PURPOSE: Insomnia is an important adverse event of mechanical thromboprophylaxis. This sleep disorder has been reported as one of the commonest adverse events of the new oral anti-Xa anticoagulant darexaban, with similar rates to mechanical thromboprophylaxis in a randomized controlled trial (RCT). However, the perceived effect could have been biased because it was an open-label RCT. Therefore, we aimed to review the incidence of insomnia with non-vitamin K antagonist oral anticoagulants (NOACs). METHODS: We performed a systematic review and meta-analysis of Phase III RCTs. Electronic databases MEDLINE and CENTRAL (inception to September 2013) were searched as well as review articles and references of included studies. We included phase III RCTs which compared NOACs with any other control group. Data were analyzed and pooled to estimate risk ratio (RR) with 95% confidence intervals (95%CI) for insomnia using inverse variance method. Statistical heterogeneity was evaluated with I(2) test. RESULTS: We included seven studies (two apixaban RCTs, two dabigatran RCTs, one darexaban RCTs, and two rivaroxaban RCTs), enrolling a total of 23,023 patients. Overall, NOACs were not associated to an increased risk of insomnia: RR 0.94 (95%CI 0.83-1.08; I(2) = 0%). In blinded studies (six studies), NOACs also did not show increased risk of insomnia (RR 0.94, 95%CI 0.83-1.08; I(2) = 0%). Results were similar irrespective of the comparators. CONCLUSIONS: NOACs (apixaban, dabigatran, darexaban, rivaroxaban) did not show increased risk of insomnia. Results according to study design (blinded vs. open-label trials) overlap the main analysis.
PURPOSE:Insomnia is an important adverse event of mechanical thromboprophylaxis. This sleep disorder has been reported as one of the commonest adverse events of the new oral anti-Xa anticoagulant darexaban, with similar rates to mechanical thromboprophylaxis in a randomized controlled trial (RCT). However, the perceived effect could have been biased because it was an open-label RCT. Therefore, we aimed to review the incidence of insomnia with non-vitamin K antagonist oral anticoagulants (NOACs). METHODS: We performed a systematic review and meta-analysis of Phase III RCTs. Electronic databases MEDLINE and CENTRAL (inception to September 2013) were searched as well as review articles and references of included studies. We included phase III RCTs which compared NOACs with any other control group. Data were analyzed and pooled to estimate risk ratio (RR) with 95% confidence intervals (95%CI) for insomnia using inverse variance method. Statistical heterogeneity was evaluated with I(2) test. RESULTS: We included seven studies (two apixaban RCTs, two dabigatran RCTs, one darexaban RCTs, and two rivaroxaban RCTs), enrolling a total of 23,023 patients. Overall, NOACs were not associated to an increased risk of insomnia: RR 0.94 (95%CI 0.83-1.08; I(2) = 0%). In blinded studies (six studies), NOACs also did not show increased risk of insomnia (RR 0.94, 95%CI 0.83-1.08; I(2) = 0%). Results were similar irrespective of the comparators. CONCLUSIONS:NOACs (apixaban, dabigatran, darexaban, rivaroxaban) did not show increased risk of insomnia. Results according to study design (blinded vs. open-label trials) overlap the main analysis.
Authors: Lesley Wood; Matthias Egger; Lise Lotte Gluud; Kenneth F Schulz; Peter Jüni; Douglas G Altman; Christian Gluud; Richard M Martin; Anthony J G Wood; Jonathan A C Sterne Journal: BMJ Date: 2008-03-03
Authors: Bengt I Eriksson; Ola E Dahl; Michael H Huo; Andreas A Kurth; Stefan Hantel; Karin Hermansson; Janet M Schnee; Richard J Friedman Journal: Thromb Haemost Date: 2011-01-12 Impact factor: 5.249
Authors: John H Alexander; Renato D Lopes; Stefan James; Rakhi Kilaru; Yaohua He; Puneet Mohan; Deepak L Bhatt; Shaun Goodman; Freek W Verheugt; Marcus Flather; Kurt Huber; Danny Liaw; Steen E Husted; Jose Lopez-Sendon; Raffaele De Caterina; Petr Jansky; Harald Darius; Dragos Vinereanu; Jan H Cornel; Frank Cools; Dan Atar; Jose Luis Leiva-Pons; Matyas Keltai; Hisao Ogawa; Prem Pais; Alexander Parkhomenko; Witold Ruzyllo; Rafael Diaz; Harvey White; Mikhail Ruda; Margarida Geraldes; Jack Lawrence; Robert A Harrington; Lars Wallentin Journal: N Engl J Med Date: 2011-07-24 Impact factor: 91.245
Authors: Alessandro Liberati; Douglas G Altman; Jennifer Tetzlaff; Cynthia Mulrow; Peter C Gøtzsche; John P A Ioannidis; Mike Clarke; P J Devereaux; Jos Kleijnen; David Moher Journal: BMJ Date: 2009-07-21
Authors: Michael Rud Lassen; Gary E Raskob; Alexander Gallus; Graham Pineo; Dalei Chen; Ronald J Portman Journal: N Engl J Med Date: 2009-08-06 Impact factor: 91.245