Adverse Reactions of Argatroban in the Treatment of Ischemic Stroke Leading to Gastrointestinal Bleeding

doi:10.19803/j.1672-8629.20240435

Abstract

Abstract: Objective To investigate the adverse reactions of argatroban in the treatment of acute ischemic stroke (AIS) leading to gastrointestinal bleeding and the results of pharmacist interventions. Methods Clinical pharmacists provided pharmaceutical care for patients with gastrointestinal bleeding who had used argatroban for AIS treatment between 2020 and 2023. The causes of bleeding, courses of treatment, and outcomes of adverse drug reaction (ADR) were analyzed. CNKI, Wanfang, VIP and PubMed were searched for related literature on treatment of AIS with argatroban before the safety of this drug was analyzed. Results There were a total of 196 patients with AIS and transient ischemic attack (TIA) who had used argatroban injections. Gastrointestinal bleeding caused by argatroban was observed in 15 cases (an incidence rate 7.65 %). Thirteen patients were only positive for occult blood, which had no significant effect on the primary disease, and two patients had active bleeding that prolonged hospitalization. After pharmacist interventions, such as drug withdrawal and the use of proton pump inhibitors (PPIs), the conditions were improved, and the progression of the primary disease was not obviously affected. Seven articles about the safety of argatroban therapy for AIS were retrieved, with a total of 1070 patients enrolled. Six articles showed that one patient had gastrointestinal bleeding in the argatroban group (an incidence rate 0.45%) while 3 had gastrointestinal bleeding in the control group (an incidence rate 1.36%). One article categorized gastrointestinal bleeding as other bleeding events, and the data showed no increase in the rate of other bleeding events. Conclusion The treatment of AIS with argatroban may cause gastrointestinal bleeding that is usually minimal, with a good prognosis, and has little effect on AIS treatment. Previous studies have also suggested that argatroban does not increase the risk of gastrointestinal bleeding in patients.

Key words: Acute Ischemic Stroke, Agatroban, Injection, Gastrointestinal Bleeding, Thrombin Inhibitor, Proton Pump Inhibitor, Safety, Adverse Drug Reactions

CLC Number:

R972
R994.11

ZHAO Qiuyue, WEI Hongtao, LI Dandan, YAN An, DI Xuan. Adverse Reactions of Argatroban in the Treatment of Ischemic Stroke Leading to Gastrointestinal Bleeding[J]. Chinese Journal of Pharmacovigilance, 2025, 22(1): 88-92.

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https://zgywjj.magtechjournal.com/EN/Y2025/V22/I1/88

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