Huy Pham, Halford Warlick, Ricardo Bermudez, Quan Nguyen, Jose A Rey
{"title":"奥氮平/萨米朵芬:治疗成人精神分裂症或双相I型障碍的新选择","authors":"Huy Pham, Halford Warlick, Ricardo Bermudez, Quan Nguyen, Jose A Rey","doi":"10.1177/87551225221114281","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To review the pharmacology, pharmacokinetics, and efficacy and safety data of a combination of olanzapine and samidorphan (OLZ/SAM) for the treatment of schizophrenia and bipolar I disorder, which mitigates the possible unwanted side effects of weight gain associated with olanzapine (OLZ).</p><p><strong>Data sources: </strong>The review was done with a bibliographic survey of studies using MEDLINE/PubMed (January 1999-May 2021) database using the keywords olanzapine and samidorphan. Abstracts, scientific posters, and information from the manufacturer's product labeling were evaluated for inclusion. Inclusion criteria: phase 2, phase 3, and open-labeled studies that evaluated the use of OLZ/SAM for the treatment of schizophrenia and bipolar I disorder.</p><p><strong>Data synthesis: </strong>We have included one phase 2 dose-ranging exploratory study, two phase 3 efficacy and safety studies, and several open-label extension studies without a comparator. For the treatment of schizophrenia, OLZ/SAM and OLZ alone were analyzed in 2 randomized, double-blind comparison studies of approximately 960 patients. Analysis indicated that OLZ (5-20 mg)/SAM (10 mg) significantly mitigated the side effect of weight gain compared with OLZ alone (control) while maintaining antipsychotic efficacy. For bipolar I disorder, OLZ/SAM was approved as an acute treatment for manic or mixed episodes, as well as an adjunct to valproate or lithium for manic/mixed episodes based on bridging strategy allowed by the Food and Drug Administration.</p><p><strong>Relevance to patient care and clinical practice: </strong>The combination of olanzapine and samidorphan demonstrated efficacy for the treatment of schizophrenia with a dosage range of 5 to 20 mg OLZ to a 10-mg fixed dose of samidorphan. Advantages of this drug combination include once-daily dosing, favorable tolerability, and most importantly, mitigation of weight gain, which may encourage adherence, when compared with OLZ alone.</p><p><strong>Conclusion: </strong>The new combination treatment of OLZ/SAM is a unique antipsychotic formulation to provide the recognized efficacious treatment of OLZ, while mitigating the weight gain and possibly the weight-related adverse effects secondary to OLZ monotherapy.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":null,"pages":null},"PeriodicalIF":1.1000,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9420915/pdf/10.1177_87551225221114281.pdf","citationCount":"0","resultStr":"{\"title\":\"Olanzapine/Samidorphan: A New Option for the Treatment of Adults With Schizophrenia or Bipolar I Disorder.\",\"authors\":\"Huy Pham, Halford Warlick, Ricardo Bermudez, Quan Nguyen, Jose A Rey\",\"doi\":\"10.1177/87551225221114281\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To review the pharmacology, pharmacokinetics, and efficacy and safety data of a combination of olanzapine and samidorphan (OLZ/SAM) for the treatment of schizophrenia and bipolar I disorder, which mitigates the possible unwanted side effects of weight gain associated with olanzapine (OLZ).</p><p><strong>Data sources: </strong>The review was done with a bibliographic survey of studies using MEDLINE/PubMed (January 1999-May 2021) database using the keywords olanzapine and samidorphan. Abstracts, scientific posters, and information from the manufacturer's product labeling were evaluated for inclusion. Inclusion criteria: phase 2, phase 3, and open-labeled studies that evaluated the use of OLZ/SAM for the treatment of schizophrenia and bipolar I disorder.</p><p><strong>Data synthesis: </strong>We have included one phase 2 dose-ranging exploratory study, two phase 3 efficacy and safety studies, and several open-label extension studies without a comparator. For the treatment of schizophrenia, OLZ/SAM and OLZ alone were analyzed in 2 randomized, double-blind comparison studies of approximately 960 patients. Analysis indicated that OLZ (5-20 mg)/SAM (10 mg) significantly mitigated the side effect of weight gain compared with OLZ alone (control) while maintaining antipsychotic efficacy. For bipolar I disorder, OLZ/SAM was approved as an acute treatment for manic or mixed episodes, as well as an adjunct to valproate or lithium for manic/mixed episodes based on bridging strategy allowed by the Food and Drug Administration.</p><p><strong>Relevance to patient care and clinical practice: </strong>The combination of olanzapine and samidorphan demonstrated efficacy for the treatment of schizophrenia with a dosage range of 5 to 20 mg OLZ to a 10-mg fixed dose of samidorphan. Advantages of this drug combination include once-daily dosing, favorable tolerability, and most importantly, mitigation of weight gain, which may encourage adherence, when compared with OLZ alone.</p><p><strong>Conclusion: </strong>The new combination treatment of OLZ/SAM is a unique antipsychotic formulation to provide the recognized efficacious treatment of OLZ, while mitigating the weight gain and possibly the weight-related adverse effects secondary to OLZ monotherapy.</p>\",\"PeriodicalId\":16796,\"journal\":{\"name\":\"Journal of Pharmacy Technology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.1000,\"publicationDate\":\"2022-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9420915/pdf/10.1177_87551225221114281.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Pharmacy Technology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/87551225221114281\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Pharmacy Technology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/87551225221114281","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Olanzapine/Samidorphan: A New Option for the Treatment of Adults With Schizophrenia or Bipolar I Disorder.
Objective: To review the pharmacology, pharmacokinetics, and efficacy and safety data of a combination of olanzapine and samidorphan (OLZ/SAM) for the treatment of schizophrenia and bipolar I disorder, which mitigates the possible unwanted side effects of weight gain associated with olanzapine (OLZ).
Data sources: The review was done with a bibliographic survey of studies using MEDLINE/PubMed (January 1999-May 2021) database using the keywords olanzapine and samidorphan. Abstracts, scientific posters, and information from the manufacturer's product labeling were evaluated for inclusion. Inclusion criteria: phase 2, phase 3, and open-labeled studies that evaluated the use of OLZ/SAM for the treatment of schizophrenia and bipolar I disorder.
Data synthesis: We have included one phase 2 dose-ranging exploratory study, two phase 3 efficacy and safety studies, and several open-label extension studies without a comparator. For the treatment of schizophrenia, OLZ/SAM and OLZ alone were analyzed in 2 randomized, double-blind comparison studies of approximately 960 patients. Analysis indicated that OLZ (5-20 mg)/SAM (10 mg) significantly mitigated the side effect of weight gain compared with OLZ alone (control) while maintaining antipsychotic efficacy. For bipolar I disorder, OLZ/SAM was approved as an acute treatment for manic or mixed episodes, as well as an adjunct to valproate or lithium for manic/mixed episodes based on bridging strategy allowed by the Food and Drug Administration.
Relevance to patient care and clinical practice: The combination of olanzapine and samidorphan demonstrated efficacy for the treatment of schizophrenia with a dosage range of 5 to 20 mg OLZ to a 10-mg fixed dose of samidorphan. Advantages of this drug combination include once-daily dosing, favorable tolerability, and most importantly, mitigation of weight gain, which may encourage adherence, when compared with OLZ alone.
Conclusion: The new combination treatment of OLZ/SAM is a unique antipsychotic formulation to provide the recognized efficacious treatment of OLZ, while mitigating the weight gain and possibly the weight-related adverse effects secondary to OLZ monotherapy.
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