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Original Article
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Volume 355:1525-1538 October 12, 2006 Number 15
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Effectiveness of Atypical Antipsychotic Drugs in Patients with Alzheimer's Disease
Lon S. Schneider, M.D., Pierre N. Tariot, M.D., Karen S. Dagerman, M.S., Sonia M. Davis, Dr.P.H., John K. Hsiao, M.D., M. Saleem Ismail, M.D., Barry D. Lebowitz, Ph.D., Constantine G. Lyketsos, M.D., M.H.S., J. Michael Ryan, M.D., T. Scott Stroup, M.D., David L. Sultzer, M.D., Daniel Weintraub, M.D., Jeffrey A. Lieberman, M.D., for the CATIE-AD Study Group

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ABSTRACT

Background Second-generation (atypical) antipsychotic drugs are widely used to treat psychosis, aggression, and agitation in patients with Alzheimer's disease, but their benefits are uncertain and concerns about safety have emerged. We assessed the effectiveness of atypical antipsychotic drugs in outpatients with Alzheimer's disease.

Methods In this 42-site, double-blind, placebo-controlled trial, 421 outpatients with Alzheimer's disease and psychosis, aggression, or agitation were randomly assigned to receive olanzapine (mean dose, 5.5 mg per day), quetiapine (mean dose, 56.5 mg per day), risperidone (mean dose, 1.0 mg per day), or placebo. Doses were adjusted as needed, and patients were followed for up to 36 weeks. The main outcomes were the time from initial treatment to the discontinuation of treatment for any reason and the number of patients with at least minimal improvement on the Clinical Global Impression of Change (CGIC) scale at 12 weeks.

Results There were no significant differences among treatments with regard to the time to the discontinuation of treatment for any reason: olanzapine (median, 8.1 weeks), quetiapine (median, 5.3 weeks), risperidone (median, 7.4 weeks), and placebo (median, 8.0 weeks) (P=0.52). The median time to the discontinuation of treatment due to a lack of efficacy favored olanzapine (22.1 weeks) and risperidone (26.7 weeks) as compared with quetiapine (9.1 weeks) and placebo (9.0 weeks) (P=0.002). The time to the discontinuation of treatment due to adverse events or intolerability favored placebo. Overall, 24% of patients who received olanzapine, 16% of patients who received quetiapine, 18% of patients who received risperidone, and 5% of patients who received placebo discontinued their assigned treatment owing to intolerability (P=0.009). No significant differences were noted among the groups with regard to improvement on the CGIC scale. Improvement was observed in 32% of patients assigned to olanzapine, 26% of patients assigned to quetiapine, 29% of patients assigned to risperidone, and 21% of patients assigned to placebo (P=0.22).

Conclusions Adverse effects offset advantages in the efficacy of atypical antipsychotic drugs for the treatment of psychosis, aggression, or agitation in patients with Alzheimer's disease. (ClinicalTrials.gov number, NCT00015548 [ClinicalTrials.gov] .)


Source Information

From the Keck School of Medicine, University of Southern California, Los Angeles (L.S.S., K.S.D.); the Banner Alzheimer's Institute, Phoenix, AZ (P.N.T.); Quintiles, Research Triangle Park, NC (S.M.D.); the National Institute of Mental Health, National Institutes of Health, Bethesda, MD (J.K.H.); the University of Rochester Medical Center, Rochester, NY (M.S.I., J.M.R.); the School of Medicine, University of California, San Diego, La Jolla (B.D.L.); the Department of Psychiatry, Johns Hopkins Bayview, Johns Hopkins University, Baltimore (C.G.L.); the School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill (T.S.S.); Veterans Affairs Greater Los Angeles Healthcare System, University of California, Los Angeles, Los Angeles (D.L.S.); the School of Medicine, University of Pennsylvania, Philadelphia (D.W.); and the College of Physicians and Surgeons, New York (J.A.L.).

Address reprint requests to Dr. Schneider at the Keck School of Medicine, University of Southern California, 1510 San Pablo St., HCC 600, Los Angeles, CA 90033, or at lschneid{at}usc.edu.

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Related Letters:

Atypical Antipsychotic Drugs and Alzheimer's Disease
Hussain H. M., Hotopf M., Oyebode F., Jockers-Scherübl M. C., Hellweg R., Schneider L. S., Tariot P. N., Weintraub D.
Extract | Full Text | PDF  
N Engl J Med 2007; 356:416-418, Jan 25, 2007. Correspondence

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