Older Schizophrenia Medication as Effective as Newer Treatments, Study Finds
Newer, more expensive prescription drugs to treat schizophrenia are no more effective and no safer than an older, less expensive medication that many physicians no longer use, according to a National Institute of Mental Health study released on Monday, the Washington Post reports (Vedantam, Washington Post, 9/20). The study -- led by Jeffrey Lieberman of Columbia University and director of the New York State Psychiatric Institute -- involved 1,493 schizophrenic patients at 57 medical centers nationwide (Neergaard, AP/Long Island Newsday, 9/19).
For the study, researchers randomly assigned participants a perphenazine, an older antipsychotic, or one of four newer atypical antipsychotics: Risperdal, manufactured by Johnson & Johnson; Seroquel, manufactured by AstraZeneca; Geodon, manufactured by Pfizer; or Zyprexa, manufactured by Eli Lilly. In the first phase of the study, which will appear on Thursday in New England Journal of Medicine, participants received a medication for 18 months.
In cases in which study participants felt that their medication was ineffective or experienced side effects, researchers switched them to a different treatment. The length of time that participants continued to take a medication served as the main measure of effectiveness used in the study (Abboud, Wall Street Journal, 9/20).
After 18 months, the study found that 36% of participants had taken only Zyprexa, compared with 26% for Risperdal, 25% for perphenazine, 21% for Geodon and 18% for Seroquel (Allen, Boston Globe, 9/20). Participants continued to take Zyprexa for a median period of 9.2 months, compared with 5.6 months for perphenazine, 4.8 months for Risperdal, 4.6 months for Seroquel and 3.5 months for Geodon, the study found (Wall Street Journal, 9/20).
The most common reasons that study participants cited for switches to a different medication included the ineffectiveness of their current treatment and side effects, such as fatigue, weight gain, stiffness or tremors (Carey, New York Times, 9/20). About 25% of participants said that they ended treatment with perphenazine, Risperdal, Seroquel and Geodon because the medications were ineffective, the study found.
The study found no significant difference among the medications in the prevalence of neurological side effects, a result that contradicts the "prevailing view shaped by" pharmaceutical companies "that the newer drugs cause fewer movement side effects," the Journal reports. However, the study found that participants who ended treatment with perphenazine because of side effects were more likely to cite neurological side effects as the cause compared with those who took other medications.
Participants who took Zyprexa were more likely to experience weight gain, a common side effect of all atypical antipsychotics, compared with those who took other medications. In addition, the study found that participants who took Zyprexa gained an average of two pounds per month, and one-third gained 7% of their initial body weight, compared with 16% of those who took Seroquel, 14% of those who took Risperdal, 12% of those who took perphenazine and 7% of those who took Geodon (Wall Street Journal, 9/20).
The study also found that Zyprexa patients also experienced a higher increase in lipid levels, a risk factor for diabetes, compared with those who took other medications (New York Times, 9/20). Eleven percent of participants who took Zyprexa were hospitalized for schizophrenia symptoms, compared with 15% to 20% of those who took other medications, the study found (AP/Long Island Newsday, 9/19).
Thomas Insel, director of NIMH, said, "The study has vital public health implications. It is the largest, longest and most comprehensive, independent trial ever done to examine existing therapies for this disease." He added, "CMS pays tens of billions to support medication, and there is no way they know what the appropriate value of these medications is."
The U.S. in 2004 spent $10 billion on atypical antipsychotics, which cost about 10 times more than perphenazine. The study cost NIMH $44 million (Washington Post, 9/20).
According to the Boston Globe, the study likely will have "an immediate effect on the treatment of schizophrenia." Insel said, "We have a lot more to do here. These results should cry out for the need for us to develop a whole new generation of drugs to treat schizophrenia" (Boston Globe, 9/20).
Researchers said that the study should serve only as a "guidepost" for physicians, "not a definitive ranking of the five drugs," the Newark Star-Ledger reports (May, Newark Star-Ledger, 9/20).
Lieberman said, "Probably the biggest surprise of all was that the older medication produced about as good an effect as the newer medications, three of them anyway, and did not produce neurological side effects at greater rates than any of the other drugs." He added, "The message is the glass is half full. The drugs work, but they are not satisfactory to many patients" (New York Times, 9/20).
However, Darrel Regier, director of the division of research for the American Psychiatric Association, said, "It would be a tremendous mistake to assume from this study that the cheaper, older drugs are, quote, 'just as good,'" as newer antipsychotics.
Alan Goldhammer of the Pharmaceutical Research and Manufacturers of America said, "We have always made it clear during drug development that it is only the first stage, that it ... never tells the whole story about safety and efficacy" (Washington Post, 9/20).
NPR's "Morning Edition" on Tuesday reported on the study. The segment includes comments from Robert Freedman, a psychiatrist at the University of Colorado Health Sciences Center, and Insel (Shapiro, "Morning Edition," NPR, 9/20). The complete segment is available online in RealPlayer.This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.