Spotlight on once-monthly long-acting injectable aripiprazole and its potential as maintenance treatment for bipolar I disorder in adult patients

Abstract

The lack of long-term medication adherence is a challenge in the treatment of bipolar disorder, particularly during the maintenance phase when symptoms are less prominent. The rate of nonadherence is ~20%–60% depending on how strict a definition is used. Nonadherence worsens the course of bipolar disorder and can add hundreds of thousands of dollars to the lifetime cost of treating the illness. Long-acting injectable (LAI) medication is an attractive alternative to daily dosing of oral medication, especially among patients who are ambivalent about treatment. The purpose of this paper is to review the evidence for the safety and efficacy of LAI aripiprazole, which was recently approved for the treatment of bipolar disorder. The approval was based on a single double-blind, placebo-controlled, multisite trial that recruited participants from 103 sites in 7 countries. A total of 731 participants with bipolar disorder were enrolled in the study. Out of that total, 266 were successfully stabilized on LAI aripiprazole and entered the randomization phase. Treatment-emergent adverse events were, for the most part, mild to moderate. Akathisia was the most common adverse event, which, combined with restlessness, was experienced by 23% of the sample. At the end of the 52-week study period, nearly twice as many LAI-treated participants remained stable compared to those treated with placebo. Stability during the maintenance phase is arguably the most important goal of treatment. It is during this period of relative freedom from symptoms that patients are able to build a meaningful and satisfying life. The availability of a new treatment agent, particularly one that has the potential to enhance long-term adherence, is a welcome development.

Paliperidone LAI and Aripiprazole LAI Plasma Level Monitoring in the Prophylaxis of Bipolar Disorder Type I with Manic Predominance

“…Although AM was more effective than placebo, only about half of the AM-treated participants remained stable for the entire 52-week follow up. The study highlighted the challenge of BD monotherapy: most patients requiring at least 3 drugs, underlining the need for a combination therapy, primarily due to the difficulty of preventing depressive episodes [50,51]. In light of our study results, it seems possible to suggest a maintenance therapy with AM, maintaining PLs at intermediate values.…”

“…In general, the weight variation was 0.7 %. The literature reports fatigue in 5 % of cases; akathisia is reported in 23 %, insomnia in 10 %, and anxiety in 7 % [50,51].…”

Second Generation Long-Acting Antipsychotics in the Treatment of Bipolar Disorder: A Clinical Viewpoint

“…Aripiprazole may be a potential favorable option in the treatment of patients with BD due to its clinical efficacy and the relative lacking of metabolic, endocrine and extrapyramidal effects. There is one large study, some case reports and several reviews that have investigated the efficacy of the once-monthly long-acting aripiprazole formulation (AOM) in the treatment of BD [44][45][46].…”

Case Report: Paliperidone Palmitate in the Management of Bipolar I Disorder With Non-compliance

“…Although the etiology of BD is not yet clear, long-term pharmaceutical treatment is still the most effective methods to ameliorate symptoms and prevent relapses and chronification. However, the high non-adherence rate ranging from 20 to 60% remains as a formidable challenge in the clinical practice for patients with BD ( 3 ). For BD patients with current major depressive episode (MDE), our previous report ( 4 ) has demonstrated that over 60% of treatment interruption occurred within 12 months after treatment initiation, and that over 40% of treatment discontinuation happened in the first 3 months.…”