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GERD Induced Sleep Disorders and a Reversible Driving Impairment with Esomeprazole - A Prospective Pilot Study: 2010 ACG Governors Award Recipient for Excellence in Clinical Research


Johnson, David MD2; Holmes, Louise RN2; May, Jennifer PhD1; Ware, Catesby J. PhD1

American Journal of Gastroenterology: October 2010 - Volume 105 - Issue - p S13
Abstracts: ESOPHAGUS

1. Eastern Va Medical School, Norfolk, VA; 2. Digestive and Liver Disease Specialists, Norfolk, VA.

Purpose: Sleep dysfunction (e.g. sleep apnea) has been correlated with impaired psychomotor function including worsening driving simulator (DS) performance. Extreme lane variability increases the risk of simulator crash events. GERD impairs sleep quality and next day function as measured by quality of life and work productivity assessments.The aim of this study was to evaluate the potential for GERD induced sleep dysfunction on simulated driving and to assess the treatment effect of esomeprazole (ESO).

Methods: This prospective pilot-proof of concept study evaluated 11 healthy pts with well established GERD with nocturnal symptoms snf w/o known sleep disorder (9 women 2 males; age mean 49, sd 8.6 yrs/range 32-60). All were studied at baseline off protein pump inhibitor (PPI) therapy for at least 14 days and then again after 4 weeks of taking ESO 40mg q am. Testing was done in a validated commercial driving simulator STISIM Drive (Systems Technology, Inc) that responds to driver inputs (steering, throttle, brake) and generates realistic roadway images. Driving performance (standard deviation of lane variation-SDLP) over 60mins was measured every 0.5 second for the duration of the task. Subjects first completed a 10-minute practice drive that is similar to a city drive with stoplights, turns, pedestrians, and traffic, to help adaptation to the vehicle dynamics. Results were compared to 15 normal <60 yrs, 15 elderly normal (mean 78 yrs), and 15 sleep apnea patients.

Results: Primary measure of SDLP was compared across six consecutive 10-minute driving periods while subjects were on and off drug using repeated measures ANOVA. SDLP increased over time (p=0.002); (Figure 1) and improved with ESO (p=0.004). On ESO: overall average % nights with SD were reduced (62.5% vs. 9.5%; p<0.001), Epworth Sleepiness Scale (ESS) decreased to 5.9 + 3.5 from 7.9 + 2.5 (p=0.056) and GERD symptom score decreased from 2.10 to 0.33 (p <0.001).

Conclusion: GERD-induced SD has a previously unrecognized and significantly adverse effect on simulated driving performance, which improved with ESO treatment. The improved ESS score suggests that reduced sleepiness contributed to improved performance. Appropriate treatment for patients with GERD and nocturnal symptoms may have potentially new and life saving implications. Further prospective blinded controlled trials are warranted to validate these findings.

Disclosure: Dr Johnson - clinical investigator: AstraZeneca, Takeda,Esai Consultant - Takeda, Esai, Proctor and Gamble, Xenoport, Novartis.

This research was supported by an industry grant from Investigator initiated research grant.



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