Johnson & Johnson and Eli Lilly have permanently halted a clinical trial of their antithrombotic drug ReoPro (abciximab) in patients with acute ischaemic stroke.
Earlier this month the two companies said they were suspending enrolment in the study known as AbESTT-II, because of safety concerns [[05/10/05a]]. And in May, treatment was stopped in a subgroup of the study involving patients who suffered strokes in their sleep because a higher risk of brain haemorrhage was seen with ReoPro.
The decision to terminate the entire study came because of a higher than expected rate of brain haemorrhage, said J&J subsidiary Centocor, although as the trial is still blinded it cannot be said with certainty that ReoPro is behind the increase.
ReoPro becomes just the latest in a long list of drugs that have tried – and failed – to have an impact in warding off the debilitating effects of a stroke. To date the only drug approved to treat the condition remains Genentech/Boehringer Ingelheim’s thrombolytic alteplase [[29/01/03a]], but use of this product has been limited, simply because many patients do not reach hospital soon enough after developing stroke symptoms to be eligible for treatment.
ReoPro was being studied for use in patients who presented with symptoms outside the 3-4 hour treatment window for thrombolysis. It has already been registered for more than a decade for use in people undergoing coronary procedures such as angioplasty or stenting.