Study Questions Superiority Of Newer Antipsychotics

Abstract

Back to table of contents Previous article Next article Clinical & Research NewsFull AccessStudy Questions Superiority Of Newer AntipsychoticsJim RosackJim RosackSearch for more papers by this authorPublished Online:3 Nov 2006https://doi.org/10.1176/pn.41.21.0023Research funded by the United Kingdom's National Health Service suggests that when patients with schizophrenia need to change their medication, either because of ineffectiveness or intolerable side effects, the newer, nonclozapine second-generation antipsychotics (SGAs) do not appear to offer significant benefits over the first-generation antipsychotics (FGAs).The study's findings, reported in the October Archives of General Psychiatry, have generated significant discussion (see article below).The study, known as the Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study (CUtLASS 1), is the second over the last year to challenge the widely held perception that SGAs are safer and more effective in treating patients with schizophrenia than are the FGAs. In April, results from the National Institute of Mental Health's CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness) study indicated that in general patients were likely to do as well on the FGA perphenazine as on newer SGAs (Psychiatric News, April 21).For nearly 50 years, patients taking the older medications would often relapse or develop severe side effects, including sedation and involuntary muscle movements. The development of SGAs was thought to be a major advance primarily because the medications reduced the risk of extrapyramidal symptoms and the potential for development of tardive dyskinesia over the long term. Claims that the SGAs are more effective than the FGAs resulted in significant shifting of prescribing patterns away from the older drugs, even though research comparing the old and the new has produced mixed results.In the Archives report, Peter Jones, M.D., Ph.D., a professor of psychiatry at the University of Cambridge and Cambridgeshire and Peterborough Mental Health NHS Trust, and colleagues studied 227 people with schizophrenia aged 18 to 65 from 14 community psychiatric services in the English National Health Service.“The key question was whether the additional acquisition costs of second-generation antipsychotics over first-generation antipsychotics would be offset by improvements in health-related quality of life or savings in the use of other health and social care services in people with schizophrenia for whom a change in drug treatment was being considered for clinical reasons, most commonly suboptimal efficacy or adverse effects,” Jones and his coauthors wrote.The participants were randomly assigned to receive one class of drug or the other. (Clozapine was not included in the study; see Original article: box) However, their treating physicians determined which of the first- or second-generation medications would be best for them. In the FGA group, 49.15 percent of the patients were started on sulpiride, which is not available in the United States. In the SGA group, 46 percent were started on olanzapine.Participants were assessed at baseline and at 12, 26, and 52 weeks after the change in treatment with the Quality of Life Scale, where higher scores reflect a better quality of life.The researchers hypothesized that the SGAs would produce a five-point improvement in quality-of-life scores compared with the FGAs. Symptoms, side effects, treatment costs, and satisfaction with the drug also were measured.The researchers expressed surprise in finding their hypothesis was not validated (see chart).“Participants in the first-generation antipsychotic arm showed a trend toward greater improvements in Quality of Life Scale and symptom scores,” the authors noted. “Participants reported no clear preference for either drug group; and lastly, costs were similar.”Over the course of the 52 weeks of the trial, mean total costs per patient in the FGA arm were $34,750, compared with $37,185 per patient in the SGA arm. Antipsychotic drug costs accounted for only a small portion of the total costs encountered (2.1 percent for FGAs, and 3.8 percent for SGAs). There was a greater difference in hospitalization costs: inpatient admissions accounted for 93.2 percent of total costs in the FGA arm and 81.5 percent in the SGA arm. Overall the authors concluded that costs were similar between the FGA and SGA arms though they noted that there was a trend toward greater costs in the SGA arm.“All the data suggest that careful prescribing of first-generation antipsychotics, at least in the context of a trial, is not associated with poorer efficacy or a greater adverse-effect burden, both of which would translate into lower quality of life in the medium term,” Jones and his coauthors concluded. “This suggests that despite recent policy statements and prescribing patterns, further randomized and other evaluations of second-generation antipsychotics would still be useful in establishing their role in the long-term management of schizophrenia and, likewise, the continued role of older drugs.”An abstract of “Randomized Controlled Trial of the Effect on Quality of Life of Second- vs. First-Generation Antipsychotic Drugs in Schizophrenia” is posted at<http://archpsyc.ama-assn.org/cgi/content/full/63/10/1079>.▪ ISSUES NewArchived