The drug may, in fact, increase mortality; trial stopped early because of death rate
FRIDAY, Nov. 5 (HealthDay News) -- Rivastigmine, a cholinesterase inhibitor, does not appear to reduce the duration of delirium in critically ill patients, and it may even hasten death, according to research published online Nov. 5 in The Lancet.
Maarten M.J. van Eijk, M.D., of the University Medical Centre in Utrecht, Netherlands, and colleagues planned to equally randomize 440 patients 18 and older with delirium to either an increasing dose of rivastigmine or placebo to establish the effect of the cholinesterase inhibitor as an adjunct to haloperidol in critically ill patients.
After inclusion of 104 patients, the trial was halted by recommendation of the data safety and monitoring board due to morality in the rivastigmine group, which was 22 percent (12 of 54 patients); the placebo group experienced a mortality rate of 8 percent, or 4 out of 50 patients (P = 0.07). Further, the researchers found that median duration of delirium was longer in the treatment group (five versus three days; P = 0.06).
"Rivastigmine did not decrease duration of delirium and might have increased mortality so we do not recommend use of rivastigmine to treat delirium in critically ill patients," the authors write.
The study was funded in part by Novartis, which supplied the rivastigmine and placebo for the study.
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