4 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
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- 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
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- Cigarr\ue1n Guldris Secundino
- Cimino Roberto
- Clavel Sylvaine
- Clodi Martin
- Cobos Jorge
- Colman Peter
- Colquhoun David
- Constantin Ciprian
- Contzen Christel
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- Coronel Julian
- Cortes-Maisonet Gregorio
- Cortes-Maisonet Gregorio
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- 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
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- Dong Youping
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- Ebenbichler Christoph
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- Frank Malin
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- H Boonstra A
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- Habwe Violet
- Hagemeier Robert
- Hagenow Andreas
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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
Evolocumab and clinical outcomes in patients with cardiovascular disease
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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
Edoxaban versus warfarin in patients with atrial fibrillation
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- Zamlynskyy M
- Zamorano JL
- Zanotti A
- Zanwar I
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- Zarebinski M
- Zareczky P
- Zarpentin C
- Zateyshchikov D
- Zateyshchikova A
- Zeig S
- Zellner C
- Zeltser D
- Zenin S
- Zhang HQ
- Zhang P
- Zhang X
- Zhang YL
- Zhang Z
- Zhao RP
- Zhao XL
- Zharinov O
- Zheng X
- Zheng Y
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- Zhou SX
- Zhukova N
- Zhurba S
- Zidkova E
- Zidkova E
- Ziegler K
- Zielinski M
- Zienciuk-Krajka A
- Zimmermann EB
- Zimmermann S
- Zoghi M
- Zoghi M
- Zondag M
- Zotova I
- Zubeeva G
- Zyatenkova E
- Ă…kerberg A
- Ă–stberg S
- Ĺśpinar J
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2013
- Field of study
Contains fulltext :
125374.pdf (publisher's version ) (Open Access)BACKGROUND: Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects. The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known. METHODS: We conducted a randomized, double-blind, double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation (median follow-up, 2.8 years). The primary efficacy end point was stroke or systemic embolism. Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period. The principal safety end point was major bleeding. RESULTS: The annualized rate of the primary end point during treatment was 1.50% with warfarin (median time in the therapeutic range, 68.4%), as compared with 1.18% with high-dose edoxaban (hazard ratio, 0.79; 97.5% confidence interval [CI], 0.63 to 0.99; P<0.001 for noninferiority) and 1.61% with low-dose edoxaban (hazard ratio, 1.07; 97.5% CI, 0.87 to 1.31; P=0.005 for noninferiority). In the intention-to-treat analysis, there was a trend favoring high-dose edoxaban versus warfarin (hazard ratio, 0.87; 97.5% CI, 0.73 to 1.04; P=0.08) and an unfavorable trend with low-dose edoxaban versus warfarin (hazard ratio, 1.13; 97.5% CI, 0.96 to 1.34; P=0.10). The annualized rate of major bleeding was 3.43% with warfarin versus 2.75% with high-dose edoxaban (hazard ratio, 0.80; 95% CI, 0.71 to 0.91; P<0.001) and 1.61% with low-dose edoxaban (hazard ratio, 0.47; 95% CI, 0.41 to 0.55; P<0.001). The corresponding annualized rates of death from cardiovascular causes were 3.17% versus 2.74% (hazard ratio, 0.86; 95% CI, 0.77 to 0.97; P=0.01), and 2.71% (hazard ratio, 0.85; 95% CI, 0.76 to 0.96; P=0.008), and the corresponding rates of the key secondary end point (a composite of stroke, systemic embolism, or death from cardiovascular causes) were 4.43% versus 3.85% (hazard ratio, 0.87; 95% CI, 0.78 to 0.96; P=0.005), and 4.23% (hazard ratio, 0.95; 95% CI, 0.86 to 1.05; P=0.32). CONCLUSIONS: Both once-daily regimens of edoxaban were noninferior to warfarin with respect to the prevention of stroke or systemic embolism and were associated with significantly lower rates of bleeding and death from cardiovascular causes. (Funded by Daiichi Sankyo Pharma Development; ENGAGE AF-TIMI 48 ClinicalTrials.gov number, NCT00781391.)
Evolocumab and clinical outcomes in patients with cardiovascular disease
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- Abelson M
- Aboufakher R
- Abrahamsen Te
- Accini Mendoza Jl
- 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 Ja
- Alfieri A
- Alt I
- Alzohaili O
- Amerena J
- Amin J
- Amoedo R
- Amuchastegui M
- Anderson T
- Andreka P
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- Angoulvant D
- Ansell B
- Antalik L
- Antkowiak-Piatyszek K
- Appel K
- Arakawa T
- Arana Londoño C
- Ardissino D
- Ardito Wr
- Arkhipov M
- Arsenescu-Georgescu C
- Asamoah N
- Ascaso Gimilio Jf
- Atar S
- Atassi K
- Athyros V
- Auerbach E
- Awtry E
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- Baigent C
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- Baird I
- Baker J
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- Baldari D
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- Chorin E
- Christensen T
- Christofides E
- Cifkova R
- Civeira Murillo F
- Cizinsky S
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- Conejeros Kindel C
- Connolly D
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- Cordero Fort A
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- Mandviwala M
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- Melchior T
- Melidonis A
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- Norheim P
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- Oomen A
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- Orourke D
- Osea E
- Osipova I
- Oude Ophuis A
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- Pacora F
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- Panov A
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- Parkhomenko O
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- Pastrnakova E
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- Pedersen
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- Pei H
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- Peniston J
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- Pereira A
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- Perez Alva Jc
- Perna E
- Perrone Filardi P
- Pesant Y
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- Peterson S
- Petrella R
- Petrov I
- Pettersson Si
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- Piepiorka M
- Pierpont B
- Piippo T
- Pijanowski Z
- Pillay S
- Pimenov L
- Pimentel Filho P
- Pincetti Jofre Cp
- Pintilei E
- Pinto Sala X
- Piros Ga
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- Podolec P
- Podpera I
- Pogue B
- Poirier P
- Pojsl S
- Polasek R
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- Schenkenberger I
- Schernthaner G
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- Shutemova E
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- Sigurdsson A
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- Sime I
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- Singhal A
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- Siostrzonek P
- Siu Cw
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- Strobl D
- Stukena I
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- Tsai Cf
- Tseluyko V
- Tsoukas G
- Tudoran M
- Tyagi S
- Tydén P
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- Ulla Mr
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- Vakaliuk I
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- van der Zwaan C
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- Vanbelle E
- Vandekerckhove H
- Vasco Salgado A
- Vawda G
- Velchev V
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- Venegas Carrillo La
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- Vertes G
- Veze I
- Vida Gutierrez M
- Vidotti Mh
- Viigimaa M
- Vijay N
- Vikman S
- Vinanska D
- Vintila Mm
- Violante Ortiz Rm
- Vishnevsky A
- Visman A
- Vita J
- Voevoda M
- Vogel Dr
- Volkov V
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- von Hodenberg E
- Vora K
- Vorpahl M
- Wada A
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- Wan Ahmad Wa
- Wang D
- Wang Huei
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- Wasserman Scott M.
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- Weinberg B
- Weinstein D
- Welker J
- Wermuth S
- Westendorp I
- Weyland K
- Whitney R
- Wierzbicka K
- Wilhoit G
- Wilson S
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- Wiseman A
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- Wittert G
- Wiviott Stephen D.
- Wnetrzak-Michalska R
- Wollaert B
- Wood Sk
- Wozakowska-Kaplon B
- Wozniak I
- Wu C
- Wyatt N
- Wöhrle J
- Xu P
- Xue L
- Yakhontova P
- Yamamoto K
- Yamashita K
- Yan J
- Yang E
- Yang P
- Yang X
- Yang Y
- Yang Z
- Yao Z
- Yasumura Y
- Yataco A
- Yeh H
- Yena L
- Yeoman G
- Yigit Z
- Yilmaz Mb
- Yokoya K
- Yoshimichi G
- Yotov Y
- Youngman D
- Younis L
- Yuge M
- Zabowka M
- Zahn L
- Zamorano Gomez Jl
- Zarich S
- Zateyshchikov D
- Zdrenghea D
- Zechowicz T
- Zeig S
- Zemanek J
- Zeng X
- Zhang L
- Zhang X
- Zhao S
- Zheng Y
- Zheng Z
- Zhou C
- Zhu Y
- Zhurba S
- Zidkova E
- Zieba B
- Ziegler O
- Zilahi Z
- Zrazhevskiy K
- Ă–stergren 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