7 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.
- Bakris G.
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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
Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy
- Author
- Abdallah J
- Abdul Ghani R
- Abdul Kadir K
- Abdullah R
- Abejuela Z
- Abouglila K
- Abraham O
- Abrahamsen I
- Abraira Munoz Ld
- Abramowitz M
- Abusnana S
- Accini Mendoza Jl
- Acosta I
- Agafyina A
- Agarwal R
- Agarwal Rajiv
- Aggarwal N
- Agra J
- Ahmed F
- Ahuad Guerrero Ra
- Aiello J
- Ainsworth P
- Aizenberg D
- Akiyama H
- Akright L
- Akyea-Djamson A
- Al-Karadsheh A
- Alamartine E
- Alappan R
- Albisu Jp
- Ali N
- Ali Z
- Alicic R
- Allison Dc
- Alvarez Garcia P
- Alvarisqueta A
- Alves da Costa Fa
- Amerena J
- Amigo A
- Amodeo C
- Andreeva V
- Andreotti Turatti La
- Angelescu Lm
- Angelova A
- Anghel V
- Antic S
- Aoki H
- Aquitania G
- Arauz-Pacheco C
- Arcos E
- Arfeen S
- Arif A
- Aronson R
- Arutchelvam V
- Arvind M
- Asano A
- Asmarats Mercadal L
- Atray N
- August P
- Avendano J
- Avram Ri
- Awad A
- Babikova J
- Badat A
- Bajaj H
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- Vyasam Rc
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- Wadud K
- Wahba M
- Wakasugi M
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- Wang H
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- Wassermann A
- Watanabe T
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- Weiner P
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- Woo V
- Yakov A
- Yamada M
- Yamada S
- Yanagida K
- Yanase T
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- Yao C
- Yap Ye
- Yavin Yshai
- Ygpuara Mdl
- Yin A
- Yoiti Hayashida C
- Yoon Kh
- Yost L
- Young S
- Yu X
- Yumita W
- Yupanqui H
- Zaidman Cj
- Zalunardo N
- Zamarripa Escobedo R
- Zanata Petry Tb
- Zanella Mt
- 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
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
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- Souhila Ounadjela
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- Srikanth Bellary
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- Stanislaw Mazur
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- 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
Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients
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- Abbott J. Dawn
- Abdullah S.
- Abib E.
- Ables L. R.
- Abrantes J. A. M.
- Acosta R.
- Adams A.
- Adams F.
- Adroer Martori R.
- Agafina A. S.
- Agaiby J. M.
- Aggarwala G.
- Agraou B.
- AguilarSalinas C. A.
- Ahmad A.
- Ajala B.
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- Aksentiev S.
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- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
BACKGROUN
Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients
- Author
- A A
- Abbott Jd
- Abdullah S
- Abib E Jr
- Ables Lr
- Abrantes Ja
- Acosta R
- Adams A
- Adams F
- Adroer Martori R
- Agafina As
- Agaiby Jm
- Aggarwala G
- Agraou B
- Aguilarsalinas Ca
- Ahmad A
- Ajala B
- Akdeniz B
- Akhtar N
- Akright L
- Aksentiev S
- Al-Zoebi A
- Alappat P
- Albert M
- Alfieri Ad
- Alhakim M
- Allaw Ma
- Alpizar-Salazar M
- Altafullah Im
- Alvarado Op
- Alvarez Ca
- Alvarez Jg
- Alvarez Ms
- Alvarez-Sala Walther La
- Alves AR Jr
- Alwine Lk
- Alzand B
- Amarenco P.
- Ambrovicova V
- Amerena J
- Andersen Jl
- Andersen Lt
- Anderson P
- Anderson Tj
- Andrassy P
- Andrei Ld
- Andreka P
- Angoulvant D
- Angun M
- Annamalai N
- Ansari Sh
- Anselmi M
- Antonicelli R
- Appel Kf
- Aracil Villar J
- Arain S
- Arambula Rm
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- Arcanese Ml
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- Ari H
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- Arstila L
- Arya Kw
- Asamoah-Owusu N
- Askonen K
- Aslam Aa
- Assadourian A
- Assef V
- Atar S
- Auriel E
- Avaca H
- Averna M
- Avornyo Aa
- Avram Ri
- Axthelm C
- Ayesu K
- Aylward Pe
- Ayoub Jc
- Baar M
- Babapulle M
- Badat Ae
- Bailey Sr
- Bajaj H
- Bajcsi D
- Baker J
- Bakhai A
- Baldari D
- Ball Em
- Ballantyne Cm
- Ballyuzek M
- Balo T
- Banaszkiewicz K
- Bandeira e Farias FA
- Banerjee M
- Banik M
- Banyai M
- Baranova E
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- Behmanesh B
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- Burnier M
- Burova N
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- Busegeanu M
- Butuk Dj
- Buynak Rj
- Buysschaert I
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- Cabella Pr
- Cabezas Mc
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- Calin A
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- Camp Ad
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- Castro Montes Be
- Castro Ma
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- Catano Js
- Caudmont S
- Cayla G
- Cech V
- Cecil Jt
- Cequier Fillat Ar
- Cerci R
- Ceska R
- Ceyhan C
- Cha Jy
- Chahin M
- Chakrabarti A
- Chambers Jd
- Chandna H
- Chang Ar
- Chang Kc
- Changlani M
- Chati Z
- Chaudhuri S
- Cheek Hb
- Chen J
- Chen Jc
- Cherlin Rs
- Chernyatina Ma
- Cheung Ss
- Chiang Ce
- Chilka S
- Chiong R
- Cho Br
- Cho Ys
- Chochinov Rh
- Chorin E
- Chouinard G
- Chueca Fernandez Je
- Chun H
- Cifkova R
- Ciomag Rm
- Civeira Murillo F
- Civeira F.
- Clark Gb
- Clark R
- Claudio J
- Clemens Pc
- Codutti Or
- Coetzer Tf
- Cohen Aj
- Cohen Ss
- Coisne D
- Collier Dj
- Colombo Hr
- Colquhoun D
- Colquhoun D
- Comlekci A
- Conde Dg
- Cone Cl
- Connelly T
- Connery L
- Contzen C
- Conway Jr
- Cools F
- Copaci I
- Corder Cn
- Corin A
- Cornett Gm
- Cortada Jb
- Couffinhal T
- Cramer E
- Crater Ta
- Crean P
- Crimmins Ds
- Crisby M
- Cropp A
- Cruz Fernandez Jm
- Csanadi Ma
- Cuadrado Ja
- Cucher Fh
- Cui G
- Curiac D
- Curto M
- Cusimano S
- Czarnecka D
- D'Emden M
- da Costa Fa
- Da Stephan U
- Dada Fa
- Dahl Cf
- Dan Ga
- Dan Ga
- Dart Am
- Dave Kn
- Davidovits Z
- Davidsen F
- Davidson E
- Davis Sm
- Davis T
- de Barros e Silva PG
- De Belder M
- De Bruyne L
- De Castro R
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- De La Cuesta Mayor C
- De La Fuente Ra
- de Lima e Silva FA
- De Looze F
- De los Rios Ibarra Mo
- de Mora Martin M
- de Moraes Junior Jb
- De Nooijer C
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- de Santos Mo
- de Souza Wk
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- Delforge Md
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- Delgado Mi
- Demin A
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- den Hartog Fr
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- Descamps Os
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- Desrosiers D
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- Dimas Al
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- Distiller La
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- Dracoulakis Md
- Drapkina Om
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- Duprez D
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- Duris T
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- Dzupina A
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- El-Shahawy M
- Elbaz M
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- Epsley C
- Eraso Am
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- Escudier Villa Jm
- Esperon Ga
- Essandoh Lk
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- Fabryova L
- Faes D
- Fagan Tc
- Faghih M
- Fahdi Ie
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- Farhat Nz
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- Farsad R
- Fazekas F
- Fedacko J
- Fedele Francesco
- Feldman J
- Felicio Js
- Felix S
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- Ferrari E
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- Field A
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- Filippov A
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- First Bp
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- Ganesh S
- Gao R
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- Garcia Hernandez Pa
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- Goldenberg Rm
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- Gorog Da
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- Gottlieb Dw
- Gottsater A
- Goube P
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- Graff A
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- Groenemeijer Be
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- Madu Ij
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- Maggioni A
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- Markovic Tp
- Marshall A
- Marten I
- Martens Fm
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- Muniz Grijalvo O
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- Murcia A
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- Nikolaev Ky
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- Pei D
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- Pinto Sala X
- Pinto D
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- Plaza Perez I
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- Polanczyk Ca
- Ponikowski P.
- Pons Amate Jm
- Pop Cf
- Popa Ar
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- Popoviciu Ms
- Porcu M
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- Potthoff S
- Pouzar Je
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- Prasada S
- Precoma Db
- Pretorius Ce
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- Pride Y
- Probst V
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- Promisloff Sd
- Pryke Jr
- Przekwas-Jaruchowska M
- Pudi Kk
- Puhakka M
- Purdy Da
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- Quyyumi Aa
- Rabahi F
- Radin Dm
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- Ramos Mj
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- Ramos-Lopez Ga
- Ramstad Ds
- Randall Wj
- Randhawa Pm
- Range G
- Ranjith N
- Raoof Tj
- Raslova K
- Rasmanis G
- Rasmussen Tk
- Rech Rl
- Reddy Rd
- Redifer P
- Reed R
- Reedy Ma
- Reiber I
- Reis G
- Remmen Jj
- Rendell Ms
- Rensing Bj
- Resende Es
- Reshetko O
- Resk Jh
- Revkin J.
- Reyes Rg
- Reyna Ls
- Reynolds Rd
- Rhee My
- Rhudy Jm
- Rice S
- Rickers H
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- Rictor Kw
- Ridker P. M.
- Riesenberg Ra
- Rigolosi R
- Rihani R
- Riksen Np
- Rim Sj
- Rinke A
- Riojas Charles Cm
- Ripoll Vera Tv
- Risser Ja
- Ritt Le
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- Robinson Jg
- Robinson Mf
- Robles Iniesta A
- Rocco Mb
- Rodriguez Ij
- Rodriguez Wr
- Rodriguez-Briones I
- Roman G
- Roman O
- Romer Tj
- Romero Hinojosa Ja
- Roncon L
- Ronner E
- Roos Js
- Roosen J
- Roquer Gonzalez J
- Rosenfeld Jc
- Rosenstock J
- Roskova E
- Ross S
- Rossi Pr
- Roubille F
- Roux Sm
- Rozpondek P
- Rubenfire M
- Ruiz La
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- Ruoff Ge
- Rusculleda Mm
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- Saini S
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- Somogyi A
- Soosova I
- Soran H.
- Soroka E
- Sosa-Padilla Ma
- Soto Gonzalez A
- Soto Jr
- Sotolongo R
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- Soufflet V
- Sparks J
- Spence Jd
- Srimahachota S
- Sritara P
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- St-Amour E
- Staab Pk
- Stamps Hb
- Stawowy P
- Steffensen R
- Steinberg Aa
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- Strzinek Ra
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- Suarez-Fernandez C
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- Sullivan B
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- Sultan S
- Sumbal J
- Suomi J
- Supronik J
- Suryanarayana Pg
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- Szilagyi I
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- Tellier G
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- Tengmark Bo
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- The Sh
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- Thom S
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- Tivadar S
- Tofe Povedano S
- Toldy-Schedel E
- Tolkacheva V
- Torre Amione G
- Tortensson I
- Toth K
- Toth L
- Townsend Jc
- Traboulssi Ma
- Treasure Cb
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- Trenk D
- Triana Eh
- Trimarco B
- Trippett Jm
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- Tökgozoğlu L
- Ueng Kc
- Uhliar R
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- Updegrove Jd
- Uresin Ay
- Urhammer S
- Urina M
- Urina-Triana Ma
- Uusinarkaus Kt
- Vaca Ce
- Vahed Ya
- Valdez Lopez Hg
- Valtonen M
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- van de Wal Rm
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- van de Wiel A
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- van der Zwaan Ct
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- van Hal Jm
- Van het Hof-Wiersma Jj
- van Kempen Ww
- Van Koningsbruggen P
- van Landegem P
- van Leendert Rj
- van Nieuwenhuizen E
- van Rossum P
- van Royen N
- van Zyl Lj
- Vannatta B
- Vanttinen E
- Varleta P
- Vazan A
- Vazquez-Tanus Jb
- Veenendaal A
- Vejar M
- Venereo Jm
- Venter Dj
- Verdeza C
- Vertes A
- Vervoort G
- Verwerft J
- Vesely J
- Vico Ml
- Viergever Ep
- Viklund J
- Vila Belmonte A
- Villaman-Bencosme Y
- Vinanska D
- Vincent J.
- Vincent S
- Vinyoles Bargallo E
- Violante Ortiz R
- Vishlitzky V
- Vishneva E
- Visser Rp
- Visseren F
- Vivekananthan K
- Vizel S
- Vlach Jj
- Vodnansky P
- Voehringer Hf
- Vogel Dr
- Vohnout B
- Vojacek J
- Volkova A
- Voller H
- von Engelhardt Cb
- von Hodenberg Ef
- Vora Kn
- Vora Sk
- Voros P
- Vrablik M.
- Vrkoc J
- Vukotic G
- Wadud K
- Wainstein J
- Wakefield Ph
- Wakeling J
- Walczak M
- Walczewska J
- Walukiewica P
- Wang D
- Wang E
- Wang G
- Wang Y
- Wasserburger B
- Waxler Ar
- Wayne Jd
- Weber D
- Weber K
- Wegner J
- Wei C
- Weigmann I
- Weinstein Dl
- Weiss R
- Welker Ja
- Welty F
- Wenetz Lm
- Wermuth S
- Wesson T
- West Sh
- Westerndorp I
- Wetzel T
- White H.
- Whitlock L
- Whitney Rt
- Wiggers H
- William M
- Williams Dg
- Williams M
- Willis Jg
- Willits Vl
- Winkelmann B
- Witt N
- Wittmann I
- Woehrle J
- Worner Diz F
- Wozniak I
- Wright R. S.
- Wronska D
- Wuerzner G
- Wychota K
- Xu P
- Xue L
- Yakusevich Vv
- Yang P
- Yang X
- Yao Lc
- Yared Z
- Yarows Sa
- Yigit Z
- Yoon J
- Yunis C.
- Zadra R
- Zaidman Cj
- Zamorano Gomez Jl
- Zannad F
- Zarandon Rb
- Zarich Sw
- Zateyshchikov D
- Zavaro Sh
- Zebrack Js
- Zeig S
- Zemek S
- Zemour G
- Zeng X
- Zeno Ml
- Zhang L
- Zhang X
- Zhang Y
- Zhao Y
- Zhou C
- Zhou Y
- Zhu Y
- Zidkova E
- Zieba B
- Zilahi Z
- Zoet-Nugteren Sk
- Zrazhevskiy K
- Zubek V
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
Bococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin- kexin type 9 (PCSK9) and reduces levels of low-density lipoprotein (LDL) cholesterol. We sought to evaluate the efficacy of bococizumab in patients at high cardiovascular risk. METHODS In two parallel, multinational trials with different entry criteria for LDL cholesterol levels, we randomly assigned the 27,438 patients in the combined trials to receive bococizumab (at a dose of 150 mg) subcutaneously every 2 weeks or placebo. The primary end point was nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina requiring urgent revascularization, or cardiovascular death; 93% of the patients were receiving statin therapy at baseline. The trials were stopped early after the sponsor elected to discontinue the development of bococizumab owing in part to the development of high rates of antidrug antibodies, as seen in data from other studies in the program. The median follow-up was 10 months. RESULTS At 14 weeks, patients in the combined trials had a mean change from baseline in LDL cholesterol levels of -56.0% in the bococizumab group and +2.9% in the placebo group, for a between-group difference of -59.0 percentage points (P<0.001) and a median reduction from baseline of 64.2% (P<0.001). In the lower-risk, shorter-duration trial (in which the patients had a baseline LDL cholesterol level of ≥70 mg per deciliter [1.8 mmol per liter] and the median follow-up was 7 months), major cardiovascular events occurred in 173 patients each in the bococizumab group and the placebo group (hazard ratio, 0.99; 95% confidence interval [CI], 0.80 to 1.22; P = 0.94). In the higher-risk, longer-duration trial (in which the patients had a baseline LDL cholesterol level of ≥100 mg per deciliter [2.6 mmol per liter] and the median follow-up was 12 months), major cardiovascular events occurred in 179 and 224 patients, respectively (hazard ratio, 0.79; 95% CI, 0.65 to 0.97; P = 0.02). The hazard ratio for the primary end point in the combined trials was 0.88 (95% CI, 0.76 to 1.02; P = 0.08). Injection-site reactions were more common in the bococizumab group than in the placebo group (10.4% vs. 1.3%, P<0.001). CONCLUSIONS In two randomized trials comparing the PCSK9 inhibitor bococizumab with placebo, bococizumab had no benefit with respect to major adverse cardiovascular events in the trial involving lower-risk patients but did have a significant benefit in the trial involving higher-risk patients
The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) Study Rationale, Design, and Baseline Characteristics
- Author
- Abdallah J
- Abdul Ghani R
- Abdul Kadir K
- Abdullah R
- Abdullah R
- Abejuela Z
- Abraham O
- Abramowitz M
- Abusnana S
- Accini Mendoza JL
- Acosta I
- Agafyina A
- Aggarwal N
- Ahmed F
- Ahuad Guerrero RA
- Aiello J
- Ainsworth P
- Aizenberg D
- Akiyama H
- Akright L
- Akyea-Djamson A
- Al-Karadsheh A
- Alamartine E
- Alappan R
- Ali N
- Ali Z
- Alicic R
- Alpizar Salazar M
- Alvarez Garcia P
- Alvarisqueta A
- Amodeo C
- Andreeva V
- Andreotti Turatti LA
- Angelescu Lm
- Angelova A
- Anghel V
- Antic S
- Aoki H
- Aquitania G
- Arauz-Pacheco C
- Arce-Nunez E
- Arcos Palma EG
- Arfeen S
- Arif A
- Aronson R
- Arutchelvam V
- Asano A
- Atray N
- Avram Ri
- Awad A
- Baas Cruz J
- Babikova J
- Badat A
- Bajaj H
- Baker J
- Bakris G
- Barbarash O
- Barna O
- Barnard M
- Barranco E
- Barrera C
- Bartaskova D
- Bartolacci I
- Barysheva O
- Behara V
- Bellary S
- Belo D
- Bentley-Lewis R
- Benusova O
- Berenguer R
- Berli Ma
- Bernardo M
- Biscoveanu M
- Bordonava Ap
- Borot S
- Botsyurko V
- Bowman-Stroud C
- Brandon D
- Bregman R
- Brusco O
- Buganova I
- Burgos Soto M
- Busch R
- Busegeanu Mm
- Calella P
- Camelo Sanches FC
- Canaan Y
- Canani Lh
- Cantero Mc
- Cariou B
- Cartasegna Lr
- Castellino P
- Cereto Castro F
- Certow G
- Chacra Ar
- Chae Dw
- Chang Ct
- Chang T
- Che Yusof MD
- Chen N
- Chen Q
- Cherney D
- Cheung Nw
- Chevaile Ramos J
- Chew Wong A
- Chiovato L
- Chizhov D
- Cho Ym
- Christiano C
- Christofides E
- Chuang Lm
- Chuateco C
- Cif A
- Cigarran Guldris S
- Cohen K
- Cohen R
- Coloma Gc
- Comia Rs
- Commendatore V
- Conway J
- Cook C
- Cosma D
- Cournoyer S
- Coyne D
- Crisan C
- Csecsei G
- Csiky B
- Cuadrado J
- Cuneo Ca
- Cunha Borges JL
- Cunha Vêncio SA
- Cusumano Am
- da Silva Franco RJ
- Daboul N
- Danos P
- Daroza G
- Davies E
- Davies M
- Davies S
- Dawson A
- De Cosmo S
- De Nicola L
- De Serres S
- de Souza Portes E
- Deak L
- Deck K
- Deepak D
- Derosa G
- Desouza C
- Dev D
- Dhillon M
- Di Carlo A
- Di Cianni G
- Diaz Escalante T
- Dimitrov S
- Distiller L
- Djordjevic M
- Dobronravov V
- Dohnalova L
- Dominguez Lopez M
- Douthat Wg
- Dran Rd
- Drasnar T
- Dreval A
- Droste C
- Dua S
- Dube F
- Dudar I
- Dudas M
- Dussol B
- Dzupina A
- Eder F
- Edwin F M.
- Egido de Los Rios J
- El Kossi M
- El-Shahawy M
- English P
- Enriquez Sosa FE
- Ervin J
- Esquenazi A
- Evans J
- Faghih M
- Farias E
- Faulmann G
- Fauvel Jp
- Ferariu Ie
- Fernandez Fresnedo G
- Fernandez Montenegro MA
- Fernandez Mf
- Finkelstein H
- Flores Lozano F
- Flota Cervera L
- Fraige Filho F
- Fraser D
- Frenk Baron P
- Fretes Jo
- Frias J
- Fuiano G
- Fulop P
- Fushtey I
- Galan Serrano A
- Galphin C
- Gan Cl
- Gan S
- Garcia Ballesteros C
- Garcia Ortiz LH
- Garcia I
- Garcia Nh
- Garrido N
- Gastaldi A
- Gelersztein E
- Geloneze Neto B
- Genadieva V
- Genova-Hristova G
- Genovese S
- Ghazi A
- Giorda C
- Glenny Ja
- Glinkina I
- Godlevska O
- Godoy Jorquera JG
- Goldenberg R
- Golovchenko O
- Gomes Bastos M
- Gomez Rangel JD
- Gomez O
- Gonzalez Dorado A
- Gonzalez Martinez FJ
- Gonzalez Orellana RA
- Gonzalez E
- Gopalakrishnan N
- Gorriz Jl
- Gorson D
- Govender V
- Gracious N
- Greco B
- Gregar R
- Greloni Gc
- Grineva E
- Guinsburg A
- Gulati R
- Gunstone A
- Gupta A
- Gupta M
- Gyrina O
- Hadjadj S
- Halciakova K
- Hall T
- Haller H
- Halmagyi I
- Hammoud J
- Hancu N
- Hanif W
- Hansraj A
- Hawley C
- Henein S
- Hermida S
- Hernandez Triana E
- Herrera Jimenez LE
- Hershon K
- Higuera Cobos JD
- Hiser D
- Hocking S
- Hon G
- Hristozov K
- Hsieh Ch
- Hura C
- Hwang Sj
- Ilavska A
- Irizar Santana SS
- Ismail M
- Jackson A
- Jain D
- Jamal A
- Januszewicz A
- Jeong Ik
- Jha V
- Jimenez Flores F
- Jodar Gimeno JE
- Johnson A
- Joseph F
- Joshi M
- Juncos Li
- Jurgens J
- Kajiyama S
- Kaminska A
- Kashine S
- Kaupke C
- Kawada T
- Keiko Kohara S
- Keitel E
- Keltai K
- Kendereski A
- Keresztesi S
- Kern E
- Kerr Saraiva JF
- Keshavamurthy Cb
- Khandwala H
- Khanna R
- Khitan Z
- Khullar D
- Kim S
- Kim Sg
- Kim Yh
- Kiss K
- Klein A
- Klyver Mi
- Kodera T
- Kolesnyk M
- Kolmakova E
- Komisarenko I
- Kong Wy
- Kong Y
- Kono H
- Konyves L
- Kopyt N
- Korzh O
- Kovar R
- Kovesdy C
- Koyama K
- Kozloviene D
- Kraft F
- Krane V
- Kravchun N
- Krishna G
- Krishnan S
- Kropp Jj
- Kumar A
- Kumar J
- Kumeda Y
- Kumwenda M
- Kurtz Lisboa HR
- Kvitkova L
- Kwon Hs
- Kwon Mj
- Lalic K
- Lalic N
- Lanchiotti Pv
- Lastuvka J
- Laviada Molina H
- Lawrence M
- Le Meur Y
- Lee Bw
- Lee J
- Lee Ly
- Lee Mk
- Legun O
- Leiter L
- Lentz J
- Leon de la Fuente RA
- Levin A
- Lewis D
- Li D
- Li W
- Li X
- Lim Sk
- Lin Cc
- Lin H
- Liss K
- Liu J
- Loh Cl
- Lombard L
- Lopez Mendoza M
- Lopez Tarabay C
- Lorenzoni d'avila DO
- Loss de Carvalho Contieri F
- Lu W
- Lu Yc
- Luna Ceballos R
- Macdougall I
- Macedo de Souza PA
- Madej A
- Madore F
- Magalhaes Montenegro Junior R
- Mah Pm
- Maheshwari H
- Major L
- Malberti F
- Malek Marin T
- Mandayam S
- Mandreoli M
- Manisha S
- Mankovskyy B
- Mannucci E
- Manocha Ab
- Mao H
- Marar I
- Marasaev V
- Marchetta N
- Martin Del Campo Blanco B
- Martinka E
- Martynyuk L
- Maxeiner S
- Mazur S
- Mcmahon A
- Medina Farina M
- Mehta B
- Middleton J
- Mileder M
- Miyauchi S
- Mizuyama K
- Mkrtumyan A
- Mlodawska-Choluj D
- Molina de Salazar DI
- Molnar M
- Mookadam M
- Morales Franco G
- Morales Portillo C
- Mordujovich J
- Moreira de Brito C
- Moreira Diaz JP
- Moreno Loza OT
- Mostovoy Y
- Moustafa M
- Muirhead N
- Mujica Trenche S
- Munar Vila MA
- Munoz Torres M
- Munteanu M
- Mustieles Rocha C
- Nagibovich G
- Nam Ms
- Narvarte J
- Nasser Hissa M
- Navickas A
- Nazario Sabbag ÂR
- Nedogoda S
- Negru D
- Newman G
- Ng Ks
- Ngcakani N
- Nicholls K
- Nicol P
- Nieto Iglesias J
- Niiya T
- Nik Ahmad NNF
- Nisnisan J
- Nonchev B
- Noronha Il
- Nortje H
- Nossuli Ak
- Nowicki M
- O'Shaughnessy A
- Obialo C
- Obrador Vera G
- Ochodnicka Z
- Oh Kh
- Oishi H
- Olelewe S
- Oliver M
- Oosthuizen H
- Orio Si
- Orlowska-Kowalik G
- Oroszlan T
- Orozco Castellanos R
- Orozco J Tamayo Y.
- Orsi E
- Ory I
- Ota S
- Otreras F
- Oviedo A
- Packham D
- Padron J
- Panarotto D
- Pankhaniya R
- Pantoja Perez J
- Paragh G
- Park Cy
- Park Sh
- Pashkovska N
- Patel D
- Patel G
- Pavon H
- Pei D
- Pella D
- Penfornis A
- Peralta Calcaneo J
- Pereira Ma
- Pererva L
- Perez Vera M
- Peringat J
- Pertseva T
- Pesickova S
- Peterfai E
- Peterka K
- Petrica L
- Petro G
- Pettis K
- Pharr W
- Philip S
- Phillips A
- Piatti P
- Pichette V
- Pontiroli A
- Popa Ar
- Popenda G
- Popovic-Radinovic V
- Portoles Perez JM
- Prasad N
- Proietto J
- Prozesky H
- Pumprla J
- Purighalla R
- Quesada Simon MA
- Quesada-Suarez L
- Rabasa-Lhoret R
- Ramirez Roca LA
- Ramtoola S
- Ranetti Ae
- Rangelov R
- Ranjan R
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- Ratnasingam V
- Reddy J
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- Ren Y
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- Reyes Rosano MA
- Rich L
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- Rucker Joerg IE
- Rychlik I
- Saavedra Gajardo V
- Saavedra Sanchez SB
- Sala J
- Samoylov O
- Samoylova Y
- Sanchez Arenales JA
- Sanchez Mijangos JH
- Sanchez Polo JV
- Sankaram R
- Santoro D
- Santos F
- Santos Jc
- Sarin R
- Saudek F
- Saumell F
- Saxena M
- Sazonova O
- Schiavi Lb
- Schiller A
- Schuch T
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- Seeber M
- Seiji Yamada S
- Sekkarie M
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- Serafinceanu C
- Serrano Sanson P
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- Shamkhalova M
- Shanik M
- Shaw S
- Sheu Wh
- Shinkov A
- Shutemova E
- Silva Pecoits Filho RF
- Simo Canonge R
- Simoes de Almeida R
- Simon G
- Singh B
- Slompo Ramos C
- Smatanova I
- Smirnov I
- Smith Casabella T
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- Soler Romeo MJ
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- Soto Gonzalez A
- Sowinski D
- Sprague A
- Sree Bhushan R
- Sreedhar R
- Sreelatha M
- Steele A
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- Strzelecka A
- Suchinda P
- Sudhakar B
- Sun J
- Sun L
- Surampudi P
- Sussman S
- Svyshchenko Y
- Symonds R
- Szlachcic Y
- Takacs R
- Takai M
- Tan G
- Tellez Chavez E
- Temelkova M
- Terns Riera M
- Terront Lozano MA
- Tesar V
- Thompson M
- Tibes Hachmann JC
- Tinahones Madueno FJ
- Tolentino M
- Tomashkevych H
- Tomonaga O
- Topchii I
- Torshizi A
- Trespalacios F
- Trevisan R
- Trueba P
- Tryshchuk N
- Tseluyko V
- Tsujimoto M
- Tu P
- Turcios Juarez E
- Turner W
- Twahirwa M
- Ulla Mr
- Updegrove J
- Urbanaviciene E
- Valderrama Cometa L
- Valdes Cepeda A
- Valenzuela A
- Valis M
- Vallejos A
- Vangel S
- Vannorsdall M
- Vargas Alonso RD
- Varghese F
- Vasas S
- Vazelov E
- Vejar M
- Velasquez-Mieyer P
- Velichkova E
- Velo M
- Venegas Carrillo L
- Vengadasalam P
- Ventrapragada S
- Villagordoa Mesa J
- Villarino Aa
- Villegas I
- Visco Ve
- Vizir V
- Vlasenko M
- Vyasam Rc
- Wada T
- Wadud K
- Wahba M
- Wakasugi M
- Wakeling J
- Wakida Y
- Walker R
- Wang G
- Warren M
- Wassermann A
- Watanabe T
- Watson E
- Watts R
- Weiner D
- Weiner P
- Welsh J
- Wheeler D
- Williams M
- Winocour P
- Woo V
- Yamada M
- Yanagida K
- Yanase T
- Yang J
- Yao C
- Yap Ye
- Ygpuara Mdl
- Yin A
- Yoiti Hayashida C
- Yoon Kh
- Young S
- Yu X
- Yumita W
- Yupanqui H
- Zaidman Cj
- Zamarripa Escobedo R
- Zanata Petry TB
- Zanella Mt
- Zaoui P
- Zavaroni I
- Zemek S
- Zhang H
- Zhao M
- Zheng H
- Zlova T
- Zsom M
- Zykova T.
- Publication venue
- Publication date
- Field of study
Background: People with diabetes and kidney disease have a high risk of cardiovascular events and progression of kidney disease. Sodium glucose co-transporter 2 inhibitors lower plasma glucose by reducing the uptake of filtered glucose in the kidney tubule, leading to increased urinary glucose excretion. They have been repeatedly shown to induce modest natriuresis and reduce HbA1c, blood pressure, weight, and albuminuria in patients with type 2 diabetes. However, the effects of these agents on kidney and cardiovascular events have not been extensively studied in patients with type 2 diabetes and established kidney disease. Methods: The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial aims to compare the efficacy and safety of canagliflozin Âversus placebo at preventing clinically important kidney and cardiovascular outcomes in patients with diabetes and established kidney disease. CREDENCE is a randomized, double-blind, event-driven, placebo-controlled trial set in in 34 countries with a projected duration of â\u88¼5.5 years and enrolling 4,401 adults with type 2 diabetes, estimated glomerular filtration rate â\u89¥30 to 300 to â\u89¤5,000 mg/g). The study has 90% power to detect a 20% reduction in the risk of the primary outcome (α = 0.05), the composite of end-stage kidney disease, doubling of serum creatinine, and renal or cardiovascular death. Conclusion: CREDENCE will provide definitive evidence about the effects of canagliflozin on renal (and cardiovascular) outcomes in patients with type 2 diabetes and established kidney disease. Trial Registration: EudraCT number: 2013-004494-28; ClinicalTrials.gov identifier: NCT02065791
Kidney and Cardiovascular Effects of Canagliflozin According to Age and Sex: A Post Hoc Analysis of the CREDENCE Randomized Clinical Trial
- Author
- Abdallah Joseph
- Abdul Ghani Rohana
- Abdullah Raied
- Abejuela Zaynab
- Abouglila Kamal
- Abraham Oomman
- Abraira Munoz Luis David
- Abramowitz Matthew
- Abusnana Salah
- Acosta Idalia
- Agafyina Alina
- Agarwal Rajiv
- Agarwal Rajiv
- Aggarwal Naresh
- Agra Jeimeen
- Ahmad Nik Nur Fatnoon Nik
- Ahmed Fayzal
- Aiello Joseph
- Ainsworth Paul
- Aizenberg Diego
- Aizenberg Diego
- Akiyama Hitoshi
- Akright Laura
- Akyea-Djamson Ayim
- Al-Karadsheh Amer
- Alamartine Eric
- Alappan Rajendran
- Albisu Juan Pablo
- Alexandra Terront Lozano Monica
- Ali Norsiah
- Ali Zishan
- Alicic Radica
- Allison Dale Crawford
- Alvarisqueta Andres
- Amodeo Celso
- Andreeva Viktoria
- Angelescu Liliana Monica
- Angelova Angelina
- Anghel Veronica
- Antic Slobodan
- Aoki Hiromi
- Aquitania Grace
- Arauz-Pacheco Carlos
- Arcos Edgar
- Arfeen Shahabul
- Arif Ahmed
- Arnott Clare
- Aronson Ronnie
- Arutchelvam Vijayaraman
- Arvind Moogali
- Asano Akimichi
- Atray Naveen
- Avendano Jorge
- Avram Rodica-Ioana
- Awad Ahmed
- Babikova Jana
- Badat Aysha
- Bajaj Harpreet
- Baker John
- Bakris George
- Bakris George
- Bakris George
- Ballesteros Cecilia Garcia
- Barbarash Olga
- Barna Olga
- Barnard Maria
- Barnhill Peggy
- Baron Paul Frenk
- Barranco Elizabeth
- Barrera Carlos
- Barrios Clara
- Bartaskova Dagmar
- Bartolacci Ines
- Barton Petr
- Barysheva Olga
- Beacom Matthew
- Behara Venkata
- Bellary Srikanth
- Belo Diogo
- Belobradkova Jana
- Bentley-Lewis Rhonda
- Benusova Olga
- Berenguer Ramon
- Berli Mario Alberto
- Bermudez Lidia
- Bernardo Marializa
- Bhushan Raju Sree
- Bijata-Bronisz Renata
- Bilyk Svitlana D.
- Biscoveanu Mihaela
- Bonadonna Riccardo
- Bordonava Anselmo
- Borges João Lindolfo Cunha
- Borot Sophie
- Botsyurko Volodymyr
- Bowman-Stroud Cynthia
- Brandon Donald
- Breedt Johannes
- Bregman Rachel
- Brenner Barry M.
- Brusco Osvaldo
- Buganova Ingrid
- Burst Volker
- Busch Robert
- Busegeanu Mihaela-Magdalena
- Calcaneo Juan Peralta
- Calella Pedro
- Canaan Yamil
- Canani Luis Henrique
- Cannon Christopher P.
- Cannon Christopher P.
- Canonge Rafael Simo
- Cantero Maria Cecilia
- Cardoza Kathryn
- Caringal Clodoaido
- Cariou Bertrand
- Carrillo Luis Venegas
- Cartasegna Luis Rodolfo
- Casabella Tomas Smith
- Castellanos Ricardo Orozco
- Castellino Pietro
- Castro Fernando Cereto
- Cepeda Alejandro Valdes
- Cercos Esteban
- Ceriello Antonio
- Chacra Antônio Roberto
- Chae Dong-Wan
- Chae Dong-Wan
- Chandra Vyasam Ramesh
- Chang Chwen-Tzuei
- Chang Tara
- Charytan David M.
- Charytan David M.
- Charytan David M.
- Chavez Eloisa Tellez
- Che Yusof Mohd Daud
- Chen Nan
- Chen Qinkai
- Cherney David
- Cherney David
- Chertow Glenn
- Cheung Ngai Wah
- Chilito Alicia
- Chiovato Luca
- Chizhov Daniil
- Cho Young Min
- Chouinard Guy
- Christensen Tom
- Christiano Cynthia
- Christofides Elena
- Chuang Lee-Ming
- Chuateco Caroucel
- Cif Adriana
- Cohen Kenneth
- Cohen Robert
- Cohen-Stein Debbie
- Colaso Patricia del Carmen Gonzalez
- Coloma Gabriela Cecilia
- Colombo Hugo
- Cometa Luis Valderrama
- Comia Rhea Severina
- Commendatore Victor
- Contieri Fabiana Loss de Carvalho
- Conway James
- Cook Charles
- Correa Rotter Jose Ricardo
- Cosma Dana
- Costa Fernando Augusto Alves da
- Cournoyer Serge
- Coyne Daniel
- Crisan Carmen
- Cruz Juan Baas
- Csecsei Gyongyi
- Csiky Botond
- Cuadrado Jesus
- Culak Jan
- Cuneo Carlos Alberto
- Cusumano Ana Maria
- Daboul Nizar
- Danos Peter
- DaRoza Gerald
- Darwish Riad
- Daswani Adarsh
- David null
- Davies Emyr
- Davies Mark
- Davies Simon
- Dawson Alison
- de Almeida Roberto Simões
- de Brito Claudia Moreira
- De Cosmo Salvatore
- De Nicola Luca
- De Nicola Luca
- de Salazar Dora Inés Molina
- De Serres Sacha
- de Souza Pedro
- de Zeeuw Dick
- de Zeeuw Dick
- Deak Laszlo
- Deboni Luciane Mônica
- Deck Kenneth
- Deepak Dewan
- del Campo Blanco Belia Martin
- Demian Luiza Despina
- Derosa Giuseppe
- Desouza Cyrus
- Dev Devasmita
- Dhillon Monika
- Di Carlo Alberto
- Di Cianni Graziano
- Di Tanna Gian Luca
- Diaz Ruiz Jorge Ernesto Andres
- Dimitrov Stefan
- Distiller Larry
- Distiller Lawrence
- Djordjevic Miodrag
- Dobronravov Vladimir
- Dohnalova Lenka
- Douthat Walter Guillermo
- Dran Ricardo Dario
- Drasnar Tomas
- Dreval Alexander
- Dreval Alexander
- Droste Carolyn
- Dua Sohan
- Dubé François
- Dudar Iryna
- Dudas Mihaly
- Dussol Bertrand
- Dzupina Andrej
- Dzuponova Jana
- d’Avila Domingos
- Eder Frank
- Edwin Fernando M.
- Egido de los Rios Jesus
- El Kossi Mohsen
- El-Shahawy Mohamed
- Elosegui Ana Maria
- English Patrick
- Enriquez Sosa Favio Edmundo
- Ervin John
- Escalante Tonatiu Diaz
- Escobedo Rolando Zamarripa
- Esquenazi Alberto
- Evans John
- Faghih Markus
- Farias Eduardo
- Fariña Marcelo Medina
- Faulmann Grit
- Fauvel Jean-Pierre
- Felício João Soares
- Ferariu Ioana Emilia
- Ferkl Richard
- Fernandez Maria Florencia
- Filho Roberto Pecoits
- Finkelstein Hernan
- Fishbane Steven
- Flores Fernando Jimenez
- Flota Cervera Luis Fernando
- Fragale Guillermo
- Fraige Filho Fadlo
- Franco Guadalupe Morales
- Franco Roberto Jorge da Silva
- Frascà Giovanni
- Fraser Donald
- Fraser Ian
- Fresnedo Gema Fernandez
- Fretes Jose Osvaldo
- Frias Juan
- Fuiano Giorgio
- Fulop Peter
- Fushtey Ivan
- Gajardo Victor Saavedra
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- Vukotic Goga
- Wada Takashi
- Wada Takashi
- Wadud Khurram
- Wahba Mona
- Wakasugi Masakiyo
- Wakeling John
- Wakida Yasushi
- Walker Robert
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- Warren Mark
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- Watanabe Takayuki
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- Weiner Daniel
- Weiner Pavel
- Welker James
- Welsh Jean
- Wheeler C.
- Wheeler David
- Wheeler David C.
- Wheeler David C.
- Williams Michael
- Williams Shelley
- Winocour Peter
- Wong Alfredo Chew
- Woo Vincent
- Yakov Andrian
- Yamada Masayo
- Yamada Sérgio
- Yanagida Kazuhiro
- Yanase Toshihiko
- Yang Jinkui
- Yao Christy
- Yap Yvette Ethel
- Yi Tae Won
- Yin Aiping
- Yoon Kun Ho
- Young Simon
- Yu Xueqing
- Yumita Wataru
- Yupanqui Hernan
- Zaidman Cesar Javier
- Zalunardo Nadia
- Zanella Maria Teresa
- Zaniewski-Singh Michelle
- Zanoli Luca
- Zaoui Philippe
- Zateyshchikova Anna
- Zateyshshikov Dmitry
- Zemek Stanislav
- Zhang Hong
- Zhang Hong
- Zhang Hong
- Zhao Minghui
- Zheng Hongguang
- Zinman Bernard
- Zinman Bernard
- Zlova Tetiana
- Zsom Marianna
- Zub Liliia
- Zykova Tatyana
- Publication venue
- Publication date
- 01/01/2023
- Field of study
Rationale & Objective: It is unclear whether the effect of canagliflozin on adverse kidney and cardiovascular events in those with diabetic kid-ney disease varies by age and sex. We assessed the effects of canagliflozin among age group categories and between sexes in the Canagli-flozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) study.Study Design: Secondary analysis of a random-ized controlled trial. Setting & Participants: Participants in the CREDENCE trial. Intervention: Participants were randomly assigned to receive canagliflozin 100 mg/d or placebo.Outcomes: Primary composite outcome of kid-ney failure, doubling of serum creatinine con-centration, or death due to kidney or cardiovascular disease. Prespecified secondary and safety outcomes were also analyzed. Out-comes were evaluated by age at baseline (<60, 60-69, and >_70 years) and sex in the intention-to-treat population using Cox regression models.Results: The mean age of the cohort was 63.0 & PLUSMN; 9.2 years, and 34% were female. Older age and female sex were independently associ-ated with a lower risk of the composite of adverse kidney outcomes. There was no evidence that the effect of canagliflozin on the primary outcome (acomposite of kidney failure, a doubling of serum creatinine concentration, or death from kidney or cardiovascular causes) differed between age groups (HRs, 0.67 [95% CI, 0.52-0.87], 0.63 [0.4 8-0.82], and 0.89 [0.61-1.29] for ages <60, 60-69, and >_70 years, respectively; P = 0.3 for interaction) or sexes (HRs, 0.71 [95% CI, 0.5 4-0.95] and 0.69 [0.56-0.8 4] in women and men, respectively; P = 0.8 for interaction). No differences in safety outcomes by age group or sex were observed.Limitations: This was a post hoc analysis with multiple comparisons.Conclusions: Canagliflozin consistently reduced the relative risk of kidney events in people with diabetic kidney disease in both sexes and across age subgroups. As a result of greater background risk, the absolute reduction in adverse kidney outcomes was greater in younger participants.Funding: This post hoc analysis of the CREDENCE trial was not funded. The CREDENCE study was sponsored by Janssen Research and Development and was conducted collaboratively by the sponsor, an academic-led steering committee, and an academic research organization, George Clinical.Trial Registration: The original CREDENCE trial was registered at ClinicalTrials.gov with study number NCT02065791