The influence of study design on the results of pharmacoepidemiologic studies of XXXX risk with antipsychotic therapy.

@entity1 @entity6 @entity716 @entity1037 @entity1089 @entity1090
BACKGROUND: Retrospective large @entity1 database studies have reported conflicting findings regarding @entity6 risks associated with antipsychotics. This study compared two study designs to assess antipsychotic-related @entity6 risk. METHODS: Claims data were analyzed for over 60,000 @entity1 with @entity716 , both treated and untreated with antipsychotics, between January 1999 and April 2002. @entity6 odds ratios for @entity1 treated with antipsychotics versus untreated @entity1 were estimated. All @entity1 and @entity1 stratified by low, medium, and high antipsychotic dose were analyzed. Logistic regression controlled for age, sex, type of @entity716 , length of observation/treatment, preexisting excess weight, and use of other drugs. RESULTS: Under a less rigorous study design, @entity6 risk was statistically significant with all antipsychotics versus no treatment. Under a more rigorous design, relative odds for @entity1089 and @entity1090 declined and became statistically nonsignificant, whereas those for @entity1037 and conventional antipsychotics increased and remained significant. By dose, only @entity1089 showed a lack of statistical significance at all dose levels. CONCLUSIONS: In database studies estimated risks of antipsychotic-related @entity6 are affected by study design. With a more rigorous design, the risk associated with @entity1089 and @entity1090 was not significantly different from that in untreated @entity1 . These findings may explain inconsistent findings in pharmacoepidemiologic database studies.
