Introduction We studied the mortality risk of long term and new antipsychotic drug use in Alzheimer's disease (AD) patients in Japan to determine improved treatment protocols. Methods This 24-week prospective cohort study included 10,079 Japanese AD patients (female, 69%; average age, 81 years) under routine clinical care in 357 medical sites. The antipsychotic medication history was varied (63.7% were long-term users). Mortality rates and odds ratio were analyzed (initial 10 weeks and from 11–24 weeks). Results The antipsychotic exposed group with shorter treatment periods had a higher mortality risk compared to controls. The newly prescribed users (antipsychotic treatment started during the follow-up) showed increased mortality (9.4% during the 11–24 week period). Conclusions New use of antipsychotic drugs represents a distinct risk for mortality; those on long-term antipsychotic therapy seem to be at less risk. The warning issued 10 years earlier on antipsychotics use for AD patients should be reviewed.
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