Hearty development

Source:Global Times Published: 2014-9-10 22:23:01

Novel oral anticoagulants seen as a better way to treat blood clots


Bayer Healthcare's booth at the European Society of Cardiology congress in Barcelona, Spain on August 30 Photo: GT



At the European Society of Cardiology (ESC) congress this year in Barcelona, Spain, top experts in the field shared the latest advances in curing cardiovascular diseases, with some of the research having featured active participation from Chinese experts.

The ESC congress, held from August 30 to September 3, is a top academic meeting in the cardiovascular field. This year's congress received 11,444 research abstracts from 100 countries and regions, and most submitted abstracts were on topics such as arrhythmias, ischaemia and interventions. China was among the largest non-European delegations, according to a congress factsheet.

Among all the latest research, the use of novel oral anticoagulants, which is a class of drugs to prevent blood clotting, has definitely been one of the highlights of this year's congress, as novel oral anticoagulants could provide greater convenience to patients compared with traditional treatment.

New drugs needed

Vitamin K Antagonists (VKAs), such as Warfarin, have been the standard prevention and treatment for blood clotting, including deep vein thrombosis and pulmonary embolism, for decades. But novel oral anticoagulants, such as Bayer Healthcare's Xarelto, have emerged as an effective substitute for the older treatment.

At the ESC congress this year, the use of novel oral anticoagulants to prevent strokes for atrial fibrillation (AF) patients, a type of arrhythmia, was hotly discussed.

AF is one of the most common heart problems. It can increase the risk of a stroke by up to 500 percent, experts said, as AF patients are more prone to developing blood clots that could possibly travel to the brain and eventually cause strokes.

About one-third of AF patients may incur stokes, Lin Jiunn-Lee from National Taiwan University College of Medicine said at a press event during the ESC congress.

When patients receive the traditional treatment of VKAs, they need to be closely monitored by specialized blood tests. The drug also interacts with many other drugs as well as patients' diet.

Novel oral anticoagulants, however, can provide effective prevention and treatment against blood clots and at the same time remove these limitations. They have rapid onset of action, no significant food and drug interactions, as well as predictable anticoagulation, experts noted.

In the case of Bayer Healthcare's Xarelto, taking the drug once daily has been proven to be sufficient to reduce the risk of strokes for AF patients.

During the ESC congress, a research finding showed that oral anticoagulant therapy with rivaroxaban, which is the chemical name of Xarelto, is a safe and effective alternative to VKAs for non-valvular AF patients who are undergoing cardioversion treatment to restore a normal heart rhythm.

The research, led by Riccardo Cappato, a cardiologist and chief of the Arrhythmia and Electrophysiology Department of the Policlinico San Donato in Milan, Italy, saw the participation of 1,504 patients from 16 countries and regions worldwide.

The trial found that a daily dose of oral rivaroxaban is an effective substitute for traditional VKA treatment like Warfarin. Also, rivaroxaban has a rapid onset of action of 2 to 4 hours, compared with at least three weeks with VKAs.

Besides, rivaroxaban not only could effectively prevent strokes for AF patients, it also reduces the possibility of more deadly bleeding, such as intracranial bleeding, which has been a major side effect of VKAs, according to the research finding.

China's participation

The research saw active participation from China, led by Ma Changsheng, director of the Department of Cardiology at Beijing Anzhen Hospital.

With an increasingly aging population in China, AF has become an alarming threat in the nation. The country's AF patients are estimated at over 8 million at present, and due to a limited knowledge of heart problems as well as limited medical care services, a large amount of AF patients are untreated, according to recent media reports.

Though the use of VKAs in China is still lower than that in developed economies, awareness among Chinese AF patients about preventing strokes is on the rise. Ma noted that the use of Warfarin has seen rapid growth in China in the past few years.

Experts noted that it would take time before novel oral anticoagulants could play a bigger role in treating Chinese patients, due to factors such as regulations.

"The good news is now we have effective new drugs [novel oral anticoagulants], but without wide coverage of medical insurance, Warfarin will still play a very important role in China," Ma noted.

The cost of novel oral anticoagulants is much higher than that of Warfarin, experts noted. In addition, the slower drug approval process in China is one factor that slows down the development of novel oral anticoagulants in China.

But there is an urgent need to promote the use of novel oral anticoagulants in China, especially as Asian patients using Warfarin face greater risks of bleeding, said Lin.

"I think in two or three years, it is likely that the medical insurance will start to cover novel oral anticoagulants, especially in first-tier cities like Beijing and Shanghai, where there is a big need for the latest drugs," Ma noted.

Latest developments

Xarelto has already been approved for five indications in seven areas of usage including the prevention of stroke and systemic embolism in adult patients with non-valvular AF, and the treatment of deep vein thrombosis and pulmonary embolism in adults.

In China, the drug is only approved for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip/knee replacement. Now, the firm is also applying to expand Xarelto's indications in China.

Ahead of the ESC congress, Bayer Healthcare and its research partner Janssen Research & Development announced in Barcelona it would expand the clinical development program of Xarelto. Three new studies of the drug were launched to explore the possibility of the drug for treating other diseases, such as embolic stroke of undetermined source.

The studies will include more than 275,000 patients in both clinical trials and real-world settings, Bayer said.

Sales of Xarelto, which competes with drugs like Eliquis developed by Bristol-Myers Squibb and Pfizer, hit $1.7 billion in the 12 months to June 2014, and analysts estimate annual sales could rise to more than $9.5 billion by 2020, with new indications explored, Reuters reported on August 29.

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