Systematic evaluation on the safety of dabigatran for anticoagulant therapy
10.13699/j.cnki.1001-6821.2015.24.030
- VernacularTitle:达比加群酯抗凝治疗安全性的系统评价
- Author:
Xiu-Bo SUN
1
;
Yuan TIE
;
Qing CHEN
;
Yi-Chen HE
;
Lei LIU
Author Information
1. 北京医院药学部
- Keywords:
dabigatran etexilate;
comparator;
safety;
systematic review
- From:
The Chinese Journal of Clinical Pharmacology
2015;(24):2465-2467,2470
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the safety of dabigatran etexilate in the anticoagulant therapy.Methods The randomized controlled trials about dabigatran etexilate in the treatment of all kinds of embolism disea-ses, which had been published from the time of library foundation to June, 2015 were collected from PubMed, ClinicalTrials.gov, CNKI data-base according to the following criterias.An the same time results of studies were analyzed through using Stata 13.1 software and Rev Man 5.3 software.Results Sixteen randomized controlled trials were includ-ed, involving 42395 patients.Meta -analysis showed that dabigatran etexilate could significantly reduce the incidence of major bleeding com-paring with comparators ( P<0.05 ) , especially compared with warfarin ( P<0.01 ) .However the incidence of major bleeding with dabigatran etexilate was similar to comparators when the dosage was increased. Moreover dabigatran etexilate could significantly increase the risk of myo-cardial infarction ( P <0.01 ) , especially compared with warfarin (P<0.01).while the incidence of myocardial infarction with dabigatran etexilate was increased with the increase of the dosage.In addition dabig-atran etexilate could significantly increase the incidence of gastrointestinal bleeding ( P <0.01 ) , especially compared with warfarin and placebo ( P<0.05) , which was dose-dependent.There was no publication bias in funnel plots and sensitivity analysis indicated the results were reliable. Conclusion The use of dabigatran etexilate was associated with a significant increase in the risk of myocardial infarc-tion and gastrointestinal bleeding.Therefore, clinicians need to take these risks into account in treatment.
