Abstract

Abstract Introduction Increased prevalence of obesity has been reported in patients with narcolepsy and obstructive sleep apnea (OSA). Results from a 1-year open-label extension (OLE) study showed ≥5% weight loss in 4.5%, 17.3%, and 32.4% of participants with narcolepsy or OSA receiving solriamfetol 75, 150, or 300mg/d. We examined whether clinically significant weight loss (≥5%) in this population had favorable effects on biomarkers of cardiometabolic risk compared to no such weight loss. Methods We evaluated changes in weight and BP (parent study baseline to OLE week 40) and clinical laboratory assessments (OLE baseline to week 40) in participants with narcolepsy (n=124) or OSA (n=250) from the OLE study. Results Of 374 participants, 96 (25.7%) had ≥5% weight loss and 34 (9.1%) had ≥5% weight gain. Demographics were similar in those with and without (n=278) ≥5% weight loss. From baseline to week 40, among participants with weight loss, there were decreases in percentage with high (ie, >ULN) serum glucose (36.6% to 28.1%) or triglycerides (26.6% to 21.9%), whereas among participants without weight loss, there was an increase in percentage with high glucose (43.3% to 50%) and no change in percentage with high triglycerides (37.1% to 37.2%). The percentage of participants with high total cholesterol was stable among participants with weight loss (22.3% to 22.9%) and increased (32.7% to 37.2%) in participants without weight loss. Participants with weight loss had mean±SD reductions in SBP (-2.6±11.4mmHg) and DBP (-1.0±9.0mmHg), whereas participants without weight loss had increases of +0.65±12.5mmHg and +1.2±8.7mmHg, respectively. Conclusion Among solriamfetol-treated participants with ≥5% weight loss, there were decreases in BP and percentage of participants with high glucose and triglycerides. Further research is required to examine prospective long-term effects of solriamfetol on specific biomarkers of cardiometabolic risk. Support Jazz Pharmaceuticals

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