a new option for stroke emergency medicine! fast-acting and effective in improving the function of chinese patients, comparable to standard drugs
2024-09-20
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▎edited by wuxi apptec content team
globally, stroke (commonly known as "stroke") is one of the leading causes of disability and death, and acute ischemic stroke (ais) accounts for about 80% of all stroke types.the guidelines recommend alteplase as the standard treatment for eligible ais patients within 4.5 hours of onset.the dosage is10% of the drug is initially administered as an intravenous push within 1 minute, and the remaining 90% is administered as a continuous drip over 1 hour.tenecteplase is a modified tissue-type plasminogen activator that is easy to administer (allowing for a single intravenous push and rapid administration) and has the characteristics of high fibrin specificity and a long half-life.previous study results support the use of tenecteplase as a treatment option for eligible ais patients. however, the evidence on the efficacy of tenecteplase in chinese ais patients remains limited.recently,JAMApublished byprofessor wang yongjun's team from beijing tiantan hospital, capital medical universitythe results of the phase 3 original study led bythe results showed that for chinese ais patients who were eligible for intravenous thrombolysis, tenecteplase was non-inferior to alteplase within 4.5 hours after onset of symptoms and had similar safety. the results of this study support that tenecteplase can be used as a suitable alternative to alteplase in the intravenous thrombolytic treatment of chinese ais patients.original is a multicenter, active-controlled, parallel-group, randomized, open-label, blinded endpoint, non-inferiority phase 3 study conducted from july 2021 to july 2023, covering 55 medical centers in china.the inclusion criteria for patients were: age ≥18, clinical diagnosis of ais, national institutes of health stroke scale (nihss) score of 1-25 (higher scores represent greater stroke severity), evaluable neurological deficits, symptoms persisting for at least 30 minutes without significant improvement, and the ability to receive thrombolytic therapy within 4.5 hours of symptom onset.a total of 1489 patients were randomly assigned in a 1:1 ratio to receive either tenecteplase (n=744) or alteplase (n=745), either at a single intravenous bolus of tenecteplase 0.25 mg/kg (maximum dose 25 mg) over 5 to 10 seconds or at a single intravenous bolus of alteplase 0.9 mg/kg (maximum dose 90 mg) within 4.5 hours of the onset of ischemic stroke symptoms.the study excluded patients who had not received treatment or who had received treatment before randomization, and a total of 1,465 patients were included in the full analysis set, including 732 in the tenecteplase group and 733 in the alteplase group. the median age of the enrolled patients was 66 years old, the median nihss score was 6.0, and 30.4% of them were female.overall, the efficacy outcomes showed that tenecteplase was noninferior to alteplase.tenecteplase was noninferior but not superior to alteplase with respect to the primary efficacy outcome of the study.at 90 days of treatment, the proportion of patients who achieved normal daily function (mrs score 0-1) was similar in the tenecteplase group and the standard medical treatment group (72.7% and 70.3%, respectively).(adjusted rr, 1.03 [95% ci 0.97~1.09], p=0.003; the lower limit of 95% ci was greater than the non-inferiority margin of 0.937).similar results were observed in sensitivity analyses and supplementary analyses of the primary outcome.tenecteplase was non-inferior to alteplase in terms of various secondary efficacy outcome indicators.specifically:- at day 90, the proportion of patients with mrs scores of 0 to 2 was similar in the tenecteplase and alteplase groups, 80.9% and 79.9%, respectively (rr, 1.01 [95% ci, 0.96~1.06]).
- a similar proportion of patients had significant neurological improvement within 24 hours, 48.0% and 45.0% in the tenecteplase and alteplase groups, respectively (rr, 1.07 [95% ci, 0.96-1.19]).
- a similar proportion of patients achieved a barthel index (activities of daily living) score of at least 95 on day 90 of treatment, 75.7% in the tenecteplase group and 73.9% in the alteplase group (rr, 1.02 [95% ci, 0.96-1.08]).
- the mean change from baseline in nihss score at day 90 was similarthe nihss score decreased by 3.70 in the tenecteplase group and by 3.02 in the alteplase group (adjusted difference, −0.45 [95% ci, −1.40 to 0.50]).
in terms of safety, the incidence of adverse events was similar in the two groups:- similar numbers of patients in the tenecteplase and alteplase groups had symptomatic intracranial hemorrhage, with 9 cases each (1.2%; rr, 1.01 [95% ci, 0.37~2.70]).
- mortality rate within 90 days in both groups（4.6%vs 5.8%；RR，0.80 [95% CI，0.51~1.23]）and the proportion of patients with mrs scores of 5 to 6（6.8% vs 7.8%；RR，0.92[95% CI，0.66~1.29]）there were no significant differences in the
in conclusion, this study showed thatfor chinese ais patients who were eligible for intravenous thrombolytic therapy within 4.5 hours after onset of symptoms, tenecteplase was noninferior to alteplase in achieving good functional outcomes at treatment day 90, with a similar safety profile.the research team pointed out that because this study was conducted on the basis of previous studies (including taais, tnk-s2b, etc.), it further deepened our understanding of the use of tenecteplase in patients with ais. given that the current study results are comparable with existing studies (including non-asian populations with different stroke severity),the overall therapeutic effect of tenecteplase in chinese patients is expected to be similar to that in other populations outside of china.
