Conclusions
Ato-Dro 80-5 mg might be useful to reduce OSA severity and lead to self-reported improvement in those who could tolerate the combination. However, given the numerous side effects and the exploratory nature of this open-label study, our results warrant further validation in larger trials. Clinical
Methods
Fifteen patients with OSA received progressively increasing Ato-Dro doses (dose escalation was performed every week, starting from Ato-Dro 40-2.5 mg, then 80-5 mg and finally 80-10 mg). A clinical, in-lab polysomnography was performed at baseline, on Ato-Dro 80-5 and Ato-Dro 80-10 mg.
Results
Ato-Dro 80-10 mg did not significantly reduce apnea-hypopnea index, hypopneas associated with 4% oxygen desaturation, and hypoxic burden and yielded limited clinical benefit vs. baseline and atomoxetine alone. However, Ato-Dro 80-5 mg did improve OSA severity (Δapnea-hypopnea index = 8.3[0.3, 16.3] events/h; mean [confidence interval]; Δhypoxic burden = 37.7[12.5, 62.7] %min/h) and multiple self-reported outcomes vs. baseline and/or atomoxetine alone. Ato-Dro administration was characterized by several potentially harmful side effects and treatment discontinuation in 1/3 of cases. Conclusions: Ato-Dro 80-5 mg might be useful to reduce OSA severity and lead to self-reported improvement in those who could tolerate the combination. However, given the numerous side effects and the exploratory nature of this open-label study, our results warrant further validation in larger trials. Clinical
Trial registration
Registry: ClinicalTrials.gov; Title: Study for Efficacy and Dose Escalation of AD313 + Atomoxetine (SEED) (SEED); URL: https://clinicaltrials.gov/ct2/show/NCT05101122; Identifier: NCT05101122. Citation: Messineo L, Norman D, Ojile J. The combination of atomoxetine and dronabinol for the treatment of obstructive sleep apnea: a dose-escalating, open-label trial. J Clin Sleep Med. 2023;19(7):1183-1190.