Safety and tolerability of aripiprazole at doses higher than 30 mg

Auby, Philippe; Saha, A.R.; Ali, Mohamed Yassin; Ингенито, Г.; Wilber, Richard B.; Bramer, Steven L.

doi:10.1016/s0924-977x(02)80406-0

Cited by 15 publications

(8 citation statements)

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“…Stock et al (84) reported no adverse metabolic changes during long-term (26 week) aripiprazole therapy in patients with schizophrenia. In another trial, aripiprazole has been found to be safe and well tolerated at doses of 30 to 90 mg/day (8).…”

Section: Safety and Tolerabilitymentioning

confidence: 97%

Aripiprazole: A Novel Atypical Antipsychotic Drug With a Uniquely Robust Pharmacology

2004

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Aripiprazole (Abilify ® ) is an atypical antipsychotic drug that has been recently introduced for clinical use in the treatment of schizophrenia. Aripiprazole has a unique pharmacologic profile that includes partial agonism at several G-protein coupled receptors (GPCRs) [especially dopamine (D 2 ) and 5-HT 1A ] and antagonistic action at others (especially 5-HT 2A ). Clinical trials indicate that aripiprazole is effective in treating the positive and negative symptoms of schizophrenia. In short-term studies rapid onset of action (within one week) has been demonstrated. Preliminary data indicate that aripiprazole may also be effective in the treatment of manic symptoms of bipolar disorder. At recommended doses, aripiprazole appears to be safe and well tolerated in most adult patients with schizophrenia and schizoaffective disorder. There is only limited information available on the use of aripiprazole in children and adolescents, and pilot data suggest that a revised dosing strategy, based on weight, is indicated in this population. In the long-term studies, the use of aripiprazole was associated with continued efficacy, good compliance and increased time-to-relapse.Aripiprazole represents the first functionally selective atypical antipsychotic drug.

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Section: Safety and Tolerabilitymentioning

confidence: 97%

Aripiprazole: A Novel Atypical Antipsychotic Drug With a Uniquely Robust Pharmacology

2004

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“…The relapse probabilities, and hence the model results, would be sensitive to changes in this cut-off point, but we were unable to explore this in the present study as we used an existing pharmacodynamic model [ 24 ]. Evidence of a positive relationship between aripiprazole levels and the probability of side effects is limited [ 39 ]; however, the current approach may underestimate the potential disadvantage of higher dosed regimens because of increased adverse events. The risk of mortality was assumed equal for patients in remission and relapsed patients, as detailed evidence was not available.…”

Section: Discussionmentioning

confidence: 99%

An Integrated Pharmacokinetic–Pharmacodynamic–Pharmacoeconomic Modeling Method to Evaluate Treatments for Adults with Schizophrenia

et al. 2021

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Introduction Schizophrenia is a chronic mental disorder that worsens with each relapse. Long-acting injectable (LAI) antipsychotics may prevent the exacerbation of symptoms and occurrence of relapses through improved continuity of care. Different dose regimens are available for the LAIs aripiprazole monohydrate (AM) and aripiprazole lauroxil (AL), but their cost effectiveness is unclear. Objectives The study aim was to compare costs and effects (relapses) of the different aripiprazole LAI dose regimens to inform clinical and US payer decisions. Methods A state-transition model calculated the outcomes of eight LAI dose regimens based on their relapse rates. As effectiveness data from randomized controlled trials were unavailable, relapse rates were modeled using pharmacokinetic and pharmacodynamic evidence. These described blood plasma levels of aripiprazole as a function of AM and AL dose regimens and described the probability of relapse as a function of aripiprazole blood plasma levels. The analysis had a time horizon of 1 year and took the US healthcare payer perspective. The incremental cost per relapse avoided and the probability of cost effectiveness were calculated in deterministic and probabilistic analyses. Scenario analyses explored the model's main assumptions, and results were validated against external data and other cost-effectiveness analyses. Results Monthly administration of AM 400 mg consistently yielded the lowest predicted number of relapses across deterministic, probabilistic, and scenario analyses. The costs of treatment and relapses were projected to be the lowest with a monthly administration of AL 441 mg. The incremental cost per relapse avoided with AM 400 mg ranged from AM 400 mg being dominant to $US83,300. From willingness-to-pay thresholds of $US30,000 per relapse avoided, the probability of cost effectiveness was highest for AM 400 mg. The validation showed alignment with external data. Conclusion The analysis highlighted the robustness of the novel framework based on pharmacokinetic and pharmacodynamic evidence and demonstrated an application in a postmarketing setting.

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“…Saha et al examined the effects of moderate and high doses of aripiprazole (30-90 mg/day) given for 15 days. 33 Plasma levels of aripiprazole increased proportionately with dose but this did not give rise to significant weight gain, changes in prolactin or ECG changes. Only akathisia and tachycardia were more common in patients given 90 mg/day.…”

Section: Refe-rencementioning

confidence: 94%

Aripiprazole: A Review of Its Pharmacology and Clinical Use

Taylor

2003

Int J Clinical Practice

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SUMMARYAtypical antipsychotics generally have a lower propensity for extrapyramidal side‐effects (EPSE), hyperprolactinaemia and tardive dyskinesia than that associated with typical antipsychotics but may still produce troublesome side‐effects, such as weight gain, cardiac rhythm changes and impaired glucose tolerance. Aripiprazole is a new atypical antipsychotic with a unique receptor binding profile that combines partial agonist activity at D2 and 5HT1A receptors with potent antagonism at 5HT2A receptors. Clinical studies in acute schizophrenic relapse, chronic schizophrenia and acute mania show it is robustly more effective than placebo. Once‐daily aripiprazole 15–30 mg is as effective as haloperidol 10 mg/day and risperidone 6 mg/day in short‐term treatment of schizophrenia and more effective than haloperidol 7–10 mg/day in maintenance of response in chronic schizophrenia. Aripiprazole appears to be well tolerated, with most studies suggesting a frequency of adverse effects similar to placebo. Aripiprazole seems not to cause significant EPSE, hyperprolactinaemia, excessive weight gain or cardiac rhythm disturbance. Limited data suggest that aripiprazole is not associated with impaired glucose tolerance.

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Safety and tolerability of aripiprazole at doses higher than 30 mg

Cited by 15 publications

References 0 publications

Aripiprazole: A Novel Atypical Antipsychotic Drug With a Uniquely Robust Pharmacology

Aripiprazole: A Novel Atypical Antipsychotic Drug With a Uniquely Robust Pharmacology

An Integrated Pharmacokinetic–Pharmacodynamic–Pharmacoeconomic Modeling Method to Evaluate Treatments for Adults with Schizophrenia

Aripiprazole: A Review of Its Pharmacology and Clinical Use

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