Research Roundup

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Debbie Rigby takes a look at the latest research news

Manufacturer failed to disclose faulty device in rivaroxaban trial

An investigation by The BMJ finds that companies were aware of concerns about a faulty device in a regulatory trial and reveals data that suggests participants were put at unnecessary risk. Janssen, the pharmaceutical arm of Johnson and Johnson, withheld data from the Food and Drug Administration about problems with the INRatio device, which was used in the phase III trial (ROCKET AF) of the blockbuster anticoagulant.

BMJ 2016;354:i5131


BMJ Commentary



The possible risks of proton pump inhibitors

Use of PPIs may be associated with an increased risk of certain GI and non-GI conditions, although most studies associated with these risks are observational or retrospective. Whilst these associations may be statistically significant, they are less likely to be clinically relevant. Nevertheless the authors of this article support judicious use with a clear indication and regular review. No routine monitoring is recommended other than periodic measurement of serum magnesium in long-term use.

Med J Aust 2016

MJA InSight


Selective serotonin reuptake inhibitors and breast cancer mortality in women receiving tamoxifen

A population-based cohort study has shown an increased risk of death from breast cancer in patients taking tamoxifen and paroxetine, a potent CYP2D6 inhibitor. Absolute increases of 25%, 50%, and 75% in the proportion of time on tamoxifen with overlapping use of paroxetine were associated with 24%, 54%, and 91% increases in the risk of death from breast cancer. This interaction is significant as up to 25% of patients with breast cancer experience a depressive disorder. No such risk was seen with other antidepressants.

BMJ 2010;340:c693


Risk of mortality with concomitant use of tamoxifen and selective serotonin reuptake inhibitors

In contrast, a multi-database cohort study of 14 532 women who were new users of tamoxifen shown no association between risk of death among patients taking potent CYP2D6 inhibiting SSRIs versus other SSRIs. The authors concluded that SSRI inhibition of CYP2D6 does not seem to reduce the effectiveness of tamoxifen.

BMJ 2016;354:i5014


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