Reteplase may be viable, less costly alternative vs. alteplase for treatment of stroke
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Key takeaways:
- In a phase 2 study, reteplase demonstrated similar efficacy and safety vs. alteplase for the treatment of acute ischemic stroke.
- The cost per person for reteplase was $385 vs. $735 for alteplase.
In a phase 2 trial, reteplase was well tolerated with a similar efficacy and safety profile to that of alteplase as an alternative IV thrombolytic treatment for acute ischemic stroke, researchers reported.
In addition, the cost of reteplase (China Resources Angde Biotech Pharma Co.) is nearly half that of alteplase (Actilyse, Genentech) per person, according to data published in Stroke.
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“Only a minority of patients with stroke (5.64%-16.3%) receive intravenous thrombolysis (IVT) worldwide due to the strict time window and high cost of intravenous alteplase,” Shuya Li, MD, of the department of neurology and department of clinical trial center at Beijing Tiantan Hospital, Capital Medical University in Beijing, and colleagues wrote. “Innovative intravenous pharmacological reperfusion strategies with easier use and lower costs may greatly enhance reperfusion therapy in patients with acute ischemic stroke.”
Reteplase vs. alteplase
In 1996, reteplase, a non-glycosylated variant of alteplase, was approved for use in Europe and the U.S. and was later approved in China in 2007 for acute MI.
The cost of reteplase is less than alteplase at $385 per person compared with $735 per person in China.
“In contrast to alteplase, the epidermal growth factor and fibronectin finger domains are absent in reteplase,” the researchers wrote. “The result of these deletions is extended plasma half-life that permits a double-bolus regimen with fixed dosage. In the preclinical study, reteplase showed an ability to penetrate into blood clots but also had reduced fibrin specificity vs. alteplase.”
Li and colleagues, therefore, conducted the present phase 2 randomized controlled trial to evaluate the efficacy and safety of reteplase compared with alteplase for the treatment of acute ischemic stroke.
Overall, 180 patients were randomly assigned to reteplase 12+12 mg (n = 61), reteplase 18+18 mg (n = 67) or alteplase 0.9 mg/kg (n = 52) within 4.5 hours of stroke onset. Four patients received neither study agent.
The primary safety outcome was symptomatic intracranial hemorrhage within 36 hours. The primary efficacy outcome was the proportion of patients with the NIH Stroke Scale score of no more than 1 or a decrease of 4 points or more from baseline at 14 days.
Safety and efficacy of reteplase
The primary safety outcome occurred in 5% of the reteplase 12+12 mg group, 1.5% of the reteplase 18+18 mg group and 2% of the alteplase group (P = .53), according to the study.
The primary efficacy outcome occurred in 75% of the reteplase 12+12 mg group (OR = 0.85; 95% CI, 0.35-2.06) and 72.7% of the reteplase 18+18 mg group (OR = 0.75; 95% CI, 0.32-1.78) compared with 78% of the alteplase group.
“No statistically significant differences were found for the rate of death and symptomatic intracranial hemorrhage among the 12+12 mg of reteplase group, the 18+18 mg of reteplase group, and the alteplase group in patients with acute ischemic stroke within 4.5 hours onset who were eligible for IVT treatment,” the researchers wrote. “This result suggested that the evaluation of reteplase as an alternative to alteplase for thrombolytic therapy in acute ischemic stroke warrants investigation in a phase 3 trial.”
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