Recent Developments In New Oral Anticoagulants Eric Watts Basildon Hospital

Eric Watts, Basildon Hospital

Eric Watts, Basildon Hospital

Prevention of Atrial Fibrillation-Related Stroke

Prevention of Atrial Fibrillation-Related Stroke

Prevention of Atrial Fibrillation-Related Stroke

Prevention of Atrial Fibrillation-Related Stroke

Prevention of Atrial Fibrillation-Related Stroke

Background - AF Warfarin is effective, 2/3 risk reduction for CVA Better than maximal antiplatelet therapy Cumbersome to use Discontinuation rates high Many patients have inadequate control Several drug interactions

Dabigatran etexilate Oral prodrug –rapidly converted to Dabigatran Predictable bioavailbility 80% renal excretion ½ life 12-17 hrs “does not require regular monitoring”

Patient Baseline Characteristics 3 groups “well balanced” Mean age 71 63% male Mean CHADS score 2.1 CCF Hypertension Age Diabetes

Mortality Warfarin …………………….4.13% pa Dabigatran 110mg ……...…3.75% pa .ns Dabigatran 150mg …………3.64% pa .ns

Myocardial Infarction Warfarin ……………….0.53 % Dabigatran 110mg ...…0.72 % p= 0.07 Dabigatran 150mg ……0.74% p= 0.048 Is the antithrombin effect cardioprotective?

Major Bleeding Warfarin…………….3.36 % Dabigatran 110 ……2.71 %, p=0.003 Dabigatran 150 ……3.11% n.s. Life threatening, intracranial Minor bleeding higher with warfarin More major GI bleeding with 150 Dabigatran

Haemorrhagic Stroke Warfarin …………................. 0.38% Dabigatran 110mg ………... 0.12% Dabigatran 150mg ……….… 0.10% NNT = 370 “significant”

GI bleeding & discomfort Discontinuation Warfarin ……………….……. 10.2%pa Dabigatran 110mg ……...…..14.5% pa Dabigatran 150mg …………..15.5% pa

Can we Rely on RE-LY Fairly good INR control -64% (Rosendal) for warfarin to be equally effective – 74% No hepatic toxicity Does have some interactions –P-glycoprotein inhibitors verapamil, amioderone & quinidine Lower dose for renal patients ? Risk stratification for GI pathologies

Can we Rely on RE-LY Is selective antithrombin activity a mixed blessing? “Because of Dabigatran’s twice daily dosing & greater risk of non haemorrhagic side effects patients already taking warfarin with excellent INR control have little to gain by switching” “in contrast, many other patients who have atrial fibrillation and at least one additional risk factor for stroke could benefit from Dabigatran”

Efficacy Outcomes Apixaban Enoxaparin Intended treatment period no. / total no. (%) no. /total no. (%) All VTE and death from any cause 104 / 1157 (9.0) 100 / 1130 (8.8) Major VTE and death from any cause 26 / 1269 (2.0) 20 / 1216 (1.6) Symptomatic VTE and VTE-related death 19 / 1599 (1.2) 13 / 1596 (0.8)

From Xarelto’s Website

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2011 & beyond ????? New drugs licensed Costs will need to be competitive NICE recommendation clinical & cost effectiveness Warfarin wobblers & patients on interacting drugs may be changed over No INR monitoring More complex patients e.g. VR may stay on warfarin for the benefit of monitoring

The future of anticoagulant services ? There will still be a need for clinicians with specialist knowledge & experience Diagnosing & initiating treatment for DVT has been developed by many anticoagulant nurses where this service works well it will probably be maintained Some old drugs are still in use despite the introduction of modern alternatives (UFH)

From the Health Service Journal ‘Clunky’ GP contracts raise questions on quality 8 October 2009 | By Sally Gainsbury There are huge variations in what different PCTs pay for the same services, yet there is no detectable correlation between cost and quality or patient satisfaction. Sally Gainsbury looks at why commissioning has not yet addressed these stark contrasts If you have ever attended a conference on making NHS commissioning “world class” the dominant theme will have been primary care trusts getting to grips with their hospitals. You hear less, if anything, about what PCTs are doing to improve the value for money of their primary care contracts with GPs. There are huge variations in what different PCTs payfor the same services, yet there is no detectable correlation between cost and quality nor patient satisfaction. Sally Gainsbury asks why has commissioning not yet addressed these stark contrasts ?

From the Health Service Journal ‘Clunky’ GP contracts raise questions on quality 8 October 2009 | By Sally Gainsbury Ms Helen Northall says the absence of a value for money focus in primary care is evident in the results of Primary Care Commissioning’s latest benchmarking survey, which found huge and persistent variations in what PCTs pay for ostensibly the same thing.

Discussion Points A “tighter” control with Dabigatran gives fewer bleeds ? The bleeds only need supportive treatment?

Basildon Costs Pradaxa - both 75mg and 110mg are £48.30 for 60 – 80p each Xarelto is £47.40 for 30 tablets …….. £1.59 each