Health Secretary Jeremy Hunt has published strategy documents on tackling premature mortality and cardiovascular disease (CVD).

The DH strategy on premature mortality calls for improvements in the prevention, diagnosis and treatment of cancer, heart disease, stroke, respiratory disorders and liver disease.

The CVD strategy emphasises treating CVD as a single family of diseases with integrated NHS treatment, and making wider use of NHS Health Checks.

Hunt pointed to a current report in the Lancet, according to which the level of premature deaths in the UK has fallen in the last decade but remains higher than in most of Europe.

He claimed that the measures outlined in the two strategy documents could save 30,000 lives by 2020.

Key actions outlined in the CVD strategy include:

• Providing integrated and co-ordinated care by treating CVD as a single family of diseases, and ending the pattern of ‘silo consulting’.

• Using NHS Health Checks to improve the prevention and management of CVD with targeted advice and support.

• Ending the postcode variation in treatment of CVD.

• Better detection and management of CVD risk factors such as atrial fibrillation.

Peter Hollins, Chief Executive of the British Heart Foundation, commented: “We welcome the Outcomes Strategy. It has all the ingredients to tackle the threat posed by cardiovascular diseases, which remain the major public health challenge of our time. We are particularly pleased to see the emphasis on an integrated approach to patients with multiple conditions.”

The strategy document on avoiding premature mortality argued that over half of premature deaths (under the age of 75) could be prevented through more effective public health.

It highlighted the need to address the increasing prevalence of multiple morbidities, where individuals suffer from two or more major conditions.

Alongside action on risk factors and lifestyles, the strategy called on the NHS Commissioning Board to facilitate early diagnosis and “access to the right treatment”, with consistency of outcomes between hospitals.

The document did not explain how, with hospitals that meet clinical targets but overspend facing closure, the emphasis on treatment quality would be funded.

NICE has recommended the use of Eliquis (apixaban) as a treatment option for the NHS for the prevention of stroke and systemic embolism in some people with non-valvular atrial fibrillation (AF) in final guidance.

The recommendation came after NICE’s Appraisal Committee concluded Eliquis was more clinical effective than warfarin in reducing stroke and systemic embolism.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said that patients would benefit using the convenient treatment “because it doesn’t require such regular monitoring and dose adjustments.”

Eliquis, which only received its license for this indication in November 2012, is an orally administered anticoagulant that helps prevent the blood from clotting.

AF is the most common irregular heart beat. People with the condition are at a higher risk of developing blood clots and subsequent stroke. Existing therapies, such as warfarin, substantially reduces the risk of stroke.

“Many people with the condition find it difficult to comply with the most commonly used antithrombotic, warfarin, because, among other things, its use requires regular monitoring of the blood’s clotting properties and dose adjustments which can cause disruption and inconvenience,” said Professor Longson.

“From the evidence submitted, the Committee concluded that Eliquis was more clinically effective than warfarin for the primary efficacy outcome of reducing stroke and systemic embolism. The Committee also noted that treatment with Eliquis resulted in fewer bleeding events than warfarin, including a reduced rate of intracranial bleeding. The Committee recognised that intracranial bleeding has a high mortality rate and a large impact on a person’s quality of life, and is the most feared bleeding outcome for people taking any type of anticoagulant.”

The Scottish Medicines Consortium (SMC) has accepted Eliquis (apixaban) for prevention of strokes in patients with atrial fibrillation (AF).

The drug, produced by Pfizer and Bristol-Myers Squibb (BMS), has also been provisionally recommended by NICE.

Its use in Scotland with AF patients over 40 is predicted to prevent nearly 1,000 strokes and over 300 deaths per year.

Following its EMA approval in November 2012, the SMC has accepted Eliquis for prevention of strokes in patients with non-valvular AF who have one or more risk factors (e.g. hypertension, diabetes).

Based on recent clinical trials, the SMC said Eliquis was superior to warfarin in preventing strokes and was associated with fewer major bleeds.

It also requires no monitoring and dosage adjustment, thus reducing the cost of treatment and avoiding the risks associated with poor monitoring.

AF affects over 60,000 people in Scotland over the age of 40. It causes a fivefold increase in stroke risk, resulting in 7% of all strokes. Strokes due to AF are more severe, and more likely to recur, than strokes with other causes.

Difficulties in setting the dosage of warfarin, the standard anticoagulant, mean that fewer than half of Scottish AF patients at high risk of stroke are receiving it.

Dr Derek Connelly, Consultant Cardiologist at the Royal Infirmary, Glasgow, said: “The SMC acceptance of apixaban is an important step forward for patients with atrial fibrillation in Scotland. The availability of a new treatment option that does not require [clotting time] monitoring may help decrease the impact atrial fibrillation has on the quality of life of patients, their families and carers.”

According to Amadou Diarra, BMS General Manager, UK and Ireland, the risk of stroke in patients with non-valvular AF is “a serious public health concern” that Eliquis can help to address.

NICE has provisionally recommended Eliquis in the same indication, with final guidance expected shortly.

The alliance between BMS and Pfizer to develop drugs against cardiovascular disease began in 2007.

The Atrial Fibrillation Association has welcomed NICE’s recommendation in final draft guidance of Eliquis (apixaban) for the prevention of stroke and systemic embolism in certain people with non-valvular atrial fibrillation.

NICE’s independent Appraisal Committee concluded the convenient drug was more clinically effective than warfarin and resulted in fewer bleeding events.

Trudie Lobban MBE, founder and CEO of the charity Atrial Fibrillation Association, said NICE’s decision is “excellent news for patients” with AF in England and Wales.

Eliquis’ recommendation follows the recent recommendations by the Institute of Xarelto (rivaroxaban) and Pradaxa (dabigatran etexilate) for the same indication.

“Having the choice of effective new treatments which do not require INR monitoring can help reduce the impact that atrial fibrillation has on patients, their families and carers,” said Trudie Lobban.

Final draft guidance states that Eliquis can be considered a treatment option on the NHS in accordance with its licensed indications if informed discussions about the risks and benefits of the drug compared with warfarin, Xarelto and Pradaxa are conducted.

Eliquis, which only received its license for the indication in November 2012, is co-marketed by Bristol-Myers Squibb and Pfizer.

Amadou Diarra, Vice-President, BMS UK and Ireland, said the “fast-tracked recommendation” by NICE highlights the value of the drug as a cost-effective treatment. “We look forward to working with the NHS and other partners to ensure that, where clinically appropriate, patients are provided with rapid access to apixaban, which has been shown to prevent strokes, reduce bleeds and be potentially life-saving compared to the current standard of care, warfarin.”

A new drug for stroke prevention that offers a safer and more effective alternative to warfarin has been launched in the UK.

Eliquis (apixaban) from BMS and Pfizer is available for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) and one or more risk factors such as diabetes or advanced age.

Whereas patients treated with warfarin risk serious side-effects and need frequent dosage adjustment, Eliquis is taken (in tablet form) in one of two approved doses.

AF affects 1.2 million people and causes 12,500 strokes every year in the UK.

Clinical trials have shown that Eliquis is more effective than warfarin in preventing strokes and causes less bleeding, as well as presenting less challenge in terms of monitoring.

The ARISTOTLE trial evaluated apixaban versus warfarin in 18,201 patients with non-valvular AF who were suitable for warfarin. Professor John McMurray of the Institute of Cardiovascular & Medical Sciences, University of Glasgow, said that in the study “apixaban has demonstrated superiority in the reduction of stroke and systemic embolism over warfarin together with a significant reduction in major bleeding.”

In addition, he noted, “apixaban was better tolerated than warfarin, with fewer people stopping treatment.”

Trudie Lobban, CEO of the Atrial Fibrillation Association, added: “Patients being treated with warfarin have to undergo regular blood tests. Having the choice of effective new treatments which do not require monitoring provides the option to tailor therapy to the individual patient.

“This could also help to reduce the burden on the NHS to monitor INR and the associated impact on patients, their families and carers.”

BMS developed Eliquis, and since 2007 has worked in partnership with Pfizer to promote and sell the drug.

A new drug for stroke prevention that offers a safer and more effective alternative to warfarin has been launched in the UK.

Eliquis (apixaban) from Bristol-Myers Squibb (BMS) and Pfizer is available for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) and one or more risk factors such as diabetes or advanced age.

Whereas patients treated with warfarin risk serious side-effects and need frequent dosage adjustment, Eliquis is taken (in tablet form) in one of two approved doses.

AF affects 1.2 million people and causes 12,500 strokes every year in the UK.

Clinical trials have shown that Eliquis is more effective than warfarin in preventing strokes and causes less bleeding, as well as presenting less challenge in terms of monitoring.

The ARISTOTLE trial evaluated apixaban versus warfarin in 18,201 patients with non-valvular AF who were suitable for warfarin. Professor John McMurray of the Institute of Cardiovascular & Medical Sciences, University of Glasgow, said that in the study “apixaban has demonstrated superiority in the reduction of stroke and systemic embolism over warfarin together with a significant reduction in major bleeding.”

In addition, he noted, “apixaban was better tolerated than warfarin, with fewer people stopping treatment.”

Trudie Lobban, CEO of the Atrial Fibrillation Association, added: “Patients being treated with warfarin have to undergo regular blood tests. Having the choice of effective new treatments which do not require monitoring provides the option to tailor therapy to the individual patient.

“This could also help to reduce the burden on the NHS to monitor INR and the associated impact on patients, their families and carers.”

BMS developed Eliquis, and since 2007 has worked in partnership with Pfizer to promote and sell the drug.

The European Medicines Agency (EMA) has requested a label update to provide clearer guidance on the safe use of the anticoagulant Pradaxa (dabigatran).

The review has confirmed the drug’s positive benefit-risk balance as a stroke prevention treatment for certain patients, but stated the need for clearer notes on the medicine’s risks and what to do in case of bleeding.

The Boehringer Ingelheim drug is recommended for patients with non-valvular atrial fibrillation or following hip or knee replacement.

Because all blood-thinning drugs can cause bleeding, the EMA has maintained close post-market surveillance of this product.

The EMA’s scientific advisory committee, the CHMP, found that the incidence of fatal bleedings with Pradaxa in post-marketing data was significantly lower than in the clinical trials that led to the drug’s authorisation in 2008.

In November 2011, a safety review concluded that the drug should be used with caution, and at lower doses, with patients who were elderly or had moderate renal impairment.

Pradaxa “remains an important alternative to other blood-thinning agents,” the EMA said.

However, the guidance for doctors and patients should be strengthened to include details of the risks, when the drug must not be used, and how to manage patients if bleeding occurs.

In particular, patients taking Pradaxa should seek urgent medical attention of they fall or suffer any injury.

The European Commission is expected to confirm this opinion.

NICE has recommended Xarelto (rivaroxaban) in final guidance as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation (AF).

The recommendation means patients will get access to the first single tablet, once-daily, oral stroke prevention medicine since the introduction of warfarin in the 1950s

Luis-Felipe Graterol, Medical Director, Bayer HealthCare UK, said the company is “delighted” with NICE’s decision and will now work with local NHS fundraisers to “help evolve services” with Xarelto.

Up to 700,000 people in England and Wales have AF. People with the condition are at a higher risk of developing blood clots and subsequent stroke.

Xarelto is an orally administered drug that helped prevent blood from clotting and has a UK marketing authorisation for the prevention of stroke and system embolism in those with non-valvular AF who have associated risks.

The guidance adds that the decision to swap treatment from warfarin to Xarelto should be discussed between the clinician and patient to highlight any reported risks and benefits.

“We know that some people taking warfarin can find it difficult to maintain their blood clotting at a proper level,” said Professor Carole Longson, NICE Health Technology Evaluation Centre Director. 

“Rivaroxaban, like dabigatran etexilate, which NICE recently approved as an option for this indication, can benefit people with AF. We are therefore pleased to recommend rivaroxaban as another cost-effective option for the prevention of stroke and systemic embolism in people with atrial fibrillation.”

NICE recommended Boehringer Ingelheim’s Pradaxa as a treatment option in final guidance for the same indication back in March.

Boehringer Ingelheim’s anticoagulant Pradaxa (dabigatran etexilate) has been shown by a phase III clinical trial to be safer than warfarin, the standard stroke prevention drug.

The global 18,000-patient RE-LY trial showed significantly lower rates of fatal and traumatic intracranial haemorrhage (ICH) in patients treated with Pradaxa rather than with well-controlled warfarin.

The new findings suggest that Pradaxa may offer an alternative to warfarin in patients with atrial fibrillation (AF), easing the burden of dosage adjustment.

AF is experienced by one in four adults over the age of 40, and is a major risk factor for strokes. Anticoagulation therapy is widely used as a preventative measure – but ICF is a widespread side-effect, causing disability and death.

Warfarin (first introduced in 1948 as a rodent poison) is the standard treatment for prevention of strokes. However, very careful dosage adjustment is needed to minimise the risk of ICF.

The RE-LY trial evaluated 154 intracranial haemorrhages that occurred in 153 patients during the trial period, comparing the effects of Pradaxa and well-controlled warfarin:

• Pradaxa 110mg and 150mg doses were associated with significantly fewer fatal ICH events (11 and 13 respectively vs. 32) than warfarin.

• Pradaxa was associated with significantly fewer traumatic ICH events (11 vs. 24) than warfarin.

• The rate of ICH with Pradaxa was similar to the rate in patients receiving antiplatelet therapy.

Dr Stuart Connolly, Director of the Division of Cardiology at McMaster University, Hamilton, Ontario, said: “In our hospital, we see patients frequently presenting with intracranial haemorrhage as a result of warfarin and unfortunately, this complication is associated with a high mortality rate.

“These data show us that not only is Pradaxa associated with lower rates of intracranial haemorrhage overall, but that fatal and traumatic intracranial bleeding is also reduced, highlighting the favourable safety profile of Pradaxa.”

Bayer HealthCare’s Xarelto (rivaroxaban) has been recommended in final draft guidance as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation (AF).

NICE revised its original decision not to recommend the convenient pill after Bayer supplied requested additional evidence on the clinical and cost effectiveness of the medication.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said she was “pleased” additional information had been supplied enabling NICE to recommend the treatment.

It is estimated there are currently up to 700,000 people with AF in England and Wales. People with the condition are at a higher risk of developing blood clots and subsequent stroke.

However, the risk of stroke can be reduced by the appropriate use of antithrombotic therapy. Xarelto is the first in a class of drugs known as Factor Xa inhibitors, which act at a critical point in the blood-clotting process to prevent clots forming.

It has a UK marketing authorisation for the prevention of stroke and systemic embolism in patients with non-valvular AF who have one or more risk factors and has been demonstrated in a clinical study to be non-inferior to warfarin, the current standard of care.

Professor John Camm, Professor of Clinical Cardiology at St George’s University of London, welcomed its recommendation. He said: “This news could be particularly important for patients who require long-term or lifelong anticoagulation (for non-valvular AF) who may be seeking a simplified regimen.”

Final guidance is now expected as early as next month.

NICE recently published final guidance recommending the use of Pradaxa (dabigatran) – which recently had its UK price reduced by Boehringer Ingelheim – for the same indication.