Physicians' reasons not to discontinue long‐term used off‐label antipsychotic drugs in people with intellectual disability

J intellect Disabil Res

Scheers

et al. 2019

Self Cite

Background Many people with intellectual disabilities use risperidone long term for the management of challenging behaviours, despite its limited proof of effectiveness and its clear association with adverse events. Therefore, this study aimed to investigate the effectiveness of ongoing treatment with risperidone in reducing challenging behaviours versus controlled discontinuation on behaviour and health parameters. Method This was a placebo‐controlled, double‐blind, randomised discontinuation trial of risperidone. In the discontinuation group, risperidone was gradually replaced by a placebo over 14 weeks, while the control group maintained their existing dosage. Eight weeks after discontinuation, behaviour (as measured by the ‘Aberrant Behavior Checklist’) and health parameters (dyskinesia, akathisia, parkinsonism, weight, waist circumference, sedation and laboratory outcomes) were compared in both groups. Results A total of 25 participants were included in the trial, of which 11 were randomised into the discontinuation group and 14 were randomised into the continued treatment group. In the discontinuation group, 82% completely withdrew from risperidone. There was no significant change in irritability, compared with the continuation group, although there was a Group*Time effects on stereotypical behaviour in favour of the continuation group. Significant Group*Time effects were also found for weight, waist, body mass index, prolactin levels and testosterone levels, with beneficial effects for the discontinuation group. Conclusion Discontinuation of long‐term risperidone for reducing challenging behaviours is possible, without an increase in irritability. Discontinuation of risperidone may have beneficial effects on weight, waist circumference, prolactin levels and testosterone levels. The study suffered from difficulties in achieving the required sample size, which affected study power and generalizability.

Section: Discussionmentioning

confidence: 99%

Is risperidone effective in reducing challenging behaviours in individuals with intellectual disabilities after 1 year or longer use? A placebo‐controlled, randomised, double‐blind discontinuation study

Ramerman

J intellect Disabil Res

Scheers

et al. 2019

Self Cite

“…There is growing awareness among clinicians and policy makers that long‐term, off‐label use of psychotropic drugs for challenging behaviors should be avoided as much as possible, yet, the prevalence of psychotropic drug use remains high . In a recent study, nearly 30% of individuals with intellectual disability used psychotropic medication, of which 95% were off‐label prescriptions; clinicians decided in just half of these cases that their clients were eligible to discontinue . Main reasons for deciding against discontinuation were fears of their clients’ increasing restlessness, aggression, and other behavioral disturbances, as well as the presence of autism and previous unsuccessful discontinuation attempts.…”

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confidence: 99%

“…2 In a recent study, nearly 30% of individuals with intellectual disability used psychotropic medication, of which 95% were off-label prescriptions; clinicians decided in just half of these cases that their clients were eligible to discontinue. 3 Main reasons for deciding against discontinuation were fears of their clients' increasing restlessness, aggression, and other behavioral disturbances, as well as the presence of autism and previous unsuccessful discontinuation attempts. Furthermore, environmental factors, such as unfavorable living circumstances, changes in living situation or recent life events were main reasons not to discontinue.…”

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confidence: 99%

An Open‐Label Discontinuation Trial of Long‐Term, Off‐Label Antipsychotic Medication in People With Intellectual Disability: Determinants of Success and Failure

The Journal of Clinical Pharma

Hoekstra

2018

Although physicians are aware of the risks of prescribing long-term off-label antipsychotics in people with intellectual disability, attempts to discontinue often fail. This study aimed to identify potential determinants of successful and failed discontinuation. Long-term off-label antipsychotics were tapered in 14 weeks, with 12.5% of baseline dose every 2 weeks. Participants living in facilities offered by intellectual disability service providers, ≥6 years, with an IQ <70 were eligible to discontinue antipsychotic use, as judged by their physicians. The primary outcome was achievement of complete discontinuation at 16 weeks; changes in the Aberrant Behavior Checklist (ABC) and its 5 subscales were secondary outcomes. Potential determinants of the success or failure in discontinuing antipsychotics were psychotropic drug use and participants' living circumstances, medical health conditions, and severity of behavioral symptoms and neurologic side effects. Of 499 eligible clients, 129 were recruited. Reasons for client non-participation were clinician concerns that discontinuation might increase challenging behaviors and changes in clients' environment. Of the 129 participants, 61% had completely discontinued antipsychotics at 16 weeks, 46% at 28 weeks, and 40% at 40 weeks. ABC total scores increased in 49% of participants with unsuccessful discontinuation at 16 weeks. Autism, higher dose of antipsychotic drug, higher ABC and akathisia scores, and more-frequent worsening of health during discontinuation were associated with a lower incidence of complete discontinuation. Thus, in a selected sample of participants whom responsible clinicians had deemed discontinuation of antipsychotics could be attempted, 40% had achieved and maintained discontinuation at end of follow-up. Physicians should try to address patients' conditions that may hamper discontinuation.

“…Antipsychotic drugs are frequently prescribed in people with intellectual disabilities for the management of challenging behaviors 1 ; the prevalence rate of antipsychotic drug use in the Netherlands is 29.6%. 2,3 Contrary to what antipsychotic drugs were developed for, that is, the treatment of psychotic symptoms and schizophrenia, the drugs are more often prescribed outside of this licensed indication (off-label) in people with intellectual disabilities. Of the prescriptions in the Netherlands, 95% was off-label, mainly for challenging behaviors.…”

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confidence: 99%

“…Of the prescriptions in the Netherlands, 95% was off-label, mainly for challenging behaviors. 2,4 Despite conflicting evidence for their effectiveness in this indication, treatment is often long term. [5][6][7][8][9] Moreover, there is a risk of side effects of antipsychotic drugs, for example, metabolic symptoms, neurological symptoms, and endocrine symptoms, 10 with 53% of those on long-term antipsychotics having 1 or more extrapyramidal symptoms, 46% being overweight or obese, and 64% having clinically elevated prolactin levels in our previous study.…”

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confidence: 99%

Changes in Health‐Related Quality of Life in People With Intellectual Disabilities Who Discontinue Long‐Term Used Antipsychotic Drugs for Challenging Behaviors

Ramerman

Hoekstra

The Journal of Clinical Pharma

2018

Health-related quality of life in people with intellectual disabilities can be affected by challenging behaviors and side effects of antipsychotics. The aim of this study was to evaluate the effect of discontinuation antipsychotic drugs on health-related quality of life, including data from 2 discontinuation trials: an open-label trial of various antipsychotic drugs and a double-blind trial of risperidone. In both studies, antipsychotics were discontinued in 14 weeks, with steps of 12.5% of the baseline dosage every 2 weeks. Health-related quality of life was measured at baseline and at 16 weeks, and 40 weeks after baseline, by means of the RAND-36 (domains on physical well-being, role limitations caused by physical or emotional problems, vitality, pain, mental well-being, social functioning, general health, and changes in health). Participants who had completely discontinued antipsychotics according to the scheduled discontinuation and were still free of use at 40 weeks were compared with those who had incompletely discontinued. Physical well-being showed an increase in the group that had achieved complete discontinuation. Social functioning showed a decrease in the group that incompletely discontinued, which recovered at follow-up. Mental well-being decreased at 16 weeks but recovered at follow-up, regardless of complete or incomplete discontinuation. To conclude, discontinuation of antipsychotics had a positive effect on physical well-being when complete discontinuation was possible. When complete discontinuation was not possible, there was a negative effect on health-related quality-of-life domains. However, none of the unfavorable effects were irreversible.