8 research outputs found
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
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- Assaad S
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- Avram RI
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- Baccaro C
- Bailey G
- Bain S
- Barbarash O
- Barbarich V
- Bartolacci I
- Bascil Tutuncu N
- Basu A
- Bayram E
- Bednarski J
- Belousov Y
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- Benjamin S
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- Block B
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- Bordonava A
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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
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
- Aguilar D
- Aizenberg D
- Allen P
- Alvarez C
- Alvarisqueta A
- Amerena John
- Baccaro C
- Barkoudah E
- Bartolacci I
- Bentley-Lewis R
- Bordonava A
- Brahimi A
- Bustamante Labarta M
- Caccavo A
- Calella P
- Cantero M
- Charytan D
- Chaturvedi N
- Claggett B
- Codutti R
- Commendatore V
- Costamagna O
- Cuello J
- Danilova L
- Del Prato S
- DeMets D
- Diaz R
- Dickstein K
- Fasching P
- Fernandez A
- Finn P
- Flynn A
- Garcia Duran R
- Gerstein HC
- Gomez Vilamajo O
- Gorban De Lapertosa S
- Granger C
- Grinfeld D
- Hartley LH
- Henderson G
- Hermida S
- Johnston P
- Joseph J
- Kaplan A
- Køber LV
- Lagrutta M
- Lawson F
- Leon De La Fuente R
- Lewis EF
- Licheri A
- Lieberman P
- Luciardi H
- Mackinnon I
- Maffei L
- Maggioni AP
- Marino J
- McMurray JJV
- Montaña O
- Novaretto L
- O\u27Reilly E
- Odutayo K
- Orio S
- Orlandini A
- Oviedo A
- Patel K
- Patocchi C
- Paul V
- Petrie J
- Pfeffer MA
- Pieber T
- Ping L
- Probstfield JL
- Pérez Manghi F
- Raccah D
- Rajesh V
- Ramos H
- Riddle MC
- Rolandi F
- Rouleau J
- Saa Zarandon R
- Saavedra SS
- Sangla K
- Scarpa A
- Schattner M
- Schiavi L
- Schygiel P
- Solomon SD
- Tardif JC
- Trivi M
- Ulla M
- Urdiales P
- Vallejos J
- Van Gaal W
- Vazir A
- Vico M
- Waisman F
- Weinrauch L
- Wu Y
- Yeap B
- Zuraw BL
- Publication venue
- 'Elsevier BV'
- Publication date
- 01/05/2015
- Field of study
Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients
- Author
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- Vinanska D.
- Vincent John
- Vincent S.
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- Violante Ortiz R.
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- Visseren F. L.
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- Wang Ellen
- Wang G.
- Wang Y.
- Wasserburger B.
- Waxler A. R.
- Wayne J. D.
- Weber D.
- Weber K.
- Wegner John
- Wei Caimiao
- Weigmann I.
- Weinstein D. L.
- Weiss R.
- Welker J. A.
- Welty Francine
- Wenetz L. M. M.
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- Westerndorp I.
- Wetzel T.
- White H.
- Whitlock L.
- Whitney R. T.
- Wiggers H.
- William M.
- Williams D. G.
- Williams M.
- Willis J. G.
- Willits V. L.
- 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 V. V.
- Yang P.
- Yang X.
- Yao L. C.
- Yared Z.
- Yarows S. A.
- Yigit Z.
- Yoon J.
- Yunis C.
- Zadra R.
- Zaidman C. J.
- Zamorano Gomez J. L.
- Zannad Faiez
- Zarandon R. B. S.
- Zarich S. W.
- Zateyshchikov D.
- Zavaro S. H.
- Zebrack J. S.
- Zeig S.
- Zemek S.
- Zemour G.
- Zeng X.
- Zeno M. L.
- Zhang L.
- Zhang X.
- Zhang Y.
- Zhao Y.
- Zhou C.
- Zhou Y.
- Zhu Y.
- Zidkova E.
- Zieba B.
- Zilahi Z.
- Zoet-Nugteren S. K.
- Zrazhevskiy K.
- Zubek V.
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
BACKGROUN
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.
- 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.
- Allen P.
- Alvarez C.
- Alvarisqueta A.
- Alzohaili O.
- Ambos A.
- Amerena J.
- Amolina I.
- Andjelic Jelic M.
- Andrade M.
- Andrews R.
- Antorrena I.
- Araneda G.
- Arango J.
- Ariani M.
- Arnold S.
- Arora C.
- Arteaga J.M.
- Assaad S.
- Atar S.
- Avram R.I.
- Azad N.
- Azzam S.
- Baccaro C.
- Bailey G.
- Bain S.
- Barbarash O.
- Barbarich V.
- Barkoudah E.
- Bartolacci I.
- Bascil Tutuncu N.
- Basu A.
- Bayram E.
- Bednarski J.
- Belousov Y.
- Ben Abdallah N.
- Benjamin S.
- Bentley-Lewis R.
- Berns S.
- Berra C.
- Bertrand O.
- Bhargava R.
- Bhatnagar D.
- Bickerton A.
- Bijata-Bronisz R.
- Block B.
- Boberg G.
- Bodi V.
- Bokarev I.
- Bolshakova O.
- Bordonava A.
- Borzadek E.
- Botelho R.V.
- Botella M.
- Botero R.
- Boyarkin M.
- Bragança N.
- Brahimi A.
- Breisblatt W.
- Bright T.
- Bronnum-Schou J.
- Browne D.
- Bryniarski L.
- Bunster L.
- Burgess L.
- Burton J.
- Bustamante Labarta M.
- Busz-Papiez B.
- Byrd L.
- Caccavo A.
- Calderon J.
- Calella P.
- Campeau J.
- Camsari A.
- Cantero M.
- Cardosa-Torres F.
- Cariou B.
- Carranza-Madrigal J.
- Castillo G.
- Castro E.
- Castro M.G.
- Catargi B.
- Cerqueira M.J.
- Chacra A.
- Charytan D.
- Chaturvedi N.
- Chavez C.
- Chen L.
- Chiang C.-E.
- Chiou C.
- Chiu Y.-W.
- Chochinov R.
- Chopda M.
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- Christensen T.
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- Dempsey M.
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- Dinccag N.
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- Dong Y.
- Dos Santos F.
- Dragomir D.
- Drzewiecka A.
- Du J.
- Duarte J.
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- Ducena K.
- Ducloux R.
- Dulak E.
- Dumas R.
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- Dutta R.
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- East C.
- Ebrahim I.
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- Elder C.
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- Enciso F.
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- Farfan J.
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- Ferariu I.E.
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- Frederiks J.
- French W.
- Frohnauer M.
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- Gaffney M.
- Galeana C.
- Galyavich A.
- Gandhi P.
- Gangopadhyay S.
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- Garcia-Hernandez P.
- Garcia-Soria M.
- Garza J.
- Gaztambide S.
- Gerstein H.C.
- Gibson M.
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- Giordano C.
- Glezer M.
- Glonti S.
- Godoy G.
- Gogia H.
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- Gomez Vilamajo O.
- Gomez C.
- Gomez M.H.
- Gonzalez Castillo B.
- Gonzalez E.
- Gonzalez J.G.
- Gonzalez R.
- Gorban De Lapertosa S.
- Gorska M.
- Gosmanov A.
- Granados A.
- Granger C.
- Greenberg C.
- Greenway F.
- Grinfeld D.
- Guo X.
- Gupta J.B.
- Gupta S.
- Gupta S.K.
- Hadjadj S.
- Hagenow A.
- Halpern A.
- Hamankiewicz M.
- Hammond P.
- Han P.
- Hanna E.
- Hanna F.
- Haouala H.
- Hargrove J.
- Harris A.
- Harris B.
- Hart T.
- Hartley L.H.
- Hata Y.
- Hatterjee S.
- Helda R.
- Henderson G.
- Hermans W.
- Hermida S.
- Hernandez Triana E.
- Hernandez H.
- Hernandez-Muñuzuri J.
- Herrera M.
- Herrington D.
- Hewitt M.
- Himeno H.
- Himpel-Bönninghoff A.
- Hirayama A.
- Hiregouder N.
- Hissa M.
- Howard D.
- Hu T.
- Huang T.-Y.
- Huidobro L.A.
- Iancu A.-C.
- Ismail S.
- Issa B.
- Istratoaie O.
- Ivanica G.
- Ivanov V.
- Ivanova L.
- Izuora K.
- Jaap A.
- Jakovlev U.
- Jang H.
- Janik K.
- Jendle J.
- Jetty P.
- Jha S.
- Jiang B.
- Jimenez S.
- Johnston P.
- Joseph F.
- Joseph J.
- Joshi A.
- Jude E.
- Jörneskog G.
- Kaddaha G.M.
- Kaiser Nielsen P.
- Kakariekiene V.
- Kalashnikov V.
- Kalashnikova M.
- Kaplan A.
- Kapoor A.
- Karnieli E.
- Karpenko O.
- Karpov Y.
- Kasper J.F.
- Kavaliauskiene R.
- Ke Y.
- Kelbe D.
- Kelehan S.
- Kelly C.
- Kelly R.
- Kereiakes D.
- Kerlan V.
- Khaira A.
- Khaisheva L.
- Khalimov Y.
- Khan A.
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- Khan S.
- Kihm L.
- Killat H.
- Kim C.-J.
- Kim J.
- Kim K.
- Kim U.
- Kincel K.
- Kishimoto I.
- Klainman E.
- Kleinertz K.
- Klyuchkova N.
- Kobalava Z.
- Kobayashi Y.
- Kocic R.
- Komnenovic S.
- Konieczny M.
- Konrade I.
- Korban E.
- Korpachev V.
- Korsoff P.
- Kosch C.
- Kosiborod M.
- Koski A.-M.
- Kosmachova E.
- Kostenko V.
- Koval O.
- Koziolova N.
- Kreutzmann K.
- Kulibaba E.
- Kultursay H.
- Kumbla M.
- Kyoleyan M.
- Køber L.V.
- Lagrutta M.
- Laguerre J.
- Lahsen R.
- Lahtela J.
- Lalic K.
- Lalic N.
- Lanas F.
- Lappegård K.T.
- Lappo M.
- Lara S.
- Larenas G.
- Larocque J.
- Latif K.
- Lawson F.
- Lee N.H.
- Leon De La Fuente R.
- Lesnov V.
- Lester F.
- Levin P.
- Levine S.
- Levterov G.
- Lewis E.F.
- Li C.
- Li Z.
- Libov I.
- Licheri A.
- Lichiardopol R.
- Lieberman P.
- Lisboa H.
- Llamas G.
- Lok D.
- Lominadze Z.
- Lonso E.
- Lopez Rosas E.
- Lopez G.A.
- Lopez M.
- Lopez P.
- Lovell C.
- Lu C.-H.
- Lu J.
- Lu L.
- Lubi M.
- Lubinski A.
- Lucheva M.
- Luciardi H.
- Lujan J.
- Lupovitch S.
- Luque E.
- Lyamina N.
- Ma C.
- Mackinnon I.
- Madu I.-J.
- Maffei L.
- Magdum M.
- Maggioni A.P.
- Mahabadi V.
- Mahmood A.
- Malecot J.-M.
- Malik R.
- Mannucci E.
- Manrique H.
- Manriquez L.
- Manzur F.
- Maragos S.
- Marck C.
- Mariash C.
- Marin F.
- Marino J.
- Markov V.
- Marmol Alvear R.
- Martin P.
- Martin V.
- Maslyanko V.
- Mathew J.
- Mathew J.
- Mathiesen U.
- Mathieu C.
- Mauricio D.
- May M.
- Mayfield R.
- McCall A.
- Mcdaniel C.
- Mcgrew F.
- Mckenzie M.
- McMurray J.J.V.
- Medina M.
- Meeder J.
- Mefford I.
- Mehta A.
- Mertes B.
- Micic D.
- Mikdadi G.
- Mikhail M.
- Militaru C.
- Minescu B.
- Minuchin O.
- Mitkovskaya N.
- Miyaoka H.
- Moccetti T.
- Mogrovejo W.
- Moiseev V.
- Molchanova O.
- Molina D.
- Monchamp T.
- Montaña O.
- Monteiro P.
- Montenegro P.
- Moore C.
- Moraes J.
- Moran M.
- Morrar N.
- Mosenzon O.
- Mosley J.
- Mukhopadhyay B.
- Mulford M.
- Munoz R.
- Murray J.
- Murthy K.
- Märtsin K.
- Naidoo V.
- Nakhle S.
- Nallasivan M.
- Nedrebø B.G.
- Nelimarkka L.
- Nery M.
- Nielsen H.
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- Novaretto L.
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- Nunohiro T.
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- O'Reilly E.
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- Paliwal Y.
- Palma J.C.
- Panelo A.
- Panov A.
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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
Edoxaban versus warfarin in patients with atrial fibrillation
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- Zamlynskyy M
- Zamorano JL
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- 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
- Zheng ZQ
- 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
- Åkerberg A
- Östberg S
- Ŝpinar 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.)
Ezetimibe added to statin therapy after acute coronary syndromes
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- Aambakk MB
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- Zweiker R
- Ångman K
- Édes I
- Östberg S
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2015
- Field of study
BACKGROUND: Statin therapy reduces low-density lipoprotein (LDL) cholesterol levels and the risk of cardiovascular events, but whether the addition of ezetimibe, a nonstatin drug that reduces intestinal cholesterol absorption, can reduce the rate of cardiovascular events further is not known. METHODS: We conducted a double-blind, randomized trial involving 18,144 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and had LDL cholesterol levels of 50 to 100 mg per deciliter (1.3 to 2.6 mmol per liter) if they were receiving lipid-lowering therapy or 50 to 125 mg per deciliter (1.3 to 3.2 mmol per liter) if they were not receiving lipid-lowering therapy. The combination of simvastatin (40 mg) and ezetimibe (10 mg) (simvastatin-ezetimibe) was compared with simvastatin (40 mg) and placebo (simvastatin monotherapy). The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, unstable angina requiring rehospitalization, coronary revascularization ( 6530 days after randomization), or nonfatal stroke. The median follow-up was 6 years. RESULTS: The median time-weighted average LDL cholesterol level during the study was 53.7 mg per deciliter (1.4 mmol per liter) in the simvastatin-ezetimibe group, as compared with 69.5 mg per deciliter (1.8 mmol per liter) in the simvastatin-monotherapy group (P<0.001). The Kaplan-Meier event rate for the primary end point at 7 years was 32.7% in the simvastatin-ezetimibe group, as compared with 34.7% in the simvastatin-monotherapy group (absolute risk difference, 2.0 percentage points; hazard ratio, 0.936; 95% confidence interval, 0.89 to 0.99; P = 0.016). Rates of pre-specified muscle, gallbladder, and hepatic adverse effects and cancer were similar in the two groups. CONCLUSIONS: When added to statin therapy, ezetimibe resulted in incremental lowering of LDL cholesterol levels and improved cardiovascular outcomes. Moreover, lowering LDL cholesterol to levels below previous targets provided additional benefit
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
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- Anderson Tj
- Andrassy P
- Andrei Ld
- Andreka P
- Angoulvant D
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- Ansari Sh
- Anselmi M
- Antonicelli R
- Appel Kf
- Aracil Villar J
- Arain S
- Arambula Rm
- Araz M
- Arca M
- Arcanese Ml
- Arden C
- Areas Ca
- Ari H
- Ariani Mk
- Arif I
- Aroney C
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- van Leendert Rj
- van Nieuwenhuizen E
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- Vinanska D
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- Vincent S
- Vinyoles Bargallo E
- Violante Ortiz R
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- Vishneva E
- Visser Rp
- Visseren F
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- Vodnansky P
- Voehringer Hf
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- Volkova A
- Voller H
- von Engelhardt Cb
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- Vora Kn
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- Vrkoc J
- Vukotic G
- Wadud K
- Wainstein J
- Wakefield Ph
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- Walczak M
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- Walukiewica P
- Wang D
- Wang E
- Wang G
- Wang Y
- Wasserburger B
- Waxler Ar
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- 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
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- 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
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 Mohamed
- Accini Jose Luis
- Acuña Silvia
- Adawi Faiad
- Adenuga Babafemi
- Adina Pop-Moldovan
- Ageev Fail
- Aguilar David
- Aguilar-Orozco Raul
- Ahmad Zia
- Aimaretti Gianluca
- Aizenberg Diego
- Akahori Hiroshi
- Akhmedzhanov Nadir
- Akinboboye Olakunle
- Akright Laura
- Al Mahmeed Wael
- Alanko Juha
- Alappat Paul
- Alawad Mohamad
- Alfonso Teresa
- Alimard Ramin
- Allen Peter
- Alvarez Carlos
- Alvarisqueta Andres
- Alzohaili Opada
- Ambos Anu
- Amerena John
- Amolina Ildze
- Andjelic Jelic Marina
- Andrade Miguel
- Andrews Robert
- Antorrena Isabel
- Araneda Guillermo
- Arango Juan
- Ariani Mehrdad
- Arnold Susan
- Arora Chander
- Arteaga Juan Manuel
- Assaad Samir
- Atar Shaul
- Avram Rodica Ioana
- Azad Nasrin
- Azzam Samir
- Baccaro Claudia
- Bailey Gordon
- Bain Stephen
- Barbarash Olga
- Barbarich Vladimir
- Barkoudah Ebrahim
- Bartolacci Ines
- Bascil Tutuncu Neslihan
- Basu Ambar
- Bayram Edmundo
- Bednarski Janusz
- Belousov Yury
- Ben Abdallah Nejib
- Benjamin Sabrina
- Bentley-Lewis Rhonda
- Berns Svetlana
- Berra Cesare
- Bertrand Olivier
- Bhargava Rakesh
- Bhatnagar Deepak
- Bickerton Alex
- Bijata-Bronisz Renata
- Block Bradley
- Boberg Gunnar
- Bodi Vicent
- Bokarev Igor
- Bolshakova Olga
- Bordonava Anselmo
- Borzadek Eliza
- Botelho Roberto Vieira
- Botella Marta
- Botero Rodrigo
- Boyarkin Mikhail
- Bragança Nuno
- Brahimi Abdel
- Breisblatt Warren
- Bright Tamis
- Bronnum-Schou Jens
- Browne Duncan
- Bryniarski Leszek
- Bunster Lia
- Burgess Lesley
- Burton Jeffrey
- Bustamante Labarta Miguel
- Busz-Papiez Benita
- Byrd Leroy
- Caccavo Alberto
- Calderon Jorge
- Calella Pedro
- Campeau Jean
- Camsari Ahmet
- Cantero Maria
- Cardosa-Torres Francisco
- Cariou Bertrand
- Carranza-Madrigal Jaime
- Castillo Gilberto
- Castro Eholo
- Castro Maria Guadalupe
- Catargi Bogdan
- Cerqueira Maria Jose
- Chacra Antonio
- Charytan David
- Chaturvedi Nishi
- Chavez Carlos
- Chen Li
- Chiang Chern-En
- Chiou Choyen
- Chiu Yu-Wei
- Chochinov Ronald
- Chopda Manoj
- Chopra Vijay
- Christensen Tom
- Christofides Elena
- Chumakova Galina
- Chumburidze Vakhtang
- Chung Choon Hee
- Chung Wook Jin
- Ciardullo Anna Vittoria
- Cif Adriana
- Claggett Brian
- Cobos Leonardo
- Codutti Renzo
- Coetzee Kathleen
- Cohen Ohad
- Cohen Robert
- Commendatore Victor
- Consoli Agostino
- Contzen Christel
- Cooper John
- Corbalán Ramón
- Cornel Jan Hein
- Coronel Julian
- Correa Flores Roger Martin
- Costamagna Osvaldo
- Creteanu Gabriela
- Cucinotta Domenico
- Cuello Jose
- Cure Carlos
- Czajkowska-Kaczmarek Eugenia
- Danilova Larisa
- Dans Antonio
- Dawood Gamil
- Dawood Saleem
- De La Fuente Javier
- De Souza Jose
- Dekkers Paulus
- Del Prato Stefano
- Delchev Alexy
- Delgado Elías
- Delibasi Tuncay
- Delport Eluned
- DeMets David
- Dempsey Michael
- Deshpande Neeta
- Di Marco Sandra
- Diaz Rafael
- Dickstein Kenneth
- Dinccag Nevin
- Dmitry Platonov
- Dong Yugang
- Dos Santos Fabio
- Dragomir Dinu
- Drzewiecka Anna
- Du Jianling
- Duarte João
- Duarte-Vera Yan
- Ducena Kristine
- Ducloux Roxane
- Dulak Elzbieta
- Dumas Richard
- Duran Garcia Santiago
- Dussaillant Gaston
- Dutta R.
- Dwivedi Sudhanshu
- Eagerton Donald
- East Cara
- Ebrahim I.
- Efrati Shai
- Eggers German
- Eki Yutaka
- Elder Charles
- Ellis Graham
- Elorza Jose
- Enciso Fidel
- Escalante Miguel
- Farfan Julio
- Fasching Peter
- Feitosa Gilson
- Ferariu Ioana Emilia
- Fernandez Alberto
- Fernando Ronald
- Filteau Pierre
- Finn Peter
- Fischer Hermann
- Fitilev Sergey
- Florenzano Fernando
- Flynn Aiden
- Fogelfeld Leon
- Forti Adriana
- Foucauld Jean
- Frederiks J.
- French William
- Frohnauer Mary
- Fujii Kenshi
- Gaffney Mary
- Galeana Cielmar
- Galyavich Albert
- Gandhi Pramod
- Gangopadhyay Subroto
- Garcia Duran Ruben
- Garcia Henry
- Garcia Luis
- Garcia-Castillo Armando
- Garcia-Hernandez Pedro
- Garcia-Soria Martin
- Garza Jose
- Gaztambide Sonia
- Gerstein Hertzel C.
- Gibson Martin
- Giorda Carlo
- Giordano Carla
- Glezer Maria
- Glonti Salome
- Godoy Gonzalo
- Gogia Harinder
- Golbert Milton
- Gomez Vilamajo Oscar
- Gomez Claudia
- Gomez Maria Honolina
- Gonzalez Castillo Baldomero
- Gonzalez Elis
- Gonzalez Jose Gerardo
- Gonzalez Ronaldo
- Gorban De Lapertosa Silvia
- Gorska Maria
- Gosmanov Aidar
- Granados Arnoldo
- Granger Christopher
- Greenberg Craig
- Greenway Frank
- Grinfeld Diego
- Guo Xiaohui
- Gupta Jugal Bihari
- Gupta Sandeep Kumar
- Gupta Sunil
- Hadjadj Samy
- Hagenow Andreas
- Halpern Alfredo
- Hamankiewicz Maciej
- Hammond Peter
- Han Ping
- Hanna Edward
- Hanna Fahmy
- Haouala Habib
- Hargrove Joe
- Harris Anthony
- Harris Bill
- Hart Terence
- Hartley L. Howard
- Hata Yoshiki
- Hatterjee Sanjay
- Helda Renate
- Henderson Galen
- Hermans Wrm
- Hermida Sonia
- Hernandez Triana Eric
- Hernandez Hector
- Hernandez-Muñuzuri Jesus
- Herrera Milton
- Herrington David
- Hewitt Mitzie
- Himeno Hideo
- Himpel-Bönninghoff Agnes
- Hirayama Atsushi
- Hiregouder Narendra
- Hissa Miguel
- Howard David
- Hu Taohong
- Huang Tsuei-Yuan
- Huidobro Laura Andrea
- Iancu Adrian-Corneliu
- Ismail Siddique
- Issa Basil
- Istratoaie Octavian
- Ivanica Gabriel
- Ivanov Valentin
- Ivanova Luidmila
- Izuora Kenneth
- Jaap Alan
- Jakovlev Ulle
- Jang Hakchul
- Janik Krzysztof
- Jendle Johan
- Jetty Preetham
- Jha Sujeet
- Jiang Bin
- Jimenez Silvia
- Johnston Peter
- Joseph Franklin
- Joseph Jacob
- Joshi Abhijeet
- Jude Edward
- Jörneskog Gun
- Kaddaha Ghaida Mohamad
- Kaiser Nielsen Peter
- Kakariekiene Vaida
- Kalashnikov Victor
- Kalashnikova Marina
- Kaplan Allen
- Kapoor Anoop
- Karnieli Eddy
- Karpenko Oleksandr
- Karpov Yuri
- Kasper Joseph F.
- Kavaliauskiene Roma
- Ke Yuannan
- Kelbe Dudley
- Kelehan Shaun
- Kelly Chris
- Kelly Richard
- Kereiakes Dean
- Kerlan Veronique
- Khaira Ajit
- Khaisheva Larisa
- Khalimov Yuri
- Khan Atir
- Khan Misal
- Khan Noor
- Khan Salman
- Kihm Lars
- Killat Holger
- Kim Chong-Jin
- Kim Jaetaek
- Kim Kyehun
- Kim Ung
- Kincel Krzysztof
- Kishimoto Ichiro
- Klainman Eliezer
- Kleinertz Klaus
- Klyuchkova Neli
- Kobalava Zhanna
- Kobayashi Youichi
- Kocic Radivoj
- Komnenovic Snezana
- Konieczny Marek
- Konrade Ilze
- Korban Elie
- Korpachev Vadym
- Korsoff Pirkko
- Kosch Christine
- Kosiborod Mikhail
- Koski Anna-Mari
- Kosmachova Elena
- Kostenko Victor
- Koval Olena
- Koziolova Natalya
- Kreutzmann Kristin
- Kulibaba Elena
- Kultursay Hakan
- Kumbla Mukund
- Kyoleyan Michael
- Køber Lars V.
- Lagrutta Mariana
- Laguerre Jacques
- Lahsen Rodolfo
- Lahtela Jorma
- Lalic Katarina
- Lalic Nebojsa
- Lanas Fernando
- Lappegård Knut Tore
- Lappo Mariola
- Lara Susano
- Larenas Gladys
- Larocque James
- Latif Kashif
- Lawson Francesca
- Lee Nae Hee
- Leon De La Fuente Ricardo
- Lesnov Victor
- Lester Frank
- Levin Philip
- Levine Steven
- Levterov Georgi
- Lewis Eldrin F.
- Li Charles
- Li Zhanquan
- Libov Igor
- Licheri Alberto
- Lichiardopol Radu
- Lieberman Phil
- Lisboa Hugo
- Llamas Guillermo
- Lok Dirk
- Lominadze Zaza
- Lonso Elena
- Lopez Rosas Enrique
- Lopez Gabriel Arturo
- Lopez Monica
- Lopez Patricio
- Lovell Charles
- Lu Chieh-Hsiang
- Lu Juming
- Lu Libia
- Lubi Maire
- Lubinski Andrzej
- Lucheva Mariya
- Luciardi Hector
- Lujan Jesus
- Lupovitch Steven
- Luque Edith
- Lyamina Nadezhda
- Ma Changsheng
- Mackinnon Ignacio
- Madu Ivy-Joan
- Maffei Laura
- Magdum Mohan
- Maggioni Aldo P.
- Mahabadi Vahid
- Mahmood Asif
- Malecot Jean-Marc
- Malik Rayaz
- Mannucci Edoardo
- Manrique Helard
- Manriquez Leopoldo
- Manzur Fernando
- Maragos Stavros
- Marck Cornelia
- Mariash Cary
- Marin Francisco
- Marino Javier
- Markov Valentin
- Marmol Alvear Ricardo
- Martin Paul
- Martin Victoria
- Maslyanko Vitaliy
- Mathew James
- Mathew John
- Mathiesen Ulrik
- Mathieu Chantal
- Mauricio Didac
- May Michael
- Mayfield Ronald
- McCall Anthony
- Mcdaniel Clayton
- Mcgrew Frank
- Mckenzie Marcus
- McMurray John J. V.
- Medina Marcelo
- Meeder Joan
- Mefford Ivan
- Mehta Arvind
- Mertes Bernardo
- Micic Dragan
- Mikdadi Ghiath
- Mikhail Magdy
- Militaru Constantin
- Minescu Bogdan
- Minuchin Oscar
- Mitkovskaya Natalya
- Miyaoka Hiroaki
- Moccetti Tiziano
- Mogrovejo Walter
- Moiseev Valentin
- Molchanova Olga
- Molina Dora
- Monchamp Travis
- Montaña Oscar
- Monteiro Pedro
- Montenegro Pablo
- Moore Charles
- Moraes Joao
- Moran Michael
- Morrar Nidal
- Mosenzon Ofri
- Mosley Jonathan
- Mukhopadhyay Babu
- Mulford Mim
- Munoz Ricardo
- Murray John
- Murthy Keshava
- Märtsin Kaja
- Naidoo Visvakuren
- Nakhle Samer
- Nallasivan Mani
- Nedrebø Bjørn Gunnar
- Nelimarkka Lassi
- Nery Max
- Nielsen Henrik
- Nierop Peter
- Nieto Ortega Ruben
- Niiya Tetsuji
- Nishi Yutaro
- Novaretto Leonardo
- Nozaki Akira
- Ntsekhe Mpiko
- Nunohiro Tatsuya
- O'Kane M.
- O'Reilly Eileen
- Odio Alberto
- Odutayo Kayode
- Oh Charles
- Olelewe Sarah
- Oleynikov Valentin
- Olszanecka-Glinianowicz Magdalena
- Onaca Adriana
- Orio Silvia
- Orlandini Andres
- Orlikova Olga
- Orsi Emanuela
- Otasevic Petar
- Oto Ali
- Oviedo Alejandra
- Palchick Bryce
- Paliwal Yogesh
- Palma Juan Carlos
- Panelo Araceli
- Panov Alexey
- Papademetriou Vasilios
- Parikh Naresh
- Pariona-Javier Marcos
- Park Kyong Soo
- Patel Keyur
- Patel Sudhirkumar
- Patocchi Cristian
- Paul Vincent
- Pei Dee
- Peng Yongde
- Perepelytsya Mykhaylo
- Perez Luis
- Pertseva Tetyana
- Pesic Milica
- Petit Catherine
- Petrie John
- Petrosyan Olena
- Petrulioniene Zaneta
- Peñaherrera-Patiño Carlos
- Pfeffer Marc A.
- Phillips Lawrence
- Piatti Piermarco
- Pieber Thomas
- Piechatzek Richard
- Ping Lin
- Pintilei Ella
- Pinto Miguel
- Pirags Valdis
- Pitts Thomas
- Podoleanu Cristian
- Ponikowski Piotr
- Pontiroli Antonio
- Ponzani Paola
- Pop Lavinia
- Popa Bogdan
- Potthoff Sergio
- Pouleur Anne-Catherine
- Pozzilli Paolo
- Prabhu Mukhya
- Prieto Francisco
- Probstfield Jeffrey L.
- Prohaska Martin
- Pulka Grazyna
- Puttnam Rachel
- Pérez Manghi Federico
- Quadros Alexandre
- Quyyumi Arshed
- Raccah Denis
- Raduan Roberto
- Raev Dimitar
- Rafalskiy Vladimir
- Raffo Carlos
- Rajesh Vinutha
- Ramos Hugo
- Ramos null
- Randhawa Preet
- Ranetti Aurelian Emil
- Rasmussen Soeren
- Rayman Gerry
- Reis Gilmar
- Rekosz Jerzy
- Rendell Marc
- Rey Nannette
- Reyes Eduardo
- Reyes Eliana
- Rha Seungwoon
- Rhie Francis
- Ribeiro Filho Fernando
- Riddle Matthew C.
- Rim Sejoong
- Rinke Andrea
- Rivellese Angela
- Roberts James
- Robinson Anthony
- Robinson Jerome
- Robinson Michael
- Rodier Michel
- Rodionova Tatiana
- Rodrigues Elisabete
- Rodriguez Edgar
- Rodriguez Ignacio
- Rodriguez Jaime
- Rolandi Florencia
- Roldan Yudy
- Rollin Guilherme
- Rooney Desmond
- Rosenthal Svea
- Rossi Paulo
- Rosu Doina
- Rouleau Jean
- Rubino John
- Rudenko Leonid
- Rungby Jørgen
- Ryan Eugene
- Rønne Henning
- Saa Zarandon Raquel
- Saathoff Steven
- Saavedra Silvia Salome
- Saavedra Victor
- Sachmechi Isaac
- Sahay Rakesh
- Sahin Mahmut
- Saifi Ali
- Sainsbury Chris
- Saito Tomiyoshi
- Sakalyte Gintare
- Salacata Abraham
- Samitin Vasily
- Sanchez Vallejo Gregorio
- Sanders Robyn
- Sangla Kunwarjit
- Sanhueza Patricio
- Sanson Jodi
- Santos Elizabete
- Saravanan Ponnusamy
- Satoh Yasuhiro
- Savin Virginia
- Saygili Fusun
- Scarpa Aldo
- Schabauer Alex
- Schattner Mark
- Schellenberg Detlev
- Schiavi Lilia
- Schmedtje John
- Schokotov Vladimir
- Schwartz Alan
- Schygiel Pablo
- Scott Cranford
- Sebastian Peter John
- Seferovic Petar
- Selagamsetty Munni
- Sepulveda Pablo
- Sethuraman Selvamani
- Sgarbi Jose
- Shah Navneet
- Shakher Jayadave
- Shamanna Paramesh
- Shannon Michael
- Shaw Sylvia
- Shelbaya Salah
- Shi Yongquan
- Shilkina Nataliya
- Shin Sung-Hee
- Shogenov Zaur
- Shumkova Rositsa
- Shustov Sergey
- Shvarts Yuri
- Shyu Kou-Gi
- Siebert Mirna
- Sime Iveta
- Singal Dinesh
- Singh Baldev
- Singh K. Singh
- Singh Paminder
- Sjoberg Robert
- Skagen Knud
- Skudlarski Dariusz
- Slimane Hedia
- Smith Kenneth
- Sobolev Konstantin
- Sofley Carl
- Sokolova Jelena
- Solis Carmen Lia
- Solomon Scott D.
- Somasekharan Arun
- Sonn Anthony
- Sorof Suzanne
- Soroka Eugene
- Soto Alfonso
- Soto Nestor
- Souza Juliana
- Souza Maria Regina
- Spellman C. W.
- Sreenivasamurthy Lakshminarayanappa
- Stankovic Goran
- Steinhoff Jeffrey
- Stern Naftali
- Stobschinski De Alba Carlos Alejandro
- Stryuk Raisa
- Su Guohai
- Sudzhaeva Svetlana
- Sulit Dennis Jose
- Supe Pravin
- Suplotova Ludmila
- Suresh Damodhar
- Svensson Karl-Axel
- Sy Rosa Allyn
- Syan Gurcharan
- Syan Rajinder
- Sychov Oleg
- Synenko Volodymyr
- Szymkowiak Katarzyna
- Tahir Mohammad
- Takahashi Akihiko
- Takahashi Junichiro
- Takase Hiroyuki
- Takase Shinichi
- Tanenberg Robert
- Tang Baopeng
- Tardif Jean-Claude
- Tase Adrian
- Tesloianu Dan Nicolae
- Thawani Hemant
- Thomsen Kristian Korsgaard
- Thomson Stephen
- Thrasher James
- Timonera Miriam
- Todua Fridon
- Tokmakova Mariya
- Torp-Pedersen Christian
- Torres Claudia
- Torstensson Ingemar
- Toursarkissian Nicole
- Trachtenbarg David
- Trivi Marcelo
- Trotta Michael
- Tseluyko Vira
- Tsoukas George
- Tsuboko Yusuke
- Tsujimoto Mitsuru
- Tsujino Motoyoshi
- Tsuzuki Masahiro
- Tuan Weiming
- Tuomilehto Jaakko
- Turcios Erick
- Turgeman Yoav
- Turner Jeremy
- Twahirwa Marcel
- Tzekova Maria
- Ueng Kwo-Chang
- Ulla Maria
- Umpierrez Guillermo
- Urboniene Audrone
- Urdiales Pedro
- Uribe Marittza
- Vaid Brij
- Vallejos Julio
- Van Gaal William
- Van Zyl Louis
- Vance Carl
- Vasko Peter
- Vazir Ali
- Vazquez-Garcia Abraham
- Velasco-Sanchez Raul
- Venter Tjaart
- Vico Marisa
- Vida Manuel
- Vides Hella
- Vidrio Maricela
- Viktorova Inna
- Villalobos Renato
- Vinereanu Dragos
- Vinhas Margarida
- Vishnevsky Alexander
- Vorokhobina Natalia
- Wainstein Julio
- Waisman Florencia
- Wang Thomas
- Wang Tzung-Dau
- Warner Alberta
- Warnica James Wayne
- Watanabe Shuichi
- Watson Henry
- Weber Sandra
- Webster Brian
- Weindorff Kathleen
- Weinrauch Larry
- Welch Michelle
- Welker James
- Westerberg Bernhard
- White Anthony
- White Lindsey
- Whitelaw Donald
- Wilczewski Przemyslaw
- Wilding John
- Wiles Philip
- Williams Marcus
- Wu Wen-Chih
- Wu Yujun
- Wynne Alan
- Wyss Fernando
- Xu Biao
- Yakusevich Vladimir
- Yakushin Sergey
- Yamada Takahisa
- Yang Jiefu
- Yang Jinkui
- Yang Yanmin
- Yañez Mario
- Yeap Bu
- Yigit Zerrin
- Yocono Mark
- Yordanov Viktor
- Yuen Kevin
- Yupanqui Hernan
- Zadionchenko Vladimir
- Zalevskaya Alsu
- Zalevsky Grigory
- Zarankiene Rima
- Zateyshchikova Anna
- Zavala Alejandro
- Zhuravleva Larisa
- Zidi Borni
- Zorkun Cafer
- Zubiate Carlos
- Zuraw Bruce L.
- 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 glucagon-like 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, parallel-group, 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/m(2), and duration of T2DM was 9.3 ± 8.2 years. The qualifying ACS was a myocardial infarction in 83% and unstable angina 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