6 research outputs found
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
- Aboufakher R
- Abrantes J
- Abreu M
- Abulencia K
- Acampora D
- Acampora M
- Accini Mendoza Jl
- Aceto L
- Acevedo B
- Acevedo L
- Acheatel R
- Actis Mv
- Adams M
- Adjic Nc
- Affaki Gs
- Agarwal Dk
- Aggarwal Rk
- Agosta Gf
- Aguilar M
- Aguilar M
- Ahire N
- Ahmad I
- Ahmed Sh
- Ahn Y
- Aish B
- Aiub F
- Aiub J
- Ajax K
- Ajioka M
- Akai Y
- Akatova E
- Akrap B
- Al Joundi T
- Al-Khalili F
- Albisu J
- Alcalde Jm
- Alcide P
- Alfonso T
- Allen J
- Alllison Dc
- Almaliky T
- Amerena J
- Andersen K
- Andor M
- Angelova I
- Angiolillo D
- Anita S
- Anker Sd
- Antalik L
- Antonicelli R
- Aparicio Cv
- Apel T
- Apostolovic S
- Ara M
- Aragorn L
- Arango Jl
- Araujo Fonseca M
- Ardissino D
- Arenas Leon Jl
- Arevalo S
- Argiolas G
- Arif I
- Armas E
- Aron G
- Arora S
- Asafu-Adjaye N
- Ashcom T
- Ashford M
- Ashino K
- Asim Oktay Ao
- Assarsson E
- Ata B
- Ather N
- Atieh M
- Aull L
- Avalos V
- Avdonina N
- Awasthi Ak
- Axthelm C
- Ayala M
- Ayasse D
- Ayasse M
- Azizad M
- Azize Gm
- B Becker
- Baar M
- Babu R
- Backer T
- Badea C
- Baden M
- Baehl S
- Baek C
- Baeumer A
- Bagi Es
- Bai A
- Bailey K
- Bailey S
- Bair S
- Baker A
- Baker C
- Bakhai A
- Bakker H
- Baksi A
- Baldin Mg
- Bali Hk
- Ballantyne C
- Ballmajo M
- Balode A
- Balukova E
- Bang Sa
- Banker D
- Banker K
- Baquero A
- Barbarash Ol
- Barbato E
- Barbosa E
- Barnett S
- Baron S
- Barreto M
- Barroso A
- Barroso W
- Bartkowiak A
- Bartosh L
- Bartuseviciene S
- Bashir K
- Baszak J
- Bata Ir
- Bayram E
- Beall K
- Beaudry M
- Beauregard La
- Beckett L
- Belejchak P
- Belle Isle J
- Belohlavek J
- Bendelow T
- Bender D
- Benedetti G
- Benjamin S
- Benton J
- Berdoff R
- Berger V
- Bergeron P
- Bergholtz T
- Bergler-Klein J
- Berk M
- Berli Ma
- Bernstein M
- Berra Fc
- Berti S
- Berulfsen A
- Bevilacqua Mt
- Bhadade S
- Bilazarian S
- Bilodeau N
- Binder A
- Binns Y
- Birdane A
- Bisne V
- Bitzer V
- Blagdon M
- Blahey M
- Blankenberg S
- Blazsek Z
- Bloch S
- Blom Kb
- Bluemel J
- Blumberg C
- Blumenthal R
- Bocanera M
- Bodanese L
- Boffetti P
- Bohra P
- Bohula E
- Boivin Mc
- Bolduc H
- Boley K
- Bolognesi Mg
- Bolsmann C
- Boman K
- Bonner J
- Borrayo Na
- Boström På
- Botelho R
- Botta C
- Boudreaux R
- Boulanger K
- Bourgeois S
- Bouvy C
- Bowen L
- Boyarkin M
- Bradley A
- Brady L
- Bramlet D
- Brath H
- Braun P
- Bredlau C
- Brickman T
- Briggs S
- Briké C
- Brodmann M
- Brons S
- Brousalis L
- Brouwer M
- Brown C
- Brown N
- Brown S
- Buchannan C
- Budaj A
- Budassi N
- Budkova J
- Bugan V
- Buhlman S
- Bulashova O
- Bunschoten P
- Burke W
- Burley T
- Burova N
- Burris H
- Burton C
- Burton J
- Burton M
- Burtt D
- Busak L
- Busic N
- Byars W
- Bøen Rh
- C Clavier-Firmin
- C Conradie
- C Contzen
- C Cotes
- C Covert
- C Cuneo
- Caballero-Valiente B
- Cabau Jr
- Calabrese A
- Campanale Eg
- Candusso R
- Cantor W
- CANTOS Trial Group. Krum H
- Capova L
- Carabajal T
- Carr K
- Carrillo J
- Caruso G
- Casala J
- Caso P
- Casoinic F
- Castillo J
- Castillo T
- Cech V
- Cei L
- Cendali G
- Cepinskiene L
- Cerda L
- Cermak O
- Chachalis G
- Chaggar S
- Chambers J
- Chamblee T
- Chang K
- Chang Kc
- Chang Wh
- Charlier F
- Charmarthi B
- Chattin W
- Chauhan D
- Chauhan H
- Chaussé I
- Chavada J
- Chaverra I
- Chaware G
- Chee L
- Chella S
- Chen Cp
- Chen J
- Chen Mh
- Chen Y
- Chen Yc
- Chen Zc
- Cheng Jj
- Cheng S
- Cheng Sm
- Cherlin R
- Cheung D
- Chhabra A
- Chintala P
- Chiodi L
- Choi Aj
- Chou S
- Chouinard G
- Christensen L
- Christenson S
- Chung A
- Churina S
- Cifkova R
- Ciglenecki N
- Cioffi A
- Cislowski D
- Cleveland T
- Clocotan M
- Cmrecnjak J
- Colfer H
- Colhoun H
- Collier D
- Collins R
- Coloma G
- Colquhoun D
- Colvin T
- Coman S
- Commerford P
- Commerford P
- Conrado Y
- Cools F
- Cornel Jh
- Corona V
- Coronel J
- Cosgrove N
- Cosgrove S
- Cosmi F
- Costa Amorim R
- Coufalova Z
- Covell W
- Cox B
- Cox R
- Craig W
- Crandall L
- Crawford G
- Crea F
- Crepps K
- Crocamo A
- Cromer M
- Cruz H
- Cruz H
- Cruz M
- Csala L
- Cucher F
- Cuentas I
- Cuervo A
- Curiac D
- Cymerman K
- Cyprian R
- Czerski T
- D'Amours Dg
- D Dash
- D Dattani
- D Denham
- D Desai
- D Desalle
- D Digangi
- D Dunn
- Da Costa F
- Da Silva A
- Da Silva D Jr
- Da Silva O Jr
- Dahlen G
- Dalseg Am
- Damron M
- Danik J
- Davalos C
- Dave B
- Dave K
- Davidsson K
- Davies M
- Davies N
- Davis B
- Davis M
- Dawkins-Hughes S
- Dawood Sy
- Dayer M
- De Boer P
- De Caterina R
- De Jong C
- De Knijf K
- De Krumbach L
- De Los Milagros Had M
- De Los Rios M
- De Rosa S
- De Vos A
- De Wolf L
- Dean J
- Debnam S
- Decsi K
- Decsi Kl
- Dedek V
- Dedkova S
- Defosse C
- Degennaro N
- Dehning M
- Dela Llana A
- Delfonso F
- Delforge M
- Delgadillo T
- Dellasa M
- Dellborg M
- Dellorso M
- Demidova M
- Den Hartog F
- Denecke C
- Dengler T
- Dermitzakis A
- Deslongchamps F
- Dessalvi Cc
- Destro M
- Dettmer M
- Devasia T
- Deweerdt N
- Dhanak R
- Dhawan M
- Di Biase M
- Diago M
- Diaz M
- Dicken T
- Dickstein K
- Diederich C
- Diederich M
- Diehl R
- Diller P
- Dimattia M
- Dimitrov G
- Diodati J
- Dobariya H
- Dobilas V
- Dodds G
- Doesborg L
- Doggett J
- Dognini Gp
- Doi M
- Dokupilova A
- Dommerholt R
- Donahue K
- Donath M
- Donaubauer T
- Dong X
- Dormidontova G
- Dorogova I
- Dos Santos A
- Dos Santos F
- Dos Santos P
- Doughty A
- Doughty L
- Dovgalevskiy Y
- Dovgolis S
- Dragutksy B
- Dreese M
- Drost I
- Drouin K
- Duchesne L
- Duckert A
- Duda N
- Dudarev M
- Dudhatra N
- Duff J
- Duhan S
- Dunhurst F
- Dussan Ma
- Dutka C
- Dwenger E
- Dzupina A
- Dékány Jn
- E Eleuteri
- E Englmann
- Earl J
- East C
- Eaton C
- Eaves W
- Ebeling K
- Ebrahim I
- Eccleston D
- Echeverria L
- Eder F
- Edgerton L
- Edillo C
- Edwards J
- Edwards T
- Eichinger G
- Einhorn D
- Eki Y
- El Hachem M
- El Hafi S
- Ellenbroek D
- Ellis M
- Emil B
- Endo T
- Engelen W
- Erhard M
- Erickson B
- Ervin W
- Eskridge L
- Espinosa V
- Everett Bm
- F Fedele
- F Fonseca
- F Fucci
- Facello A
- Facello M
- Faghih M
- Fail P
- Falcon D
- Fang C
- Fang Cy
- Farias E
- Fattal P
- Fawson A
- Feitosa G
- Felario Junior Ga
- Felix L
- Feng Y
- Feng Z
- Ferdinand K
- Ferkl R
- Fernandez Aa
- Ferrari V
- Ferrario M
- Ferraz R
- Ferreira Dos Santos T
- Ferreira-Jardim A
- Fien E
- Filardi Pp
- Filho P
- Fintel D
- Firek C
- Fischer Sm
- Fisher J
- Fitilev S
- Fitz-Patrick D
- Fitzpatrick L
- Flaksa I
- Flather M
- Flezar M
- Fliesser-Goerzer E
- Flores E
- Flores E
- Flores Gs
- Flores H
- Floro T
- Foerster A
- Folkeringa Rj
- Fonseca A
- Fontaine S
- Forgon T
- Forgosh L
- Forker A
- Forster T
- Foster M
- Foucauld J
- Fowler V
- Fox B
- Franco M
- Francoeur L
- Frandsen B
- Frandsen B
- Frankenstein L
- Fratczak M
- Freitas E
- French J
- Frivold G
- Fruchter G
- Fu G
- Fucak E
- Fuchs R
- Fucili A
- Fukuike C
- Fullerton D
- Fulop P
- Fulop T
- Fulwani M
- Furch G
- Furuseth B
- G Gacioch
- G Gosselin
- Gabito A
- Gabor M
- Gabriel J
- Gabrielli D
- Gaeb-Strasas B
- Gamba C
- Ganau A
- Gapon L
- Garas S
- Garcia Duran R
- Garcia Pinna J
- Garcia Rinaldi R
- Garcia F
- Garcia N
- Garcia-Fragoso V
- Garcia-Portela M
- Garner K
- Gazizianova V
- Gelb R
- Genest J
- Genova D
- George F
- Germann H
- Gersh B
- Gervais B
- Ghali J
- Ghondale N
- Ghosh N
- Ghosh S
- Giese C
- Gilbert J
- Gilley J
- Gits F
- Glancy R
- Glenny J
- Glover J
- Glynn Rj
- Godoy Sanchez M
- Goette A
- Goff R
- Goffinet C
- Gohel P
- Goldberg N
- Gomez Sanchez J
- Gonsorcik J
- Gonzales D
- Gonzales V
- Gonzalez E
- Gordeev I
- Gorges R
- Gospodinov K
- Gotcheva N
- Goudev A
- Gould R
- Govindaraj D
- Goyal B
- Goyal S
- Grabeau R
- Grable M
- Graham J
- Graham Ja
- Graif J
- Gralow J
- Gravellone M
- Gravenhorst-Muenter U
- Green E
- Greener R
- Greenway F
- Grieshaber V
- Griffin S
- Grigaraviciene I
- Grigorova V
- Gros C
- Grosse A
- Grover A
- Grundtvig M
- Gudipati Rvc
- Guerrero A
- Guillinta P
- Gundala Ak
- Gupta A
- Gupta A
- Gupta M
- Gupta V
- Gutmann J
- Guzman I
- Guzman P
- Gwyn M
- Gyorgyova E
- H Haldane
- H Hansen
- H Haught
- H Hill
- Haase F
- Haege R
- Haenel T
- Hage F
- Hageman T
- Hagemann D
- Hagenow A
- Hagiwara Y
- Haidar A
- Haider K
- Hakas J
- Haldis T
- Hall C
- Hall L
- Hall S
- Halliwell Tc
- Halpern S
- Hamer Bjb
- Hamud-Socoro A
- Han B
- Han S
- Hanak P
- Hanefeld M
- Hangyal T
- Hansson A
- Hanustiakova A
- Hao Y
- Hardas S
- Hardee L
- Harrell W
- Harrington A
- Harris B
- Hartleib M
- Hartwell J
- Hasan F
- Hasbani E
- Hasegawa K
- Hattler B
- Haughton G
- Haynes E
- Haywood A
- He Y
- He Z
- Heaney L
- Hecht J
- Heeren G
- Hegedus V
- Heider J
- Heisters J
- Henley L
- Hennig D
- Henriksson A
- Hermans K
- Hernandez E
- Hernandez I
- Hernandez M
- Hernández N
- Herrman Jp
- Herzog W
- Hess E
- Hettwer Magedanz E
- Hickey L
- Hiden C
- Hielscher S
- Higuchi T
- Higuchi Y
- Hilkert R
- Hilton T
- Himpel-Boenninghoff A
- Hinderaker P
- Hioki M
- Hirayama A
- Hiroma J
- Ho Cj
- Hodnett P
- Hoffman M
- Hofsoey K
- Hogan C
- Hollanders G
- Holmes Z
- Holoubek D
- Holscher A
- Hominal M
- Homza M
- Hong T
- Hong T
- Hoogslag Pam
- Horackova K
- Horak A
- Hornig M
- Horvat P
- Hosokawa S
- Hotchkiss D
- Houra M
- Hristova K
- Hsieh Ic
- Huang A
- Huang P
- Huang Ph
- Humbert J
- Hurtig U
- Hutchens E
- Huynh T
- Hwang Jj
- Hwang Jj
- Hyun K
- Härstedt N
- Høivik Ho
- I Ilic
- I Ivanov
- Iachini K
- Iannopollo G
- Ibarra J
- Ibarra M
- Ibañez J
- Iby M
- Ichisawa M
- Igbokidi O
- Iijima T
- Ilahi T
- Ilic S
- Ilsley M
- Imbrognio M
- Imre Bs
- Inada T
- Inagaki M
- Indolfi C
- Infusino F
- Invitti C
- Ipp E
- Isaza D
- Istratoaie O
- Istvan Kp
- Iteld B
- Ito K
- Ivan P
- Iveta H
- Izmozherova N
- J Jiang
- J Johnson
- J Johnston
- J Jose
- Jacques G
- Jafri A
- Jafry B
- Jagtap P
- Jaguszewska G
- Jain A
- Jansen M
- Jardula M
- Jayasinghe R
- Jefferson D
- Jenkins R
- Jensen Ed
- Jeric M
- Jerzewski A
- Jeserich M
- Jia Z
- Jiang T
- Jiang X
- Jimenez D
- Jirvankar P
- Johansen Bb
- Johansen E
- Johansson K
- Johnson E
- Jones S
- Jonsson Je
- Joosten C
- Joshi U
- Julien Ve
- JuliĂŁo K
- Jure D
- Jure H
- Jutrisa N
- K Kaigawa
- K Katahira
- K Kiroglu
- K Kordic
- K Kostov
- Kabakchieva Vm
- Kaczmarek N
- Kafarakis P
- Kaiserova L
- Kajihara S
- Kala P
- Kaldara E
- Kalina A
- Kalkman C
- Kam J
- Kamensky G
- Kamiya H
- Kamiya J
- Kan G
- Kaneno Y
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- Kapp I
- Kara Yd
- Karakai H
- Karel I
- Karpuram M
- Karsai Xz
- Kastelein Jjp
- Kataoka M
- Katona A
- Katova T
- Kaur H
- Kawahara M
- Kawai M
- Kawasaki T
- Kawka-Urbanek T
- Kazanskay E
- Ke Y
- Keba E
- Keenan S
- Kelehan S
- Kellnerova I
- Kelly R
- Kelt T
- Kendall T
- Kereiakes D
- Khan A
- Khan M
- Khan R
- Khan S
- Khariouzov A
- Khirmanov V
- Khromtsova O
- Kick J
- Kiefer R
- Kietselaer B
- Kim B
- Kim Ks
- Kim M
- Kimmel M
- King A
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- Kirkland S
- Kiss Rg
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- Kitchens D
- Klamm M
- Klein C
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- Klemsdal To
- Kleve R
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- Kodem Dr
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- Konradi A
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- Kopaczewski J
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- Krupciakova B
- Krupicka J
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- Kumbla M
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- Kuramochi T
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- Lorenzatti A
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- Luecke-Uzar M
- Luedemann J
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- Lupkovics G
- Luquez H
- Luz Serrano H
- Lv Y
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- Lysek R
- Lönnberg I
- M Malek
- M Mallagray
- M Mandati
- M Mandviwala
- M Marsters
- M Mays
- M Mcdonald
- M Medvegy
- M Meinrich
- M Mikus
- M Milanova
- M Moustafa
- Ma C
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- Macdonald J
- Macfadyen Jg
- Machova V
- Madder R
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- Maheshwari A
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- Majercak I
- Majul C
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- Makotoko E
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- Malik J
- Mancikova I
- Mandic L
- Manenti E
- Manfreda S
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- Manning B
- Mannucci E
- Manolis A
- Manolis Aj
- Manov E
- Mantas I
- Manuel J
- Manukov D
- Manukov I
- Manyari D
- Manzur F
- Marcela Wenetz Lm
- Marchelletta N
- Marchi Al
- Marcinkeviciene J
- Marcun R
- Marengo Garcia De Carvalho L
- Marinaro S
- Marino P
- Mariottoni B
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- Marshall L
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- Martinez J
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- Maximov D
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- Mazutavicius R
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- Mccullough-O'Brien H
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- Mcgrew F
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- Mckenzie A
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- Mckibbin A
- Mclaurin B
- Mclellan Ba
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- Mcneil D
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- Mcpherson C
- Medina F
- Megalou A
- Mehrle A
- Mehta A
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- Meijlis P
- Meissner A
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- Melbie K
- Mellberg L
- Melliza T
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- Mercuro G
- Merkely B
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- Mestdagh I
- Meyer R
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- Mickel C
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- Mihaly N
- Mikdadi G
- Mikusova T
- Milicic D
- Militaru C
- Miliuniene R
- Milkas A
- Miller A
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- Miller G
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- Miller W
- Minescu B
- Minocha G
- Mitchell J
- Mittal A
- Miyamoto T
- Moats Djr
- Modi R
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- 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.
Family of gas sensors based on multi-layer composition of nano-scaled thickness
- Author
- Publication venue
- Publication date
- 01/01/1999
- Field of study
Quality evaluation of the appearance of virtual close-fitting woven garments
- Author
- Publication venue
- 'Informa UK Limited'
- Publication date
- Field of study
Evolocumab and clinical outcomes in patients with cardiovascular disease
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- Yeoman G.
- Yigit Z.
- Yilmaz M. B.
- Yokoya K.
- Yoshimichi G.
- Yotov Y.
- Youngman D.
- Younis L.
- Yuge M.
- Zabowka M.
- Zahn L.
- Zamorano Gomez J. L.
- 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
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
Evolocumab and clinical outcomes in patients with cardiovascular disease
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- Aboufakher R
- Abrahamsen Te
- Accini Mendoza Jl
- Acheatel R
- Ackermann D
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- 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
Antiinflammatory therapy with canakinumab for atherosclerotic disease
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- 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. Copyright © 2017 Massachusetts Medical Society