The Ministry of Food and Drug Safety said Friday it has revised dosage recommendations for Bayer’s oral anticoagulant (NOAC) Xarelto for use in combination with a P2Y12 inhibitor.
Xarelto (ingredient: rivaroxaban) is a blood-thinning drug used to treat nonvalvular atrial fibrillation (NVAF) patients who received percutaneous coronary intervention (PCI). PCI is a non-surgical widening of the coronary artery using a balloon catheter to treat coronary heart disease. A metallic stent is usually placed in the artery after dilatation.
General guidelines have suggested these patients undergo a three-combo therapy composed of VKA and double antiplatelet therapy (DAPT). However, there has been a continuing need for safer and more effective treatment since the combo therapy carries a high risk of bleeding (4 to 12 percent) within one year, Bayer Korea said.
The ministry now recommends NVAF patients who underwent PCI to take 15 mg Xarelto daily in combination with a P2Y12 inhibitor to reduce the risk of stroke and systemic embolism, Bayer Korea said. The recommendation comes as a first for these patients to lessen the possibility of stroke, the company said.
The ministry’s changes were based on the PIONEER AF-PCI study, which was the first randomized, multicenter trial of the NOAC in NVAF patients who underwent stent-based PCI. The results showed a Xarelto plus a single antiplatelet agent reduced the risk of bleeding by 41 percent compared to a VKA and DAPT combination over 12 months.
The results of the study were published in the American Heart Association conference in 2016 and the New England Journal of Medicine. The subscale data also showed that the Xarelto arm had a lower rate of recurrent hospitalization due to adverse events, including death, according to the company.
Atrial fibrillation is a disease that affected about 33.5 million people worldwide as of 2010 with 20 to 40 percent of patients having coronary artery disease as a comorbid condition. Around 5 to 15 patients received PCI with stents, the company said.