PMID- 30109845 OWN - NLM STAT- MEDLINE DCOM- 20200819 LR - 20200819 IS - 1092-8529 (Print) IS - 1092-8529 (Linking) VI - 24 IP - 4 DP - 2019 Aug TI - Long-term safety and tolerability of aripiprazole lauroxil in patients with schizophrenia. PG - 395-403 LID - 10.1017/S1092852918001104 [doi] AB - OBJECTIVE: Safety and tolerability of long-term treatment with the long-acting antipsychotic aripiprazole lauroxil (AL) were evaluated in patients with schizophrenia. METHODS: This was an international, multicenter, phase 3, 52-week safety study of 2 fixed doses of AL (441 mg or 882 mg intramuscular every 4 weeks). Safety endpoints included adverse events (AEs) and extrapyramidal symptoms (EPS) including akathisia, injection-site reactions (ISRs), and clinically relevant changes in metabolic and endocrine values. RESULTS: Of 478 patients entering this study, 236 (49%) continued from a previous 12-week, phase 3 efficacy study of AL, and 242 (51%) were newly enrolled. Overall, 77% and 23% of patients received AL 882 mg (N = 368) and 441 mg (N = 110), respectively. AEs occurred in 50.4% of patients; most were mild (28.7%) or moderate (18.2%). The most common AEs were insomnia (8.4%) and increased weight (5.0%). Akathisia was reported as an AE in 3.8% of the overall population, with higher rates in patients initiating AL on study entry than those continuing on AL. EPS-related AEs occurred in 9.4% of patients, and AEs related to metabolic parameters were reported in 4.6% of patients. Weight gain was minimal (0.8 kg), and no clinically relevant changes were observed for metabolic parameters. The overall incidence of ISRs was 3.8%; most were associated with the initial injections in patients receiving their first injection in this study. CONCLUSION: Long-term treatment with AL is generally well tolerated, with a safety profile consistent with that of oral aripiprazole. It is a suitable option for patients with schizophrenia. FAU - Nasrallah, Henry A AU - Nasrallah HA AUID- ORCID: 0000-0002-8567-1094 AD - Department of Psychiatry and Behavioral Neuroscience,Saint Louis School of Medicine,St. Louis,Missouri,USA. FAU - Aquila, Ralph AU - Aquila R AD - Fountain House,New York City,New York,USA. FAU - Du, Yangchun AU - Du Y AD - Clinical Development and Medical Affairs,Alkermes,Inc.,Waltham,Massachusetts,USA. FAU - Stanford, Arielle D AU - Stanford AD AD - Clinical Development and Medical Affairs,Alkermes,Inc.,Waltham,Massachusetts,USA. FAU - Claxton, Amy AU - Claxton A AD - Clinical Development and Medical Affairs,Alkermes,Inc.,Waltham,Massachusetts,USA. FAU - Weiden, Peter J AU - Weiden PJ AUID- ORCID: 0000-0001-5583-5871 AD - Clinical Development and Medical Affairs,Alkermes,Inc.,Waltham,Massachusetts,USA. LA - eng SI - ClinicalTrials.gov/NCT01626456 SI - EudraCT/2012-003996-20 PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20180815 PL - United States TA - CNS Spectr JT - CNS spectrums JID - 9702877 RN - 0 (Antipsychotic Agents) RN - 82VFR53I78 (Aripiprazole) RN - B786J7A343 (aripiprazole lauroxil) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Antipsychotic Agents/administration & dosage/*adverse effects/therapeutic use MH - Aripiprazole/administration & dosage/*adverse effects/therapeutic use MH - Drug Tolerance MH - Female MH - Humans MH - Long Term Adverse Effects/*epidemiology/etiology MH - Male MH - Middle Aged MH - Schizophrenia/*drug therapy OTO - NOTNLM OT - Akathisia OT - aripiprazole lauroxil OT - extrapyramidal symptoms OT - injection-site reactions OT - long-acting injectable antipsychotic OT - long-term study OT - metabolic parameters OT - prolactin OT - safety OT - tolerability EDAT- 2018/08/16 06:00 MHDA- 2020/08/20 06:00 CRDT- 2018/08/16 06:00 PHST- 2018/08/16 06:00 [pubmed] PHST- 2020/08/20 06:00 [medline] PHST- 2018/08/16 06:00 [entrez] AID - S1092852918001104 [pii] AID - 10.1017/S1092852918001104 [doi] PST - ppublish SO - CNS Spectr. 2019 Aug;24(4):395-403. doi: 10.1017/S1092852918001104. Epub 2018 Aug 15.