Long-term effectiveness of aripiprazole once monthly on functioning and quality of life in schizophrenia: results of year 2 of the ReLiAM study.

Autor: Roy MA; Centre de Recherche CERVO, Département de Psychiatrie Et de Neurosciences, Faculté de Médecine de L'Université Laval, 2525, Chemin de La Canardière, Porte A-1-2, Québec City, QC, G1J 2G3, Canada. marc-andre.roy@fmed.ulaval.ca., Therrien F; Medical Affairs, Otsuka Canada Pharmaceutical Inc, St-Laurent, QC, Canada., Boucher M; Medical Affairs, Otsuka Canada Pharmaceutical Inc, St-Laurent, QC, Canada.; Department of Pharmacology and Therapeutics, Faculty of Medicine and Health Sciences, McGill University, Montreal, QC, Canada., Oluboka O; Department of Psychiatry, University of Calgary, Calgary, AB, Canada.
Jazyk: angličtina
Zdroj: BMC psychiatry [BMC Psychiatry] 2024 Nov 14; Vol. 24 (1), pp. 797. Date of Electronic Publication: 2024 Nov 14.
DOI: 10.1186/s12888-024-06240-x
Abstrakt: Background: Aripiprazole once-monthly (AOM) has proven effective in the treatment of schizophrenia, although little is known about its impact on global functioning and quality of life beyond 1 year. Here, we investigate the continued impact of AOM on the participants of the ReLiAM study during the second year of follow-up.
Methods: The participants who were evaluated at ≥ 1 time point during the second year of the ReLiAM study (months 15, 18, 21, and 24; year 1 completers) were assessed via the GAF scale. Secondary outcomes were reported on the SOFAS, CGI-S, and QLS.
Results: 109 (86%) completed at least 1 post-12-month visit and 33 (30.3%) patients completed the final assessment at month 24. The improvements observed in the year 1 completers in GAF total score were maintained through to year 2 completers. The improvements in CGI-S and SOFAS that were observed at the end of year 1 were also maintained through the end of the second year. Similar trends of sustained improvement in GAF total score, CGI-S score, and SOFAS were observed in the post-hoc analyses of the year 2 completers. Seventy-four percent (74.3%) of year 1 completers experienced mild treatment-emergent adverse events during the second year, the most frequently reported being weight gain, akathisia, and insomnia. Seventeen percent (17.4%) experienced serious adverse events. Similar findings regarding effectiveness and tolerability were reported in the year 1 completers and in year 2 completers.
Conclusions: These findings suggest that the favorable effectiveness, including tolerability observed during the first year following AOM initiation, are maintained and may even continue to improve during the second year of treatment.
Trial Registration: ClinicalTrials.gov NCT02131415, first posted on May 6, 2014. Overall trial status: Terminated.
Competing Interests: Declarations Ethics approval and consent to participate All patients signed an informed consent form before any study related procedures were performed for the ReLiAM study. Central Ethics approval was obtained from IRB Services, Aurora, Ontario, Canada. In addition, approval from local institutional ethics boards (University of Windsor, McGill University Health Centre, Institut Universitaire en Sante Mentale de Quebec, Capital Health, Ottawa Health Science Network, Royal Ottawa Health Care Group, University of Calgary, Western University, Queen’s University, Douglas Mental Health Institute, University of British Columbia) was obtained as required. Consent for publication Not applicable. Competing interests Dr. Oloruntoba Oluboka works as a consultant, advisor and presented for the following pharmaceutical companies: Purdue, Sunovion, Pfizer, AbbVie/Allergan, Janssen Pharm., HLS Pharm., and Otsuka/Lundbeck Alliance. During the last five years, Dr. Marc-André Roy has received honoraria as an advisor or lecturer from the following pharmaceutical companies Janssen, Otsuka-Lundbeck-Alliance, Viatris, AbbVie, Teva. He has received research contracts or grants from Otsuka-Lundbeck-Allliance, Viatris, Lundbeck.
(© 2024. The Author(s).)
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje