From Medscape Medical News
ICSR 2009: New, Updated Recommendations for Schizophrenia Treatment in the Works
Information from Industry
March 31, 2009 (San Diego, California) – New recommendations from the Patient Outcomes Research Team (PORT) for schizophrenia call for first- and second-generation antipsychotic agents to be considered as first-line treatment for an acute, positive-symptom episode in treatment-responsive individuals with multiepisode schizophrenia.
"Five years ago, this recommendation was controversial, but since then [Clinical Antipsychotic Trials of Intervention Effectiveness] CATIE and [Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study] CUTLASS support the idea of equivalent efficacy between the first- and second-generation agents," said Robert Buchanan, MD, from the University of Maryland School of Medicine, in Baltimore.
This and other updated and new treatment recommendations were presented by Dr. Buchanan on behalf of PORT here at the 2009 International Congress on Schizophrenia Research.
With a mandate to develop recommendations for the treatment of persons with schizophrenia based on a synthesis of the best scientific evidence, PORT was established in 1992 under the auspices of the Agency for Health Care Policy and Research and the National Institute of Mental Health at the University of Maryland School of Medicine and the Johns Hopkins University School of Public Health. Its ultimate goal is to improve the quality and cost-effectiveness of patient care.
These latest recommendations were presented to an expert panel in November 2008 and are now awaiting the panel's review, which is expected later this year.
The expert panel includes leading clinical and research experts from across the United States, many of whom have contributed to the development of the previous PORT recommendations. They will evaluate the quality of the evidence supporting the new and updated recommendations and provide feedback.
Clozapine, Olanzapine, Exceptions to the Rule
The new recommendations also endorse the use of antipsychotic agents from both generations to treat a first positive-symptom episode. The exceptions are clozapine (Clozaril, Novartis) and especially olanzapine (Zyprexa, Eli Lilly), which are associated with a high risk of adverse effects such as obesity, insulin resistance, and elevated cholesterol levels in this patient population. These drugs should be reserved as second- or third-line treatment.
If positive symptoms persist despite 2 courses of treatment with first-line agents, the PORT investigators recommended trying clozapine. "There is a strong evidence base to support the use of clozapine for clinically persistent, positive symptoms," Dr. Buchanan said.
Clozapine also should be offered to schizophrenic patients with persistent violent or hostile symptoms. This distinguishes it from the other second-generation antipsychotics, which appear to have limited efficacy against persistent violence or hostility. Similarly, clozapine should be offered to patients who struggle with marked and persistent suicidal thoughts or behaviors.
Combining antipsychotic agents with antidepressants is "an incredibly important issue," but no new studies in this area have been published over the past 5 years, Dr. Buchanan said. In particular, the action of second-generation antipsychotic agents has not been studied with selective serotonin-reuptake inhibitors, a lapse that he described as "unbelievable."
The team felt that there was not enough new evidence to support new recommendations for treating negative symptoms or cognitive impairment in people with schizophrenia. However, it did issue several summary statements of the research published since 2003.
In the realm of psychosocial interventions, "modest" updates were made to previous recommendations regarding assertive community treatment, supported employment, skills training, cognitive behavioral therapy, and token economy, said Lisa B. Dixon, MD, also from the University of Maryland School of Medicine.
Substance Abuse, Smoking Cessation, and Weight Gain Addressed
She concentrated on a more significant update that was made for family interventions. PORT now recommends that this last at least 6 to 9 months and include these key elements: illness education, crisis intervention, emotional support, and training in how to cope with symptoms of schizophrenia. The duration of treatment is shorter than in previous recommendations, but the new elements represent "a substantial expansion of the family-intervention recommendation," Dr. Dixon said.
Recommendations also were made in 3 new areas: substance abuse, weight management, and smoking cessation.
PORT now recommends that substance-abuse disorder be integrated into the schizophrenia treatment program when patients have both conditions. No specific substance-abuse treatment was recommended, other than that treatment include motivational enhancement and training in coping skills and relapse prevention.
PORT recommended offering weight-management training to schizophrenia patients who are overweight, defined as a body-mass index of 25 to 29.9 kg/m2, or obese (30 or more kg/m2). This treatment should consist of nutritional counseling, portion control, regular weigh-ins, and exercise and should last at least 3 months in order to produce any weight loss, "which is likely to be modest."
For smoking cessation, the team recommended bupropion therapy for 10 to 12 weeks, with or without nicotine replacement. Ideally, treatment should also include psychosocial support, although PORT deemed the current evidence on this topic insufficient to recommend any 1 approach.
The importance of the PORT reviews lies in 2 areas, Alexander Miller, MD, from the University of Texas Health Science Center, in San Antonio. Dr. Miller, who was not involved in the PORT project, said. "This work is important not only in terms of defining the quality of the evidence from which to make treatment recommendations, but also for defining a standard of evidence against which to compare the treatment we actually deliver."
2009 International Congress on Schizophrenia Research: Oral Symposium 2, Health Services Research and Outcomes. Presented March 29, 2009.
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