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Experts Say Tread Slowly When Trying to Interpret Study Results

Limitations of the studies comparing FGAs and SGAs make it premature to arrive at a bottom-line decision about which drugs should be available in formularies.

The recent publication of a British study comparing the effectiveness of first-generation antipsychotic (FGA) medications with second-generation (SGA) medications for patients with schizophrenia who are either not adequately responding to or not tolerating their current medications has generated considerable discussion and debate.

The study (see article above), funded by the United Kingdom's National Health Service, concluded that in the first year of treatment, there was no disadvantage to using an FGA over an SGA in terms of quality of life, symptoms, or associated costs.

"Those who agreed to enter the [British] study were randomized to receive any drug within the FGA class or any drug within the SGA class. However, the most effective drug in the SGA class—clozapine—was not included, and the most prominent drug prescribed in the FGA class—sulpiride—is not available in the United States," noted Darrel Regier, M.D., M.P.H., executive director of the American Psychiatric Institute for Research and Education and director of APA's Division of Research.

"Clinicians have long recognized that SGAs were no more effective than FGAs in reducing psychotic symptoms," Regier told Psychiatric News. "However, the apparent lower risk of tardive dyskinesia and extrapyramidal symptoms [associated with SGAs] has been one of the major clinical rationales for selecting an SGA. With the emerging recognition that SGAs carried a greater risk of other side effects, such as metabolic syndromes, selection of FGAs versus SGAs is now done more on the basis of overall side-effect risks of specific drugs for individual patients than on the basis of choosing a general class of either FGA or SGA. Hence the impact of the [British] study on clinical practice and for health policy [in the United States] is difficult to determine at this time."

Two commentaries accompanied the publication of the study. Jeffrey Lieberman, M.D., director of the New York State Psychiatric Institute and the principal investigator for the CATIE study, noted in the first of the two commentaries that the British study largely reached the same conclusions as did CATIE.

"This convergence of evidence," Lieberman wrote, "should dispel the illusion of the vast superiority of the SGAs and should have wide-ranging effects on practice patterns and policies."

Lieberman asked, "How are we to explain the enthusiastic claims that the SGAs have greater efficacy against negative symptoms, cognitive deficits, negative mood symptoms" and so on when the evidence base is stacking up against those claims? "Were these claims overstated or simply wrong?" Or, he added, could the studies be "methodologically flawed, and therefore misleading?"

After a thorough review of the data, Lieberman wrote that the evidence "must lead to the conclusion that with the possible exception of clozapine, the SGAs are not the great breakthrough in therapeutics they were once thought to be; rather, they represent an incremental advance at best."

In the second commentary, Robert Rosenheck, M.D., director of the North-East Program Evaluation Center at the Department of Veterans Affairs Connecticut Health Care System, also reviewed methodological considerations inherent in the growing evidence base on effectiveness and tolerability and the relative costs of SGAs and FGAs.

Rosenheck wrote, "In the face of substantial cost differences between FGA and SGA treatments and small, inconsistent differences in effectiveness and adverse effects in clinical trials, some may be tempted to conclude from this research that the benefits of SGAs have not justified their costs and that `fail first' or other pharmacy benefit policies should be implemented to foster more selective and judicious use of these expensive drugs."

He cautioned, however, "These unexpected empirical findings should not lead to a precipitous turn away from policies that support open formularies for psychotropic drugs."

A "comprehensive public dialogue is needed prior to policy action and should involve patients, health care professionals, researchers, industry representatives, and other stakeholders."

Policy change might eventually be warranted, Rosenheck wrote, but not before "comprehensive review, consensus building, and shared understanding."

Both commentaries can be accessed at <http://archpsyc.ama-assn.org/content/vol63/issue10/index.dtl>.

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