The introduction of dabigatran etexilate (Pradaxa )

Size: px

Start display at page:

Download "The introduction of dabigatran etexilate (Pradaxa )"

Stephen Rogers
5 years ago
Views:

1 The introduction of dabigatran etexilate (Pradaxa ) Draft frequently asked questions ~ October 2011

2 Contents 1 Introduction 3 2 Frequently asked questions 4 What is dabigatran and what is it used for? 4 Will all patients currently on warfarin be switched to dabigatran? 4 I am on warfarin because I have non-valvular atrial fibrillation, is it worth changing? 4 I have just been diagnosed with atrial fibrillation and am due to start warfarin, 4 is it better to go straight to dabigatran? 4 Is dabigatran better but simply too expensive to use? 4 Does dabigatran cause less bleeding than warfarin? 5 If I have excessive bleeding, can the anticoagulant effect of dabigatran be reversed? 5 Dabigatran does not need monitored; this is surely an advantage? 5 Will dabigatran interact with my other medicines, food or alcohol? 5 Should I stop taking dabigatran if I m going to have a dental or medical procedure? 5 Appendix 1: Membership of the patient FAQ subgroup 6 Appendix 2: Membership of the expert advisory group 7 2

3 1 Introduction This document provides information and guidance regarding a new oral anticoagulant (blood-thinning medicine) which has become available for prevention of stroke and embolism (a blood clot causing a blockage in an artery) in patients with non-valvular atrial fibrillation. Dabigatran etexilate (Pradaxa ) is a possible alternative to warfarin; currently the most commonly used anticoagulant. The draft frequently asked questions (FAQs) have been produced to help patients understand the reasons for the advice their doctor has given them regarding dabigatran. The draft FAQs have been published in conjunction with the Consensus Statement for the Prevention of Stroke and Systemic Embolism in Adult Patients with Non-valvular Atrial Fibrillation which is available on s website ( and provides advice to prescribers on which groups of patients to consider for treatment with dabigatran. The draft FAQs do not replace the necessity to refer to the summary of product characteristics and patient information leaflet provided by the manufacturer. These are key documents to inform clinician and patient decision making. A draft consensus statement was developed by an expert advisory group of doctors, pharmacists and nurses from across, and finalised following a national consensus meeting hosted by on 21 September This national meeting included consultant cardiologists, haematologists, stroke physicians, GPs, pharmacists, specialist nurses, healthcare planners and voluntary sector and patient representatives from across. The expert advisory group and a virtual network of GPs identified the key questions and responses for the draft FAQs, which were then shaped for patient use by a patient FAQ subgroup of the expert advisory group. Membership of the expert advisory group and patient FAQ subgroup is detailed in appendices 1 and 2. Dabigatran is a new type of anticoagulant and there is little experience of its use in preventing stroke in patients with non-valvular atrial fibrillation in the UK outwith clinical trials. Dabigatran may only benefit some patient groups. We want to ensure as safe and effective an introduction of dabigatran as is possible for patients in. Given the limited experience of dabigatran s use, we are issuing the FAQs in draft form. We are keen to hear from patients who begin to take dabigatran about their experience. We would welcome comments from patients and the public on these FAQs, which we will finalise in early Please get in touch via our website ( or via to our patient focus and public involvement team (contactpublicinvolvement.his@nhs.net) if you would like to make any comment on this document. 3

4 2 Frequently asked questions What is dabigatran and what is it used for? Dabigatran is an anticoagulant (blood thinning medicine) used to reduce the risk of blood clot formation in patients with atrial fibrillation (an abnormal heart beat) and additional stroke risk factors. A blood clot causing a blockage in an artery is called an embolism. If the embolism occurs in the arteries of the brain it can cause a stroke. Anticoagulants are used to reduce the risk of these events happening. Will all patients currently on warfarin be switched to dabigatran? No; not all patients will be suitable for dabigatran. Dabigatran has only been studied in people with non-valvular atrial fibrillation (when the heart rhythm is abnormal, but the heart valves are healthy) and people with a medium to high risk of having a stroke. It is only approved for use in patients with non-valvular atrial fibrillation. People who are on warfarin for other reasons; for example, they have had a clot in their leg or lung, or have a mechanical heart valve, cannot be considered for treatment with dabigatran and will need to continue on warfarin. I am on warfarin because I have non-valvular atrial fibrillation, is it worth changing? Warfarin has been prescribed for over 60 years so there is plenty of experience of its clinical use. If you are well controlled on warfarin then it is probably not advisable to change. The information from the clinical trial demonstrated that when warfarin was used well, it was as effective as dabigatran; and if anticoagulant control was good (as measured by blood tests), warfarin seemed to perform better overall. For patients who have poor anticoagulant control then a switch to dabigatran might be considered. I have just been diagnosed with atrial fibrillation and am due to start warfarin, is it better to go straight to dabigatran? The majority of people do well on warfarin so there would be no reason to use dabigatran initially. Dabigatran might be considered if there were subsequent problems with your anticoagulant control; for example, you have had difficulty getting the full benefit of warfarin therapy, allergy to warfarin, or intolerable side effects from warfarin. Is dabigatran better but simply too expensive to use? The advice within the consensus statement is about the safe and effective use of dabigatran, not its cost. 4

5 Does dabigatran cause less bleeding than warfarin? As dabigatran and warfarin affect blood clotting, most side effects are related to signs such as bruising and bleeding. Intracranial bleeding (bleeding into the brain) is worrying because it is usually very serious but gastrointestinal (stomach and bowel) bleeding is more common. Dabigatran does cause less intracranial bleeding than warfarin but increases gastrointestinal symptoms (eg indigestion, stomach ache) and more seriously, gastrointestinal bleeding, particularly in those over 75 years of age. If you are over 75, or have an increased bleeding risk your doctor may only prescribe dabigatran at a reduced dose or may not prescribe at all. If I have excessive bleeding, can the anticoagulant effect of dabigatran be reversed? Unlike warfarin, there is not a licensed product currently available to reverse the effect of dabigatran. Dabigatran does not need monitored; this is surely an advantage? This will be an advantage for some but may be a disadvantage for others. We cannot easily monitor its effect which means that we cannot easily know if it is working. It may also be a problem in the elderly with reduced kidney function as this can increase the risk of bleeding. The dabigatran dose will have to be reduced in certain patient groups, for example, the elderly, those with kidney disease and those on some other medicines. Will dabigatran interact with my other medicines, food or alcohol? It has fewer potential interactions with other medicines compared with warfarin, and at present there are no known interactions with specific foods or alcohol. There are some medicines that dabigatran does interact with. Tell your prescriber the names of all the medicines you are taking (including prescription and over-the-counter medicines, vitamins and herbal supplements) so that they can consider all potential interactions. Should I stop taking dabigatran if I m going to have a dental or medical procedure? Dabigatran may need to be stopped, if possible, for one or more days before any surgery, dental or medical procedure. Do not stop taking dabigatran without first talking to the doctor who prescribes it for you. 5

6 Appendix 1: Membership of the patient FAQ subgroup Name Title NHS board area/ organisation Mary Ballantyne Chair Angus Cardiac Group Moray Baylis Robert Bell Helen Cadden David Clark Project Officer Public Partner Public Partner Chief Executive Chest, Heart & Stroke Hirek Kwiatkowski Patient Representative NHS Forth Valley Stella Macpherson Stephen McGlynn Joyce Mouriki Joy Nicholson Public Partner Specialist Principal Pharmacist (Cardiology) Senior Public Partnership Officer Consultant Pharmacist 6

7 Appendix 2: Membership of the expert advisory group* Name Title NHS board area/ organisation Julia Anderson Consultant Haematologist NHS Lothian Moray Baylis Project Officer Allan Bridges Consultant Cardiologist NHS Forth Valley Alison Campbell Andrew Coull Anne Marie Etherington Simon Hart Public Health Pharmacist Consultant Physician Medicine of the Elderly Nurse Consultant Consultant Physician Stroke Medicine NHS Lothian NHS Lothian Christopher Lush Consultant Haematologist NHS Highland David MacDougall Stephen McGlynn Laura McIver Paul Micallef-Eynaud Cath Lab Director & Consultant Cardiologist Specialist Principal Pharmacist (Cardiology) Chief Pharmacist Lead Clinician Anticoagulant Services NHS Lanarkshire NHS Ayrshire & Arran Andrew Moore General Practitioner NHS Highland David Murdoch Sandra Nash Consultant Physician and Cardiologist Senior Pharmacist Medicine of the Elderly NHS Lothian Marjory Neill Cardiology Pharmacist NHS Lothian Joy Nicholson Consultant Pharmacist David Northridge (Chair) Consultant Cardiologist NHS Lothian In addition a further network of eight General Practitioners was consulted for the FAQs. 7

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation Consensus Statement ~ October 2011 Contents 1 About 3 2 Introduction 5 3 Development of the consensus