Risk of insomnia with non-vitamin K oral anticoagulants: systematic review and meta-analysis
| Autor: | Márcio Barra, Joaquim J. Ferreira, Daniel Caldeira, João Costa, Daisy Abreu, Ana T. Santos |
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| Rok vydání: | 2015 |
| Předmět: |
medicine.medical_specialty
Vitamin K medicine.drug_class Administration Oral law.invention chemistry.chemical_compound Randomized controlled trial law Sleep Initiation and Maintenance Disorders Internal medicine medicine Insomnia Humans Adverse effect Randomized Controlled Trials as Topic Sleep disorder business.industry Darexaban Anticoagulant Anticoagulants Thrombosis Azepines medicine.disease Clinical trial Clinical Trials Phase III as Topic Otorhinolaryngology chemistry Meta-analysis Benzamides Physical therapy Neurology (clinical) medicine.symptom business |
| Zdroj: | Sleep and Breathing. 19:1043-1049 |
| ISSN: | 1522-1709 1520-9512 |
| DOI: | 10.1007/s11325-014-1112-8 |
| Popis: | 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).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.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.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. |
| Databáze: | OpenAIRE |
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