Showing posts with label antipsychotic drugs for dementia. Show all posts
Showing posts with label antipsychotic drugs for dementia. Show all posts

Wednesday, May 10, 2017

Antipsychotics use drops 20%

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If Focus is on What Dementia Residents CAN Do

Dementia residents in 100 care facilities saw a significant drop in their antipsychotics when staff were trained to focus on "treating the residents as human beings with needs, not as patients with problems." Find out more about this study, the largest of its kind, ever.




The use of antipsychotic medication in nearly 100 Massachusetts nursing homes was significantly reduced when staff was trained to recognize challenging behaviors of cognitively impaired residents as communication of their unmet needs, according to a new study led by Jennifer Tjia, MD, MSCE, associate professor of quantitative health sciences. Results of the study were published in JAMA Internal Medicine on April 17.

Reduce Use

“This is the largest study to show that it is possible to reduce antipsychotic use in the nursing home population,” said Dr. Tjia. “This intervention focused on treating the residents as human beings with needs, not as patients with problems. We don’t medicate babies when they cry or act out, because we assume that they have a need that we need to address. However, when people with dementia are unable to communicate, the current approach medicates them when they have undesirable behaviors.” 


The off-label prescription of antipsychotics for nursing home residents with dementia is common, despite numerous studies that have shown it increases risk of stroke and death and is only minimally effective in controlling behavioral symptoms of dementia.

Meet the Needs of Residents

Tjia studied the influence of a communication training program called “Oasis” for nursing home staff on off-label antipsychotic use. The Oasis curriculum and training—launched by the Massachusetts Senior Care Association in collaboration with the Massachusetts Department of Health and developed by geriatric psychiatrist Susan Wehry, MD,—equips frontline nursing home staff, such as nursing assistants, nurses, dietary staff and receptionists, with the knowledge, skills and attitudes to meet the needs of residents with dementia using nonpharmacologic approaches rather than medication. Ironically, the program reached very few prescribers, but was still able to significantly reduce antipsychotic use. 

“The Oasis program asks nursing staff to create care plans that include what residents can do, shifting away from the model that focuses on what they can’t do,” Tjia said. “This is a fundamental shift in how to think about caring for persons with dementia and we showed that it is effective.”

Significant Drop

This study examined the rate of off-label antipsychotic use in 93 Massachusetts nursing homes enrolled in the Oasis intervention from 2011 to 2013, compared to 831 nursing homes in Massachusetts and New York who were not using that program, (although some were using a different reduction program.) Among Oasis facilities, the prevalence of antipsychotic prescriptions was cut from 34 to 27 percent after nine months, a 7 point drop, making for a relative 20% decrease. At the comparative facilities, the prevalence of those drugs was cut from 23 to 19 percent; a 4 point drop. No increases in other psychotropic medicine or behavioral disturbances were observed. Over the maintenance period of the intervention, however, the decreases did not continue. 

“Since 1987, no fewer than 11 controlled studies have been published that report varying efficacy in reducing antipsychotics in nursing homes using a variety of approaches. The largest successful intervention enrolled 12 nursing homes; however it was time and resource intensive. In contrast, the Oasis program reached almost 100 nursing homes, and was effective,” Tjia said. 

Tjia said nursing homes using the Oasis program need to reinforce training periodically to maintain success at reducing the rate of antipsychotics. 


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Friday, September 23, 2011

Atypical psychotics may hasten dementia decline (part 2)

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Medscape Today
Deborah Brauser

great deal of care," said Dr. Schneider.

He added that the meta-analysis showing a link between atypical antipsychotics and increased mortality risk in an elderly population with dementia helped support the Food and Drug Administration's (FDA's) subsequent black box warning in 2005.

A recent study published in the Archives of General Psychiatry and reported by Medscape Medical News at that timeshowed use of atypicals to treat behavioral symptoms has decreased significantly since the FDA warning was issued. However, other studies have shown that the overall prescription rate has not decreased ( Arch Intern Med. 2010;170:89-95 and CMAJ. 2008;179:438-446).

In the current study, investigators evaluated data on the 421 outpatients with AD and psychosis or aggressive behavior from CATIE-AD, which was conducted at 45 sites in the United States between April 2001 and November 2004.

Significant Decline

During the first phase of the trial all participants were randomized to receive flexible doses of either olanzapine (n = 100; mean dose, 5.5 mg/day), quetiapine (n = 94; mean dose, 56.5 mg/day), risperidone (n = 85; mean dose, 1.0 mg/day), or placebo (n = 142).

After 2 weeks, they could discontinue their allocated treatment and switch to another randomly assigned medication, on their clinicians' request. If they discontinued use of that medication, patients could move into phase 3 of the study, which consisted of open-label treatment with one of the other randomly assigned study drugs.

"At any time, the clinician could choose to enter the patient into phase 4, where data collection continued but the physician prescribed medication," explain the researchers.

The subjects were followed up for 9 months and scheduled to undergo cognitive assessments at the 12-, 24-, and 36-week timepoints. This new analysis assessed the 357 patients (54% male; mean age, 77.6 years) who participated in at least 1 baseline and 1 follow-up cognitive measure.

Measurements included the Mini-Mental State Examination (MMSE), the cognitive subscales of the AD Assessment Scale (ADAS-Cog) and of the Brief Psychiatric Rating Scale (BPRS), a cognitive summary score that combined changes on 18 cognitive tests, and the Clinical Global Impression of Change (CGIC).

Results showed that at 36-week follow-up all of the patients had declined significantly in most cognitive areas, including worsening scores on the MMSE (−2.4 points) and ADAS-Cog (−4.4 points).

The only statistically significant difference between individual antipsychotic groups and the placebo group were greater cognitive decline in the following:

•the cognition summary for those taking olanzapine or risperidone (P = .04 and P = .001, respectively);
•the MMSE for those taking olanzapine (P = .05); and
•BPRS for those taking quetiapine (P = .05).
When all 3 atypical groups were combined, participants' cognitive function decreased significantly more than their counterparts who were taking placebo on the MMSE (P = .004), BPRS (P = .05), and cognitive summary (P = .004).

"Over the 36-week trial period, patients receiving any antipsychotic had an average decline 2.46 points greater on the MMSE than placebo patients, a difference both statistically significant and clinically relevant," write the researchers.

The average CGIC scores for all 4 groups indicated minimal improvement and did not differ significantly (placebo, 3.13; olanzapine, 3.11; quetiapine, 2.83; risperidone, 2.81).

Permanent Effect?

"Because we did not measure differences in the rates of cognitive decline over longer exposure periods, we cannot address the question of whether these drugs would accelerate [the] decline permanently or merely impair cognition during acute administration," the investigators write.

They note that they also do not know whether the decrease in cognition was due to a worsening of Alzheimer's pathology or if it was an independent effect.

Much of medication use is due to the lack of interest, willingness, funding, or ability to provide psychosocial or environmental interventions to patients with agitation, aggression, and psychosis who have dementia.
Although the investigators write that the declines found in this study reached "at least as great a magnitude as the effect of cholinesterase inhibitors but in the negative direction," they add that use of atypicals may still be warranted in individual cases.

"The relative adverse effects on cognitive function within the class of medication need to be addressed in further studies that include assessment of attention, psychomotor function, and executive function," they write.

Dr. Schneider noted that nonpharmacologic treatments should also be investigated.

"Much of medication use is due to the lack of interest, willingness, funding, or ability to provide psychosocial or environmental interventions to patients with agitation, aggression, and psychosis who have dementia."

He explained that much agitation can be redirected and that aggression often comes about due to cognitive impairment — and can be mitigated by the way caregivers react to or communicate with patients.

"These approaches have limits too, but certainly they are not applied enough because they involve significant amounts of time and training," said Dr. Schneider.

Few Alternative Treatments

"Risk-benefit analysis is always part of the decision to use psychotropic medication. The aged are a particularly vulnerable group, and this study strongly underscores that vulnerability," write D. P. Devanand, MD, from the Division of Geriatric Psychiatry at the College of Physicians and Surgeons at Columbia University in New York City, and Susan K. Schultz, MD, from the Department of Psychiatry at the University of Iowa College of Medicine in Iowa City, in an accompanying editorial.

"Neuropsychological testing across a range of domains in this study offers a powerful look at the progression of AD in the context of treating neuropsychiatric symptoms," they add.

However, they caution that several caveats should be considered "when interpreting the findings and their potential impact on clinical practice," including that the investigators had to combine the 3 treatment groups to find statistical differences from placebo on the MMSE and the summary scores.

"It is likely that individual vulnerabilities to specific antipsychotics are mediated by a variety of factors, including concomitant medications, medical comorbidity, and underlying frailty, that are beyond the scope of this analysis."

Despite the widespread awareness of adverse consequences, we can only infer that atypical antipsychotics continue to be prescribed for dementia treatment because there is a lack of alternatives and there is a perceived clinical benefit by care providers.
In addition, the editorialists note that "while dose effects were not addressed in this analysis, adverse events in this population are dose related, and treatment dropouts occur more frequently with risperidone doses above 2 mg and olanzapine doses above 5 mg."

Other concerns cited include that data for any patient receiving an antipsychotic for at least 2 weeks was included, whether they had switched medications or not, which may result in short-term harmful effects that may not continue with longer treatment exposure.

Dr. Devanand and Dr. Schultz note that alternative pharmacologic treatments, such as benzodiazepines, also provide risky cognitive liabilities.

"Despite the widespread awareness of adverse consequences, we can only infer that atypical antipsychotics continue to be prescribed for dementia treatment because there is a lack of alternatives and there is a perceived clinical benefit by care providers," they write.

"These complex issues will require a thoughtful and balanced evaluation with an appreciation of the care setting, individual patient vulnerabilities, and goals of care."

The study was supported by the National Institute of Mental Health, the USC Alzheimer's Disease Research Center, and the Department of Veterans Affairs. Medications were provided by AstraZeneca, Forest, Janssen, and Eli Lilly. The study authors report several disclosures, which are listed in the original article. The editorialists report having received research support from Eli Lilly and Novartis and are currently consultants for Bristol-Myers Squibb and Sanofi-Aventis.




Wednesday, September 21, 2011

Atypical antipsychotic drugs may hasten dementia decline

Here is a great dementia resource for caregivers and healthcare professinals,

Here is information on being the best caregiver you can be

Here is a way for nurses administrators, social workers and other health care professionals to get an easyceu or two

Medscape Today
Deborah Brauser

Use of atypical antipsychotics to treat agitation or psychosis in patients with Alzheimer's disease (AD) may lead to severe cognitive impairment, according to new findings from the Clinical Antipsychotic Trials of Intervention Effectiveness–Alzheimer's Disease (CATIE-AD) study.

In the analysis, investigators found that patients with AD randomly assigned to olanzapine, quetiapine, or risperidone showed a significant decrement in neuropsychological functioning, as seen on several cognition measurements, compared with those receiving placebo.

"We found that the atypical antipsychotics used in this study were as a group associated with worsening cognitive function and that the magnitude of this impairment was, on average, the rough equivalent of 1 year's progression of illness," principal investigator of the CATIE-AD studies Lon S. Schneider, MD, professor of psychiatry, neurology, and gerontology at the University of California (USC) Keck School of Medicine in Los Angeles, told Medscape Medical News.

"It really comes down to the fact that the current medications aren't very effective in treating agitation, aggression, or psychosis in dementia. So maybe we should be trying to address these problems in different ways than merely prescribing the medications that have been licensed for treating patients with schizophrenia or major depression."

The study is published in the August issue of the American Journal of Psychiatry.

Efficacy Offset by Adverse Effects

"Delusions or hallucinations appear in 30% to 50% of patients with AD, and up to 70% demonstrate agitated or aggressive behaviors," report the researchers.

In a meta-analysis conducted the same year, Dr. Schneider's team found small effect sizes on symptom rating scales for aripiprazole and risperidone along with significant adverse events, including cerebrovascular events and worsening cognitive test scores, in older patients with AD.

"Any advantages of efficacy found for these drugs were offset in general by lack of tolerability and by adverse effects. So they should be used with a

Thursday, June 9, 2011

In defense of Antipsychotic drugs for dementia

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By Daniel Carlat CNN

Although it's true that a prescription for antipsychotics to treat agitation in dementia is "off-label," this hardly means they are ineffective or that Medicare claims for these drugs are "erroneous." In fact, large placebo-controlled trials have shown that antipsychotics are the most effective medications for the agitation that often bedevils patients with dementia.

When these drugs are successful, they soothe the inner turmoil that makes life intolerable for these patients, improving their quality of life dramatically.

Off-label prescribing simply means the medicine has not undergone the vastly expensive process of gaining FDA approval. Doctors are allowed to prescribe medications off-label; indeed, without this prerogative, much of medical care would grind to a halt. More than 60% of drugs prescribed by both pediatricians and oncologists are "off-label," and almost all drugs prescribed by obstetricians fall into that category. Has your doctor every given you Valium to help you sleep? If so, your doctor was "erroneously" billing your insurance, according to the Office of the Inspector General, because Valium is FDA approved for anxiety, not for insomnia.

The unfortunate fact is that not a single medication is FDA-approved for the agitation of dementia, and yet the condition is common. About 15% of people over 65 have dementia, and half of them will develop agitation at some point. Anybody who has visited a loved one in the Alzheimer's unit of a nursing home understands agitation only too well; it includes combativeness, shouting, verbal abuse, extreme hyperactivity and sometimes outright violence to caregivers and family.

Agitation is often due to psychosis. For example, I recall one unfortunate gentleman with Alzheimer's disease who ripped an IV line out of his arm because he woke up in a strange room and believed his wife was in the next room calling his name. The room that seemed strange to him was a nursing home room he had occupied for three years, and his wife had died 15 years earlier.

This kind of agitation is dangerous for the patient, for staff and very upsetting for family members. When geriatric psychiatrists are asked to treat agitation, they look first for potential triggers that can be solved without resorting to behavioral drugs. Infections, drugs interacting with drugs, or pain are sometimes the culprits. At times, changes in the environment can help, such as increasing contact with a caregiver, changing roommates, or even adjusting the room's temperature.

But in many cases, such measures don't help enough.

Antipsychotics, such as Risperdal, Seroquel, and Zyprexa, have all been shown to be convincingly more effective than placebos in quelling agitation in the elderly. Their vaunted "lethal" risks are based on data that is surprisingly unimpressive. When each antipsychotic was studied separately, no significant difference in mortality was found between patients on drugs or on placebos. But when data on thousands of patients were combined, the mortality rate with four specific drugs was 4.5% in the medication group vs. 2.6% in the placebo group. The most common causes of death? Heart failure and pneumonia, which are the most common causes of death for all patients with dementia.

Physicians are not prescribing these medications in order to do harm to their patients. They are using them because there are no better options. Antipsychotics, by helping patients to be calm, are humane treatments for patients who are reaching the end of their days.

The solution is to expand research on safer and more effective treatments of dementia. It is not, as proposed by Levinson, to hire government auditors to decide whether doctors are prescribing drugs "appropriately." God help us if they do.
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