Real-world effectiveness of long-acting injectable vs. oral antipsychotics in patients with bipolar I disorder: a 1-year retrospective observational study

Abstract

Objective

Long-acting injectable (LAI) antipsychotics are recommended in the treatment non-adherence. Despite the widespread use of LAI antipsychotics, there is limited data on clinical outcomes in bipolar I disorder (BD-I) patients with real-world data. We aimed to compare BD-I patients treated with LAI and oral antipsychotics (OAP) in terms of treatment effectiveness in a 1-year follow-up period.

Methods

The study was conducted retrospectively with electronic health records of 116 BDI patients. The primary outcomes were whether patients in the LAI group and the OAP group differed in relapse, rehospitalization, emergency room (ER) visits, and all-cause treatment discontinuation at 1-year follow-up after a mania episode. Cox regression modeling was used to predict the recurrence of any mood episode and all-cause treatment discontinuation during follow-up. The secondary outcomes evaluated were the effects of sociodemographic and clinical parameters and concomitant psychotropic medications on the course of the illness and treatment adherence.

Results

Of all 116 patients, 33 (28.4%) were under LAI, and 83 (71.6%) were under OAP treatment. LAI users had a history of more hospitalizations and total mood episodes. Patients in the LAI group had more treatment non-adherence before the index hospitalization. At 1-year follow-up, there was no difference between the groups in terms of any mood relapse, rehospitalization, ER visits, and all-cause treatment discontinuation. As a secondary outcome, lithium users were found to have fewer new episodes and discontinuations of treatments.

Conclusions

In real-world data, there is no evidence that LAI antipsychotics (compared to OAP) are superior in the maintenance treatment of BD. These results are important in terms of reflecting clinical practices for the treatment of BD-I. These results do not devalue the use of LAI therapy in BD; however, more studies are needed to identify positive predictors for LAI treatments in BD.

Keywords:

• Antipsychotic depots
• antipsychotic long‐acting injection
• bipolar disorder
• maintenance treatment
• relapse
• rehospitalization

Transparency

Declaration of funding

This research received no specific grant from any funding agency, commercial or not-for-profit sectors. Data availability statement: Data is available upon reasonable request.

Declaration of financial/other relationships

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

A reviewer on this manuscript has declared that they are an employee of J&J Medicine. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Author contributions

ŞAK designed the research; ŞAK and SG performed the research; ŞAK analyzed the data; ŞAK and SG wrote the manuscript.

Acknowledgements

The authors would like to thank Dr Emir Arif Erten, a psychiatrist in the Psychiatry Department of Ankara Bilkent City Hospital, for his help in the data collection process (Emir Arif Erten has provided permission to be acknowledged).

Data availability statement

The data that support the findings of this study are available from the corresponding author upon reasonable request.