29 research outputs found
Varespladib and cardiovascular events in patients with an acute coronary syndrome: the VISTA-16 randomized clinical trial
- Author
- Abraham J
- Abramson B
- Acheatel R
- Ahmed M
- Akhunova S
- Alegret JM
- Alonso-Pulpón L
- Amerena J
- Amkieh A
- Amlani M
- Anand D
- Anderson J
- Antolin JM
- Areses EL
- Arkhipov M
- Aroney C
- Arstall M
- Asfour A
- Ashchi M
- Auguadro C
- Azar R
- Balog C
- Banker D
- Barbarash O
- Barbarich V
- Bash Dianna
- Battaglia J
- Belenky D
- Benczur B
- BERNI Andrea
- Berti S
- Bertolet B
- Biasucci LM
- Black R
- Blanchard A
- Blonder R
- Bokern MJ
- Bosschaert M
- Braun-Dullaeus R
- Breedveld RW
- Brennan Danielle M.
- Brilakis E
- Broadwater S
- Bronisz M
- Bronzwaer PN
- Brown A
- Brown WV
- Browne K
- Burtt D
- Camp A
- Cannon K
- Cavender JB
- Cavender Matthew A.
- Cendon AA
- Cervinka P
- Chandna H
- Chandra S
- Chandrashekhar Y
- Chapidze G
- Chawla K
- Chernick R
- Chronos N
- Chumburidze V
- Collins N
- Constance C
- Corrada E
- Cortés JM
- Crowley S
- Csapo K
- Cuccia C
- Dabrowski M
- Dani S
- Dart A
- Davies C
- Delafontaine P
- Della-Siega A
- DeMets D
- Den Hartog F
- den Hartoog M
- Dengler T
- Denning S
- Derlaga B
- Devlin G
- Dezsi C
- Dinnyes J
- Dobrzycki S
- Doevendans P
- Dorsel T
- Dovgalevskiy Y
- Downes T
- Drenning D
- Drozdz J
- Drzewiecki A
- East C
- Eaton G
- Edes I
- Eich D
- Elliott J
- Ermoshkina L
- Esquivias GB
- Farshid A
- Faynyk A
- Fedele F
- Fernández JD
- Ferrier L
- Feskov O
- Fineschi M
- Franco SN
- French W
- Frey N
- Fulwani M
- Gebel J
- Genth-Zotz S
- Genís AB
- Gessek J
- Gielen S
- Gillespie E
- Gniot J
- Go B
- Goloborodko B
- Goloshchekin B
- González MJ
- Gordeev I
- Gormaz CL
- Gosselin G
- Goswami R
- Goya IL
- Gunalingam B
- Gupta S
- Guseva G
- Haldis T
- Haltern G
- Harding S
- Hart H
- Heckman MJ
- Hengstenberg C
- Henry P
- Hermans W
- Herrman J
- Heuer H
- Horak D
- Horowitz J
- Hubacek J
- Huff C
- Hulinsky V
- Hutyra M
- Huynh T
- Ilmer B
- Ingelmo JM
- Janik M
- Jarne EF
- Jay D
- Jukema J. Wouter
- Kahali D
- Kancz S
- Karpenko O
- Karpenko Y
- Kashou H
- Kastelein John J. P.
- Katerenchuk O
- Katzan I
- Kedhi E
- Keijzers M
- Khaisheva L
- Khintibidze I
- Kie SH
- Kiss R
- Kleiman N
- Klein G
- Klimovic T
- Klimsa Z
- Kmetzo J
- Kobulia B
- Kochmanski M
- Koenig W
- Koenig Wolfgang
- Kokis A
- Kopytsya M
- Korban E
- Kornacewicz-Jach Z
- Kostenko V
- Kovacs Z
- Koval O
- Kozhukhov S
- Kozlowski A
- Kraiz I
- Kreuzer J
- Kukuy E
- Kuznetsov V
- Lago VN
- Lai C
- Lamas G
- Lambert C
- Lapp H
- Lauer M
- Lavi S
- Leithäuser B
- Lenderink T
- Leschke M
- Libis R
- Lieberman S
- Liem A
- Lincoff A. Michael
- Linev K
- Lioy E
- Lochridge S
- Lok D
- Loussararian A
- Lu D
- Lupkovics G
- MacDonald L
- Madej A
- Magagnini E
- Mahar L
- Maly M
- Mamatsashvili M
- Mann J
- Marenzi G
- Markov V
- Marso S
- Martin Mde M
- Martin IH
- Martin L
- Mayer O
- McCullum K
- Megreladze I
- Mennuni M
- Menon Venu
- Merenda R
- Merkely B
- Miekus P
- Mikhin V
- Minisi A
- Miranda JM
- Monhart Z
- Monraats P
- Montero JS
- Moretti L
- Motovska Z
- Movahed M
- Mudra H
- Mukherjee A
- Muller G
- Musial W
- Möllmann H
- Nagy A
- Nambi Vijay
- Nava JS
- Navarro MJ
- Nicholls Stephen J.
- Nierop P
- Nissen
- Nogai K
- Oei F
- Ortiz AI
- Ovcharenko E
- Paradis JM
- Parikh K
- Parker J
- Peñaranda AS
- Pfeffer M
- Piscione F
- Pleva L
- Pluta W
- Polasek P
- Polgar P
- Polk D
- Pollock S
- Ponikowski P
- Prasad C
- Prati F
- Premchand R
- Prokhorov O
- Psuja P
- Pudil R
- Pérez MB
- Rajput R
- Ramaswamy G
- Rassi A
- Reichert P
- Rekosz J
- Rezkalla S
- Richardson J
- Rivera E
- Robertson R
- Rodes-Cabau J
- Roleau J
- Romero AJ
- Romo AI
- Ronaszeki A
- Ronner E
- Rosenberg M
- Rosenson Robert S.
- Rotterova H
- Rubio AM
- Ruda M
- Rudenko L
- Runquist L
- Rynkiewicz A
- Sangiorgi G
- Sanmartín M
- Sanz M
- Sanz RR
- Saucedo J
- Schwartz G
- Schwartz Gregory G.
- Seigel P
- Semenka J
- Senaratne M
- Sereg M
- Shaburishvili T
- Shah A
- Shalnev V
- Shishehbor M
- Shvarts Y
- Silverman P
- Simanenkov V
- Simonyi G
- Skelding K
- Soriano FR
- Speciale G
- Spinar J
- Stellbrink C
- Steven E. Hennekens C
- Stillabower M
- Strain J
- Strasser R
- Sultan P
- Suriano P
- Tans JG
- Testa R
- Thadani U
- Thompson P
- Timofeev A
- Tolerico P.
- Treasure C
- Trip MD
- Trivedi S
- Troquay R
- Uchino K
- Ujda M
- Urbano RH
- Vadaganelli P
- Vakaliuk I
- Valgimigli M
- van de Wetering ML
- van der Heijden R
- van Gaal W
- van Wijk L
- Veen G
- Vertes A
- Vest A
- Vijay N
- Vishnevsky A
- Voehringer HF
- Volkova E
- Wachter R
- Werner N
- White M
- Wiley M
- Wilkins G
- Williams J
- Witkowski A
- Wright R. Scott
- Wysokinski A
- Youssef G
- Zadra R
- Zateyshchikov D
- Zishiri E
- Zubiri JJ
- Publication venue
- 'American Medical Association (AMA)'
- Publication date
- 01/01/2014
- Field of study
IMPORTANCE: Secretory phospholipase A2(sPLA2) generates bioactive phospholipid products implicated in atherosclerosis. The sPLA2inhibitor varespladib has favorable effects on lipid and inflammatory markers; however, its effect on cardiovascular outcomes is unknown. OBJECTIVE: To determine the effects of sPLA2inhibition with varespladib on cardiovascular outcomes. DESIGN, SETTING, AND PARTICIPANTS: A double-blind, randomized, multicenter trial at 362 academic and community hospitals in Europe, Australia, New Zealand, India, and North America of 5145 patients randomized within 96 hours of presentation of an acute coronary syndrome (ACS) to either varespladib (n = 2572) or placebo (n = 2573) with enrollment between June 1, 2010, and March 7, 2012 (study termination on March 9, 2012). INTERVENTIONS: Participants were randomized to receive varespladib (500 mg) or placebo daily for 16 weeks, in addition to atorvastatin and other established therapies. MAIN OUTCOMES AND MEASURES: The primary efficacy measurewas a composite of cardiovascular mortality, nonfatal myocardial infarction (MI), nonfatal stroke, or unstable angina with evidence of ischemia requiring hospitalization at 16 weeks. Six-month survival status was also evaluated. RESULTS: At a prespecified interim analysis, including 212 primary end point events, the independent data and safety monitoring board recommended termination of the trial for futility and possible harm. The primary end point occurred in 136 patients (6.1%) treated with varespladib compared with 109 patients (5.1%) treated with placebo (hazard ratio [HR], 1.25; 95%CI, 0.97-1.61; log-rank P = .08). Varespladib was associated with a greater risk of MI (78 [3.4%] vs 47 [2.2%]; HR, 1.66; 95%CI, 1.16-2.39; log-rank P = .005). The composite secondary end point of cardiovascular mortality, MI, and stroke was observed in 107 patients (4.6%) in the varespladib group and 79 patients (3.8%) in the placebo group (HR, 1.36; 95% CI, 1.02-1.82; P = .04). CONCLUSIONS AND RELEVANCE: In patients with recent ACS, varespladib did not reduce the risk of recurrent cardiovascular events and significantly increased the risk of MI. The sPLA2inhibition with varespladib may be harmful and is not a useful strategy to reduce adverse cardiovascular outcomes after ACS. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01130246. Copyright 2014 American Medical Association. All rights reserved
Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease
- Author
- A Abbate
- A Abhyankar
- A Adams
- A Agafina
- A Akyea-Djamson
- A Alan
- A Alfieri
- A Alfrey
- A Alvarisqueta
- A Amos
- A Anadiotis
- A Anneveldt
- A Antolick
- A Arthur
- A Aslam
- Abaci F
- Abdullakutty J
- Abhaichand R
- Abib E Jr
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- Abrantes J
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- Affaki Gs
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- Walukiewicz P
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- Westberg Jc
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- Yaoqing H
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- Yasutake M
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- Yilmaz Mb
- Yim Kh
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- Yokoyama M
- Yong H
- Yoshida M
- Yoshimoto E
- Yossen M
- Young A
- Younis L
- Youssef G
- Yuan Z
- Yunoki C
- Yupanqui H
- Z Zhai
- Z Zilahi
- Zadionchenko V
- Zadra R
- Zagozen P
- Zaidman C
- Zalazar L
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- Zareczky P
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- Zdrenghea D
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- Zhang W
- Zhang Y
- Zhao R
- Zhou H
- Zidova M
- Zielinski M
- Zieve F
- Zineldine A.
- Zirlik A
- Zucchetti C
- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2017
- Field of study
Background: Experimental and clinical data suggest that reducing inflammation without affecting lipid levels may reduce the risk of cardiovascular disease. Yet, the inflammatory hypothesis of atherothrombosis has remained unproved. Methods: We conducted a randomized, double-blind trial of canakinumab, a therapeutic monoclonal antibody targeting interleukin-1β, involving 10,061 patients with previous myocardial infarction and a high-sensitivity C-reactive protein level of 2 mg or more per liter. The trial compared three doses of canakinumab (50 mg, 150 mg, and 300 mg, administered subcutaneously every 3 months) with placebo. The primary efficacy end point was nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. RESULTS: At 48 months, the median reduction from baseline in the high-sensitivity C-reactive protein level was 26 percentage points greater in the group that received the 50-mg dose of canakinumab, 37 percentage points greater in the 150-mg group, and 41 percentage points greater in the 300-mg group than in the placebo group. Canakinumab did not reduce lipid levels from baseline. At a median follow-up of 3.7 years, the incidence rate for the primary end point was 4.50 events per 100 person-years in the placebo group, 4.11 events per 100 person-years in the 50-mg group, 3.86 events per 100 person-years in the 150-mg group, and 3.90 events per 100 person-years in the 300-mg group. The hazard ratios as compared with placebo were as follows: in the 50-mg group, 0.93 (95% confidence interval [CI], 0.80 to 1.07; P = 0.30); in the 150-mg group, 0.85 (95% CI, 0.74 to 0.98; P = 0.021); and in the 300-mg group, 0.86 (95% CI, 0.75 to 0.99; P = 0.031). The 150-mg dose, but not the other doses, met the prespecified multiplicity-adjusted threshold for statistical significance for the primary end point and the secondary end point that additionally included hospitalization for unstable angina that led to urgent revascularization (hazard ratio vs. placebo, 0.83; 95% CI, 0.73 to 0.95; P = 0.005). Canakinumab was associated with a higher incidence of fatal infection than was placebo. There was no significant difference in all-cause mortality (hazard ratio for all canakinumab doses vs. placebo, 0.94; 95% CI, 0.83 to 1.06; P = 0.31). Conclusions: Antiinflammatory therapy targeting the interleukin-1β innate immunity pathway with canakinumab at a dose of 150 mg every 3 months led to a significantly lower rate of recurrent cardiovascular events than placebo, independent of lipid-level lowering. (Funded by Novartis; CANTOS ClinicalTrials.gov number, NCT01327846.
Effects of alirocumab on types of myocardial infarction: insights from the ODYSSEY OUTCOMES trial
- Author
- Abbas J
- Abbate A
- Abdullakutty J
- Abhyanakar AD
- Aboyans V
- Abrantes JAM
- Abu-Fadel M
- Acevedo M
- Adamkova V
- Adhyapak S
- Agarwal H
- Aggarwal R
- Aggarwal RK
- Aguirre A
- Ahmed H
- Ahremark U
- Ahuad Guerrero RA
- Aidar Ayoub JC
- Airaksinen JK
- Aitken D
- Akatova E
- Akhter F
- Ako J
- Akright L
- Akyea-Djamson A
- Al Joundi T
- Al-Windy NYY
- Alan D
- Alcocer Gamba MA
- Alexander JH
- Alexander K
- Alexandru TM
- Alings M
- Alonso Martin JJ
- Alvarisqueta AF
- Alves De Lima AE
- Amarasekera S
- Amarasena N
- Amir O
- Amlani M
- Amosova E
- Amuchastegui M
- Andersen K
- Andersen R
- Anderson J
- Ando K
- Angel Hominal M
- Annam S
- Anscombe R
- Apostolovic SR
- Appel K-F
- Arandjelovic A
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- Zuniga JDH
- Zurakowski A
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- Zweiker R
- Publication venue
- 'Oxford University Press (OUP)'
- Publication date
- 01/01/2019
- Field of study
Aims The third Universal Definition of Myocardial Infarction (MI) Task Force classified MIs into five types: Type 1, spontaneous; Type 2, related to oxygen supply/demand imbalance; Type 3, fatal without ascertainment of cardiac biomarkers; Type 4, related to percutaneous coronary intervention; and Type 5, related to coronary artery bypass surgery. Low-density lipoprotein cholesterol (LDL-C) reduction with statins and proprotein convertase subtilisin–kexin Type 9 (PCSK9) inhibitors reduces risk of MI, but less is known about effects on types of MI. ODYSSEY OUTCOMES compared the PCSK9 inhibitor alirocumab with placebo in 18 924 patients with recent acute coronary syndrome (ACS) and elevated LDL-C (≥1.8 mmol/L) despite intensive statin therapy. In a pre-specified analysis, we assessed the effects of alirocumab on types of MI. Methods and results Median follow-up was 2.8 years. Myocardial infarction types were prospectively adjudicated and classified. Of 1860 total MIs, 1223 (65.8%) were adjudicated as Type 1, 386 (20.8%) as Type 2, and 244 (13.1%) as Type 4. Few events were Type 3 (n = 2) or Type 5 (n = 5). Alirocumab reduced first MIs [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.77–0.95; P = 0.003], with reductions in both Type 1 (HR 0.87, 95% CI 0.77–0.99; P = 0.032) and Type 2 (0.77, 0.61–0.97; P = 0.025), but not Type 4 MI. Conclusion After ACS, alirocumab added to intensive statin therapy favourably impacted on Type 1 and 2 MIs. The data indicate for the first time that a lipid-lowering therapy can attenuate the risk of Type 2 MI. Low-density lipoprotein cholesterol reduction below levels achievable with statins is an effective preventive strategy for both MI types.For complete list of authors see http://dx.doi.org/10.1093/eurheartj/ehz299</p
Effect of alirocumab on mortality after acute coronary syndromes. An analysis of the ODYSSEY OUTCOMES randomized clinical trial
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- Yerra SK
- Yin W-H
- Yong H
- Yoon JH
- Younis L
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- Yusoff K
- Yusoff K
- Zahger D
- Zaidman CJ
- Zainea M
- Zaman A
- Zapata G
- Zdravko B
- Zea Nunez CA
- Zeiher AM
- Zeiher AM
- Zhang R
- Zhang W
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- Zheleznyy V
- Zheng Y
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- Zobouyan I
- Zong W
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- Zurakowski A
- Zuran I
- Zweiker R
- Publication venue
- 'Ovid Technologies (Wolters Kluwer Health)'
- Publication date
- 04/01/2019
- Field of study
Background: Previous trials of PCSK9 (proprotein convertase subtilisin-kexin type 9) inhibitors demonstrated reductions in major adverse cardiovascular events, but not death. We assessed the effects of alirocumab on death after index acute coronary syndrome. Methods: ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) was a double-blind, randomized comparison of alirocumab or placebo in 18 924 patients who had an ACS 1 to 12 months previously and elevated atherogenic lipoproteins despite intensive statin therapy. Alirocumab dose was blindly titrated to target achieved low-density lipoprotein cholesterol (LDL-C) between 25 and 50 mg/dL. We examined the effects of treatment on all-cause death and its components, cardiovascular and noncardiovascular death, with log-rank testing. Joint semiparametric models tested associations between nonfatal cardiovascular events and cardiovascular or noncardiovascular death. Results: Median follow-up was 2.8 years. Death occurred in 334 (3.5%) and 392 (4.1%) patients, respectively, in the alirocumab and placebo groups (hazard ratio [HR], 0.85; 95% CI, 0.73 to 0.98; P=0.03, nominal P value). This resulted from nonsignificantly fewer cardiovascular (240 [2.5%] vs 271 [2.9%]; HR, 0.88; 95% CI, 0.74 to 1.05; P=0.15) and noncardiovascular (94 [1.0%] vs 121 [1.3%]; HR, 0.77; 95% CI, 0.59 to 1.01; P=0.06) deaths with alirocumab. In a prespecified analysis of 8242 patients eligible for ≥3 years follow-up, alirocumab reduced death (HR, 0.78; 95% CI, 0.65 to 0.94; P=0.01). Patients with nonfatal cardiovascular events were at increased risk for cardiovascular and noncardiovascular deaths (P<0.0001 for the associations). Alirocumab reduced total nonfatal cardiovascular events (P<0.001) and thereby may have attenuated the number of cardiovascular and noncardiovascular deaths. A post hoc analysis found that, compared to patients with lower LDL-C, patients with baseline LDL-C ≥100 mg/dL (2.59 mmol/L) had a greater absolute risk of death and a larger mortality benefit from alirocumab (HR, 0.71; 95% CI, 0.56 to 0.90; Pinteraction=0.007). In the alirocumab group, all-cause death declined wit h achieved LDL-C at 4 months of treatment, to a level of approximately 30 mg/dL (adjusted P=0.017 for linear trend). Conclusions: Alirocumab added to intensive statin therapy has the potential to reduce death after acute coronary syndrome, particularly if treatment is maintained for ≥3 years, if baseline LDL-C is ≥100 mg/dL, or if achieved LDL-C is low. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01663402
Identification of Optimal Set of Driver Nodes in Complex Networked Systems Using Region of Attraction
- Author
- A. Rahmani
- A. Y. Yazicioglu
- C. T. Lin
- D. Henrion
- D. J. Smith
- Deepak M. Fulwani
- F. Pasqualetti
- G. Chen
- G. Yan
- J. Ding
- J. Gao
- J. Ruths
- K. Fitch
- L. Ding
- L. Zhao
- M. Heyouni
- M. Singh
- M. Turner
- Mahaveer Singh
- P. Benner
- P. Benner
- P.-O. Gutman
- R. A. Horn
- R. Haghighi
- R. N. Mahia
- R. N. Mahia
- R. N. Mahia
- Ram Niwash Mahia
- S. Boyd
- T. H. Summers
- T. Hu
- T. Jia
- T. Nepusz
- V. Tzoumas
- Y. Li
- Y. Wei
- Y. Wei
- Y. Wei
- Y. Wei
- Y. Wei
- Y. Y. Liu
- Publication venue
- 'Springer Science and Business Media LLC'
- Publication date
- Field of study
Sliding Mode Control with Nonlinear Disturbance Observer based on Genetic Algorithm for Inverted Pendulum with Mismatched Disturbances
- Author
- Barmish B Leitmann G.
- Camacho EF Bordons C.
- Chen PC Chen CW, Chiang WL.
- Choi HH.
- Choi HH.
- Douiri MR Cherkaoui M, Assadki A.
- Errouissi R Ouhrouche M, Chen WH, Trzynadlowski AM.
- Feng Y Yu X, Man Z.
- Fulwani D Bandyopadhyay B, Fridman L.
- Islam S Xiaoping P. Liu, and El Saddik A.
- Li S Yang J, Chen WH, Chen X.
- Pang HP Yang Q.
- Perruquetti W Barbot JP.
- Rani MR Selamat H, Zamzuri H.
- Soltanpour MR Shafiei SE.
- Yang J Li S and Yu X.
- Yeh FK.
- Publication venue
- 'Indian Society for Education and Environment'
- Publication date
- Field of study
Lipoprotein(a) and Benefit of PCSK9 Inhibition in Patients With Nominally Controlled LDL Cholesterol
- Author
- Abbas J.
- Abbate A.
- Abdallah M.
- Abdullakutty J.
- Abdullkutty J.
- Abhyanakar A. D.
- Aboyans V.
- Abrantes J. A. M.
- Abu-Fadel M.
- Accini Mendoza J. L.
- Acevedo M.
- Adamkova V.
- Adamo A.
- Adhyapak S.
- Agarwal H.
- Aggarwal R.
- Aggarwal R. K.
- Aguirre A.
- Ahmed H.
- Ahremark U.
- Ahuad Guerrero R. A.
- Aidar Ayoub J. C.
- Aitken D.
- Akatova E.
- Akhter F.
- Ako J.
- Akright L.
- Akyea-Djamson A.
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- Al-Windy N. Y. Y.
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- Alcocer Gamba M. A.
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- Alsweiler C.
- Alvarisqueta A. F.
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- Amir O.
- Amlani M.
- Amosova E.
- Amuchastegui M.
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- Anderson J.
- Ando K.
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- Anscombe R.
- Antonio Llamas Esperon G.
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- Appel K. -F.
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- Arif I.
- Armaganijan L.
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- Asita de Silva H.
- Assi N.
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- Athyros V.
- Auguadro C.
- Ayaz M.
- Aylward P. E.
- Azizad M. M.
- Babic Z.
- Badreddine E.
- Bagai A.
- Bagriy A.
- Bahit M. C.
- Bai F.
- Baldari D.
- Balinovac J.
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- Bang L. E.
- Banuru S.
- Barakovic F.
- Baranov E.
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- Barbato E.
- Barna O. M.
- Barone-Rochette G.
- Barr C.
- Barraud P.
- Barrera Silva S. I.
- Barrucco R.
- Bartels G. L.
- Basart D.
- Bashir R.
- Bastos J. M.
- Bata I.
- Batushkin V.
- Bayat J.
- Bayram Llamas E. A.
- Bayron C.
- Beauloye C.
- Bednarski J.
- Behrens S.
- Bejuit R.
- Bekkouche M.
- Belhassane A.
- Beltran P.
- Benbernou F.
- Bencic M. L.
- Benedicto A.
- Bengrait N.
- Bengston J.
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- Berdan L.
- Berger R.
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- Publication venue
- 'Elsevier BV'
- Publication date
- 01/01/2021
- Field of study
Background: Guidelines recommend nonstatin lipid-lowering agents in patients at very high risk for major adverse cardiovascular events (MACE) if low-density lipoprotein cholesterol (LDL-C) remains ≥70 mg/dL on maximum tolerated statin treatment. It is uncertain if this approach benefits patients with LDL-C near 70 mg/dL. Lipoprotein(a) levels may influence residual risk. Objectives: In a post hoc analysis of the ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial, the authors evaluated the benefit of adding the proprotein subtilisin/kexin type 9 inhibitor alirocumab to optimized statin treatment in patients with LDL-C levels near 70 mg/dL. Effects were evaluated according to concurrent lipoprotein(a) levels. Methods: ODYSSEY Outcomes compared alirocumab with placebo in 18,924 patients with recent acute coronary syndromes receiving optimized statin treatment. In 4,351 patients (23.0%), screening or randomization LDL-C was 13.7 mg/dL or ≤13.7 mg/dL; corresponding adjusted treatment hazard ratios were 0.82 (95% CI: 0.72-0.92) and 0.89 (95% CI: 0.75-1.06), with Pinteraction = 0.43. Conclusions: In patients with recent acute coronary syndromes and LDL-C near 70 mg/dL on optimized statin therapy, proprotein subtilisin/kexin type 9 inhibition provides incremental clinical benefit only when lipoprotein(a) concentration is at least mildly elevated. (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402
Alirocumab and cardiovascular outcomes after acute coronary syndrome
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- Publication venue
- 'Massachusetts Medical Society'
- Publication date
- 01/01/2018
- Field of study
BACKGROUND Patients who have had an acute coronary syndrome are at high risk for recurrent ischemic cardiovascular events. We sought to determine whether alirocumab, a human monoclonal antibody to proprotein convertase subtilisin-kexin type 9 (PCSK9), would improve cardiovascular outcomes after an acute coronary syndrome in patients receiving high-intensity statin therapy. METHODS We conducted a multicenter, randomized, double-blind, placebo-controlled trial involving 18,924 patients who had an acute coronary syndrome 1 to 12 months earlier, had a low-density lipoprotein (LDL) cholesterol level of at least 70 mg per deciliter (1.8 mmol per liter), a non-highdensity lipoprotein cholesterol level of at least 100 mg per deciliter (2.6 mmol per liter), or an apolipoprotein B level of at least 80 mg per deciliter, and were receiving statin therapy at a high-intensity dose or at the maximum tolerated dose. Patients were randomly assigned to receive alirocumab subcutaneously at a dose of 75 mg (9462 patients) or matching placebo (9462 patients) every 2 weeks. The dose of alirocumab was adjusted under blinded conditions to target an LDL cholesterol level of 25 to 50 mg per deciliter (0.6 to 1.3 mmol per liter). The primary end point was a composite of death from coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization. RESULTS The median duration of follow-up was 2.8 years. A composite primary end-point event occurred in 903 patients (9.5%) in the alirocumab group and in 1052 patients (11.1%) in the placebo group (hazard ratio, 0.85; 95% confidence interval [CI], 0.78 to 0.93; P<0.001). A total of 334 patients (3.5%) in the alirocumab group and 392 patients (4.1%) in the placebo group died (hazard ratio, 0.85; 95% CI, 0.73 to 0.98). The absolute benefit of alirocumab with respect to the composite primary end point was greater among patients who had a baseline LDL cholesterol level of 100 mg or more per deciliter than among patients who had a lower baseline level. The incidence of adverse events was similar in the two groups, with the exception of local injection-site reactions (3.8% in the alirocumab group vs. 2.1% in the placebo group). CONCLUSIONS Among patients who had a previous acute coronary syndrome and who were receiving highintensity statin therapy, the risk of recurrent ischemic cardiovascular events was lower among those who received alirocumab than among those who received placebo
Effects of alirocumab on cardiovascular and metabolic outcomes after acute coronary syndrome in patients with or without diabetes: a prespecified analysis of the ODYSSEY OUTCOMES randomised controlled trial
- Author
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- Publication venue
- 'Elsevier BV'
- Publication date
- 01/01/2019
- Field of study
Background: After acute coronary syndrome, diabetes conveys an excess risk of ischaemic cardiovascular events. A reduction in mean LDL cholesterol to 1·4–1·8 mmol/L with ezetimibe or statins reduces cardiovascular events in patients with an acute coronary syndrome and diabetes. However, the efficacy and safety of further reduction in LDL cholesterol with an inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9) after acute coronary syndrome is unknown. We aimed to explore this issue in a prespecified analysis of the ODYSSEY OUTCOMES trial of the PCSK9 inhibitor alirocumab, assessing its effects on cardiovascular outcomes by baseline glycaemic status, while also assessing its effects on glycaemic measures including risk of new-onset diabetes. Methods: ODYSSEY OUTCOMES was a randomised, double-blind, placebo-controlled trial, done at 1315 sites in 57 countries, that compared alirocumab with placebo in patients who had been admitted to hospital with an acute coronary syndrome (myocardial infarction or unstable angina) 1–12 months before randomisation and who had raised concentrations of atherogenic lipoproteins despite use of high-intensity statins. Patients were randomly assigned (1:1) to receive alirocumab or placebo every 2 weeks; randomisation was stratified by country and was done centrally with an interactive voice-response or web-response system. Alirocumab was titrated to target LDL cholesterol concentrations of 0·65–1·30 mmol/L. In this prespecified analysis, we investigated the effect of alirocumab on cardiovascular events by glycaemic status at baseline (diabetes, prediabetes, or normoglycaemia)—defined on the basis of patient history, review of medical records, or baseline HbA1c or fasting serum glucose—and risk of new-onset diabetes among those without diabetes at baseline. The primary endpoint was a composite of death from coronary heart disease, non-fatal myocardial infarction, fatal or non-fatal ischaemic stroke, or unstable angina requiring hospital admission. ODYSSEY OUTCOMES is registered with ClinicalTrials.gov, number NCT01663402. Findings: At study baseline, 5444 patients (28·8%) had diabetes, 8246 (43·6%) had prediabetes, and 5234 (27·7%) had normoglycaemia. There were no significant differences across glycaemic categories in median LDL cholesterol at baseline (2·20–2·28 mmol/L), after 4 months' treatment with alirocumab (0·80 mmol/L), or after 4 months' treatment with placebo (2·25–2·28 mmol/L). In the placebo group, the incidence of the primary endpoint over a median of 2·8 years was greater in patients with diabetes (16·4%) than in those with prediabetes (9·2%) or normoglycaemia (8·5%); hazard ratio (HR) for diabetes versus normoglycaemia 2·09 (95% CI 1·78–2·46, p<0·0001) and for diabetes versus prediabetes 1·90 (1·65–2·17, p<0·0001). Alirocumab resulted in similar relative reductions in the incidence of the primary endpoint in each glycaemic category, but a greater absolute reduction in the incidence of the primary endpoint in patients with diabetes (2·3%, 95% CI 0·4 to 4·2) than in those with prediabetes (1·2%, 0·0 to 2·4) or normoglycaemia (1·2%, −0·3 to 2·7; absolute risk reduction pinteraction=0·0019). Among patients without diabetes at baseline, 676 (10·1%) developed diabetes in the placebo group, compared with 648 (9·6%) in the alirocumab group; alirocumab did not increase the risk of new-onset diabetes (HR 1·00, 95% CI 0·89–1·11). HRs were 0·97 (95% CI 0·87–1·09) for patients with prediabetes and 1·30 (95% CI 0·93–1·81) for those with normoglycaemia (pinteraction=0·11). Interpretation: After a recent acute coronary syndrome, alirocumab treatment targeting an LDL cholesterol concentration of 0·65–1·30 mmol/L produced about twice the absolute reduction in cardiovascular events among patients with diabetes as in those without diabetes. Alirocumab treatment did not increase the risk of new-onset diabetes. Funding: Sanofi and Regeneron Pharmaceuticals
Angiotensin receptor neprilysin inhibition compared with enalapril on the risk of clinical progression in surviving patients with heart failure.
- Author
- Abhyankar A
- Accini J
- Adamson P
- Adelberger V
- Agarwal D K
- Ageev F
- Aggarwal R
- Aguilera M
- Ahlström P
- Ahmad W
- Ahmed F
- Akimov A
- Akinboboye O
- Aktoz M
- Akyea-Djamson A
- Al-Zoebi A
- Albisu J
- Albornoz F
- Alegre R
- Alexeeva-Kovalchuk A
- Almanzar A
- Almeida F
- Alvarez M
- Alvarisqueta A
- Amin A
- Amkieh A
- Amos A
- Amuchastegui M
- Anand I
- Anastasio L
- Andersen H
- Andersen K
- Andor M
- Andrade A
- Andrade C
- Andrassy G
- Andreka P
- Anonuevo J
- Antalík L
- Apostolakis S
- Arango J L
- Arango Juan Luis
- Arenas J
- Arias-Castaño J C
- Arnold J Malcolm
- Arnold M
- Aronson D
- Arriola J
- Astesiano A
- Atilano A
- Avendaño A
- Avendaño P
- Averkov O
- Avila E
- Avilés E
- Awasty V
- Azañero R
- Baben L
- Badat A
- Baek S H
- Bagirath R
- Bakai J
- Baldin M G
- Ballyuzek M
- Banerjee P
- Banish D
- Bank A
- Banker D
- Baníková A
- Baranov E
- Baranova E
- Barbarash O
- Barcin C
- Bargout R
- Barnard D
- Barr C
- Bartos D
- Basarab G
- Basart D
- Basavanagowdappa H
- Bassan R
- Basson D
- Bastian A
- Bauer F
- Beacom M
- Bebenek W
- Behrens S
- Bellersen L
- Belohlavek J
- Beloscar J
- Ben Gal T
- Benov H
- Berdague P
- Berg I
- Bergeron S
- Berk M
- Berkovich O
- Berli M
- Berneau J-B
- Berns S
- Bessler H
- Bessonova N
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- Bouvier J-M
- Boyarkin M
- Boytsov Sergey
- Bozkurt B
- Braga J
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- Bulashova O
- Bulugahapitiya S
- Burgess L
- Burianova H
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- Bělohlávek Jan
- Cabrera W
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- Carbajales J
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- Chu A
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- Chung E
- Cieslinski G
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- Cobos L
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- Dovgalevsky Y
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- Gong Jianjian
- Gonzàlez-Medina Angel
- González A
- González B
- González J
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- Guerrero A
- Guetlin A
- Gui M
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- Guray Y
- Gurlek C
- Guzman P
- Gøtzsche O
- Haas G
- Habet K
- Hack T
- Hagege A A
- Hagenow A
- Hagerman I
- Hagège Albert A
- Haidar A
- Hajimirsadeghi A
- Hajko E
- Halpern S
- Hampf J
- Hansson A
- Hanustiakova A
- Hargrove J
- Harris J
- Hart T
- Hartmann A
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- Hegemann P
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- Hergeldjieva V
- Hermes S
- Hernandes M
- Heroux A
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- Himpel-Bönninghoff A
- Hiremath S
- Hoedemaker G
- Hoeltz S
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- Horak A
- Horny I
- Hotchkiss D
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- Ismail O
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- Jain A
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- Jansen van Rensburg D
- Jardula M
- Jazwinska-Tarnawska E
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- Jerwan-Keim R
- Jiménez M
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- Joseph J
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- Jääskeläinen T
- Kaasik A
- Kabaivanov P
- Kabara A
- Kadel C
- Kadr H
- Kaik J
- Kalina A
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- Kamensky I
- Kaneshige A
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- Kang S-M
- Kania G
- Kaplan A
- Kaplan R
- Kapp C
- Kardos A
- Karle C
- Karpov Y
- Kastanayan A
- Katova T
- Katz A
- Ke Y N
- Kempe A
- Keren A
- Kerkar P
- Khan M
- Khromtsova O
- Kiatchoosakun S
- Kiilavuori K
- Kim B-J
- Kim D-S
- Kim K-S
- Kim Kee-Sik
- Kim U
- Kindermann I
- Kisliak O
- Klapholz M
- Klinke P
- Knapp M
- Kobalava Z
- Koehler I
- Kolaczyk P
- Kolar K
- Komajda M
- Konradi A
- Koolen J
- Koren M
- Kornder J
- Korolev M
- Kosmacheva E
- Kostenko V
- Kostis J
- Kotliar C
- Kovacs Z
- Kovács J
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- Kozan Ömer
- Koziolova N
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- Krosse B
- Krupicka J
- Kucharski W
- Kudat H
- Kuhrs M
- Kuimov A
- Kulibaba E
- Kumbla M
- Kvasnicka J
- Køber L
- Kühne U
- Laane E
- Labeque J-N
- Labonte R
- Lanas F
- Landa K
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- Larrain G
- Lasala G
- Latiff G
- Laufer N
- Lauzon C
- Lazov P
- Leal S
- Lebedev P
- Lederballe O
- Lee C
- Lee K
- Lefkowitz Martin P
- Leicht M
- Lembo G
- Leon de la Fuente R
- Leon S
- Leonen M
- Lepage S
- Lerumo T
- Leslie S
- Lesnov V
- Levy T
- Lewis B
- Li L G
- Li S K
- Li W M
- Li X D
- Li X L
- Liberato N L
- Liberman A
- Libis R
- Lieber I
- Liem L
- Lighezan D
- Lin L Y
- Lindovsky P
- Liniado G
- Liu M
- Liu S W
- Liu X H
- Livarek B
- Llamas E B
- Llamas Edmundo Bayram
- Llamas G
- Llanos J
- Lobo Marquez L
- Locnen S
- Logeart D
- Lombaard J
- Lombardi F
- Loos H
- Lopatin Y
- Lorenc Z
- Lu L
- Luis-Arias J
- Luiz Rech R
- Luksiene D
- Lupkovics G
- Luquez H
- Lvova T
- Lynch M
- László Z
- López E
- Löbe M
- Ma G S
- MacFadyen R
- Macias A
- Mackinnon I
- Magno J
- Magrini F
- Maher J
- Mahmood S
- Mainar L
- Maisel A
- Maislos F
- Majerčák I
- Mak S
- Makukhin V
- Maleckas T
- Malek F
- Malik J
- Malipeddi B
- Malkowski M
- Mallagray M
- Mallis G
- Mamas M
- Mandovec A
- Mandviwala M
- Manga P
- Mani C
- Manlutac B
- Mannarino E
- Manukov I
- Manzur F
- Marchese D
- Marchev S
- Marin I
- Mariscal C
- Markham D
- Marmol R
- Marmor A
- Marple R
- Martelet M
- Martin W
- Martinez F
- Martinez P
- Martingano R
- Martínez-Sellés M
- Marzal D
- María E
- Masterov I
- Mathan G
- Matoltsy A
- Maurer M
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- Mazutavicius R
- Mazúr J
- Maček V
- McKenzie W
- McMurray J
- Meaney A
- Megarry S
- Mehling H
- Mehrle A
- Mehta A
- Melchior K
- Mendez J
- Mendoza I
- Menzel F
- Mercado D
- Merkely B
- Mesquita E
- Mihalíková A
- Mihov L
- Milanova M
- Mileva-Manolova A
- Milhous J
- Militaru C
- Miliuniene R
- Miller A
- Miller R
- Miller V
- Mincheva-Kabakchieva V
- Minneci C
- Mirek-Bryniarska E
- Mishkin J
- Missault L
- Mitchell J
- Mkhwanazi M
- Modena M G
- Mody F
- Moe G
- Mohamed Z
- Mohan M
- Mohindra R
- Moiseeva Y
- Moises Azize G
- Montgomery B
- Moraes J
- More R
- Moriarty A
- Morozova T
- Mos L
- Mosterd A
- Motylev I
- Mpe M
- Mulleners T
- Murashkina S
- Murphy J
- Murray A
- Murray D
- Murthy D
- Murthy L
- Muthusamy R
- Muñoz B
- Muñoz R
- Müller G
- Münzel T
- Nagy A
- Naidoo D
- Naidu J
- Nair A
- Nanea T
- Napoli T
- Natour M
- Naudts I
- Naumann R
- Nazeyrollas P
- Nechita C
- Negrusz-Kawecka M
- Neto J
- Neuder Y
- Neuenschwander F
- Neutel J
- Neyses L
- Nguyen D
- Nieto R
- Nightingale A
- Nischik R
- Noori E
- Nosov V
- Nourredine M
- Nyolczas N
- Núñez J
- O'Brien T
- O'Toole L
- Oberoi M S
- Olbrich H-G
- Olexa P
- Oleynikov V
- Oliveira L
- Olsen S
- Ong H
- Ong T
- Ooi H
- Opasich C
- Orchard R
- Orihuela B
- Orihuela O
- Ovando A
- Pacherová J
- Packer M
- Padayachee T
- Padua F
- Pai P Y
- Pai V
- Paiva M
- Pajes G
- Palatkina T
- Palinský M
- Pandey A
- Pandey S
- Paniagua A
- Papp A
- Park D-G
- Parker J
- Parmon E
- Parody L
- Parrott C
- Parvanova Z
- Pascual D
- Paulino A
- Pavía A
- Pedersen O
- Pella D
- Pencheva G
- Perez Rey R
- Perticone F
- Petenian E
- Petersen J
- Petranov S
- Petrova I
- Petrulioniene Z
- Peuhkurinen K
- Peña G
- Piepiorka M
- Pijanowski Z
- Pileri P V
- Pimenov L
- Piyayotai D
- Pocock S
- Poddighe G
- Podzemska B
- Pohl W
- Poling T
- Poulard J-E
- Povolny P
- Prakash V
- Price D
- Privalov D
- Prodafikas J
- Prohaska M
- Pronk A
- Proskynitopoulus N
- Ptacin M
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- Rabelo A
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- Rajda M
- Rama B
- Ramanathan K
- Ramires F
- Ramshev K
- Rancane G
- Ranjith N
- Rassi S
- Rawitscher D
- Rebrov A
- Reddy N
- Refsgaard J
- Regner S
- Reimer D
- Reis G
- Reis H
- Remišová S
- Reyes A
- Reynales H
- Reznik I
- Richter M
- Rickers H
- Riha V
- Rizkala Adel R
- Robinson S
- Rodriguez A
- Rodriguez I
- Rodriguez M
- Rodriguez T
- Rodríguez D
- Rodríguez M
- Roeder S
- Rogelio G
- Rojas C
- Roldan Y
- Romano A
- Ronchi E
- Ronner E
- Rosado J
- Rosenthal A
- Rosenthal S
- Rosita R
- Rossi P
- Rouleau J
- Ruales A
- Ruda M
- Rummel R
- Rupka D
- Ryding A
- Saaiman J
- Saba P S
- Sabatier R
- Sabe-Affaki G
- Sabl P
- Saifutdinov R
- Salamon C
- Salbach P
- Salcido E
- Salvatierra Ruiz A
- Samal A
- Sanchez A
- Sanguanwong S
- Sanmartín M
- Saporito W
- Sarjanovich R
- Sarma P
- Sarries A
- Sayganov S
- Schaefer S
- Schaum T
- Schenkenberger I
- Schiavi L
- Schichorová J
- Schindler A
- Schmalfuss C
- Schmidt A
- Schmidt E
- Schnabel A
- Schneider R
- Schneider W
- Schreckenberg A
- Schreibmüller F
- Schreiner M
- Schröder T
- Schumacher M
- Schwartz S
- Schäfer T
- Sciborski R
- Seals A
- Sebopa B
- Segner A
- Seibert H
- Selektor Y
- Senni M
- Sepulveda P
- Sessa H
- Sestier F
- Seto T
- Shah P
- Shah S
- Shamsudden K
- Shanes J
- Sharma K
- Sheppard R
- Shi Victor C
- Shin J-H
- Shochat M
- Shpagina L
- Shustov S
- Shutemova E
- Shvarts Y
- Siao G
- Siao K
- Sibulo A S
- Sibulo Antonio S
- Sicuro M
- Sigurdsson A
- Silva E
- Silva-Cardoso José
- Silvestre I
- Silvestri F
- Sime I
- Simoes M
- Sims J
- Singh S
- Sinha S
- Sirakova V
- Sitnikova M
- Sizova J
- Slaby J
- Slapikas R
- Smik R
- Smith D
- Smolders W
- Smolenskaya O
- Soares R
- Sobkowicz B
- Sobolewska J
- Sohn H-Y
- Sokolová B
- Solache G
- Soler J
- Solomon S
- Solovieva A
- Soo L
- Sooudi S
- Sotolongo R
- Sotomayor A
- Souza W
- Spagnuolo V
- Sprovieri M
- Squire I
- Srinivasa Rao M
- Srinivasa Rao N
- Staneva A
- Starling R
- Staroverov I
- Steffensen F
- Stockins B
- Strain D
- Struk R
- Stöhring R
- Suiter D
- Sun N L
- Sunderam S
- Svejda J
- Svistov A
- Swart H
- Swedberg K
- Szocs A
- Szpajer M
- Szántai G
- Taddei S
- Tangerding G
- Tarasov N
- Tarlovskaya E
- Taubert G
- Taurio J
- Tayob M
- Teerlink J
- Telekes P
- Tereschenko S
- Terhorst A
- Terrosu P
- Tesch C
- Tespili M
- Thadani U
- Thakkar B
- Thanvi S
- Theron H
- Thomas M
- Thongsri T
- Thorgeirsson G
- Thorsén C
- Thrasher J
- Tisheva-Gospodinova S
- Tjeerdsma G
- Todorov G
- Tokmakova M
- Tomcsányi J
- Tomescu M
- Torres F
- Torres P
- Toth D
- Toursarkissian N
- Tran N-T To
- Trelawny J
- Trevelyan J
- Trichon B
- Trivedi P
- Trofimov N
- Tsao H M
- Tse H F
- Tudoran M
- Tyler K
- Tyminski M
- Tzekova M
- Tzeng B H
- Uebel P
- Ulman J
- Ural D
- Uriarte A S
- Uriarte J
- Urina M
- Urquiaga J
- Uspensky Y
- Valchanova P
- Vally T
- van der Merwe N
- van Eck J
- van Zyl L
- Vandekerckhove H
- Vanhaecke J
- Varjú I
- Vasilieva E
- Velasco R
- Velasquez J
- Velasquez L
- Venter T
- Veress G
- Vergara G
- Vergoni W
- Vertes A
- Vesga B
- Vezikova N
- Vico M
- Vicuna R
- Vida M
- Vijan V
- Vilas Boas F
- Vilela G
- Vincent M
- Vinereanu D
- Vishnevsky A
- Viňanská D
- Volkov D
- Volterrani M
- Vomacka Z
- Vranian R
- Vélez S
- Wallach S
- Ward N
- Watkin R
- Weglarz P
- Weinstein D
- Wellmann H
- Wells T
- Weyland K
- Weytjens C
- Wickemeyer W
- Wight J
- Wilke A
- Willems F
- Williams C
- Witherow F
- Wojciechowska C
- Woldman S
- Wollaert B
- Wong R
- Wronska D
- Wu L
- Wyss F
- Xu G
- Yakhontov D
- Yakovlev A
- Yan B
- Yang K
- Yannick N
- Yao L
- Yavdosyuk A
- Yavuzgil O
- Yenigun M
- Yeo D
- Yigit Z
- Yilmaz A
- Yilmaz M B
- Yip G
- Yokusoglu M
- Yoo B-S
- Yotov Y
- Yousef Z
- Yovaniniz P
- Yuan Z Y
- Yugandhar B
- Zaidman C
- Zannad F
- Zateyshchikova A
- Zebrack J
- Zeh W
- Zemek S
- Zemmrich C
- Zethson-Halldén M
- Zhang J
- Zhao R P
- Zharkov O
- Zhelev V
- Zhilyaev E
- Zilahi Z
- Zile M
- Zo J-H
- Zotov D
- Zotz R
- Zrazhevsky K
- Zuraw B
- Zámolyi K
- Édes I
- Šuch S
- Publication venue
- 'Ovid Technologies (Wolters Kluwer Health)'
- Publication date
- 06/01/2015
- Field of study