EU first approved NOAC Xarelto

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EU approved the very first NOAC (or novel oral anticoagulant) Xarelto (rivaroxaban) for broad application. With Bayer and Janssen at the helm, Xarelto can now be broadly used for patients suffering from atrial fibrillation (AF). AF patients experience tumultuous blood flow, a condition that may lead to the development of blood clots in the heart. To prevent this, the patients receive anticoagulants routinely. Specifically, Xarelto can be used for procedures that aim at restoring the heart’s normal beat rhythm.

An exploratory X-VeRT trial was conducted and yielded favourable results. Over 1,500 patients suffering from AF participated in the trial. One inclusion requirement is the patient should be undergoing cardioversion procedure. Cardioversion refers to the application of electric current, wheedling the heart into its normal rhythm. Nevertheless, one weakness of the trial is the relatively small number of participants, affecting the statistical significance of the trial.
With Xarelto, it was shown that an AF patient could undergo the procedure compared with VKAs (Vitamin K anticoagulants). An example of VKA is warfarin. Apart from this, the treatment using Xarelto is simplified because of two things. First, it is only given once every day and second, a routine monitoring to check the status of anticoagulation (or simply INR check) is no longer required.

During the 2-month X-VeRT trial, the participants were divided into two distinct groups. The first group received the procedure 1 to 5 days earlier compared to the second group. Within the eight-week enrolment, the second group received the treatment after 3 weeks. It was discovered that the patients receiving Xarelto can be possibly cardioverted earlier compared to those who are receiving VKA. A probable reason is the inherent difficulties to achieve reliable coagulation in the second group.

Further, about 77% of the Xarelto-treated patients and only around 36.3% of the VKA treated patients were able to be cardioverted within the eight weeks target time frame. The study also discovered that this drug is an effective, safe and well-tolerated warfarin alternative. According to Riccardo Cappato, the lead investigator hailing from the University of Milan, optimal coagulation is not achieved among patients treated with warfarin due to some reasons. This leads to postponing the procedure and thereby, further increasing the risk of thromboembolic events such as stroke.
Ultimately, the use of rivaroxaban was associated with an overall trend towards the minimized incidences of cardiovascular events such as myocardial infarction, stroke, peripheral embolism, transient ischemic attack and even death. True enough, without implementing the use of anticoagulants, patients undergoing cardioversion procedure are exposed to higher risk of complications like stroke and other cardiovascular illnesses.

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With the approval of the European Medicines Agency (EMA), the Committee for Medicinal Products for Human (CHMP) backed the new labelling for Xarelto to include this information. In this way, the cardiologists who wish to use this on his or her patients are guided despite the lack of pre-specification regarding the time to cardioversion. Trials and real-world data programming are continuous.

Finally, the update in rivaroxaban’s label will eventually boost its current share within the NOAC market. It is presently competing with equally known brands such as Pradaxa (dabigatran) from Boehringer Ingelheim, Eliquis (apixaban) by Pfizer/Bristol-Myers Squibb and Savaysa (edoxaban) by Daiichi Sankyo. Of the three, Savaysa is the newest NOAC in the market; it was recently approved for use and distribution in the United States.

REFERENCES

1. ClinicalTrials.gov “Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion”.www.clinicaltrials.gov NCT01674647.
2. Farag M, Gorog DA. Future Cardiol. “Rivaroxaban in atrial fibrillation cardioversion: insights from the X-VeRT trial.” 2015 Mar;11(2):147-51. doi: 10.2217/fca.15.4.
3. European Medicines Agency “Xarelto – Rivaroxaban” http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000944/human_med_001155.jsp