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Comment & Response
May 2017

Dabigatran Compared With Rivaroxaban vs Warfarin—Reply

Author Affiliations
  • 1University of California, San Francisco, San Francisco, California
JAMA Intern Med. 2017;177(5):744. doi:10.1001/jamainternmed.2017.0571

In Reply With the growth in the popularity of novel oral anticoagulants (NOACs), vigilance on the part of physician-researchers, regulators, and consumers is warranted. The points made by Vora and colleagues in their response to Graham et al1 and our accompanying Editor’s Note2 are astute contributions to ensure the safe and appropriate use of these drugs. While we agree with their call for caution in over-interpreting results, we would also highlight the importance of postapproval observational data. First, we reiterate that randomized clinical trials comparing NOACs are not forthcoming due to lack of incentives for drug manufacturers. Moreover, Vora and colleagues rightly point out that observational studies provide information about real-world rates of bleeding and thromboembolism that may not be accurately represented in an exclusive clinical trial population.3 Thus, in our current therapeutic marketplace, robust comparative effectiveness data can complement randomized clinical trials as important tools for monitoring of efficacy and safety.4 While we cannot comment on whether the US Food and Drug Administration should apply this information to their approval process. We support rigorous observational studies—studying large numbers of diverse patients and using robust statistical methods—which, taken as a whole, can provide guidance to physicians and patients on these issues of great clinical significance.

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