-
Expert Opinion on Drug Safety Jun 2019: Safety and tolerability of medications are key variables to inform treatment choice for patients with bipolar disorder (BD). This review focuses on the overall... (Comparative Study)
Comparative Study Review
: Safety and tolerability of medications are key variables to inform treatment choice for patients with bipolar disorder (BD). This review focuses on the overall tolerability and safety profile of aripiprazole when used for its bipolar disorder indications, which include acute treatment of manic and mixed episodes and maintenance treatment of bipolar I disorder for the oral formulation, agitation associated with bipolar mania for the injectable immediate-release formulation, and maintenance treatment of bipolar I disorder for the long acting once-monthly (AOM) formulation. : The authors reviewed aripiprazole safety in bipolar disorder according to product labeling. English language reports located through PubMed and information available on the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) websites, with a focus on the safety and tolerability of aripiprazole, were reviewed. : Compared to many other antipsychotics, aripiprazole has a relatively favorable tolerability profile, with a lower risk for weight gain, dyslipidemia, diabetes, and hyperprolactinemia. Compared to first-generation antipsychotics, and similar to most second-generation antipsychotics, aripiprazole has a reduced propensity for extrapyramidal side effects and a better cardiovascular safety.
Topics: Antipsychotic Agents; Aripiprazole; Bipolar Disorder; Delayed-Action Preparations; Humans; Weight Gain
PubMed: 31072228
DOI: 10.1080/14740338.2019.1617847 -
Clinical Neuropharmacology 2017The aim of this study was to review the safety and efficacy of aripiprazole as monotherapy and adjunct therapy for the treatment of post-traumatic stress disorder (PTSD). (Review)
Review
OBJECTIVE
The aim of this study was to review the safety and efficacy of aripiprazole as monotherapy and adjunct therapy for the treatment of post-traumatic stress disorder (PTSD).
METHODS
A search of both MEDLINE (1956 to May 2017) and EMBASE (1957 to May 2017) was conducted using the terms "aripiprazole" and "post-traumatic stress disorder," "posttraumatic stress disorder," or "PTSD." Studies evaluating the primary endpoint of PTSD in patients taking aripiprazole as monotherapy or adjunct therapy were analyzed for relevance. Those that met the objective of this study were included for evaluation: 1 placebo-controlled trial; 4 open-label trials; and 1 retrospective chart review.
RESULTS
In patients with a history of PTSD, aripiprazole resulted in significant improvements in the primary outcome, including Clinician-Administered PTSD Symptom Scale or PTSD Checklist-Military scores, in all but 1 study analyzed. Study durations ranged from 10 to 16 weeks. Initial doses of aripiprazole ranged from 2 to 15 mg daily that could be titrated up or down in the range of 2 to 30 mg daily based on efficacy and tolerability. Overall, aripiprazole was well tolerated with the most common treatment-related study discontinuations attributed to the adverse events of anxiety, insomnia, akathisia, asthenia, restlessness, and somnolence.
CONCLUSIONS
Based on the reviewed literature, aripiprazole is a reasonable therapy option as monotherapy or adjunct therapy in patients with PTSD. Larger randomized controlled trials are needed to better understand the role of this atypical antipsychotic in patients with PTSD.
Topics: Antipsychotic Agents; Aripiprazole; Clinical Trials as Topic; Humans; Stress Disorders, Post-Traumatic
PubMed: 29059134
DOI: 10.1097/WNF.0000000000000251 -
Expert Opinion on Investigational Drugs Jun 2016Among other approaches, the modulation of the dopaminergic pathway has been advocated in the therapeutic management of Alcohol Use Disorders (AUD). A potential avenue... (Review)
Review
INTRODUCTION
Among other approaches, the modulation of the dopaminergic pathway has been advocated in the therapeutic management of Alcohol Use Disorders (AUD). A potential avenue toward the modulation of the dopaminergic pathway across varying substance disorders seems to be provided by aripiprazole, a second-generation antipsychotic characterized by a peculiar pharmacodynamics signature.
AREAS COVERED
In this review, the authors provided a qualitative synthesis and a critical perspective on the efficacy of aripiprazole in relapse prevention and craving in AUD. A systematic search was carried out through MEDLINE/Embase/PsycINFO/Cochrane Library from inception until September 2015, combining free terms and MESH headings for the topics of AUD and aripiprazole as following: (((Alcohol use Disorder) OR (Alcohol use)) AND aripiprazole).
EXPERT OPINION
Based both on a qualitative synthesis and a critical interpretation of the evidence, the authors submit that aripiprazole would promote alcohol abstinence and reduce the alcohol seeking behaviour possibly via dopaminergic and serotoninergic modulations at the fronto-subcortical circuits underpinning alcohol reward and craving, impulsive behaviour as well as reduce alcohol-related anxiety/low mood and anhedonia. However, due to the lack of published studies, a conclusive statement about any direct effect of aripiprazole in the prevention of craving and/or alcohol consumption is not possible.
Topics: Alcohol Drinking; Alcoholism; Animals; Antipsychotic Agents; Aripiprazole; Craving; Humans; Impulsive Behavior; Reward; Secondary Prevention
PubMed: 27098451
DOI: 10.1080/13543784.2016.1175431 -
Journal of Psychiatric Practice Mar 2019Delusional disorder is a relatively rare psychotic illness characterized by delusions with contents that are theoretically possible but highly unlikely, and an absence...
Delusional disorder is a relatively rare psychotic illness characterized by delusions with contents that are theoretically possible but highly unlikely, and an absence of the disorganized thought and negative symptoms characteristic of schizophrenia. The illness is rarely studied systematically and most guidance with regard to the treatment derives from case reports and small case series. Antipsychotic medications are the mainstay of treatment, but it is not clear whether any particular agent is more effective than others. We report the case of a patient with delusional disorder who had failed to respond to risperidone but improved markedly with aripiprazole. Aripiprazole may show promise as a treatment for delusional disorder, possibly as a result of its effects on both dopaminergic and serotonergic receptors.
Topics: Aged, 80 and over; Antipsychotic Agents; Aripiprazole; Humans; Male; Schizophrenia, Paranoid
PubMed: 30849061
DOI: 10.1097/PRA.0000000000000368 -
The Primary Care Companion For CNS... Dec 2016
Topics: Antipsychotic Agents; Aripiprazole; Bipolar Disorder; Humans; Male; Middle Aged; Sexual Dysfunctions, Psychological
PubMed: 28033456
DOI: 10.4088/PCC.16l01983 -
European Journal of Clinical... Oct 2018To conduct an overview to summarize the efficacy and safety of aripiprazole for the treatment of schizophrenia. (Meta-Analysis)
Meta-Analysis Review
PURPOSE
To conduct an overview to summarize the efficacy and safety of aripiprazole for the treatment of schizophrenia.
METHODS
A literature search was performed in PubMed, the Cochrane Library, LILACS, and the Centre for Reviews and Dissemination, for articles published until March 31, 2017. We included systematic reviews with meta-analyses of randomized controlled trials assessing the efficacy, and/or the safety of aripiprazole, for patients with schizophrenia. Two authors independently performed the study selection, data extraction, and quality assessment. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach and the Risk of Bias in Systematic Review (ROBIS) tool were used to appraise the quality of evidence and the risk of bias in the reviews, respectively.
RESULTS
Fourteen studies fulfilled the inclusion criteria. Aripiprazole showed efficacy similar to that of both typical and atypical antipsychotic drugs (except olanzapine and amisulpride). Aripiprazole caused significantly lower weight gain and alterations in glucose and cholesterol levels, as compared to clozapine, risperidone, and olanzapine. In addition, aripiprazole caused significantly fewer general extrapyramidal side effects, less use of antiparkinsonian drugs, and akathisia, compared with typical antipsychotic drugs and risperidone. The overall quality of evidence in the reviews ranged from "very low" to "moderate," principally because of the risk of bias of original trials, inconsistency, and imprecision in the outcomes. According to the ROBIS tool, there are four reviews with "high" risk of bias and five with "unclear" risk of bias.
CONCLUSIONS
Aripiprazole exhibited efficacy similar to that of other antipsychotic drugs and a better safety profile than that of typical (i.e., less some extrapyramidal side effects) and atypical (i.e., less metabolic changes) antipsychotic drugs.
Topics: Antipsychotic Agents; Aripiprazole; Basal Ganglia Diseases; Cholesterol; Glucose Metabolism Disorders; Humans; Lipid Metabolism; Schizophrenia; Treatment Outcome; Weight Gain
PubMed: 29905899
DOI: 10.1007/s00228-018-2498-1 -
Psychogeriatrics : the Official Journal... Mar 2015The effects and tolerability of antipsychotics in delirium treatment remain controversial. Compared to other antipsychotics, aripiprazole differs in pharmacological... (Comparative Study)
Comparative Study Review
The effects and tolerability of antipsychotics in delirium treatment remain controversial. Compared to other antipsychotics, aripiprazole differs in pharmacological activity because it exerts its effect as a dopamine D2 partial agonist. The guidelines of the American Psychiatric Association rank aripiprazole highly among antipsychotics with regard to safety, and this drug is likely to be useful for delirium treatment. Here, we reviewed the efficacy and safety of aripiprazole for delirium. The results of our literature review on the efficacy and safety of delirium treatments suggest that aripiprazole is an effective treatment option for delirium in the elderly. Aripiprazole is as effective as other antipsychotics in improving delirium symptoms, and it is safer because it is less likely to cause extrapyramidal symptoms, excessive sedation, and weight gain. However, these findings are based on only a few clinical studies of elderly patients with delirium. Therefore, further investigations are necessary.
Topics: Aged; Antipsychotic Agents; Aripiprazole; Delirium; Humans; Receptor, Serotonin, 5-HT1A; Receptor, Serotonin, 5-HT2A; Receptors, Dopamine D2; Treatment Outcome
PubMed: 25514894
DOI: 10.1111/psyg.12088 -
The Cochrane Database of Systematic... Mar 2016Cocaine dependence is a public health problem characterised by recidivism and a host of medical and psychosocial complications. Cocaine dependence remains a disorder for... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Cocaine dependence is a public health problem characterised by recidivism and a host of medical and psychosocial complications. Cocaine dependence remains a disorder for which no pharmacological treatment of proven efficacy exists.
OBJECTIVES
To evaluate the efficacy and the acceptability of antipsychotic medications for cocaine dependence.
SEARCH METHODS
This review is an update of a previous Cochrane review published in 2007. We searched up to 15 July 2015 in Cochrane Drugs and Alcohol Group Specialised Register (searched in CRSLive); the Cochrane Library (including the Cochrane Central Register of Controlled Trials (CENTRAL); the Database of Abstracts of Reviews of Effects (DARE)); PubMed; EMBASE; CINAHL and Web of Science. All searches included non-English language literature.
SELECTION CRITERIA
All randomised controlled trials and controlled clinical trials with focus on the use of any antipsychotic medication for the treatment of cocaine dependence.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
We included 14 studies (719 participants). The antipsychotic drugs studied were risperidone, olanzapine, quetiapine, lamotrigine, aripiprazol, haloperidol and reserpine. Comparing any antipsychotic drugs versus placebo, we found that antipsychotics reduced dropout: eight studies, 397 participants, risk ratio (RR) 0.75 (95% confidence interval (CI) 0.57 to 0.97), moderate quality of evidence. We found no significant differences for any of the other primary outcomes considered: number of participants using cocaine during the treatment, two studies, 91 participants: RR 1.02 (95% CI 0.65 to 1.62); continuous abstinence, three studies, 139 participants: RR 1.30 (95% CI 0.73 to 2.32); side effects, six studies, 291 participants: RR 1.01 (95% CI 0.93 to 1.10); and craving, four studies, 240 participants: RR 0.13 (-1.08 to 1.35). For all of these comparisons we rated the quality of evidence as low.Comparisons of single drug versus placebo or versus another drug are conducted in few trials with small sample sizes, limiting the reliability of the results. Among these comparisons, only quetiapine seemed to outperform placebo in reducing cocaine use, measured by grams per week: mean difference (MD) -0.54 (95% CI -0.92 to -0.16), by US dollars spent per week: MD -53.80 (95% CI -97.85 to -9.75), and by craving: MD -1.23 (95% CI -2.19 to -0.27), but results came from one study with 60 participants.The major limitations of the studies were the high risk of attrition bias (40% of the included studies) and low quality of reporting, mainly for the risk of selection bias, performance and detection bias, that we rated as being at unclear risk for 75% to 80% of the studies. Furthermore, most of the included studies did not report results on important outcomes such as side effects, or use of cocaine during treatment and craving, which prevented the possibility of including them in statistical synthesis.
AUTHORS' CONCLUSIONS
At present, there is no evidence supporting the clinical use of antipsychotic medications in the treatment of cocaine dependence, although results come from only 14 trials, with small sample sizes and moderate to low quality of evidence.
Topics: Antipsychotic Agents; Aripiprazole; Benzodiazepines; Cocaine-Related Disorders; Haloperidol; Humans; Lamotrigine; Olanzapine; Patient Dropouts; Quetiapine Fumarate; Randomized Controlled Trials as Topic; Reserpine; Risperidone; Triazines
PubMed: 26992929
DOI: 10.1002/14651858.CD006306.pub3 -
Drugs Dec 2017Aripiprazole lauroxil long-acting injectable (LAI) [Aristada] is an intramuscularly administered, extended-release prodrug of aripiprazole, an established atypical... (Review)
Review
Aripiprazole lauroxil long-acting injectable (LAI) [Aristada] is an intramuscularly administered, extended-release prodrug of aripiprazole, an established atypical antipsychotic agent that, in terms of its relative position within the class, is at the low end of the risk spectrum for metabolic side effects. In the USA, aripiprazole lauroxil LAI is indicated for the treatment of schizophrenia; approved doses of the drug can be injected once-monthly (q4w), every 6 weeks (q6w) or every 2 months (q8w). The efficacy of the 441 and 882 mg q4w dosages in the treatment of acute exacerbations of schizophrenia and as long-term maintenance therapy in stable schizophrenia has been directly demonstrated in a phase III clinical trial and extension, while the efficacy of the 662 mg q4w, 882 mg q6w and 1064 mg q8w dosing regimens has been established on the basis of pharmacokinetic bridging studies. Aripiprazole lauroxil LAI therapy was generally well tolerated, with an adverse event profile consistent with that of oral aripiprazole (with the exception of injection-site reactions), including a low propensity to cause metabolic disturbances. Thus, aripiprazole lauroxil LAI extends the treatment regimen options for patients with schizophrenia; as with other LAI formulations of antipsychotic agents, it can be particularly recommended for patients with recurrent relapses related to nonadherence to oral preparations and for those who prefer this mode of administration. Moreover, unlike aripiprazole monohydrate LAI, the only other commercially available long-acting formulation of aripiprazole, aripiprazole lauroxil LAI offers more than one dosing interval option, which may be a potential advantage in terms of tailoring therapy to the needs of individual patients.
Topics: Antipsychotic Agents; Aripiprazole; Humans; Injections, Intramuscular; Recurrence; Schizophrenia
PubMed: 29177572
DOI: 10.1007/s40265-017-0848-4 -
Psychiatry Research Jul 2023Combination therapy with antipsychotics has been investigated for treating schizophrenia, and has shown clear advantages among non-invasive therapies. Transcutaneous... (Randomized Controlled Trial)
Randomized Controlled Trial
Combination therapy with antipsychotics has been investigated for treating schizophrenia, and has shown clear advantages among non-invasive therapies. Transcutaneous electrical acupoint stimulation (TEAS) is a novel non-invasive treatment with definite efficacy in treating mental disorders. The current study aimed to investigate the efficacy of TEAS in further improving the psychotic symptoms in patients with first-episode schizophrenia (FES) being treated with pharmacological drugs. This 8-week, preliminary, sham-controlled, randomized clinical trial was conducted in patients with FES to compare the efficacy of TEAS and sham TEAS in combination with aripiprazole treatment. The primary outcome was a change in the Positive and Negative Syndrome Scale (PANSS) score after ending the intervention (Week 8). A total of 49 participants completed the whole treatment cycle. The linear mixed-effects regression for PANSS indicated a significant time × group interaction (F(2, 116)=9.79, p <0.001). The PANSS score differed by 8.77 points (95% CI, -2.07 to -15.47 points; p=.01) between the TEAS group and the sham TEAS group after 8 weeks of treatment; this difference was significant. This study indicates that 8 weeks of TEAS combined with aripiprazole treatment can effectively treat FES. Thus, TEAS is an effective combination therapy to improve the psychiatric symptoms of FES.
Topics: Humans; Transcutaneous Electric Nerve Stimulation; Schizophrenia; Aripiprazole; Acupuncture Points; Antipsychotic Agents
PubMed: 37245485
DOI: 10.1016/j.psychres.2023.115255