Abstract
Multiple drug class combinations are often prescribed for the treatment of schizophrenia, although antipsychotic monotherapy reflects FDA labeling and scientific justification for combinations is highly variable. This study was performed to gain current data regarding drug treatment of schizophrenia as practiced in the community and to assess the frequencies of off-label drug class combinations. 200 DSM IV-diagnosed schizophrenic patients recruited from community treatment sources participated in this cross-sectional study of community based schizophrenic patients. Drug class categories include First and Second Generation Antipsychotic drugs (FGA and SGA, respectively), mood stabilizers, antidepressants and anti-anxiety drugs. 25.5% of patients received antipsychotic monotherapy; 70% of patients received an antipsychotic and another drug class. A total of 42.5% of patients received more than one antipsychotic drug. The most common drug class combination was antipsychotic and a mood stabilizer. Stepwise linear discriminant function analysis identified the diagnosis of schizoaffective schizophrenia, history of having physically hurt someone and high scores on the General Portion of the PANSS rating scale predicted the combined use of an antipsychotic drug and a mood stabilizer. “Real world” pharmacotherapy of schizophrenia has developed its own established practice that is predominantly off-label and may have outstripped current data support. The economic implications for public sector payers are substantial as well as for the revenue of the pharmaceutical industry, whose promotion of off-label drug use is an increasingly problematic. These data are consistent with the recognition of the therapeutic limitations of both first and second generation antipsychotic drugs.
Highlights
Off-label medication use, the clinical application of prescribed drugs for indications other than those evaluated and approved by the Food and Drug Administration (FDA), is widespread in many areas of medicine[1]
There is considerable literature related to the use of mood stabilizers, antidepressants and antianxiety drugs added to antipsychotic drug treatment [2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17], none of these combinations are approved by the FDA for the treatment of schizophrenia
Clozapine is unique among antipsychotic drugs as its indication specifies that clozapine is ‘‘indicated for the management of severely ill schizophrenic patients who fail to respond adequately to standard drug treatment for schizophrenia;’’ and ‘‘for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state’’[18]
Summary
Off-label medication use, the clinical application of prescribed drugs for indications other than those evaluated and approved by the Food and Drug Administration (FDA), is widespread in many areas of medicine[1]. The unique effectiveness of clozapine contributed to the early wave of optimism regarding the therapeutic superiority of other members of the so-called Second Generation Antipsychotic drugs (SGA’s) [19] a notion supported in some measure by meta-analysis.[20] Results from the recent nonindustry funded, multi-centered CATIE trial carried out in the United States [21] and CUtLASS1trial [22] carried out in the UK, have judiciously challenged the notion of superiority of SGA over First Generation Antipsychotic Drugs (FGAs) in the treatment of schizophrenia In both trials, FGAs performed remarkably well in comparison to SGAs (clozapine not included) with regard to symptom reduction, side effect profile and cost utility [21,22,23,24,25,26]. These findings may have been unexpected, in actuality, these studies are in substantive agreement with FDA labeling: the effectiveness of SGAs (clozapine excluded) is no better than FGAs for the treatment of schizophrenia
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