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Armodafinil improves wakefulness and long-term episodic memory in nCPAP-adherent patients with excessive sleepiness associated with obstructive sleep apnea.

Roth T, Rippon GA, Arora S - Sleep Breath (2008)

Bottom Line: Armodafinil did not adversely affect desired nighttime sleep, and nCPAP use remained high (approximately 7 h/night).Adjunct treatment with armodafinil significantly improved wakefulness, long-term memory, and patients' ability to engage in activities of daily living in nCPAP-adherent individuals with ES associated with OSA.Armodafinil also reduced patient-reported fatigue and was well tolerated.

View Article: PubMed Central - PubMed

Affiliation: Henry Ford Hospital, Detroit, MI 48202, USA. Troth1@hfhs.org

ABSTRACT
Residual excessive sleepiness (ES) and impaired cognition can occur despite effective and regular nasal continuous positive airway pressure (nCPAP) therapy in some patients with obstructive sleep apnea (OSA). A pooled analysis of two 12-week, randomized, double-blind studies in nCPAP-adherent patients with ES associated with OSA evaluated the effect of armodafinil on wakefulness and cognition. Three hundred and ninety-one patients received armodafinil (150 or 250 mg) and 260 patients received placebo once daily for 12 weeks. Efficacy assessments included the Maintenance of Wakefulness Test (MWT), Cognitive Drug Research cognitive performance battery, Epworth Sleepiness Scale, and Brief Fatigue Inventory. Adverse events were monitored. Armodafinil increased mean MWT sleep latency from baseline to final visit by 2.0 min vs a decrease of 1.5 min with placebo (P < 0.0001). Compared with placebo, armodafinil significantly improved quality of episodic secondary memory (P < 0.05) and patients' ability to engage in activities of daily living (P < 0.0001) and reduced fatigue (P < 0.01). The most common adverse events were headache, nausea, and insomnia. Armodafinil did not adversely affect desired nighttime sleep, and nCPAP use remained high (approximately 7 h/night). Adjunct treatment with armodafinil significantly improved wakefulness, long-term memory, and patients' ability to engage in activities of daily living in nCPAP-adherent individuals with ES associated with OSA. Armodafinil also reduced patient-reported fatigue and was well tolerated.

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Related in: MedlinePlus

Patient disposition
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Fig1: Patient disposition

Mentions: Of 658 patients randomized, 651 were included in the safety analysis, and 601 were evaluable for efficacy (Fig. 1). Patient demographics and disease characteristics for all patients in the safety analyses are summarized in Table 1. The mean body mass index was 36.6 kg/m2. Patients reported high nightly nCPAP usage (mean [SD] hours of nightly use, armodafinil 6.9 [1.2] h; placebo 6.9 [1.0] h). The nCPAP therapy was effective, as shown by mean (SD) AHI values of 1.5 (3.3) and 1.2 (2.1) events/h in the armodafinil and placebo groups, respectively. Overall, 41% of patients had a history of hypertension at baseline.Fig. 1


Armodafinil improves wakefulness and long-term episodic memory in nCPAP-adherent patients with excessive sleepiness associated with obstructive sleep apnea.

Roth T, Rippon GA, Arora S - Sleep Breath (2008)

Patient disposition
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2194800&req=5

Fig1: Patient disposition
Mentions: Of 658 patients randomized, 651 were included in the safety analysis, and 601 were evaluable for efficacy (Fig. 1). Patient demographics and disease characteristics for all patients in the safety analyses are summarized in Table 1. The mean body mass index was 36.6 kg/m2. Patients reported high nightly nCPAP usage (mean [SD] hours of nightly use, armodafinil 6.9 [1.2] h; placebo 6.9 [1.0] h). The nCPAP therapy was effective, as shown by mean (SD) AHI values of 1.5 (3.3) and 1.2 (2.1) events/h in the armodafinil and placebo groups, respectively. Overall, 41% of patients had a history of hypertension at baseline.Fig. 1

Bottom Line: Armodafinil did not adversely affect desired nighttime sleep, and nCPAP use remained high (approximately 7 h/night).Adjunct treatment with armodafinil significantly improved wakefulness, long-term memory, and patients' ability to engage in activities of daily living in nCPAP-adherent individuals with ES associated with OSA.Armodafinil also reduced patient-reported fatigue and was well tolerated.

View Article: PubMed Central - PubMed

Affiliation: Henry Ford Hospital, Detroit, MI 48202, USA. Troth1@hfhs.org

ABSTRACT
Residual excessive sleepiness (ES) and impaired cognition can occur despite effective and regular nasal continuous positive airway pressure (nCPAP) therapy in some patients with obstructive sleep apnea (OSA). A pooled analysis of two 12-week, randomized, double-blind studies in nCPAP-adherent patients with ES associated with OSA evaluated the effect of armodafinil on wakefulness and cognition. Three hundred and ninety-one patients received armodafinil (150 or 250 mg) and 260 patients received placebo once daily for 12 weeks. Efficacy assessments included the Maintenance of Wakefulness Test (MWT), Cognitive Drug Research cognitive performance battery, Epworth Sleepiness Scale, and Brief Fatigue Inventory. Adverse events were monitored. Armodafinil increased mean MWT sleep latency from baseline to final visit by 2.0 min vs a decrease of 1.5 min with placebo (P < 0.0001). Compared with placebo, armodafinil significantly improved quality of episodic secondary memory (P < 0.05) and patients' ability to engage in activities of daily living (P < 0.0001) and reduced fatigue (P < 0.01). The most common adverse events were headache, nausea, and insomnia. Armodafinil did not adversely affect desired nighttime sleep, and nCPAP use remained high (approximately 7 h/night). Adjunct treatment with armodafinil significantly improved wakefulness, long-term memory, and patients' ability to engage in activities of daily living in nCPAP-adherent individuals with ES associated with OSA. Armodafinil also reduced patient-reported fatigue and was well tolerated.

Show MeSH
Related in: MedlinePlus