Author and Year Groups Studied and Intervention Results and Findings Conclusions
Potkin et al[@114686] (2020) 401 adults with clinically diagnosed schizophrenia who were experiencing an acute episode of psychosis were administered >1 dose of OLZ/SAM Results indicated a significant improvement in PANSS and CGI-S total scores within 4 weeks in patients receiving OLZ/SAM versus placebo. OLZ/SAM was well tolerated and had efficacy and safety similar to that of olanzapine-monotherapy
Simmons et al[@114687] (2021) 41 patients with schizophrenia whose diagnosis of schizophrenia had impacted personal, social, and financial aspects of their lives were administered OLZ/SAM Results indicated improvements in both positive and negative symptoms of psychosis in 39 of these patients Most of the patients were satisfied with their treatment of OLZ/SAM
Citrome et al[@114685] (2021) 18 studies were used to evaluate the antipsychotic and weight-mitigating efficacy and safety of OLZ/SAM in >1600 patients Results indicated that the efficacy and safety of OLZ/SAM were similar to olanzapine, with reduced weight-gain overall The efficacy and safety of OLZ/SAM were similar to olanzapine-monotherapy, with reduced weight-gain overall
Yagoda et al[@114688] (2021) Patients with clinically diagnosed schizophrenia who completed the first phase of the ENLIGHTEN-1 study program were administered OLZ/SAM (N=277 administered >1 dose OLZ/SAM; N=183 completed 52 weeks of program) Results indicated PANSS total and CGI-S scores declined in all patients that completed the trial. Increases in weight gain were stabilized by week 6, with an average 2.79% increase in weight gain OLZ/SAM was concluded to improve schizophrenia symptoms, while mitigating weight-gain in patients
Brunette et al[@115713] (2020) 234 patients with schizophrenia and AUD were enrolled in a 1:1 randomized trial of OLZ/SAM and placebo Results indicated that no significant difference was observed between schizophrenics with comorbidity of AUD treated with OLZ/SAM vs olanzapine OLZ/SAM can be used in schizophrenics with comorbidity of AUD. However, it is not superior to olanzapine and further studies are needed
Silverman et al[@114672] (2018) 106 healthy, male normal weight volunteers were administered either OLZ/SAM, SAM, or placebo in a 2:2:1:1 ratio Results indicated that OLZ/SAM was shown to have similar safety and tolerability as metabolic risk Although OLZ/SAM had lesser side effects than olanzapine, further studies are needed in order to explore the side effects and efficacy of additional doses over a longer duration of time in schizophrenic patients
Sun et al[@114695] (2020) 100 patients aged 18 to 60 years with stable schizophrenia were administered either OLZ/SAM or OLZ/SAM-matched placebo in a 3:2 ratio Results indicated there were no clinically significant QTc effects, including QT prolongation, across the OLZ/SAM doses, ranging from 110 to 160 ng/mL OLZ/SAM has no significant effect on QT intervals
Sun et al[@114694] (2020) 34 healthy adults were administered lithium carbonate or divalproex sodium in a 1:1 ratio. On days 8-18, participants were administered olanzapine. Results indicated that the safety profiles of lithium and valproate while administered with OLZ/SAM was similar to the safety profile of what was previously reported for lithium and valproate. Administration of OLZ/SAM did not have a clinically significant effect on the pharmacokinetics of lithium or valproate and was generally well-tolerated.
Sun et al[@114693] (2018) 48 healthy, nonsmoking participants were randomly assigned to either olanzapine monotherapy, OLZ/SAM, or B-OLZ in a 1:1:1:1:1:1 randomization where pharmacokinetics of the drug-drug interactions between olanzapine and samidorphan were studied. Results indicated that OLZ/SAM was shown to not have any safety concerns nor affect the pharmacokinetics and bioavailability of olanzapine monotherapy Simultaneous administration of olanzapine and samidorphan does not affect the bioavailability of olanzapine. In general, OLZ/SAM is well-tolerated by patients
Srisurapanont et al[@114689] (2021) OLZ/SAM and olanzapine administration were compared in 1195 volunteers Results indicated that the OLZ/SAM group’s weight changes were not statistically different than the olanzapine group There is not sufficient evidence that samidorphan prevents olanzapine-induced weight gain and olanzapine-induced cardiometabolic abnormalities. Samidorphan was well-tolerated by the patients treated with olanzapine in this study.
Correll et al[@114690] (2020) OLZ/SAM was administred to 280 patients while olanzapine was assigned to 281 patients to compare the effects of OLZ/SAM on weight gain Results indicated that schizophrenia symptom improvement was similar to the olanzapine treatment with statistically significant weight differences This study concluded that OLZ/SAM treatment was associated with similar schizophrenia symptom improvement, but with significantly less weight gain and smaller increases in waist circumference
Martin et al[@114673] (2019) 75 patients received olanzapine plus placebo, and the rest received OLZ/SAM in different dosages (N=80; 5 mg, N=86; 10 mg, N=68; 20 mg) to test OLZ/SAM weight gain mitigation Results indicated that OLZ/SAM resulted in statistically significant lower weight gain compared to olanzapine plus placebo patients, with OLZ/SAM showing a 37% lower weight gain compared to olanzapine plus placebo. Safety and efficacy of OLZ/SAM had a similar profile to olanzapine plus placebo, making OLZ/SAM a better option for mitigating weight gain while simultaneously treating schizophrenia
Kahn et al[@114691] (2021) 265 patients with schizophrenia were administered either OLZ/SAM or olanzapine to compare the efficacy, safety, tolerability, and side effects of OLZ/SAM to olanzapine Results indicated that fasting lipid, glycemic parameters, and PANSS scores remained stable throughout the study in patients receiving OLZ/SAM. CGI-S scores remained 3 or less in 81.3% of the patients, indicating mild illness severity. Patients that were administered OLZ/SAM tolerated the medication well with significant results including smaller waist circumferences, smaller weight gain and efficacy of the medication combination
Kahn et al[@114692] (2021) 167 patients with schizophrenia were administered either OLZ/SAM or olanzapine to compare the efficacy, safety, tolerability and side effects of OLZ/SAM to olanzapine Results indicated that fasting lipid, glycemic parameters and PANSS scores remained stable throughout the study in patients receiving OLZ/SAM. CGI-S scores remained 3 or less in 81.3% of the patients, indicating mild illness severity. Patients that were administered OLZ/SAM tolerated the medication well with significant results including smaller waist circumferences, smaller weight gain and efficacy of the medication combination