Prescrire international
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Prescrire international · Nov 2016
Reviewidarucizumab (PRAXBIND°). Don't rely too heavily on this dabigatran antidote.
Dabigatran, an oral anticoagulant that acts by inhibiting thrombin, was first marketed in the European Union in 2008. No antidote has been available, complicating the management of patients who have severe bleeding or require emergency surgery. In late 2015, idarucizumab, a monoclonal antibody directed against dabigatran, was authorised in the European Union as a specific antidote for dabigatran. ⋯ The clinical effects of idarucizumab are poorly documented. Authorisation of this antidote should not lead to trivialising the use of dabigatran. In 2016, warfarin, a vitamin K antagonist, is the standard oral anticoagulant for most patients, despite its inconvenience.
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To help healthcare professionals and patients choose high-quality treatments that minimize the risk of adverse effects, in early 2016 we updated our list of drugs to avoid. Prescrire's assessments of the harm-benefit balance of new drugs and indications are based on a rigorous procedure that includes a systematic and reproducible literature search, identification of patient-relevant outcomes, prioritisation of the supporting data based on the strength of evidence, comparison with standard treatments, and an analysis of both known and potential adverse effects. This 2016 review of medications examined by Prescrire over a six-year period, from 2010 to 2015, identified 74 drugs that are more harmful than beneficial in all the indications for which they have been authorised in France. ⋯ Even in serious situations, when no effective treatment exists, there is no justification for prescribing a drug with no proven efficacy that provokes severe adverse effects. It may be acceptable to test these drugs in clinical trials, but patients must be informed of the uncertainty over their harm-benefit balance, and the trial design must be relevant. Tailored supportive care is the best option when there are no available treatments capable of improving prognosis or quality of life, beyond the placebo effect.
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Prescrire international · Apr 2016
ReviewIbrutinib (Imbruvica). Relapsed chronic lymphocytic leukaemia and mantle cell lymphoma: uncertain impact on survival.
codynamic interactions are also likely in view of its adverse effect profile. There is no consensus on the treatment of patients with refractory or relapsed mantle cell lymphoma, or for patients with relapsed or possibly refractory chronic lymphocytic leukaemia. Ibrutinib inhibits an enzyme involved in regulating B lymphocyte activity. ⋯ The main adverse effects of ibrutinib were: gastrointestinal disorders such as diarrhoea; life-threatening infections and bleeding disorders; and cardiac disorders, including atrial fibrillation. Ibrutinib carries a risk of multiple pharmacokinetic interactions. Pharmacodynamic interactions are also likely in view of its adverse effect profile.