Rivastigmine study stopped after deaths
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Rivastigmine study stopped after deaths A large Dutch trial investigating the use of rivastigmine in addition to haloperidol for the treatment of delirium in intensive care patients has been halted after the trial’s data safety monitoring board found a higher rate of mortality among rivastigmine recipients than placebo recipients. The randomised, double-blind trial, coordinated by the University Medical Centre Utrecht, intended to recruit up to 440 patients at six hospitals. However, at an interim analysis of data from 104 completers, 12 deaths were noted among the 54 rivastigmine recipients compared with 4 deaths among 50 patients receiving placebo. While the difference in mortality rates had not reached statistical significance, the investigators could not be sure that the drug was safe. These results have prompted the Dutch Society of Intensive Care to review their treatment guidelines, which include rivastigmine as an additional treatment in cases where haloperidol alone is not adequate. Sheldon T. Study of rivastigmine for delirium in intensive care is stopped after deaths. BMJ : [2 pages], Jun 2010. Available from: URL: http:// 801140550 dx.doi.org/10.1136/bmj.c2895
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Reactions 5 Jun 2010 No. 1304
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