1 / 26

PROPRIETA’ GENERALI

PROPRIETA’ GENERALI. INDICATIONS. Apixaban is recommended as an option for preventing stroke and systemic embolism in people with nonvalvular atrial fibrillation with 1 or more risk factors such as: prior stroke or transient ischaemic attack age 75 years or older hypertension

ellis
Download Presentation

PROPRIETA’ GENERALI

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. PROPRIETA’ GENERALI

  2. INDICATIONS • Apixaban is recommended as an option for preventing stroke and systemic embolism in people with nonvalvularatrialfibrillation with 1 or more risk factors such as: • prior stroke or transient ischaemic attack • age 75 years or older • hypertension • diabetesmellitus • symptomaticheartfailure.

  3. Patientswith AF whohave stroke risk factor(s) ≥1 are recommended to receive effective stroke prevention therapy, which is essentially OAC • The evidence for effective stroke prevention with aspirin in AF is weak, with a potential for harm • The useofantiplatelettherapy … for stroke prevention in AF should be limited to the few patients who refuse any form of OAC.

  4. Of the whole study population (n=6036) • 46% of the patients received OAC, • 37.5% 1 antiplatelet agent • 16.5% received no antithrombotic therapy • 44.4% of the patients who did not receive warfarin presented with valid reasons not to be treated (side effects, refusal, no compliance, risk of bleeding) Am J Cardiol 2013

  5. AVERROES (Apixaban versus Acetylsalicylic Acid to Prevent Strokes) S Connolly (McMaster UCongressniversity, Hamilton, ON) • A study comparing the safety and efficacy of apixabanand aspirin in patients with AF • 5600 patients with AF unsuitable for or intolerant of warfarin Randomized to 5 mg of apixaban or 81 to 324 mg of aspirin for up to 36 months or until end of study • Primary efficacy outcome: time from the first dose of the study drug to the first occurrence of ischemic stroke, hemorrhagic stroke, or systemic embolism • Secondary efficacy outcome: time to the first occurrence of ischemic stroke, hemorrhagic stroke, systemic embolism, MI, or vascular death AF=atrial fibrillation

  6. ARISTOTLE Atrial Fibrillation with at Least One Additional Risk Factor for Stroke Randomize double blind, double dummy (n = 18,201) • Major exclusion criteria • Mechanical prosthetic valve • Severe renal insufficiency • Need for aspirin plus thienopyridine • Inclusion risk factors • Age ≥ 75 years • Prior stroke, TIA, or SE • HF or LVEF ≤ 40% • Diabetes mellitus • Hypertension Warfarin (target INR 2-3) Apixaban 5 mg oral twice daily (2.5 mg BID in selected patients) Warfarin/warfarin placebo adjusted by INR/sham INR based on encrypted point-of-care testing device Primary outcome: stroke or systemic embolism Hierarchical testing: non-inferiority for primary outcome, superiority for primary outcome, major bleeding, death

  7. Primary OutcomeStroke (ischemic or hemorrhagic) or systemic embolism P (non-inferiority)<0.001 21% RRR Apixaban 212 patients, 1.27% per year Warfarin 265 patients, 1.60% per year HR 0.79 (95% CI, 0.66–0.95); P (superiority)=0.011 No. at Risk Apixaban 9120 8726 8440 6051 3464 1754 Warfarin 9081 8620 8301 5972 3405 1768

  8. Major BleedingISTH definition 31% RRR Apixaban 327 patients, 2.13% per year Warfarin 462 patients, 3.09% per year HR 0.69 (95% CI, 0.60–0.80); P<0.001 No. at Risk Apixaban 9088 8103 7564 5365 3048 1515 Warfarin 9052 7910 7335 5196 2956 1491

  9. Compared with warfarin, apixaban (over 1.8 years) prevented ARISTOTLE • 6 Strokes • 15 Major bleeds • 8 Deaths 4 hemorrhagic 2 ischemic/uncertain type per 1000 patients treated.

  10. Jamaneurology 2013

  11. RENAL FAILURE Hohnloseret al, EuropeanHeart Journal 2012

  12. COST-EFFECTIVENESS • The Committee concluded that : • apixaban had been shown to be cost effective compared with warfarin, the most plausible ICER being less than £20,000 per QALY gained, and could be recommended as an option for preventing stoke and systemic embolism for people with nonvalvularatrial fibrillation who have 1 or more risk factors for stroke. • there was insufficient evidence to distinguish between the cost effectiveness of apixaban, dabigatran and rivaroxaban at thistime. • NICE technologyappraisalguidance 275

  13. UNCERTAINTY • TRANSIENT ISCHAEMIC ATTACK • HEALTH-RELATED QUALITY OF LIFE • NO ADVANTAGE ON GASTROINTESTINAL BLEEDING • NO DATA ON CARDIOVERSION

  14. Piano terapeutico

  15. PIANO TERAPEUTICO 2

  16. URGENZE • EMORRAGIA: -NON ESISTE ANTIDOTO -CARBONE VEGETALE -PLASMA FRESCO CONGELATO -FATTORE VIIa • SOVRADOSAGGIO: -50 mg/DIE X 7GG :NESSUN PROBLEMA -CARBONE : RIDUZIONE AUC DEL 50%

  17. In the population for whom warfarin was suitable, the ICER for apixaban compared with warfarin was £12757 per QALY gained. in a population for whom warfarin was unsuitable apixaban was associated with an ICER of £2903 per QALY gained compared with aspirin.

  18. ARISTOTLE

  19. APIXABAN (Eliquis®) . Potente inibitore, reversibile, diretto e altamente selettivo del sito attivo del fattore Xa libero e legato Non necessita dell'antitrombina III per esercitare l'attività antitrombotica; non ha effetti diretti sull'aggregazione piastrinica, ma inibisce indirettamente l'aggregazione piastrinica indotta dalla trombina. L'attività anti-Xa è, a diverse dosi, in rapporto lineare diretto con la concentrazione plasmatica, raggiungendo i valori massimi allo steady-state

More Related