Publications by authors named "J E Gudeman"
Background/objectives: Narcolepsy is a chronic neurologic disorder associated with substantial challenges that affect the social, emotional, and financial quality-of-life domains. A social listening analysis and structured survey were conducted to better understand the candid perspective of people with narcolepsy (PWN) and their experience with twice-nightly sodium oxybate (SXB).
Methods: To characterize conversations and experiences in narcolepsy communities where SXB was mentioned, a social media analysis was conducted from August 2011 to October 2022.
Article Synopsis
- This study examined the demographics and comorbidities of patients with narcolepsy by analyzing electronic health records (EHR) using natural language processing (NLP) algorithms, marking a novel approach in this area.
- Researchers identified 2,057 narcolepsy patients at the Mayo Clinic from 2000 to 2020 and compared them with a matched control group, focusing on various comorbid conditions.
- The findings revealed that narcolepsy patients have higher instances of sleep disorders, mood disorders, and pain-related conditions, indicating that their challenges extend beyond just narcolepsy symptoms.
Article Synopsis
- Extended-release sodium oxybate (ON-SXB) showed significant improvements in narcolepsy symptoms in the REST-ON trial, which was a phase 3 study comparing it to a placebo.
- This analysis looked at the effectiveness of ON-SXB in patients both with and without the use of other alerting medications.
- Results indicated that ON-SXB led to substantial improvements in sleep latency, cataplexy episodes, and overall sleepiness, regardless of whether participants were using alerting agents.
Objective/background: Preference for extended-release, once-nightly sodium oxybate (ON-SXB, FT218) vs twice-nightly immediate-release (IR) oxybate was assessed in participants switching from IR oxybate to ON-SXB in an open-label/switch study, RESTORE (NCT04451668).
Patients/methods: Participants aged ≥16 years with narcolepsy who completed the phase 3 REST-ON trial, were oxybate-naive, or were on a stable IR oxybate dose (≥1 month) were eligible for RESTORE. For participants who switched from twice-nightly dosing to ON-SXB, initial doses were closest or equivalent to their previous nightly IR oxybate dose.
Purpose: Individuals with narcolepsy are more likely to be obese than the general population. Changes in weight-related measures with extended-release, once-nightly sodium oxybate (ON-SXB) and characteristics of participants with ≥5% weight loss were assessed in a Randomized study Evaluating the efficacy and SafeTy of a ONce nightly formulation of sodium oxybate (REST-ON) trial post hoc analysis.
Methods: REST-ON (NCT02720744) was a Phase III, double-blind, placebo-controlled, multicenter, randomized clinical trial.