A new blood-thinning drug therapy to help prevent stroke in patients with the heart rhythm condition called non-valvular atrial fibrillation (NVAF) is launched today, extending the ability of doctors to tailor the right therapy to individual patients, say experts.

A survey of AF patients, also released today, shows a significant proportion of patients are still not receiving appropriate therapy to protect them against AF-related stroke. The survey also revealed that patients sometimes experience extreme emotional distress living with the condition.1

The new drug launched today is called Lixianaq (edoxaban). It is one of the class of blood-thinning drugs known as Novel Oral Anti-Coagulants (NOACs).

NOACs are used in NVAF as an option to warfarin to reduce the risk of blood clots. The cardiac irregularity caused by AF means clots are more likely to form in the heart, which can then travel to the brain. Patients with AF are five times more likely to suffer a stroke than those without the condition.2

Edoxaban, made by the pharmaceutical company Daiichi Sankyo, will also be used to protect patients from a recurrence if they have suffered from blood clots in the limbs and lungs, known as venous thromboembolism. This term covers both deep vein thrombosis and the potentially fatal pulmonary embolism.

Professor Gregory Lip, from the University of Birmingham, who has carried out studies on edoxaban for NVAF, welcomed an addition to the therapy armoury.

"A few years ago, all we had to prevent strokes in AF patients was warfarin, which imposes many lifestyle restrictions on patients and needs monitoring with a blood test system known as INR. Now we are spoilt for choice with modern blood-thinning drugs that do not need INR monitoring and are easy for patients to live with."

Professor Lip added: "The interesting design of the edoxaban trial helps us to tailor treatment to individual patient characteristics."

Dr Alexander Cohen, Consultant Vascular Physician from Guy's and St Thomas' Hospitals, Kings College London, who has researched edoxaban for venous thromboembolism (VTE), also welcomed an additional resource to tackle the condition.

"Venous thromboembolism has a high rate of recurrence, which can be fatal. We need more tools to protect patients from a second incident and edoxaban will be of great use to help tailor treatments to specific patients."

The new survey into the lives of people with AF looked at 200 patients, 41.5% male and 58.5% female, from across the UK, ranging in age from 36 to 84. The mean age at time of diagnosis was 59.1

Around two-thirds (68%) of patients experienced symptoms before their first consultation with a doctor, although 32% did not.1

Despite having symptoms the average delay before seeking medical help was two years. However, one in seven patients with symptoms (14%) waited five years or longer before seeing a doctor.1

The main reasons for delaying was that patients did not know their symptoms were related to AF or they did not think they were serious enough. Symptoms included irregular heartbeat, breathlessness and dizziness.1

At diagnosis around half the patients did not understand what AF was, and a similar proportion failed to realise the link between a heart condition and a possible stroke.1

After diagnosis, 70.5% of patients were put on some type of blood-thinning medication.1

Half of patients (50%) said they were not told different medications were available to reduce the risk from an AF-related stroke.1

Asked about current medication, around one in seven patients (14.7%) were taking aspirin1 although the survey data does not allow a distinction between those solely taking aspirin and those on aspirin also taking other medications.

Guidelines from the National Institute for Health and Care Excellence (NICE) said in June 2014 that aspirin should not be used on its own in AF patients for stroke prevention, as it did not work but did increase bleeding risks.3

More than half of patients (56.5%) were taking warfarin and around one in six (16.3%) one of the NOAC therapies.1

Around six out of ten patients (57%) said AF had significantly worsened their lives, with the impact on emotional well-being being highlighted as the greatest adverse effect.1

Asked to describe the impact of living with AF one patient said: "I am always concerned about the possibility of a stroke. I am always fearful of an irregular heartbeat."1

Another said: "I am confused and scared. I thought a heart condition was something you get when you are older. I feel continuously at risk and afraid of another episode."1

A third patient said "I hate it. It leaves me exhausted with no energy and disrupts my life."1

Another said: "I would like to get my life back, eat what I would like, swim, keep fit and run. I just want to be normal again."1

One said bleakly: "It's like a ticking time-bomb. I just wait around for it to do its worst, which I am sure it will do one day."1

Commenting on the findings Trudie Lobban MBE, Founder and CEO of the Atrial Fibrillation Association, said: "The survey results reinforce many of the things we have known for years. Despite AF being a growing problem in the UK, due to an ageing population, many of the public have no idea what it is.

"It is very worrying that patients with symptoms wait two years on average before seeking medical help. All that time they are exposed to a much higher risk of stroke due to suffering with AF, a major cause of stroke. The public needs to understand that symptoms such as breathlessness, dizziness and heart palpitations need to be checked at once by a doctor.

"A simple pulse check will identify if your heart rhythm is irregular and monitoring this and sharing with your doctor will help to identify and lead to a quicker diagnosis. We should all Know Your Pulse - this is now mandatory as part of the annual health checks provided by the NHS."

Mrs Lobban added: "Obviously the survey result reflects standards of care in the past, but it is of concern that some patients are still taking aspirin when NICE specifically said more than a year ago that this should not be used on its own for AF-related stroke prevention.

"It is also worrying that half of patients do not remember being given a choice of medication. NICE last year stressed that patient preference should play a key part in deciding on a therapy."

Professor Lip said the results showed the often unacknowledged psychological burden of the condition.

"The ticking time-bomb fears of many patients can ruin their lives. Newer treatments that can help people live normal lives, without constantly reminding them of the condition, have important psychological as well as physical benefits."

About Edoxaban

Edoxaban is an oral, once-daily, direct factor Xa (pronounced "Ten A") inhibitor. Factor Xa is one of the key components responsible for blood clotting, so inhibiting this makes the blood thin.

Large scale Phase 3 clinical trials were carried out for stroke prevention in non-valvular atrial fibrillation (NVAF) as well as for the treatment of venous thromboembolism (VTE) and prevention of recurrent VTE.

The ENGAGE AF-TIMI 48 global Phase 3 study investigated once-daily edoxaban in comparison to warfarin in 21,105 patients with non-valvular atrial fibrillation (NVAF). This represented the largest and longest trial with a novel anticoagulant in patients with atrial fibrillation performed to date, with a median follow-up of 2.8 years.4

Edoxaban demonstrated non-inferiority for stroke or systemic embolic events.4 Edoxaban was also found to be superior for the principal safety endpoint of major bleeding in comparison to warfarin.4

The global Phase 3 Hokusai-VTE study investigated 8,292 patients with either acute symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE), or both. This represented the largest single VTE study carried out to date with a NOAC in this indication.5

The study found that edoxaban met the primary efficacy endpoint of non-inferiority compared to warfarin, following initial use of heparin in both arms, for the treatment and prevention of recurrent symptomatic venous thromboembolism (VTE).5

Once-daily edoxaban also demonstrated superiority compared to warfarin for the principal safety outcome of clinically relevant bleeding (the composite of major or clinically relevant non-major bleeding).9

Appropriate use of Edoxaban

Haemorrhage is a common adverse effect of all anticoagulants.

  • Special care should be taken when deciding to prescribe edoxaban to patients with other conditions, procedures, and concomitant treatments, which may increase the risk of major bleeding.
  • As such, a detailed prescriber guide has been made available to HCPs to ensure correct use of the drug
  • In addition, every pack contains a patient alert card which can help alert treating HCPs in the case of routine or emergency interventions

The prescriber guide and a full list of contraindications, warnings and information on posology can be found in the edoxaban summary of product characteristics at https://www.medicines.org.uk/emc/medicine/30506