Antipsychotic drugs, which are commonly prescribed to treat psychosis, agitation and aggression in Alzheimer's patients, are essentially no more effective than a sugar pill, new research suggests.
Two of the drugs studied in this multi-centre trial did seem to ease some symptoms, but the advantages were offset by the severity of the side effects.
"It doesn't leave us in a great position," conceded Dr Thomas Insel, director of the US National Institute of Mental Health, which sponsored the study. "To me, it's a call to arms to push the research forward much more quickly."
Some may benefit
There might be some patients who benefit from certain drugs, even though the overall picture was bleak, Insel noted. And some non-drug therapies might help.
"I hope this will highlight behavioural interventions which are effective though not perfect," said Dr Gary J. Kennedy, director of geriatric psychiatry at Montefiore Medical Centre in New York City and chairman of the Geriatric Mental Health Foundation, in Bethesda, Md..
Newer antipsychotic medications are used widely for Alzheimer's patients, despite an absence of solid evidence of their efficacy.
More than half of Alzheimer's patients experience delusions, hallucinations, aggression and agitation at some point in the progression of their disease. Traditional antipsychotics such as haloperidol have a lower risk of side effects than the newer agents, although both are thought to be equally effective.
Safety concerns emerging
Recently, however, new concerns about safety have emerged with the second-generation drugs. Namely, some studies have found an increased risk of cerebrovascular problems and even death.
This study involved 421 participants, all of whom had Alzheimer's disease along with psychosis, aggression or agitation. All participants also lived with a family member or caregiver or in an assisted-living facility, not a nursing home, to give the study more relevance to a real-world setting.
In the first phase of the study, which is being reported in the October 12 issue of the New England Journal of Medicine, participants were randomised to receive one of three of the newer antipsychotic medications - olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal) - or a placebo. Different pharmaceutical companies provided the medications for the study.
The investigators were mainly interested in how long patients could take the drugs before discontinuing.
Regardless of whether they were taking an actual drug or a placebo, patients discontinued their medication, on average, after about eight weeks.
There were some outliers who benefited from treatment, including 26 percent to 32 percent of those taking the active medications who improved, compared to 21 percent of those on the placebo. Zyprexa and Risperdal seemed to perform better than Seroquel.
Side effects balance benefit
Much of this benefit, however, was counterbalanced by side effects such as sedation, confusion and weight gain.
Some 15 percent to 24 percent of those taking an active medication discontinued their use because of side effects, vs. only 5 percent of those on the placebo.
Eight-two percent of participants discontinued their medications in Phase I. These individuals are now participating in Phase 2 of the trial, in which they are randomised to one of the medications not previously taken or to citalopram, an antidepressant. The results of this phase are not yet available.
For now, some patients may still benefit from this class of medication. "Even if they don't look like they're effective in a whole population of people, there are some people who will respond and who will be able to tolerate them, so we will probably want to continue to use these drugs with great care and close monitoring of side effects," Kennedy said. "There might not be many people, but we probably want to give it a shot. We don't want to end up with the policy that nobody would have access to these medications because we don't have much else to offer."
Behavioural interventions can help
Often people with Alzheimer's who are combative actually feel provoked, and there are some behavioural interventions that can reduce this problem, he added.
For the future, Insel advocates the development of new and better drugs. "It's probably going to turn out that, in the future, treating psychosis [including schizophrenia] might be like treating hypertension," he said. "One medication isn't going to be the magic bullet. We need more than one, particularly in those with severe cases." – (HealthDayNews)