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Schizophrenia Drugs' Benefits Questioned Again

A new study shows that they weren't clearly better than a placebo when given to Alzheimer's patients.

For the third time in 13 months, a federally financed study has raised questions about the benefits of newer schizophrenia drugs, known as atypical antipsychotics.

In the latest study, researchers say the drugs, when used to treat Alzheimer's disease patients with aggression and hallucinations, are no more effective than a placebo once doctors take into account side effects.

Although these drugs, sold by some of the world's biggest pharmaceutical companies, aren't formally approved by the Food and Drug Administration for Alzheimer's-related dementia, doctors often prescribe them "off-label." By law, doctors can prescribe drugs for any use if the FDA has approved them for a single disease or condition.

The survey, published in Thursday's

New England Journal of Medicine

, looked at drugs from

Johnson & Johnson

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,

Eli Lilly

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and

AstraZeneca

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.

"The antipsychotic medications may be effective against some symptoms in Alzheimer's patients compared to placebo, but their tendency to cause intolerable adverse side effects in this vulnerable population offsets their benefits," says the study's lead author, Dr. Lon Schneider of the University of Southern California's Keck School of Medicine.

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"Antipsychotic medications have been used extensively for Alzheimer's patients without enough solid evidence of whether they are effective," adds Dr. Thomas Insel, director of the National Institute of Mental Health. "The study ... provides physicians and patients with information to more accurately weigh the medications' benefits against their drawbacks, with the needs and unique reactions of their individual patients."

The study was performed as part of a U.S. government-financed research effort called Clinical Antipsychotic Trials for Interventions Effectiveness, or CATIE. The findings of the study and those before it carry significant weight among physicians and financial analysts because many patients are tested and because companies don't control the financing or design.

The latest study looked at 421 patients at 42 sites. Researchers tested J&J's Risperdal, AstraZeneca's Seroquel and Lilly's Zyprexa on some patients while giving a placebo to others. Patients lived with a family member or caregiver at home or in an assisted-living facility. Nursing-home patients were excluded.

According to the study, no significant differences were found among the four test groups. Improvement was detected in 29% of Risperdal patients, 32% for those taking Zyprexa, 26% for those getting Seroquel and 21% among the patients receiving a placebo.

Researchers point out that the antipsychotic drugs "were more often associated with troubling side effects, such as sedation, confusion and weight gain" than the placebo, the National Institute of Mental Health says. The study says 24% of Zyprexa patients, 16% of Seroquel patients and 18% of Risperdal patients quit because of side effects. Only 5% of placebo patients cited side effects as a reason to quit.

Patients stayed with their treatments for an average of about eight weeks, and "there were no significant differences among treatments with regard to the time to the discontinuation of treatment for any reason," the study says.

If patients cited side effects as a reason for stopping their medications, they were allowed to advance to a second phase of the study. In the second phase, they received drugs they hadn't taken previously or citalopram, a now-generic antidepressant sold under the brand name Celexa by

Forest Laboratories

(FRX)

. Results will be published later.

The National Institute of Mental Health says about 25% of Alzheimer's patients living in nursing homes receive newer schizophrenia drugs. The agency doesn't know how many other Alzheimer's patients take these medications. However, it says roughly 75% of Alzheimer's patients experience symptoms such as hallucinations, aggression and agitation.

The latest CATIE study continues a trend that shows the atypical antipsychotics, may not be as effective from a clinical or cost standpoint as their developers had hoped.

Last year,

the first CATIE report noted that a 40-year old generic schizophrenia drug was about as good as three newer drugs that cost 10 times more. The first round looked at Risperdal, Zyprexa, Seroquel and

Pfizer's

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Geodon.

Then, in April, the second CATIE survey said there was

no clear winner among newer antipsychotics when benefits were compared with side effects. The study examined Risperdal, Zyprexa, Seroquel, Geodon and Clozaril from

Novartis

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.

None of the studies published so far has tested

Bristol-Myers Squibb's

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Abilify because CATIE was designed before the drug was approved by the FDA.