Pharmacotherapy Improves Function in Patients With Narcolepsy in 'Real-World' Setting
SEATTLE, WA—Pharmacotherapy improves multiple domains of functioning in patients with central disorders of hypersomnolence (CDH) in a “real-world” tertiary care setting, according to data presented at SLEEP 2015.
Currently, therapy for CDH—which includes narcolepsy, idiopathic hypersomnias (IH), and hypersomnia due to other conditions—is “purely symptomatic and treatment effects are sparse,” noted lead study author Chunmei Cui, MD, of the Cleveland Clinic's Sleep Disorders Center in Cleveland, OH.
To investigate the impact of treatment of CDH on functional status, Dr. Cui and colleagues queried the Cleveland Clinic electronic medical record for ICD-9 diagnoses of narcolepsy and IH from 2008–2010. A total of 95 subjects aged ≥18 years old who had completed Sleep Disorders Center patient-reported outcomes (PROs) at baseline and at least six months later were included in the analysis.
The PROs were obtained through the Clinic's electronic data collection system and included the Epworth Sleepiness Scale (ESS), Fatigue Severity Scale (FSS0), Functional Outcomes of Sleep Questionnaire (FOSQ), and Patient Health Questionnaire-9 (PHQ9); also recorded was total sleep time, in hours.
“Electronic medical record review collected demographic data and CDH pharmacotherapy at each time point,” Dr. Cui noted.
Of the 95 patients, 42 had IH and 53 had narcolepsy; 28.4% were male, 44.2% had sleep apnea, 64.4% were using CPAP, 8.5% were taking medication, and 26.3% had comorbid depression. At baseline, 28 patients were newly treated and 67 were on medication. At follow-up, among the newly treated group, 24 were on monotherapy and four were on polytherapy; in the group on medication, four were taking no medication; 33, monotherapy; and 30, polytherapy.
Mean changes in ESS, FSS, and FOSQ were higher, but not statistically significant, in those with medication change and not statistically significant between mono- and polytherapy groups. Compared with IH, patients with narcolepsy were more likely to use polytherapy at follow-up and to have changed to polytherapy (52.8% vs. 14.3%, P<0.001 for both). Addition of sodium oxybate was associated with reduction in other medications in 40.7% of those with narcolepsy, who also experienced a greater reduction in ESS compared with other treatments.
“These clinic-based effectiveness data enhance existing clinical trial data demonstrating reduced sleepiness in narcolepsy,” Dr. Cui concluded.