Presentation: The Effect of Modafinil on Fatigue and Cognitive Function in Patients with Sjögren’s Syndrome (2007)

1097 The Effect of Modafinil on Fatigue and Cognitive Function in Patients with Sjögren’s Syndrome

Sjögren’s Syndrome SS) has many extraglandular manifestations; fatigue and altered cognitive function are among the most troubling for many patients. Most attempts to solve these issues have focused on improving sleep or treating depression. Modafinil (M) is a eugeroic drug generally prescribed to treat narcolepsy, meant for the treatment of narcolepsy, obstructive sleep apnea and shift work sleep disorder. In some countries, it is also approved for idiopathic hypersomnia, but independent studies have shown benefit in several chronic autoimmune diseases, including patient’s with multiple sclerosis and primary biliary cirrhosis.
The exact mechanism of action of M is unclear, although in vitro studies have shown it to inhibit the reuptake of dopamine and, more potently, norepinephrine. M is thought to have less potential for abuse than other stimulants due to the absence of any significant euphoric or pleasurable effects. The purpose of this study was to explore the benefits of M on the debilitating fatigue and cognitive function experienced by the majority of SS patients.
Forty two patients with SS, 38 females and four males were given both the Epworth Sleepiness Scale (ESS) and the Krupp Fatigue Severity Scale FSS) before starting M. On the ESS, a maximum score is 21, with a score of 10 indicating excessive daytime sleepiness. The mean score for the SS patient’s was 16.1 +/- 3.3. For the FSS the maximal score is 70 and scoring 36 or higher indicates excessive fatigue. The SS patients pre-treatment score was 52.4 +/- 5.7. The SS patients were divided into two groups of 21, one group receiving a morning dose of 100 mg of M, and the second group 200mg. After 30 days on M the ESS and FSS tests were again taken by the two dosage groups. The 100 mg M group improved to 9.3 +/- 2.8 (p <0.01) for the ESS and 39.6 +/- 3.7 (p<0.02), while the 200 mg M group had slightly better scores: 9.0 +/- 2.6 (p<0.01) for the ESS and 36.1 +/- 3.8 (p<0.01) on the FSS. Most patients in the two dosage groups subjectively felt major improvement in cognitive clarity. Only two patients quit their medication, and both were in the 200mg group, one for anxiety and the other for tremor.
Paradoxical improvement in sleep was perceived by 36 of 40 patients finishing the trial.
Modafinil may represent and new and effective approach to treating two of the most debilitating clinical problems faced by SS patients.

  T.C. Namey, Pfizer, 8.