GERRARDS CROSS, England, July 10, 2015 /PRNewswire/ --
Launch comes as new patients' survey reveals a significant proportion still not receiving adequate treatment for atrial fibrillation, the commonest heart rhythm disorder
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.
The new drug launched today is called Lixiana▼ (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.
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.
Around two-thirds (68%) of patients experienced symptoms before their first consultation with a doctor, although 32% did not.
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.
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.
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.
After diagnosis, 70.5% of patients were put on some type of blood-thinning medication.
Half of patients (50%) said they were not told different medications were available to reduce the risk from an AF-related stroke.
Asked about current medication, around one in seven patients (14.7%) were taking aspirin 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.
More than half of patients (56.5%) were taking warfarin and around one in six (16.3%) one of the NOAC therapies.
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.
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."
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."
A third patient said "I hate it. It leaves me exhausted with no energy and disrupts my life."
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."
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."
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."
Notes to Editors
Resources for the media
To assist the media, UK-specific backgrounders are available on AF, VTE and edoxaban. See further information details to obtain these.
The AF patient survey
The patient survey was carried out by Opinion Health between 27 May and 5 June 2015. It was commissioned by Daiichi Sankyo UK.
Non-valvular atrial fibrillation (AF) is a condition where the heart beats irregularly meaning blood can pool and thicken in the chambers of the heart, causing a risk of clots which then go on to cause strokes.
In June 2014 the National Institute for Health and Care Excellence (NICE) published a revised guideline on the management of AF, updating its advice from its original guideline of 2006.
The revised guideline said some 835,000 people in England alone have AF. In addition there may be another 250,000 people who are undiagnosed, according to a NICE press release issued to accompany the guideline.
NICE put the prevalence of AF in England at 2% - one in 50 of the population.
Venous thromboembolism (VTE) is a condition in which a blood clot (a thrombus) forms in a vein, most commonly in the deep veins of the legs or pelvis. This is known as deep vein thrombosis, or DVT.
The thrombus can dislodge and travel in the blood (an embolus), particularly to the pulmonary (lung) arteries. This is known as pulmonary embolism, or PE. The term VTE includes both DVT and PE.
Venous thromboembolic diseases cover a spectrum ranging from asymptomatic calf vein thrombosis to symptomatic DVT. They can be fatal if they lead to PE, in which the blood supply to the lungs is blocked by the thrombus. Non-fatal VTE can cause serious long-term conditions such as post-thrombotic syndrome.
The National Institute for Health and Care Excellence (NICE) issued a report in May 2013 looking at the commissioning of anticoagulation services in England, including for VTE.
This said there were around 83,500 new cases of VTE each year in England. This equates to one in 500 of the population (200 per 100,000 of the population).
In addition to new annual cases, there was another group of patients needing long-term treatment. This number was around 42,000.
Therefore, said NICE, the annual number of patients receiving VTE treatment in England stands at some 125,500.
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.
Edoxaban demonstrated non-inferiority for stroke or systemic embolic events. Edoxaban was also found to be superior for the principal safety endpoint of major bleeding in comparison to warfarin.
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.
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).
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).
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
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, dyslipidemia and bacterial infections used by patients around the world, the Group has also launched treatments for thrombotic disorders and is building new product franchises. Furthermore, Daiichi Sankyo research and development is focused on bringing forth novel therapies in oncology and cardiovascular-metabolic diseases, including biologics. The Daiichi Sankyo Group has created a "Hybrid Business Model," to respond to market and customer diversity and optimize growth opportunities across the value chain. For more information, please visit: http://www.daiichisankyo.com.
This press release contains forward-looking statements and information about future developments in the sector, and the legal and business conditions of DAIICHI SANKYO Co., Ltd. Such forward-looking statements are uncertain and are subject at all times to the risks of change, particularly to the usual risks faced by a global pharmaceutical company, including the impact of the prices for products and raw materials, medication safety, changes in exchange rates, government regulations, employee relations, taxes, political instability and terrorism as well as the results of independent demands and governmental inquiries that affect the affairs of the company. All forward-looking statements contained in this release hold true as of the date of publication. They do not represent any guarantee of future performance. Actual events and developments could differ materially from the forward-looking statements that are explicitly expressed or implied in these statements. DAIICHI SANKYO Co., Ltd. assume no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.
- Market Research: Atrial Fibrillation Patient Research - carried out online by Opinion Health May/June 2015.
- Lip G et al. Atrial fibrillation and stroke prevention. Lancet Neurology 2007; 6(11): 981-993.
- NICE. Atrial fibrillation: the management of atrial fibrillation. Clinical guideline 180. Published 18 June 2014.
- NICE Patient Decision Aid. Atrial fibrillation: medicines to help reduce your risk of stroke - what are the options? Published 18 June 2014.
- NICE. Thousands of strokes in people with common heart rhythm disorder are avoidable, says NICE. Press release issued 18 June 2014.
- NICE. Venous thromboembolic diseases: the management of venous thromboembolic diseases and the role of thrombophilia testing. NICE clinical guideline 144. Issued June 2012.
- NICE. Support for commissioning anticoagulant therapy. Commissioning guide 49. Published 14 May 2013.
- Giugliano R et al. Edoxaban versus warfarin in patients with atrial fibrillation. New England Journal of Medicine 2013; 369(22): 2093-2104.
- Büller H et al. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. New England Journal of Medicine 2013; 369(15): 1406-1415.
For further UK information contact:
Daiichi Sankyo UK Ltd.
SOURCE Daiichi Sankyo UK Ltd