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Deaths stop Dutch rivastigmine trial

A trial in The Netherlands into the use of rivastigmine to treat delirium in ICU patients has had to be stopped because of safety concerns.

20 Jun 2010

A trial in The Netherlands into the use of rivastigmine to treat delirium in ICU patients has had to be stopped because of safety concerns.

The aim of the Rivastigmine for Delirium in Intensive Care Patients trial, coordinated by the University Medical Centre Utrecht, had been to study the use of the treatment among 440 patients in six hospitals.  But it was halted prematurely because the early safety data showed unusually higher mortality among the patients receiving rivastigmine than among those reciving placebo.

Slightly more than 100 patients had completed the trial. An interim analysis found that, among the 54 who taken rivastigmine, 12 deaths had been reported, compared with only four among those who received placebo.

No explanation has yet been produced for this.  An analysis of the data is to be published in a learned journal as soon as possible. The Centre says that the cause could have been chance. Meanwhile, it decided to shut the trial down as a precaution.

Evidently, a number of ICUs in The Netherlands have been using rivastigmine to shorten the duration of delirium when the standard treatment using the sedative haloperidol proved inadequate, in accordance with guidelines by the Dutch Society of Intensive Care and following approving advice from publications in various learned journals.


Published: 20 Jun 2010