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Abstract: Poster Presentations |

ARMODAFINIL (R-MODAFINIL) FOR FATIGUE IN SARCOIDOSIS: NOT JUST TREATING HYPERSOMNOLENCE FREE TO VIEW

Robert P. Baughman, MD*; Atul Malhorta, MD; Victoria Surdulescu, MD; Elyse E. Lower, MD
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University of Cincinnati, Cincinnati, OH


Chest


Chest. 2009;136(4_MeetingAbstracts):128S. doi:10.1378/chest.136.4_MeetingAbstracts.128S
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Abstract

PURPOSE:  Sarcoidosis is associated with both fatigue and sleep apnea. We have previously reported treatment of sarcoidosis associated fatigue (SAF) with d-methylphenidate (Lower et al. Chest 2008; 133:1189–1195), but we did not evaluate those patients for sleep apnea or excessive daytime sleepiness. We have studied armodafinil (ARM) as a potential treatment for SAF.

METHODS:  Twenty patients with SAF underwent sleep studied: 4 had uncorrected obstructive sleep apnea and one had restless leg syndrome. Of the remaining 15, 14 had apnea hypopnea index (AHI) < 5, the other had an AHI=9/h. Nine were studied on their usual CPAP settings. These 15 pts were treated with ARM or placebo (PLA) in a double blind placebo controlled cross over study, with two weeks of PLA prior to each treatment regimen. One patient discontinued the study after one week of treatment because of increased anxiety. Night time polysomnography and mean sleep latency tests (MSLT) were completed after each treatment arm in 11 of the 14 patients who completed the entire treatment regimen. Fatigue was assessed using the Fatigue Assessment Scale (FAS), where a score of 22 or higher is associated with significant fatigue. The baseline FAS was determined after two weeks of placebo prior to each treatment arm and the change in score after 4 and 8 weeks of therapy was calculated.

RESULTS:  During therapy with ARM, the FAS score fell from the baseline value (−2 (14,–20) (Median (Range))) indicating less fatigue. During PLA, there was a significantly rise in the FAS (2 (14,–16), P < 0.05). Using polysomnography and MSLT, we found that half of the patients had excessive daytime sleepiness (MSLT < 8 minutes). For both groups, there was a significant difference in the change in FAS between the ARM and PLA: MSLT < 8 minutes: ARM: −2 (−11, 3), PLA: 5 (−7, 11), p < 0.05; MSLT > 8 minutes: ARM: −10 (−20, 14), PLA: 4 (0–14), p < 0.01.

CONCLUSION:  ARM was as effective in those without excessive daytime somnolence as those with hypersomnolence.

CLINICAL IMPLICATIONS:  Armodafinil reduced sarcoidosis associated fatigue.

DISCLOSURE:  Robert Baughman, Grant monies (from industry related sources) Cephalon provided funding for this study; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. Armodafinil is not approved for sarcoidosis associated fatigue.

Wednesday, November 4, 2009

12:45 PM - 2:00 PM


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