Novel oral anticoagulant use doubles in Europe

Use of novel oral anticoagulants (NOACs) is rising dramatically in Europe as their benefits over older drugs such as warfarin become increasingly recognised, but there are big differences in take-up between EU countries.

Data from the PREFER registry study, which provides a snapshot of clinical practice across five European countries, reveals that 12.6% of patients with atrial fibrillation (AF) received a NOAC, up from 6.1% a year ago, while use of warfarin and other vitamin K antagonists (VKAs) fell from 66% to around 62%.

The three NOACs on the EU market – Boehringer Ingelheim’s thrombin inhibitor Pradaxa (dabigatran) and Factor Xa inhibitors Xarelto (rivaroxaban) from Bayer and Pfizer/Bristol-Myers Squibb’s Eliquis (apixaban) – have practical advantages over VKAs because they do not require complex dose titration and monitoring and have fewer interactions with food and other medicines.

In trials, the NOACs have been shown to be at least as effective as warfarin in reducing complications such as stroke, and also seem to equivalent in terms of safety. That said, warfarin remains a legitimate therapy for some patients and is the only option for certain patients, such as those with advanced kidney disease or with mechanical heart valves.

The data suggest patients are being switch to NOACs from VKAs, and also that the Factor Xa antagonist are showing the greatest increase, with use rising from around 2% to 6%, while Pradaxa rose from 4% to 6.5% over the year.

Factors encouraging patients to switch from VKAs to NOACs included mobility problems, likely reflecting the increase visits required with the older drugs, as well as complaints about dose adjustments and discomfort such as bruising or pain, according to study, which is sponsored by Daiichi Sankyo.

Daiichi Sankyo’s interest in the field is centred on a Factor Xa antagonist called Lixiana (edoxaban). The drug is already on the market in Japan, and is currently under regulatory review in Europe and the US.

Overall, the rising use in NOACs in Europe is encouraging, according to Cardiologist Raffaele De Caterina of D’Annunzio University in Italy. It suggests more healthcare professionals are applying guidelines – drawn up by the European Society of Cardiology (ESC) in 2012 – that call for widespread use of anticoagulant therapy in non-valvular AF patients and recommend NOACs as being broadly preferable to VKAs.

The one-year results from PREFER in AF “come at a pivotal time for AF management in Europe” she said, adding that NOACs “have the potential to offer patients an improved quality of life” compared to VKAs.

However, a sizeable minority of patients – almost 20% across the five countries (Austria, France, Germany, Italy, Spain, Switzerland, and the UK) – are still not being treated with any form of oral anticoagulant therapy.

Meanwhile, a new portion of the PREFER registry study focusing on venous thromboembolism (VTE), such as pulmonary embolism or deep vein thrombosis (DVT), reveals a variations within Europe in the use of NOAC therapy.

The data – presented for the first time at the ESC congress in Barcelona this week – showed that NOACs are used in roughly one in five VTE patients on average, with usage greater in younger patients, less high-risk patients.

However, there appears to be something of a north to south divide. In Germany, Switzerland and Austria the drugs were used in almost 47% of patients, compared to just 8% in Spain and 3% in Italy.

The difference could be reflected in part by the fact that the NOACs have only recently been introduced in Spain and Italy, and vascular physician Alexander Cohen of Guys and St Thomas’ Hospitals and King’s College London – who co-chaired the PREFER study – believes more insight will come as the registry matures.

“The ability to assess current management of VTE in practice and monitor its development over a 12 month period will help establish whether current treatment developments are translating into optimal management in practice,” he said.

 
Image courtesy of Shutterstock / Gajus

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