Advances in Emerging Therapies 2007

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Cynics may consider that review of emergent stroke therapies in 2007 is likely to make for quick reading—it is certainly true that many high profile trials reported unexpected neutral outcomes. However, although these disappointments made for headline medical news, there were still a number of encouraging results of novel acute therapies. The first “casualty” of the year was neuroprotection. The free radical trapping agent NXY-059 had been consistently shown to reduce infarct size and improve functional outcomes in published reports of animal models. The first phase III study in humans (SAINT) was positive, reporting a statistically significant improvement in global disability (Figure).1 Unfortunately, the follow up SAINT II trial did not confirm this result (Figure).2 This randomized placebo-controlled study of 3306 ischemic stroke patients up to 6 hours from ictus demonstrated no significant improvement in the primary end point of day 90 modified Rankin score (mRS). Subgroup analyses also failed to replicate the previous finding of reduced hemorrhagic transformation rate in patients treated with thrombolytic. Figure. Functional outcomes in major stroke trials of 2007; for comparison results of both SAINT trials are presented. Although the result was disappointing, the trial itself was rigorous and it optimized statistical analyses to describe functional outcomes across the treatment groups. A clear message from the SAINT trials is that even large-scale meticulously planned trials are subject to the play of chance, and that initial positive results require verification with a second adequately powered study. These themes have been echoed in other acute stroke trials throughout the year. As the European Safe Implementation of Thrombolysis in Stroke Monitoring Study (SITS-MOST) confirmed safety and efficacy of intravenous thrombolysis in routine practice, the stroke community were already advancing knowledge on novel approaches to reperfusion. The second Desmoteplase in Ischemic Acute Stroke (DIAS II) …