Intended for healthcare professionals

Feature Investigation

Rivaroxaban: can we trust the evidence?

BMJ 2016; 352 doi: https://doi.org/10.1136/bmj.i575 (Published 03 February 2016) Cite this as: BMJ 2016;352:i575

Dieu merci! Quelqu'un a utilisé leurs petites cellules grises ....

Dear Editors

I would like to say if Hercule Poirot ever existed he would have exclaimed: "Thank God! Someone has been using their little grey cells...."

May I congratulate Deborah Cohen and the BMJ investigative team on their time, effort, perseverance and bravery in reviewing the safety profile of Rivaroxaban. BMJ too has been instrumental last year in promoting awareness about the issue in analyses withheld by the makers of dabigatran involving the frequency of bleeding.

While there are many physicians have been heavily promoting the role of anticoagulation in non-vulvular atrial fibrillation, often NOAC (Novel Oral Anti-Coagulants) are also either openly or subtly touted as the panacea with safety profile similar or superior to warfarin, but the "bonus" of not requiring regular monitoring. In the same period there too has been a growing number of clinicians who reported concerns regarding the safety profile of these drugs in the real world, particularly with regard to what is considered "non-major" haemorrhagic events and the lack of immediate antidotes.

News with concerns about published trials involving NOACs reminds clinicians that much of the basis of what we know about the role and efficacy of oral anticoagulation upon many conditions is based on studies involving warfarin and so far (as I understand) many published NOACs studies are non-inferiority efficacy trials compared to warfarin, without the necessary power to assess their safety profile like those specifically performed by the manufacturers. NOACs thus should not be promoted as the first line drugs without further reanalysis of their safety profile.

I note with curiosity that NEJM has published a correspondence from the researchers of ROCKET-AF on the same day as this investigative feature in BMJ, and yet there is no apparent news so far about the letter submitted to NEJM for publication by Thomas Marcinicak. Keeping in mind the allegations surrounding the conduct of the editorial process involved in various controversial publications regarding the efficacy of knee arthroscopy and unpublished letters from editors of an orthopaedic journal ("thus, we are shocked when the debate is stifled." Ref 1) not so long ago, I shall look forward to see in what circumstances the Marcinicak letter is published (if at all, due to the lack of space) and (hopefully) the tirade of letters of opposing views.

Again I am reminded of the quote: Freedom is the oxygen without which science cannot breathe. (David Sanorff)

Reference

1. Could the New England Journal of medicine Be Biased Against Arthroscopic Knee Surgery? http://dx.doi.org/10.1016/j.arthro.2014.02.013

Competing interests: I have previously voiced concerns regarding safety profile of the NOACs

04 February 2016
Shyan Goh
Orthopaedic Surgeon
Sydney, Australia