The introduction of dabigatran etexilate (Pradaxa )

Transcription

1 The introduction of dabigatran etexilate (Pradaxa ) Frequently asked questions ~ April 2012

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 For patients with non-valvular atrial fibrillation, is it worth changing from warfarin? 4 Is it better for patients who are newly diagnosed with non-valvular atrial fibrillation to start taking dabigatran rather than warfarin? 4 Does dabigatran cause less bleeding than warfarin? 4 If a patient has excessive bleeding, can the anticoagulant effect of dabigatran be reversed? 5 Are regular blood tests needed to monitor dabigatran levels? 5 Will dabigatran interact with other medicines, food or alcohol? 5 Should patients stop taking dabigatran if they are going to have a dental or medical procedure? 5 Appendix 1: Membership of the FAQ subgroup of the expert advisory group 6 Appendix 2: Membership of the expert advisory group 7 2

3 1 Introduction Dabigatran etexilate (Pradaxa ) is a new type of blood-thinning medicine to prevent stroke and embolism (a blood clot causing a blockage in an artery) in patients with non-valvular atrial fibrillation (an abnormal heart beat). This medicine has recently become available for healthcare professionals to prescribe to patients but there is little experience of its use in the UK for preventing stroke, apart from in clinical trials. Dabigatran can be used as an alternative treatment to a commonly-used blood-thinning medicine called warfarin, but it may only benefit some patient groups. To ensure dabigatran is used safely and effectively in NHS, a statement 1 was developed by an expert advisory group of doctors, pharmacists and nurses from across, and finalised following a national meeting. This national meeting engaged the support of the following groups of people from across : cardiologists (doctors who care for patients with heart conditions) haematologists (doctors who specialise in blood disorders) stroke physicians (doctors who look after patients who have had a stroke) general practitioners (GPs) pharmacists specialist nurses healthcare planners, and voluntary sector and patient representatives. The statement provides advice to healthcare professionals on which groups of patients to consider for treatment with dabigatran. It is available on s website ( In addition to this the expert advisory group and a virtual network of GPs identified key questions and responses to form frequently asked questions, which were then shaped by an FAQ subgroup of the expert advisory group. Membership of the expert advisory group and FAQ subgroup is detailed in appendices 1 and 2. This document presents and responds to those frequently asked questions to guide healthcare professionals about the newly available dabigatran, and to help patients understand the advice given to them about dabigatran. It is published alongside the statement. This document does 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. 1 Statement for the Prevention of Stroke and Systemic Embolism in Adult Patients with Non-valvular Atrial Fibrillation ( 3

4 2 Frequently asked questions What is dabigatran and what is it used for? Dabigatran is an anticoagulant (blood-thinning medicine) used to lower the risk of blood clots developing in patients who have a condition called atrial fibrillation (an abnormal heart beat) as well as other risk factors for stroke. A blood clot which blocks an artery (blood vessel) is called an embolism. If the embolism occurs in the arteries of the brain, it can cause a stroke. Anticoagulants thin the blood and reduce the risk of these events happening. Will all patients currently on warfarin be switched to dabigatran? Not all patients will be suitable for dabigatran. Dabigatran has only been studied in people with non-valvular atrial fibrillation (where the patient does not have rheumatic valve disease, a mechanical heart valve or a valve repair) who have a medium-to-high risk of having a stroke. Dabigatran is only approved for use in patients with non-valvular atrial fibrillation. People who are taking warfarin for other reasons, for example, they do not have atrial fibrillation but have had a clot in their leg veins or lung, or have a mechanical heart valve, cannot be considered for treatment with dabigatran and will need to continue on warfarin. For patients with non-valvular atrial fibrillation, is it worth changing from warfarin? Warfarin has been prescribed for more than 60 years so there is plenty of experience of its clinical use. The clinical trial showed that when warfarin is used well, it is as effective as dabigatran, and if anticoagulant control is good (as measured by blood tests), warfarin seems to perform better overall. For patients whose condition is well controlled on warfarin, it is probably not advisable to change. For patients who have poor anticoagulant control, a switch to dabigatran might be considered. Is it better for patients who are newly diagnosed with non-valvular atrial fibrillation to start taking dabigatran rather than warfarin? Many people do well on warfarin and it may be prescribed after considering individual bleeding risk and stroke risk factors. Dabigatran might be considered if subsequent problems with anticoagulant control develop; for example, if it is difficult to get the full benefits of warfarin therapy, a patient has an allergy to warfarin, or has intolerable side effects from warfarin. Does dabigatran cause less bleeding than warfarin? As both dabigatran and warfarin affect blood clotting, patients may still experience side effects such as bruising and bleeding. Intracranial bleeding (bleeding into the brain) is worrying because it is usually very serious. In the clinical trial, dabigatran caused less intracranial bleeding than warfarin. Gastrointestinal (stomach and bowel) bleeding is also a concern as it varies widely in terms of severity and is more common. In the clinical trial, dabigatran caused more gastrointestinal symptoms than warfarin (eg, indigestion, stomach ache) and more seriously, gastrointestinal bleeding, particularly in people over 75 years of age. If a patient is older than 75 or has an increased risk of bleeding, dabigatran could be prescribed at a reduced dose or may not be prescribed at all. 4

5 If a patient has excessive bleeding, can the anticoagulant effect of dabigatran be reversed? There is no licensed product currently available to reverse bleeding with dabigatran. However, if urgent treatment is required, dabigatran will be discontinued and supportive measures will be started. It is easier to manage major bleeding in patients on warfarin. Are regular blood tests needed to monitor dabigatran levels? There is no need for regular blood tests to measure the level of anticoagulant control with dabigatran. However, a blood test is needed to measure how well the kidneys are working before starting treatment and then at least once a year while on dabigatran treatment. Will dabigatran interact with other medicines, food or alcohol? Dabigatran 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 so patients should inform their prescriber of the names of all medicines they are taking (including prescription and overthe-counter medicines, vitamins and herbal supplements). Should patients stop taking dabigatran if they are going to have a dental or medical procedure? Patients should not stop taking dabigatran without first talking to their doctor or dentist. Dabigatran may need to be stopped for one or more days before any planned surgery, dental or medical procedure. 5

6 Appendix 1: Membership of the FAQ subgroup of the expert advisory group Name Title NHS board area/ organisation Mary Ballantyne Chair Angus Cardiac Group Moray Baylis Robert Bell Helen Cadden David Clark Susan Downie Project Officer Public Partner Public Partner Chief Executive Medical Writer Chest, Heart & Stroke Hirek Kwiatkowski Patient Representative NHS Forth Valley Stella Macpherson Karen McGeary Stephen McGlynn Lorna McTernan Public Partner Communication and Publications Co-ordinator Specialist Principal Pharmacist (Cardiology) Health Information Manager Chest, Heart & Stroke Isobel Miller Patient Representative Joyce Mouriki David Murdoch Joy Nicholson Emma Riches Senior Public Partnership Officer Consultant Physician and Cardiologist Consultant Pharmacist Medical Writer 6

7 Appendix 2: Membership of the expert advisory group* Name Title NHS board area/ organisation Julia Anderson Consultant Haematologist 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 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 Marjory Neill Cardiology Pharmacist Joy Nicholson David Northridge (Chair to October 2011) Consultant Pharmacist Consultant Cardiologist *In addition a further network of eight General Practitioners was consulted for the FAQs. 7