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In ENLIGHTEN-2, combining olanzapine with the opioid receptor antagonist samidorphan (OLZ\/SAM) mitigated olanzapine-associated weight gain. These analyses tested the hypothesis that OLZ\/SAM would be associated with reduced adverse cardiometabolic effects compared with olanzapine.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design<\/jats:title><jats:p>This phase 3 double-blind study randomized adults with schizophrenia to OLZ\/SAM or olanzapine for 24 weeks. Post hoc analyses assessed changes from baseline to week 24 in cardiometabolic risk parameters, including body mass index (BMI), risk of developing obesity (BMI \u226530 kg\/m2) or metabolic syndrome, waist circumference, along with mean and potentially clinically significant changes in blood pressure, glucose, and lipids.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>After 24 weeks\u2019 treatment, compared with olanzapine, OLZ\/SAM was associated with smaller least-squares mean (LSM) changes from baseline in systolic blood pressure (LSM difference, \u22122.63 mm Hg; 95% CI: \u22124.78, \u22120.47), diastolic blood pressure (LSM difference, \u22120.75 mm Hg; 95% CI: \u22122.31, 0.80), and BMI (LSM difference, \u22120.65 kg\/m2; 95% CI: \u22121.01, \u22120.28). OLZ\/SAM treatment was also associated with reduced risk of shifting from normal blood pressure to stage 1\/2 hypertension (odds ratio [OR], 0.48; 95% CI: 0.24, 0.96), becoming obese (OR, 0.52; 95% CI: 0.32, 0.82), and developing metabolic syndrome (OR, 0.55; 95% CI: 0.31, 0.99) compared with olanzapine. No treatment group differences were noted for risk of hyperglycemia or hyperlipidemia.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>OLZ\/SAM treatment was associated with lower risk of worsening cardiometabolic risk factors related to obesity, hypertension, and metabolic syndrome relative to olanzapine. NCT02694328, https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02694328.<\/jats:p><\/jats:sec>","DOI":"10.1093\/schbul\/sbac144","type":"journal-article","created":{"date-parts":[[2022,10,28]],"date-time":"2022-10-28T14:31:45Z","timestamp":1666967505000},"page":"454-463","source":"Crossref","is-referenced-by-count":20,"title":["Reduction in Multiple Cardiometabolic Risk Factors With Combined Olanzapine\/Samidorphan Compared With Olanzapine: Post Hoc Analyses From a 24-Week Phase 3 Study"],"prefix":"10.1093","volume":"49","author":[{"given":"Christoph U","family":"Correll","sequence":"first","affiliation":[{"name":"Department of Psychiatry, Zucker Hillside Hospital, Northwell Health , Glen Oaks, NY , USA"},{"name":"Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra\/Northwell , Hempstead, NY , USA"},{"name":"Department of Child and Adolescent Psychiatry, Charit\u00e9 Universit\u00e4tsmedizin , Berlin , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Evan","family":"Stein","sequence":"additional","affiliation":[{"name":"Metabolic & Atherosclerosis Research Center , Cincinnati, OH , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christine","family":"Graham","sequence":"additional","affiliation":[{"name":"Alkermes, Inc. , Waltham, MA , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lauren","family":"DiPetrillo","sequence":"additional","affiliation":[{"name":"Alkermes, Inc. , Waltham, MA , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah","family":"Akerman","sequence":"additional","affiliation":[{"name":"Alkermes, Inc. , Waltham, MA , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arielle D","family":"Stanford","sequence":"additional","affiliation":[{"name":"Alkermes, Inc. , Waltham, MA , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ying","family":"Jiang","sequence":"additional","affiliation":[{"name":"Alkermes, Inc. , Waltham, MA , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sergey","family":"Yagoda","sequence":"additional","affiliation":[{"name":"Alkermes, Inc. , Waltham, MA , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"McDonnell","sequence":"additional","affiliation":[{"name":"Alkermes Pharma Ireland Ltd ., Dublin , Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Craig","family":"Hopkinson","sequence":"additional","affiliation":[{"name":"Alkermes, Inc. , Waltham, MA , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2022,10,28]]},"reference":[{"issue":"8","key":"2023031516462912000_","doi-asserted-by":"crossref","first-page":"675","DOI":"10.1016\/S2215-0366(19)30132-4","article-title":"The Lancet Psychiatry Commission: a blueprint for protecting physical health in people with mental illness","volume":"6","author":"Firth","year":"2019","journal-title":"Lancet Psychiatry."},{"issue":"6","key":"2023031516462912000_","doi-asserted-by":"crossref","first-page":"776","DOI":"10.1038\/s41380-018-0058-9","article-title":"Is psychosis a multisystem disorder? 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