Novel oral anticoagulants require improved safety data to challenge warfarin


More real-world safety data, especially in patients with a high risk of cardiovascular disease, could potentially address the issue of under-dosing and under-treatment with novel oral anticoagulants (NOACs) in global practice, says an analyst with research and consulting firm GlobalData.

According to Lakshmi Dharmarajan, GlobalData’s senior analyst covering cardiovascular and metabolic disorders, while the underutilisation of NOACs is a commonly acknowledged issue due to the approved lower doses of these drugs in the USA, this could change with the launch of new NOAC antidotes in the near future.

Agents in development include Boehringer Ingelheim’s soon-to-be marketed idarucizumab, which would reverse the action of their NOAC, Pradaxa (dabigatran), and Portola Pharmaceutical’s andexanet alfa, which would be effective against the other NOACs.

Dharmarajan explains: “It is clear from the discussion at this year’s European Society of Cardiology Congress that most physicians are reluctant to take responsibility for possible complications, such as gastrointestinal bleeding, that may arise from using higher doses of NOACs. As a result, there is a tendency among healthcare providers to resort to using warfarin for high-risk patients, even though it does not perform very well in these cases.”

The analyst adds that discussions in national and international conference sessions would aid in building a consensus regarding the optimal dose of NOACs, as well as increasing physicians’ confidence in the use of these drugs.

Dharmarajan continues: “Smaller observational studies and registry data should be exploited to obtain clinical evidence regarding the detrimental effects of lower doses of NOACs, which could be used to convince the US Food and Drug Administration regulators to re-think its stance on the currently approved doses.”

“NOAC manufacturers need to come together to implement strategies in order to gain universal acceptance of these drugs in the cardiovascular disease treatment market and to displace warfarin as the standard of care,” the analyst concludes.