Clinical Studies

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Studies indicate that the plasma clearance displayed by Alteplase in AMI patients occurs with an initial half-life of under 5 min and a terminal half-life of 72 min [18]. Modes of product administration include infusion of a maximum of 100 mg over 90 min ("accelerated infusion"), infusion of a maximum of 100 mg over a period of 3 h ("3 h infusion") or, in the case of acute ischemic stroke, administration of a maximum of 90 mg by infusion over 1 h [17]. A number of trials have been undertaken in order to determine the safety and efficacy of the product [19-27]. For example, accelerated infusion of Activase was studied in a multicenter international trial (GUSTO) in which 41,000 patients presenting with AMI were randomized into one of four thrombolytic regimens: (1) accelerated infusion of Activase plus IV heparin (n = 10,396); (2) infusion of streptokinase (1.5 million units over 60 min) plus IV heparin (n = 10,410), (3) streptokinase plus heparin administered subcutaneously (n = 9,841), and (4) a combined Alteplase and streptokinase regimen. Endpoint measurements of 30 d mortality, 30 d mortality or nonfatal stroke, as well as 24 h mortality were all significantly better in the case of the accelerated Activase-treated group. However, the rate of intracerebral hemorrhage in this group was marginally higher than for the other treatments [10].

Two placebo-controlled, double-blind trials have also been carried out with acute ischemic stroke patients [24]. Patients were randomized and received either a placebo or 0.9 mg/kg

Activase, to a maximum of 90 mg total dose. The initial study (n = 291) evaluated neurological improvement at 24 h after stroke onset, but revealed no significant difference between the two treatment groups. The second study (n = 333) assessed the clinical outcome 3 months after stroke occurrence; a favorable outcome was defined as minimal or no disability using four different stroke assessment scales (the Bartel index, modified Rankin scale, Glasgow outcome scale, and NIH stroke scale). In this study, a favorable outcome was recorded for 11 more patients per 100 in the Activase group than in the control group.

The effect of Activase in treating pulmonary embolism was also evaluated in a comparative randomized trial [25]. Within 2 h of treatment initiation, 69% of patients experienced moderate or marked lysis of pulmonary emboli. Patients also experienced a significant reduction in embolism-induced pulmonary hypertension.

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