Endocrine Abstracts

Introduction

Solriamfetol is a dopamine and norepinephrine reuptake inhibitor, indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). Decrease in the body weight as an adverse effect of < 2% incidence in both the narcolepsy and OSA patients has been reported. We hypothesise that the baseline Body Mass Index (BMI) may be a an independent predictive marker for the decrease in the body weight in narcolepsy and OSA

Methods

We conducted a rapid review in accordance with PRISMA guidelines for the published randomised controlled clinical trials that document BMI in studies for Solriamfetol, across PubMed and Cochrane library. We eliminated duplication by excluding publications for subgroup and post hoc analysis

Results

A total of eight clinical trials were identified and four unique studies that included BMI as baseline demographic parameter were included for narrative synthesis. The BMI range varied from 18 to < 45 kg/m², across dose groups. The mean BMI was 32 (S.D. ± 2.5, minimum 28, maximum 33, range 5.4, 95% CI 28 to 36). The patients in the OSA group had a higher BMI (33 kg/m²) which was 19.1% greater (5.35 kg/m²) than the patients with narcolepsy (28 kg/m²). We evaluated four Phase 3 trials, three for 12 weeks and one open label trial evaluating the safety and efficacy for long term (50 weeks)

Conclusions

OSA patients tend to be more obese. Baseline BMI appears be an important determinant for appropriate patient selection to initiate and predict the decrease in body weight. Mechanistically, dual reuptake inhibition properties of solriamfetol distinguishes it from the amphetamine stimulants by its lack of release of monoamines, which may have varied long term outcomes for excessive sleepiness in patients with narcolepsy and OSA. Periodic body weight monitoring would add value to the emerging clinical evidences especially for varied doses of solriamfetol.