For primary outcome of death and disability at 90 days, low dose not noninferior to standard dose
TUESDAY, May 10, 2016 (HealthDay News) — For patients with acute ischemic stroke, low-dose alteplase is not noninferior to standard-dose alteplase, according to a study published online May 10 in the New England Journal of Medicine to coincide with the 2nd European Stroke Organisation Conference, held from May 10 to 12 in Barcelona, Spain.
Craig S. Anderson, M.D., Ph.D., from the George Institute for Global Health in Sydney, and colleagues randomized 3,310 patients (63 percent Asian) who were eligible for thrombolytic therapy to low-dose or standard-dose intravenous alteplase (0.6 or 0.9 mg/kg body weight).
The researchers found that the primary outcome of death or disability at 90 days occurred in 53.2 and 51.1 percent of the low- and standard-dose groups, respectively (odds ratio, 1.09; 95 percent confidence interval, 0.95 to 1.25; upper boundary exceeded noninferiority margin of 1.14; P = 0.51 for noninferiority). In the ordinal analysis of modified Rankin scale scores, low-dose alteplase was noninferior (unadjusted common odds ratio, 1.00; 95 percent confidence interval, 0.89 to 1.13; P = 0.04 for noninferiority). Major symptomatic intracerebral hemorrhage occurred in 1.0 and 2.1 percent of the low- and standard-dose groups, respectively (P = 0.01); within seven days, fatal events occurred in 0.5 and 1.5 percent, respectively (P = 0.01).
“This trial involving predominantly Asian patients with acute ischemic stroke did not show the noninferiority of low-dose alteplase to standard-dose alteplase with respect to death and disability at 90 days,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Genentech, the manufacturer of alteplase.
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