Is once a month aripiprazole safe? Int Clin Psychopharmacol. 2013 Jul

16.07.2013

Aripiprazole has certain advantages.  Oral aripiprazole has shown a low potential for metabolic disturbances,sedation and for prolonged QTc interval .Mild to moderate akathisia early on in the treatment is a problem with Aripiprazole. Long acting injectable formulation of aripiprazole could offer clinicians another option when adherence is an issue. Kane et al  has previously (2012) published the primary efficacy data.The group is now reporting the adverse event data from the same cohort of patients , who have been on the depot for a period of 52 weeks.

The trial had four treatment phases: an oral conversion phase (phase 1, 4–6 weeks), an oral stabilization phase (phase 2, 4–12 weeks), an ARI- OM  ( monthly injection)  stabilization phase (phase 3, 12–36 weeks), and a placebo-controlled, ARI-OM randomized phase (phase 4, 52 weeks) as maintenance treatment in patients with schizophrenia .403 patients were randomized to double-blind treatment in phase 4.

Findings:

Insomnia was the only  adverse event reported at more than 5% incidence in all study phases.Spontaneously reported treatment-emergent EPSs  in  ARI Om phase was 15% against placebo rate of 10%. 10% patients in placebo arm used anti EPS medication while this was 17% in Ari OM.The movement disorders  were mostly mild or moderate in severity, discontinuations because of EPSs were uncommon throughout all study phases, and no cases of tardive dyskinesia were reported.

No clinically relevant mean changes from baseline in metabolic parameters occurred across study phases

No severe adverse events were reported to have a first onset after 6 months of continuous treatment with aripiprazole.

Authors also compare the adverse event performance against Risperidone LA injection data. ARI-OM showed a low rate of adverse events, movement disorders, metabolic side effects, and prolactin changes, compared with those observed for long-term treatment with risperidone long-acting injectable (RLAI)

Limitations: All patients were stabilized on ARI-OM for at least 12 weeks before randomization, which may have resulted in a patient population different from clinical practice. Selection bias toward a patient population that tolerated and responded to oral and injectable aripiprazole is a significant limitation of this study.cross trial comparisons ( against Risperidone LA in this case) have serious limitations.

Conclusions: The safety and tolerability profile suggests that ARI-OM has a different risk–benefit profile than currently available treatments.

Comment: Selection bias is a significant weakness of this study.

Summary of the article:

Long-term safety and tolerability of aripiprazole once-monthly in maintenance treatment of patients withschizophrenia.Fleischhacker WW, Sanchez R, Johnson B, Jin N, Forbes RA, McQuade R, Baker RA, Carson W, Kane JM.Int Clin Psychopharmacol. 2013 Jul;28(4):171-6.

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