Armodafinil for sarcoidosis-associated fatigue: a double-blind, placebo-controlled, crossover trial.
BACKGROUND
Fatigue has been identified in more than one-half of patients with sarcoidosis. Although fatigue is not synonymous with impaired quality of life, most studies of sarcoidosis identify fatigue as a major cause of impaired quality of life.


OBJECTIVE
To test the hypothesis that stimulants may have a role in the treatment of fatigued sarcoidosis patients, even without objective evidence of daytime sleepiness.


METHODS
This was a double-blind, placebo-controlled, crossover study of sarcoidosis patients followed up in one sarcoidosis clinic Sarcoidosis patients with fatigue received either armodafinil or placebo with eight weeks of therapy for each arm and a two week washout period before crossover to the other treatment. Initial armodafinil dose was 150mg and increased to 250mg after four weeks. Patients underwent polysomnography and multiple sleep latency testing (MSLT) the following day. Patients with an apnea/hypopnea index <6/hour received either armodafinil or placebo. Polysomnography with MSLT was repeated after each treatment arm.


RESULTS
Fifteen patients received the study drug. Fatigue was assessed using the Fatigue Assessment Scale (the lower the score, the less the fatigue) and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (the higher the score, the less the fatigue). After eight weeks of therapy, there was a significant improvement in the Fatigue Assessment Scale during armodafinil treatment (median -4.5, range -20, 5) compared with placebo treatment (median 3.5, range -9, 14, P<0.05) and for the FACIT-F (armodafinil: median 9, range -12, 26 vs. placebo: median -5, range -17, 11, P<0.005). This improvement in fatigue was seen for both those with and without shortened sleep onset latency time during the MSLT.


CONCLUSIONS
Armodafinil treatment led to a significant reduction in fatigue in sarcoidosis patients. This effect was seen even in patients who did not have excessive daytime somnolence.
Department of Medicine, University of Cincinnati, Cincinnati, Ohio 45267, USA.
Elyse E
EE
Lower
Atul
A
Malhotra
Victoria
V
Surdulescu
Robert P
RP
Baughman
D000328:Adult; D001559:Benzhydryl Compounds / Q000008:administration & dosage*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005221:Fatigue / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D015990:Placebo Effect; D012507:Sarcoidosis / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology*; D012891:Sleep Apnea Syndromes / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology*; D016896:Treatment Outcome
D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D000077408:Modafinil