Bipolar Disorder

Bipolar Disorder

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Review Article Lurasidone in the Treatment of Bipolar Depression: Systematic Review of Systematic Reviews

Michele Fornaro,1,2 Domenico De Berardis,3 Giampaolo Perna,4,5,6 Marco Solmi,7,8

Nicola Veronese,8,9 Laura Orsolini,10 Elisabetta Filomena Buonaguro,2 Felice Iasevoli,1

Cristiano André Köhler,11 André Ferrer Carvalho,11 and Andrea de Bartolomeis1

! Laboratory of Molecular and Translational Psychiatry, Department of Neuroscience, School of Medicine, University “Federico II”, Naples, Italy

” New York State Psychiatric Institute, Columbia University, New York, NY, USA # National Health Service, Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, Hospital “G. Mazzini”, ASL $, Teramo, Italy

$ Department of Clinical Neurosciences, Hermanas Hospitalarias, Villa San Benedetto Menni Hospital, FoRiPsi, Albese con Cassano, “”%#” Como, Italy

& Department of Psychiatry and Neuropsychology, Maastricht University, ‘”%% MD Maastricht, Netherlands ‘ Department of Psychiatry and Behavioral Sciences, Leonard Miller School of Medicine, Miami University, Miami, FL ##!#’, USA ( Department of Neurosciences, University of Padua, Padua, Italy ) Institute for Clinical Research and Education in Medicine (IREM), Padua, Italy * Department of Medicine (DIMED), University of Padua, Padua, Italy !%School of Life and Medical Sciences, University of Hertfordshire, Hat+eld, Herts, UK !!Translational Psychiatry Research Group and Department of Clinical Medicine, Faculty of Medicine, Federal University of Ceará, Fortaleza, CE, Brazil

Correspondence should be addressed to Michele Fornaro;

Academic Editor: Chi-Un Pae

Copyright © !”#$ Michele Fornaro et al. %is is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Introduction. A burgeoning number of systematic reviews considering lurasidone in the treatment of bipolar depression have occurred since its Food and Drug Administration extended approval in !”#&. While a paucity of available quantitative evidence still precludes preliminary meta-analysis on the matter, the present quality assessment of systematic review of systematic reviews, nonetheless, aims at highlighting current essential information on the topic. Methods. Both published and unpublished systematic reviews about lurasidone mono- or adjunctive therapy in the treatment of bipolar depression were searched by two independent authors inquiring PubMed/Cochrane/Embase/Scopus from inception until October !”#’. Results. Twelve included systematic reviews were of moderate-to-high quality and consistent in covering the handful of RCTs available to date, suggesting the promising e(cacy, safety, and tolerability pro)le of lurasidone. Concordance on the drug pro)le seems to be corroborated by a steadily increasing number of convergent qualitative reports on the matter. Limitations. Publication, sponsorship, language, citation, and measurement biases. Conclusions. Despite being preliminary in nature, this overview stipulates the e*ectiveness of lurasidone in the acute treatment of Type I bipolar depression overall. As outlined by most of the reviewed evidence, recommendations for future research should include further controlled trials of extended duration.

1. Introduction

Although the Diagnostic and Statistical Manual for Mental Disorders-Fourth Edition (DSM-IV) [#] poses mania as the

hallmark of bipolar disorder (BD), depression is o+en the most enduring facet of the illness as emphasized by the Fi+h edition of the Manual [!] requiring signi)cant treatment e*orts [&]. Yet, only a handful of randomized clinical trials

Hinda i Bi Med Re ea ch In e na i nal V l me 2017, A icle ID 3084859, 17 age h ://d i. g/10.1155/2017/3084859

! BioMed Research International

(RCTs) exist about bipolar depression in comparison to major depressive disorder (MDD), which may be because unipolar “endogenous” or “melancholic” major depression episodes (MDEs) have long been considered equivalent to bipolar MDEs, from clinical, neurobiological, and treatment- modality standpoints [,]. Regrettably, the only reservation was that antidepressants might switch to the manic pole; thus the enduring common clinical practice among clinicians was to seamlessly transpose the clinical data and wisdom from the treatment of unipolar to bipolar depression [-].

%is later misconception has long been corroborated by anecdotal reports suggesting that most clinicians may still perceive medications as belonging to a class with regard to a speci)c therapeutic action rather than based on aimed “neuroscience-nomenclature” approach grounded on the pharmacological pro)le of the drug [‘], both in the specialty and in general practice settings accessed by patients with BD [$]. Yet, therapeutic “class e*ect” in BD is an exception rather than rule [.].

%e majority of patients with bipolar depression fail to respond adequately to pharmacotherapy [/], whereas the use of standard antidepressant medications, even when associ- ated with established mood-stabilizers, poses major e(cacy concerns beyond overall short- and long-term tolerability issues, especially for Type I BD (BD-I) and/or in the presence of associated mixed and/or atypical features, just to mention few [#”, ##].

In contrast, evidence in support of the use of at least some of the second-generation antipsychotic (SGA) mono- or add- on therapy either for MDD [#!, #&] or bipolar depression [#,– #.] is increasing over the time, though additional safe and e*ective Food and Drug Administration- (FDA-) approved SGAs for bipolar depression are solicited [#/].

Currently, olanzapine-0uoxetine combination (OFC), quetiapine (either the standard or the extended release preparation), and lurasidone are the only FDA drugs granted (extended) approval for the (acute) treatment of bipolar depression in adults [!”, !#].

Lurasidone received FDA approval for the treatment of schizophrenia in adults in October !”#” and was granted extended approval on June !”#& for the treatment of acute depression associated with BD-I in adults [!!], either as monotherapy [!&] or as adjunctive treatment to either lithium or valproate [!,] 0exible-dose regimen trials, further assessed in subsequent retrospective/prospective data analysis [!-].

Potential safety (namely, the risk to the subject/patient, usually assessed in by laboratory testing [e.g., clinical chem- istry and hematology], physical examination [vital signs], clinical adverse event[s], AEs, and other tests, e.g., the electro- cardiogram), tolerability (namely, the degree to which overt AEs can be tolerated by the subject/patient), and e,ectiveness (usually, “e*ectiveness” trials [pragmatic trials] measure the degree of bene)cial e*ect under “real world” clinical set- tings rather than the “e(cacy” tested by “explanatory” trials aiming at determining whether an intervention produces the expected result under ideal circumstances) of adjunctive lurasidone across a broad range of treatment resistant BD outpatients otherwise excluded by routine clinical trials (e.g., those with mixed and/or rapid-cycling features; those taking

additional psychiatric or nonpsychiatric medications; and/or older-age cases of BD) have been preliminarily postulated [!’–!/] though critically appraised by independent authors [&”].

While the overall e*ect size of OFC, quetiapine (regard- less of release formulation), and lurasidone in mitigating depressive symptoms is similar, the later one showed a lower propensity for weight gain as well as overall metabolic neutrality in the bipolar population [!”, !#].

Lurasidone, compared to previous FDA-approved SGAs for bipolar depression, yielded comparable bene)ts (all had single-digit number needed [NNT] for treatment versus placebo response or remission) and less risk of harm (double- digit or greater numbers needed to harm [NNH] with lurasidone compared to single-digit NNHs for sedation with quetiapine and for !$% weight gain with olanzapine- 0uoxetine combination) and thus a substantially more favor- able likelihood to be helped or harmed [LHH] (> or”#) with lurasidone monotherapy and adjunctive therapy, compared to quetiapine and olanzapine-0uoxetine combination (LHH< or ##) [&#]. NNT, NNH, and LHH represent widely well-recognized indexes most clinicians are progressively becoming familiar with [&!]. Nonetheless, the overall clinical validity and generalizability of these later indexes have been seldom questioned by some [&&].

A burgeoning number of systematic reviews have nonetheless occurred since the pivotal RCTs leading to FDA extended approval of lurasidone, as the need for better e(cacy/tolerability pro)le drugs for bipolar depression still represents a priority for the prescribing clinicians, policy-makers, and the su*ering ones, indeed.

More recently, calls have been made for updated brief reviews to provide decision-makers with the essential evi- dence they need in a shorter time frame, but the possible limitations of such brief reviews, compared to full-systematic reviews, require further methodological research [&,].

In recent years, however, decision-makers who were once overwhelmed by the number of individual studies have become faced by a plethora of reviews [&-, &’]. %is is compelling, especially when novel compounds of potential priority interest for the clinical practice like lurasidone, even in the treatment of BD, may need to await for additional RCTs to allow reliable meta-analytic pooling [&$, &.].

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