Abstract
PURPOSE: This meta-analysis intended to evaluate the safety and metabolic effects of the combination of olanzapine (OLZ) and samidorphan (SAM) in the treatment of schizophrenia (SCZ) patients. PATIENTS AND METHODS: We searched for the English and Chinese databases for randomized controlled trials (RCTs) on the OLZ combined with SAM for SCZ. The English databases included PubMed, Web of Science, EMbase, and Cochrane Library, however, Chinese databases included Chinese Biology Medicine (CBM), VIP, Wanfang, and China National Knowledge Infrastructure (CNKI). All database searches were due by May 31, 2023. Using Review Manager 5.4 software, a meta-analysis was conducted following a literature review and data extraction. RESULTS: This study included five RCTs involving 1781 patients. Regarding safety, the meta-analysis revealed that the probability of weight gain was reduced in the OLZ and SAM group than in the OLZ group (RR = 0.83, 95% CI (0.69, 0.99), P < 0.05). Statistically, the incidence of severe adverse safety events, dry mouth, headache, drowsiness, death, and suicidal perception events was insignificant (P > 0.05); in terms of metabolism, compared with the OLZ group, the OLZ plus SAM group reduced total cholesterol (TC) levels (MD = -3.58, 95% CI (-6.81, -0.34), P < 0.05). However, it had no significant effect on metabolic indices, including low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides, glucose, and insulin index (P > 0.05). CONCLUSION: In patients with SCZ, treatment with the combination of OLZ and SAM decreased the incidence of weight gain adverse events and TC levels; nevertheless, it did not affect other adverse events or metabolic parameters. These findings provide clinicians with evidence-based guidance and support for drug selection. However, it is crucial to confirm these findings through further high-quality research.