Argatroban 50mg/50ml solution for infusion vials

Acute ischemic stroke (AIS) is a major cause of disability and mortality worldwide. While antiplatelet therapy is standard for secondary prevention, many patients still experience early neurological deterioration (END). Argatroban, a direct thrombin inhibitor, can potentially limit thrombus progression and improve AIS's functional outcomes. This meta-analysis assessed the efficacy and safety of argatroban in combination with single (SAPT) or dual antiplatelet therapy (DAPT) compared to antiplatelets alone. Following PRISMA guidelines, a systematic search of PubMed, Scopus, and Web of Science was conducted until January 2025. Randomized controlled trials (RCTs) and cohort studies evaluating argatroban plus antiplatelets versus antiplatelets alone in AIS patients were included. The primary outcome was a 90-day modified Rankin Score (mRS) of 0-2. Secondary outcomes included mRS 0-1 and mRS 3-5 at 90 days, END, and National Institutes of Health Stroke Scale (NIHSS) improvement, stroke recurrence, intracranial hemorrhage (ICH), symptomatic intracranial hemorrhage (sICH), and mortality. We used the mean difference (MD) for continuous variables and odds ratio (OR) for dichotomous ones at 95% confidence intervals (CI) and a P-value of 0.05. A total of 14 studies (four RCTs and 10 cohort studies) were included. Compared to antiplatelets alone, argatroban significantly improved functional outcomes, increasing the incidence of mRS 0-2 (OR = 1.36 [95%CI: 1.05, 1.76, P = 0.02]) and mRS 0-1 (OR = 1.54 [95%CI: 1.08, 2.2, P = 0.02]) while reducing END (OR = 0.42 [95%CI: 0.21, 0.85, P = 0.02]). Argatroban was also associated with greater NIHSS score improvement (MD =  - 0.52 [95%CI: - 0.89, - 0.15, P = 0.005]). No significant differences were observed in mRS 3-5, stroke recurrence, ICH, sICH, or mortality. Subgroup analysis indicated that argatroban combined with DAPT showed the greatest benefits. Argatroban combined with antiplatelet therapy improves functional recovery and reduces END without increasing bleeding risks. These findings support its use, particularly with DAPT, in mild to moderate AIS management. Further large-scale RCTs are needed to optimize dosing strategies and patient selection.

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BackgroundHeparin-induced thrombocytopenia (HIT) is a severe immune adverse drug reaction that requires stopping heparin and starting other types of anticoagulation. The comparative effectiveness of intravenous anticoagulants remains uncertain.AimTo systematically compare the efficacy and safety of fondaparinux with that of argatroban and bivalirudin in patients who have been suspected or confirmed to have had HIT.MethodsA systematic review of the literature has been conducted according to the PRISMA 2020 guidelines. Electronic databases were searched until January 2025. Randomized controlled trials (RCTs) and observational studies comparing the parenteral anticoagulant in patients with HIT were included. Study quality was assessed by two independent reviewers, based on the Cochrane Risk of Bias tool for RCTs and the Newcastle-Ottawa Scale for observational studies. Evidence certainty was conducted using the GRADE method.ResultsThe 2867 patients with HIT were identified in 16 of the studies that comprised this review (1 RCT, 15 RCTs). Limited head-to-head evidence was available from the single RCT. Across the studies, thrombotic events occurred at rates of 5%-15% and major bleeding at rates of 5%-15%. Research has shown differences in anticoagulation efficiency, with methodological differences being significant. Fondaparinux's safety characteristics were found favorable in retrospective reviews, whereas argatroban and bivalirudin displayed similar efficacy characteristics. The evidence certainty was classified as low to very low due to study design limitations and inconsistencies among key outcomes.ConclusionThis systematic review identified significant gap in the comparative evidence to manage HIT using parenteral anticoagulants. Based on one RCT study and 15 observational studies (n = 2867), no single anticoagulant agent was definitively superior, and the certainty level of all outcomes was low to very low. Observational evidence and its methodological heterogeneity do not allow for ranking the treatment in an evidence-based treatment. Well-designed RCT are needed to guide in selecting the best anticoagulant to use in patients with HIT.

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BackgroundEarly neurological deterioration (END) is a serious complication of acute ischemic stroke and may occur spontaneously or after reperfusion therapy.ObjectiveTo compare the efficacy and safety of different interventions for acute ischemic stroke patients with END using network meta-analysis.MethodsRandomized controlled trials were identified through systematic searches of major databases up to February 2026. The primary outcome was the 90-day modified Rankin Scale score. Secondary outcomes included neurological improvement (assessed by NIHSS), intracranial hemorrhage, and mortality.ResultsFive randomized controlled trials including 1,164 patients were analyzed. Compared with standard antiplatelet therapy (ST; which included aspirin monotherapy, placebo plus aspirin, or dual antiplatelet therapy depending on the study protocol), indobufen combined with ST, and tirofiban combined with ST, significantly improved 90-day functional outcome, whereas argatroban combined with standard treatment reduced mean mRS scores but did not significantly increase the proportion of patients achieving favorable functional outcomes (mRS 0-2) or excellent functional outcomes (mRS 0-1). Indobufen demonstrated the highest probability of being the optimal treatment for reducing the mean 90-day mRS score and improving 90-day NIHSS scores based on SUCRA rankings. Indobufen and tirofiban (each added to ST) also significantly improved neurological recovery at short- and long-term follow-up. However, argatroban and tirofiban did not significantly increase the proportion of patients achieving favorable functional outcomes. None of the interventions increased the risk of intracranial or symptomatic hemorrhage.ConclusionsIndobufen was associated with lower mean 90-day mRS and NIHSS scores, whereas tirofiban added to standard antiplatelet therapy increased the proportion of patients achieving a favorable functional outcome defined as mRS 0-2. Neither tirofiban nor argatroban significantly increased the proportion achieving an excellent functional outcome defined as mRS 0-1. These findings should be interpreted cautiously because of the limited number and size of the included trials.

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