Antipsychotic Drugs Do Little for Alzheimer's PatientsApr 4, 2008 | Parker Waichman LLP
A British study just concluded that the continuing use of antipsychotic drugs provides neither cognitive nor neuropsychiatric benefits when taken by Alzheimer’s patients. The study appears in the current issue of PLoS Medicine. Research was conducted by King's College Hospital in London where 165 patients who were already being treated with antipsychotic drugs were studied. The patients were divided into two groups: One continued treatment with the drugs; the other group stopped treatment.
The groups were assessed six and 12 months later and researchers found no difference between the two groups in terms of cognitive decline or in the number of neuropsychiatric problems. Also, the researchers reported that patients with severe neuropsychiatric problems at the start of the study may have derived some benefit from continued drug therapy, but this difference was not statistically significant. While the findings suggest continued antipsychotic drugs use offers no benefits for Alzheimer's patients, the study was small and additional research is needed to improve management of these patients, researchers noted.
Most older dementia patients display some neuropsychiatric symptoms—agitation, aggression and psychosis—and physicians often prescribe antipsychotics to manage or control symptoms; however, there are concerns, including increased risk of stroke, sedation, edema, chest infections, and parkinsonism. Long-term antipsychotics may also lead to a worsening of cognitive decline.
Two months ago studies also found that new antipsychotic drugs for severe mental illness like schizophrenia and bi-polar disorder were being prescribed in increasing numbers to young children and the elderly and that doctors were helping to increase drug sales by prescribing them for other, more common conditions such as dementia and aggression. This had many concerned if this was a result of illegal off-label marketing practices. Also, other studies questioned some of the drugs' benefits finding that some carry side effects such as sedation, obesity, and diabetes.
Drugs receive US Food and Drug Administration (FDA) approval for specific purposes; however, medications are often prescribed as off-label—purposes other than that for which they were approved—on some difficult-to-treat conditions. Off-label prescribing is legal at physician discretion; however, off-label marketing by drug companies is in violation of federal law.
The first anti-psychotics, like Thorazine, helped many but came with severe side effects, such as tardive dyskinesia—involuntary and debilitating movements. The second generation, dubbed atypicals, emerged in the 1990s and caused fewer involuntary movements, but weight gain and diabetes can result. State officials are finding atypicals have become the largest drug class in Medicaid and many question if this is due to marketing or need; several state are suing drug makers for off-label promotion to increase use. Drug makers are also obtaining new approvals from the FDA to treat more conditions and over 26 percent of the nation's nursing home residents were on antipsychotics in early 2007, compared with 19.4 percent in 1999, federal surveys show. Those drugs do little to help dementia patients, said Lon S. Schneider, a California psychiatrist and lead investigator of the CATIE-AD study of outpatients with Alzheimer's. He and his colleagues found that patients on anti-psychotics for 12 weeks had a slightly greater risk of dying sooner than those on placebo.