Compared to other antipsychotic drugs, haloperidol (Haldol) raises the risk of death in elderly patients with dementia, a new study finds.
One outside expert believes the finding should aid in dementia care. “This data provides much-needed guidance and reassurance for the ever-increasing number of health care practitioners treating older demented patients,” said Dr. Gisele Wolf-Klein, director of geriatric education at the North Shore-LIJ Health System in New Hyde Park, N.Y.
The study was published online Feb. 23 in the British Medical Journal.
In 2005, the U.S. Food and Drug Administration warned that certain antipsychotic drugs are associated with an increased risk of death in elderly patients with dementia. This warning was expanded to include conventional antipsychotics in 2008, according to a journal news release.
The authors of the new study said that, despite the FDA action, the use of antipsychotic drugs for this patient population is likely to grow. According to the Harvard Medical School researchers, that’s because there are a growing number of elderly patients with dementia who require some type of treatment.
Wolf-Klein agreed, noting that safety concerns over the use of antipsychotics are “leaving primary care physicians, geriatricians, neurologist and psychiatrists in a quandary as they attempt to respond to overwhelmed caregivers dealing with unmanageable behaviors at home. Discussion with family members of the risks and benefits of atypical antipsychotics creates additional stress and burden in an already difficult situation.”
In 2008, the FDA issued a warning that for elderly patients being treated for dementia-related psychosis, both conventional and atypical antipsychotics are associated with an increased risk of mortality. However, the authors of the new study said that antipsychotic use in these patients is likely to grow as there are an increasing number of elderly patients with dementia who require some type of treatment.
In the latest work, the researchers examined data from between 2001 and 2005 from 75 445 nursing home residents in the US aged 65 and older who had received antipsychotics such as Bristol-Myers Squibb’s Abilify (aripiprazole), Haldol (haloperidol), Eli Lilly’s Zyprexa (olanzapine), AstraZeneca’s Seroquel (quetiapine), Johnson & Johnson’s Risperdal (risperidone) and Pfizer’s Geodon (ziprasidone).
During the study period, there were around 6600 deaths from causes that were unrelated to cancer, with circulatory disorders accounting for 49 percent the deaths, respiratory disorders for 15 percent and brain disorders for 10 percent. Results indicated that patients who received Haldol were twice as likely to die compared to those who took Risperdal, while Seroquel was associated with a lower risk of death. In addition, the researchers found that the effect of Haldol was strongest during the first 40 days of treatment and that this did not change after doses were adjusted.
In the study, the Harvard group examined 2001-2005 data from more than 75,000 nursing home residents, aged 65 and older, in facilities across 45 states. They sought to assess the risk of death associated with widely used antipsychotic drugs such as aripiprazole, haloperidol, olanzapine, quetiapine, risperidone and ziprasidone.
During the six-month study period, about 6,600 of the nursing home residents died from causes that were unrelated to cancer. Those who took haloperidol had double the risk of death compared to those who took risperidone, while those who took quetiapine (Seroquel) had a lower risk of death.
The researchers found that the effect of haloperidol was strongest during the first 40 days of treatment and that this did not change after doses were adjusted. Circulatory disorders accounted for 49 percent the deaths, respiratory disorders for 15 percent and brain disorders for 10 percent.
Not all antipsychotic medications carry the same risk of death in elderly patients and doctors “may want to consider this evidence when evaluating … the best approach to treatment of behavioral problems,” the researchers wrote.
Wolf-Klein said the study offers doctors valuable guidance going forward, and she called it “a landmark approach to addressing the pressing clinical need of practicing physicians confronted with behavioral issues in elderly demented patients.”