Poster
49
(#49) Safety, Tolerability, and Durability of Treatment Effect of Olanzapine and Samidorphan: A Patient Subgroup Analysis of a 4-Year Open-Label Study
Abstract: Objective: To analyze subgroup data from a 4-year, open-label study of combined olanzapine and samidorphan (OLZ/SAM) in adults with schizophrenia, schizophreniform disorder, or bipolar I disorder.
Methods: Patients completing studies in the ENLIGHTEN clinical trial program were eligible to receive ?2ñ4 years of additional treatment in a phase 3, open-label study assessing OLZ/SAMís safety, tolerability, and durability of treatment effect. Prespecified subgroup analyses were conducted by age (18ñ29 or ?30 years), sex (male or female), race (Black/African American or non-Black/African American), baseline body mass index (BMI;
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