TY - JOUR
T1 - Health-related quality of life effects of modafinil for treatment of narcolepsy
AU - Beusterien, Kathleen M.
AU - Rogers, Ann E.
AU - Walsleben, Joyce A.
AU - Emsellem, Helene A.
AU - Reblando, Joseph A.
AU - Wang, Lixia
AU - Goswami, Meeta
AU - Steinwald, Bruce
PY - 1999/9/15
Y1 - 1999/9/15
N2 - Objective: To evaluate the burden of illness of narcolepsy and assess the health-related quality-of-life (HQL) effects of oral modafinil, a wake- promoting therapy for excessive daytime sleepiness associated with narcolepsy. Methods: Subjects with narcolepsy enrolled in a nine-week, placebo-controlled, double-blind study and were randomized to placebo, modafinil 200 mg, or modafinil 400 mg. After the study, consenting subjects received modafinil in a 40-week open-label extension. A self-administered HQL questionnaire consisting of the 36-Item Short Form Health Survey (SF-36) and supplemental narcolepsy-specific scales was given to subjects at baseline, study endpoint, and several open-label timepoints. Results: 481 subjects completed a baseline and double-blind endpoint HQL assessment. Compared to population norms, baseline HQL scores reflected substantial burden in vitality, social functioning, and performing usual activities. At study endpoint, subjects in the 400 mg modafinil group had significantly higher scores than placebo for 10 of the 17 HQL scales. The 400 mg modafinil group had more energy, fewer difficulties performing usual activities, fewer interferences with social activities, improved psychological well-being and higher productivity, attention and self-esteem compared to placebo subjects (p<.05). The positive treatment effects were sustained over the open-label extension. Conclusion: Modafinil significantly improves health-related quality of life in narcolepsy.
AB - Objective: To evaluate the burden of illness of narcolepsy and assess the health-related quality-of-life (HQL) effects of oral modafinil, a wake- promoting therapy for excessive daytime sleepiness associated with narcolepsy. Methods: Subjects with narcolepsy enrolled in a nine-week, placebo-controlled, double-blind study and were randomized to placebo, modafinil 200 mg, or modafinil 400 mg. After the study, consenting subjects received modafinil in a 40-week open-label extension. A self-administered HQL questionnaire consisting of the 36-Item Short Form Health Survey (SF-36) and supplemental narcolepsy-specific scales was given to subjects at baseline, study endpoint, and several open-label timepoints. Results: 481 subjects completed a baseline and double-blind endpoint HQL assessment. Compared to population norms, baseline HQL scores reflected substantial burden in vitality, social functioning, and performing usual activities. At study endpoint, subjects in the 400 mg modafinil group had significantly higher scores than placebo for 10 of the 17 HQL scales. The 400 mg modafinil group had more energy, fewer difficulties performing usual activities, fewer interferences with social activities, improved psychological well-being and higher productivity, attention and self-esteem compared to placebo subjects (p<.05). The positive treatment effects were sustained over the open-label extension. Conclusion: Modafinil significantly improves health-related quality of life in narcolepsy.
KW - Modafinil
KW - Narcolepsy
KW - Quality of Life
KW - Sf-36
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U2 - 10.1093/sleep/22.6.757
DO - 10.1093/sleep/22.6.757
M3 - Article
C2 - 10505821
AN - SCOPUS:0033568724
SN - 0161-8105
VL - 22
SP - 757
EP - 765
JO - Sleep
JF - Sleep
IS - 6
ER -