The safety evaluation of dabigatran etexilate in senile patients with non-valvular atrial fibrillation

YAO Lu; ZHANG Wei; TIAN Guo-xiang; XIA Chang-quan; WU Yun-tao; WANG Xiao-bing; LI Juan

doi:10.3969/j.issn.1674-4055.2016.05.10

Abstract：Objective Observe the safety of dabigatran etexilate in senile patients with non-valvular atrial fibrillation. Methods 32 patients (aged≥80) with non-valvular atrial fibrillation (never taking oral antithrombotic drug) from the department or outpatient service during November 2013 to October 2014 were enrolled. All of patients received dabigatran etexilate 55mg, orally twice a day. After two weeks, if patients do not appear gastrointestinal discomfort and bleeding, the dose of dabigatran etexilate would be adjusted to 110 mg twice a day. After 1 months, 3 months, 6 months and 12 months, D-dimer, hemoglobin, liver and kidney function were observed. Any adverse events such as embolization, bleeding, death and gastrointestinal symptoms were recorded during follow-up. Results Compared with the pretreatment, the D- dimer had a tendency to decrease after treatment. The reduction of D-dimer in the 12 months of treatment was statistically significant (P<0.05). There was no significant difference in hemoglobin, liver and kidney function after treatment (P>0.05). After taking dabigatran etexilate, 7 patients had indigestion, one patients appeared mild headache, one patient had ecchymosis, and there was no obvious hemorrhage, gastrointestinal bleeding, intracranial hemorrhage, myocardial infarction, liver and kidney damage, embolism or other adverse incidents. Conclusion Senile patients with non valvular atrial fibrillation patients with dabigatran etexilate 110 mg twice a day with good security, but the sample size is relatively small. In the future, we need to further increase the sample size and the observation time.