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Update on the new oral anticoagulants; 12 months on

Update on the new oral anticoagulants; 12 months on. Dr Dipti Chitnavis Haematology Consultant West Suffolk Hospital January 2014. Overview. Indications for oral direct inhibitor anticoagulants Key facts to remember Practical issues -careful patient selection -contraindication -cautions

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Update on the new oral anticoagulants; 12 months on

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  1. Update on the new oral anticoagulants; 12 months on Dr Dipti Chitnavis Haematology Consultant West Suffolk Hospital January 2014

  2. Overview • Indications for oral direct inhibitor anticoagulants • Key facts to remember • Practical issues • -careful patient selection • -contraindication • -cautions • -dose reductions • -drug interactions • -clotting tests • -counselling • Annual review/clinical surveillance • Case studies • Summary • Future directions • Primary care prescribing data

  3. Indications for ODIs • Stroke prevention in non-valvular AF (dabigatran, rivaroxaban, apixaban) • Prophylaxis of VTE in adults undergoing hip/knee replacement (dabigatran, rivaroxaban, apixaban) • Treatment of DVT and prophylaxis of recurrent DVT/PE in adults- NICE TA 261 (rivaroxaban) • Treatment of PE and prevention of recurrent VTE in adults- NICE TA 287 (rivaroxaban)

  4. Key facts to remember • No head to head ODI trials • Poorly represented patient groups in trials: • >80 yrs • <50kg/ >100kg • INR 3-4* • Antiphospholipid syndrome* • High bleeding risk* • *(VTE trials) • No antidote • Urgent, reliable reversal not established • Long term effects unknown • Safeguards applicable to warfarin should be applied to ODIs

  5. Practical issues • Careful patient selection- NPSA TTR>60% • Contraindications- pregnancy, <18yrs, ketoconazole, Lactose intolerance (rivaroxaban), Cr. Cl. <30ml/min (dabigatran), Cr. Cl. <15ml/min (rivaroxaban, apixaban) • Caution in renal impairment • Caution in hepatic impairment

  6. Practical issues • Dose reductions • Dabigatran- >80yrs, (75-80yrs), <50kg, Cr. Cl.<50ml/min, gastrointestinal Sx/other bleeding risk • Rivaroxaban- Cr. Cl. 15-49ml/min, high bleeding risk • Apixaban- Cr. Cl. 15-29ml/min, high bleeding risk, at least 2 of: >80yrs/ <60kg/ Creat>133 • Dose insufficiency? • NEJM June 2013 case report ischaemic stroke in patient 153kg • Drug interactions- • take dabigatran 2hrs before a PPI • Amiodarone, clarithromycin, quinidine

  7. Practical issues • Clotting tests • Baseline: FBC, U&E, Cr.Cl, LFT, APTT, PT, (TT) • Not INR • D-dimers lowered by ODIs- do not use for assessment for VTE

  8. Practical issuesCounselling • Document • Indication, drug, dose, duration, review date • Copy in notes and to patient (signed and dated) • Lack of antidote • How to take • Dabigatran- whole, with/without food, 2 hrs pre PPI, open blister pack just before use. • Rivaroxaban- with food

  9. Practical issuesCounselling • Compliance- Short half- life • Dabigatran 12-14 hrs (Cr. Cl. >80mls/min) • 27hrs (Cr. Cl. <30mls/min) • Rivaroxaban 5-9hrs (young) • 11-13hrs (elderly) • Apixaban approx. 12hrs • Warfarin 40hrs

  10. Practical issuesCounselling- missed dose • Dabigatran • Take missed dose up to 6hrs prior to next scheduled dose; if <6hrs to go, omit missed dose and continue with usual schedule. Do not double dose to catch up. • Rivaroxaban • Take missed dose immediately on the day due, even if dosing is b.d. (DVT/PE). If dosing is o.d., do not double dose to catch up. • Apixaban • Take missed dose immediately, then continue with b.d. intake.

  11. Practical issuesCounselling • Overdose • Document drug, dose, time taken, Creatinine Clearance • Bleeding/injury • Who to contact if minor/major bleeding/head injury

  12. Practical issuesCounselling • Patient information sheet • Patient alert card • Patient follow-up card for A.F. • European Heart Assoc.(WSH part 1 ODI guideline appendix 6) • Set up formal registry for review

  13. Practical issuesAnnual review/clinical surveillance • Guided by Creatinine Clearance • 6weekly to annually • Medication change • Antiplatelets, NSAIDs, interactions, nephrotoxics) • Discharge form secondary care • May be on extended prophylaxis • Bleeding • Consider checking coagulation status (in addition to baseline) at: • extremes of weight, compliance issues, overdose, bleeding, pre invasive procedures, deteriorating renal/hepatic function. • Report adverse events

  14. Summary 1 • New ODI for Stroke prevention in AF (apixaban) • New indications for ODIs (rivaroxaban for VTE) • Trials not representative of all patient groups • Calculate and monitor Creatinine Clearance • Clotting tests- D-dimers not for VTE assessment

  15. Summary 2 • Practical considerations • Dose alterations/drug interactions • Counselling- copy to patient, drug alert cards, information leaflets, how to take, compliance, missed dose, contacts if bleed/injury • Formal registry for regular review- AF follow-up card • Report adverse events

  16. Future directions • Apixaban & dabigatran for VTE • Studies on gastro-intestinal bleeds & coronary events • Studies on clotting tests • Studies on management of bleeding • Phase IV long-term post marketing surveillance ROSE study

  17. Primary Care Prescribing DataLinda LordHead of Medicines Management

  18. Thank you Questions?

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