secondary outcomes were tested hierarchically. RESULTS The trial was stopped early after a planned interim analysis on the recommendation of the data and safety monitoring committee. At that time, 4401 patients had undergone randomization, with a median follow-up of 2.62 years. The relative risk of the primary outcome was 30% lower in the canagliflozin group than in the placebo group, with event rates of 43.2 and 61.2 per 1000 patient-years, respectively (hazard ratio, 0.70; 95% confidence interval [CI], 0.59 to 0.82; P=0.00001). The relative risk of the renal-specific composite of end-stage kidney disease, a doubling of the creatinine level, or death from renal causes was lower by 34% (hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P<0.001), and the relative risk of end-stage kidney disease was lower by 32% (hazard ratio, 0.68; 95% CI, 0.54 to 0.86; P=0.002). The canagliflozin group also had a lower risk of cardiovascular death, myocardial infarction, or stroke (hazard ratio, 0.80; 95% CI, 0.67 to 0.95; P=0.01) and hospitalization for heart failure (hazard ratio, 0.61; 95% CI, 0.47 to 0.80; P<0.001). There were no significant differences in rates of amputation or fracture. CONCLUSIONS In patients with type 2 diabetes and kidney disease, the risk of kidney failure and cardiovascular events was lower in the canagliflozin group than in the placebo group at a median follow-up of 2.62 years
Effect of alirocumab on mortality after acute coronary syndromes. An analysis of the ODYSSEY OUTCOMES randomized clinical trial
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- Abbas J
- Abbate A
- Abdullakutty J
- Abdullkutty J
- Abhyanakar AD
- Aboyans V
- Abrantes JAM
- Abu-Fadel M
- Acevedo M
- Adamkova V
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- Adhyapak S
- Agarwal H
- Aggarwal R
- Aggarwal RK
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- Ahuad Guerrero RA
- Aidar Ayoub JC
- Airaksinen JK
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- Weidinger F
- Weil J
- Weintraub H
- Weissbrodt M
- Welka S
- Welker J
- Wells T
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- Westbrook M
- Westerhausen D
- Whitaker J
- White HD
- White L
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- Wiersma JJ
- Wilkins G
- Wilkinson P
- Willems FF
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- Winkelmann B
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- Yoon JH
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- Yusoff K
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- Zahger D
- Zaidman CJ
- Zainea M
- Zaman A
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- Zdravko B
- Zea Nunez CA
- Zeiher AM
- Zeiher AM
- Zhang R
- Zhang W
- Zhang X
- Zhang Z
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- Zheleznyy V
- Zheng Y
- Zheng Z
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- Zhu C
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- Zhu J
- Zirlik A
- Zizka J
- Zobouyan I
- Zong W
- Zrazhevsky K
- Zurakowski A
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- Zweiker R
- Publication venue
- 'Ovid Technologies (Wolters Kluwer Health)'
- Publication date
- 04/01/2019
- Field of study
Background: Previous trials of PCSK9 (proprotein convertase subtilisin-kexin type 9) inhibitors demonstrated reductions in major adverse cardiovascular events, but not death. We assessed the effects of alirocumab on death after index acute coronary syndrome. Methods: ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) was a double-blind, randomized comparison of alirocumab or placebo in 18 924 patients who had an ACS 1 to 12 months previously and elevated atherogenic lipoproteins despite intensive statin therapy. Alirocumab dose was blindly titrated to target achieved low-density lipoprotein cholesterol (LDL-C) between 25 and 50 mg/dL. We examined the effects of treatment on all-cause death and its components, cardiovascular and noncardiovascular death, with log-rank testing. Joint semiparametric models tested associations between nonfatal cardiovascular events and cardiovascular or noncardiovascular death. Results: Median follow-up was 2.8 years. Death occurred in 334 (3.5%) and 392 (4.1%) patients, respectively, in the alirocumab and placebo groups (hazard ratio [HR], 0.85; 95% CI, 0.73 to 0.98; P=0.03, nominal P value). This resulted from nonsignificantly fewer cardiovascular (240 [2.5%] vs 271 [2.9%]; HR, 0.88; 95% CI, 0.74 to 1.05; P=0.15) and noncardiovascular (94 [1.0%] vs 121 [1.3%]; HR, 0.77; 95% CI, 0.59 to 1.01; P=0.06) deaths with alirocumab. In a prespecified analysis of 8242 patients eligible for ≥3 years follow-up, alirocumab reduced death (HR, 0.78; 95% CI, 0.65 to 0.94; P=0.01). Patients with nonfatal cardiovascular events were at increased risk for cardiovascular and noncardiovascular deaths (P<0.0001 for the associations). Alirocumab reduced total nonfatal cardiovascular events (P<0.001) and thereby may have attenuated the number of cardiovascular and noncardiovascular deaths. A post hoc analysis found that, compared to patients with lower LDL-C, patients with baseline LDL-C ≥100 mg/dL (2.59 mmol/L) had a greater absolute risk of death and a larger mortality benefit from alirocumab (HR, 0.71; 95% CI, 0.56 to 0.90; Pinteraction=0.007). In the alirocumab group, all-cause death declined wit h achieved LDL-C at 4 months of treatment, to a level of approximately 30 mg/dL (adjusted P=0.017 for linear trend). Conclusions: Alirocumab added to intensive statin therapy has the potential to reduce death after acute coronary syndrome, particularly if treatment is maintained for ≥3 years, if baseline LDL-C is ≥100 mg/dL, or if achieved LDL-C is low. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01663402
Additional file 1 of A picture is worth a thousand words: advancing the use of visualization tools in implementation science through process mapping and matrix heat mapping
- Author
- Alanna Kulchak Rahm (8851472)
- Andrea N. Burnett-Hartman (14350917)
- Christine Y. Lu (8767026)
- Deborah Cragun (5913647)
- Ilene Ladd (5913680)
- Jamie Atondo (15356187)
- Jasmine Burton-Akright (15356190)
- Jennifer L. Schneider (5533175)
- Jessica Ezzell Hunter (11509870)
- Mara M. Epstein (9739753)
- Marc S. Williams (6830075)
- Pamala A. Pawloski (8087612)
- Ravi N. Sharaf (14488284)
- Su-Ying Liang (5913668)
- Victoria Schlieder (15356184)
- Zachary M. Salvati (15356181)
- Publication venue
- Publication date
- 25/04/2023
- Field of study
Additional file 1: Fig. 1. Data Extraction Guide for Universal Tumor Screening (UTS) Protocol Processes. Fig 2. Process and Contextual Differences within Organization 1. Fig 3. Initial Process Map for Organizational Unit 1A. Fig 4. Reconciled Process Map for Organizational Unit 1A. Fig. 5. Process Gap/Inefficiency to Optimization Component Conversion Table. Fig. 6. Matrix of UTS Protocol Optimization Levels by Organizational Unit. Fig. 7. Section of the CFIR Codebook Used for Qualitative Data Analysis. Fig. 8. Data Matrix of Factors Related to Intervention Characteristics from Organizational Unit 7. Fig. 9. Example of a Data Matrix Heat Map for Factors Related to Intervention Characteristics. Fig. 10. Example of Combined Codes for Factors Related to Intervention Characteristics. Fig. 11. Consolidated Data Matrix Heat Map for Characteristics of Intervention by Optimization Score. Fig. 12. Example of Collapsed Code ‘Evidence & Relative Advantage’ for all Organizational Units. Fig. 13. Final Heat Map of Factors Selected for Coincidence Analysis (CNA)
Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients
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- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
BACKGROUN
Liraglutide and Renal Outcomes in Type 2 Diabetes.
- Author
- Aamir S
- Ababa M
- Abbas S
- Abbink-Zandbergen E
- Abbott EC
- Abell S
- Aboo N
- Abraham P
- Abreu M
- Abu-Bakare A
- Acevedo Castañeda ES
- Acikgoz A
- Ackefelt-Frick E
- Adams D
- Adams P
- Adamson K
- Aden J
- Advani A
- Agrawal M
- Aguilar D
- Aguillon A
- Ahdi M
- Ahmed A
- Ahmed A
- Ahmed B
- Ahmed I
- Ahn HY
- Akalın S
- Akalin S
- Akhtar A
- Akin S
- Akinci B
- Akkurt A
- Akright B
- Akright L
- Akturk M
- Al-Maweri A
- Alanis RR
- Alawadi F
- Albarracin C
- Albert S
- Albertse HW
- Alcolea JO
- Aleksic S
- Alencar E
- Alencar R
- Alexander E
- Alfaraj A
- Alfredsson H
- Ali M
- Ali S
- Aliaga Verdugo A
- Aliuddin B
- Alkis N
- Allen S
- Allison R
- Almasmary A
- Almeida AC
- Altun I
- Altunbas HA
- Altuntas Y
- Alur VC
- Alvarado Ruíz R
- Alves B
- Alves E
- Alves G
- Alves J
- Alzohaili O
- Amador W
- Ambrish C
- Amine M
- Amini S
- Anderlová K
- Andersen PH
- Anderson L
- Anderson M
- Anderson R
- Andrews M
- Angel J
- Anteer W
- Antenore A
- Anthony V
- Antillon A
- Antkowiak-Piatyszek K
- Anzures P
- Appelt S
- Araujo L
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- Zolotov S
- Zoric S
- Zubair I.
- Zuradzka-Wajda D
- Zurawska-Klis M
- Zychma M
- Álvarez de Arcaya Vicente A
- Ángeles Tapia Herrero M
- Ítalo Mota J
- Ørsted DD
- Žourek M
- Publication venue
- Publication date
- 01/01/2017
- Field of study
BACKGROUND:
In a randomized, controlled trial that compared liraglutide, a glucagon-like peptide 1 analogue, with placebo in patients with type 2 diabetes and high cardiovascular risk who were receiving usual care, we found that liraglutide resulted in lower risks of the primary end point (nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes) and death. However, the long-term effects of liraglutide on renal outcomes in patients with type 2 diabetes are unknown.
METHODS:
We report the prespecified secondary renal outcomes of that randomized, controlled trial in which patients were assigned to receive liraglutide or placebo. The secondary renal outcome was a composite of new-onset persistent macroalbuminuria, persistent doubling of the serum creatinine level, end-stage renal disease, or death due to renal disease. The risk of renal outcomes was determined with the use of time-to-event analyses with an intention-to-treat approach. Changes in the estimated glomerular filtration rate and albuminuria were also analyzed.
RESULTS:
A total of 9340 patients underwent randomization, and the median follow-up of the patients was 3.84 years. The renal outcome occurred in fewer participants in the liraglutide group than in the placebo group (268 of 4668 patients vs. 337 of 4672; hazard ratio, 0.78; 95% confidence interval [CI], 0.67 to 0.92; P=0.003). This result was driven primarily by the new onset of persistent macroalbuminuria, which occurred in fewer participants in the liraglutide group than in the placebo group (161 vs. 215 patients; hazard ratio, 0.74; 95% CI, 0.60 to 0.91; P=0.004). The rates of renal adverse events were similar in the liraglutide group and the placebo group (15.1 events and 16.5 events per 1000 patient-years), including the rate of acute kidney injury (7.1 and 6.2 events per 1000 patient-years, respectively).
CONCLUSIONS:
This prespecified secondary analysis shows that, when added to usual care, liraglutide resulted in lower rates of the development and progression of diabetic kidney disease than placebo. (Funded by Novo Nordisk and the National Institutes of Health; LEADER ClinicalTrials.gov number, NCT01179048 .)
Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo
- Author
- Abid M.
- Accini J.L.
- Acuña S.
- Adawi F.
- Adenuga B.
- Adina P.-M.
- Ageev F.
- Aguilar D.
- Aguilar-Orozco R.
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- Aimaretti G.
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- Akhmedzhanov N.
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- Publication venue
- 'Elsevier BV'
- Publication date
- 01/01/2015
- Field of study
Background: Cardiovascular (CV) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Furthermore, patients with T2DM and acute coronary syndrome (ACS) have a particularly high risk of CV events. The glucagonlike peptide 1 receptor agonist, lixisenatide, improves glycemia, but its effects on CV events have not been thoroughly evaluated. Methods: ELIXA (www.clinicaltrials.gov no. NCT01147250) is a randomized, double-blind, placebo-controlled, parallelgroup, multicenter study of lixisenatide in patients with T2DM and a recent ACS event. The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population at high CV risk. The primary efficacy end point is a composite of time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. Data are systematically collected for safety outcomes, including hypoglycemia, pancreatitis, and malignancy. Results: Enrollment began in July 2010 and ended in August 2013; 6,068 patients from 49 countries were randomized. Of these, 69% are men and 75% are white; at baseline, the mean ± SD age was 60.3 ± 9.7 years, body mass index was 30.2 ± 5.7 kg/m2, and duration of T2DM was 9.3±8.2 years. The qualifying ACS wasamyocardial infarctionin83% and unstableangina in 17%. The study will continue until the positive adjudication of the protocol-specified number of primary CV events. Conclusion: ELIXA will be the first trial to report the safety and efficacy of a glucagon-like peptide 1 receptor agonist in people with T2DM and high CV event risk. © 2015 Elsevier Inc. All rights reserved