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‘Bleeding risk lowest in Eliquis among NOACs for AF patients’
  • By Nam Doo-hyun
  • Published 2018.07.02 16:47
  • Updated 2018.07.02 16:47
  • comments 0

Eliquis (ingredient: apixaban) by Bristol-Myers Squibb Korea and Korea Pfizer had the lowest bleeding risk among non-vitamin K antagonist oral anticoagulants (NOAC) for Korean patients with artrial fibrillation (AF), government data showed.

0The National Evidence-based Healthcare Collaborating Agency (NECA) on Monday released real-world data analysis on NOACs in comparison to warfarin in 56,000 local AF patients. The agency analyzed data from the National Health Insurance Service (NHIS).

The analysis showed that NOCAs had 25 percent lower death risk, 28 percent lower stroke and systemic embolism risk, and 30 percent lower risk of myocardial infarction, compared to warfarin.

All of the three kinds of NOACs – apixaban, dabigatran, and rivaroxaban -- showed better results in preventing thromboembolism and reducing mortality, compared to warfarin.

The risk of bleeding (severe hemorrhage including cerebral hemorrhage and gastrointestinal bleeding), a safety indicator, was the lowest in Eliquis among NOACs.

Compared to warfarin, apixaban had a 33 percent lower bleeding risk, and dabigatran (Boehringer Ingelheim Korea’s Pradaxa), a 19 percent lower risk. Rivaroxaban (Bayer Korea’s Xarelto) did not show a statistically meaningful difference in bleeding risk.

NOACs were more effective and safer than warfarin, in low dose, too.

The latest data is likely to boost the ever-growing domestic NOAC market, which expanded to 28.8 billion won ($25.7 million) in the first quarter this year from 21.7 billion won a year earlier.

However, NOACs had more bleeding risks in new agents than conventional agents in patients with the acute coronary syndrome.

NECA divided the acute coronary syndrome patients into three groups – one with P2Y12 inhibitor-containing conventional agent clopidogrel (Sanofi-Aventis Korea’s Plavix approved in 2007), another with a new ingredient ticagrelor (AstraZeneca Korea’s Brilinta approved in 2016), and the other with a new agent prasugrel (Daiichi Sankyo Korea’s Effient approved in 2010).

As a result, the ticagrelor group and the prasugrel group had no statistical difference in the risk of significant heart disease events (cardiac death, myocardial infarction, or stroke) compared to the clopidogrel group. However, the ticagrelor group had 18 percent lower risk of death than the clopidogrel group.

The bleeding risk was 30 percent and 19 percent higher in the ticagrelor group and the prasugrel group than in the clopidogrel group.

Researchers assumed that the study had methodological limitations as a retrospective cohort study. Nevertheless, the latest study results on the Korean cohort, previously confirmed in a trial on Westerners, will be useful in clinical practice, they said.

“The study has a great significance that it informed the medical community that physicians should properly choose drugs when they increasingly use NOACs and new antiplatelet agents, according to the nature and risk of patients,” said Park Duk-woo, a professor at cardiology department of Asan Medical Center, who led the study. “It can be used as an important reference for future clinical guidelines for using anticoagulants for Koreans.”

Yoon Ji-eun, the co-leader researcher at the NECA, said the research suggested that safety and efficacy on a drug should be continuously studied even after the entry into the pharmaceutical market.

hwz@docdocdoc.co.kr

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