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How to Interpret Findings Concerning Newly Approved Antipsychotic Agents: Clinical Implications of the Lurasidone PEARL 2 Study

J Clin Psychiatry 2012;73(8):e27
10.4088/JCP.11078ip1

The growing number of antipsychotic medications available to treat schizophrenia increases treatment options for patients, but makes clinical decision-making more complex. This article is based on a roundtable discussion by 4 experts on schizophrenia held on November 1, 2011. The goal of this project was to illustrate how to interpret findings from controlled pivotal antipsychotic trials and translate these data into useful information for managing specific patients in clinical settings. The Program to Evaluate the Antipsychotic Response to Lurasidone (PEARL 2) trial was considered relevant for discussion because it was a well-designed registration study that included an active control. Because lurasidone is the most recently approved antipsychotic, clinicians are also likely to be less familiar with this agent. Discussion of the PEARL 2 study served as a starting point for a broader discussion of how to interpret data on newly developed antipsychotic agents for the treatment of schizophrenia. The participants discussed acute and longer term extension findings from the PEARL 2 study in the context of other data on lurasidone, as well as findings concerning other antipsychotics, including the other recently approved agents, asenapine and iloperidone. The panel also provided general guidance for clinicians on how to incorporate newly approved antipsychotics into their clinical practice. Given the relatively modest efficacy differences among available first-line antipsychotics at the patient group level, the panel concluded that clinicians need to focus on safety issues, taking into account patient preferences and past experiences, when selecting the most appropriate antipsychotic for a given patient. They recommended using lower risk agents first, to achieve response with safer agents in as many patients as possible, before moving on to higher risk agents. This paradigm is important because the goal is not simply to achieve acute treatment response, but to maintain that response on a long-term basis with agents that patients can tolerate and that do not significantly increase cardiovascular risk.

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