Sleep disturbances are common in patients with gastroesophageal reflux disease (GERD). This study examined the effects of esomeprazole on nighttime heartburn, GERD-related sleep disturbances, sleep quality, work productivity, and regular activities.
This multicenter, randomized, double-blind, placebo-controlled trial included adults with GERD-associated sleep disturbances and moderate-to-severe nighttime heartburn (recorded by patient diary during screening). Patients received oral esomeprazole 40 mg (n = 220) or 20 mg (n = 226) or placebo (n = 229) once daily for 4 wk. The primary outcome was relief of nighttime heartburn. Secondary outcomes included resolution of sleep disturbances, sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire, and work productivity measured by the Work Productivity and Activity Impairment Questionnaire.
Nighttime heartburn was relieved in 53.1% (111/209), 50.5% (111/220), and 12.7% (28/221) of patients who received esomeprazole 40 mg, esomeprazole 20 mg, and placebo, respectively. Differences (95% CI) versus placebo were 40.5% (32.4%, 48.5%) and 37.8% (29.9%, 45.7%) and were highly significant (p < 0.0001). GERD-related sleep disturbances resolved in significantly more (p < 0.0001) patients who received esomeprazole 40 (73.7%) or 20 mg (73.2%) than in those who received placebo (41.2%). Both esomeprazole groups had greater PSQI global score changes from baseline (p < 0.0001 vs placebo) and more (p < 0.0001 vs placebo) work hours saved per week per patient compared with baseline (esomeprazole 40 mg, 11.6 h; esomeprazole 20 mg, 12.3 h; placebo, 6.2 h).
Esomeprazole reduced nighttime heartburn and GERD-related sleep disturbances and improved sleep quality and work productivity.
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This study was supported by AstraZeneca LP, Wilmington, Delaware.
We gratefully acknowledge Assunta Cuccia for trial management; Kathleen Spreen for her contribution to the study concept and design; Cheryl B. Marple for her assistance with the use of the assessment instruments; John Monyak and Charles Ling for statistical support; and Donna Curtis, Peter Todd, and Mary Wiggin for editorial assistance (funded by AstraZeneca LP). We also thank the other study team members, the staff of ICON Clinical Research and Quintiles Central Laboratory, the study site staff, all the patients who participated in the study, and the following primary investigators: J.D. Angeloni, Bala Cynwyd, PA; M.S. Avila, Hialeah, FL; F. Avni, Lake Worth, FL; J. Beckwith, Fort Worth, TX; W. Berry, Longmont, CO; M. Bowles, Wichita, KS; S. Brady, Naples, FL; R. Broker, Simpsonville, SC; P. Chen, Corpus Christi, TX; D.C. Chua, Oakbrook Terrace, IL; F. Cortese, Butte, MT; L.I. Cowan, Thornville, OH; A. Dahdul, Springfield, MA; S. Desautels, Salt Lake City, UT; J. Doyle, Lexington, KY; S. Duckor, Orange, CA; F. Eder, Endwell, NY; A. Elashker, Kingston, NY; S.K. Elliott, Evansville, IN; J. Fidelholtz, Cincinnati, OH; V. Fishbein, Hillsborough, NJ; C.L. Fisher, Newport News, VA; G.M. Flippo, Birmingham, AL; S. Gaddam, Garden Grove, CA; E. Gallup, Overland Park, KS; W.P. Gilbert, Johnson City, TN; H. Giller, Clive, IA; G.R. Gonzales, West Valley City, UT; R. Gupta, Florala, AL; C. Hall, Jackson, MS; T.M. Howard, Huntsville, AL; J. Hurtado, Tucson, AZ; W. Ignatowicz, Hillsboro, NJ; M. Jacobs, Las Vegas, NV; J.V. Jones, Jr., Ruston, LA; A.J. Kivitz, Duncansville, PA; V. Kolli, El Paso, TX; R. Krause, Chattanooga, TN; F.T. Kucer, Sellersville, PA; M. Kurtz, Oceanside, CA; T. Littlejohn, III, Winston-Salem, NC; J. Lowe, Ogden, UT; G.M. Mula, Covington, LA; R. Murphy, North Little Rock, AR; D. Pambianco, Charlottesville, VA; N. Patel, Kettering, OH; D.M. Paulson, Richmond, VA; K.J. Pierce, Northville, MI; J.E. Poulos, Fayetteville, NC; S. Prohaska, Kansas City, MO; M. Raikhel, Torrance, CA; C. Randall, San Antonio, TX; D. Riff, Anaheim, CA; M.A. Ringold, Christiansburg, VA; C. Rohr, Saginaw, MI; G. Rosman, Egg Harbor Township, NJ; S. Roth, Phoenix, AZ; L. Schmidt, Tucson, AZ; H. Schwartz, Miami, FL; L. Serbousek, Oklahoma City, OK; U. Shah, Hollywood, MD; G. Silver, Clearwater, FL; J. Stoker, Flint, MI; C. Strout, Mt. Pleasant, SC; G. Szenkiel, Perth Amboy, NJ; R. Tamayo, Altamonte Springs, FL; A.S. Thannoun, Amarillo, TX; J. Van Valkenburg, Medford, OR; J.L. Wang, Jefferson City, MO; S.J. Wegley, Seattle, WA; B.D. Winston, Houston, TX; A.H. Wong, Boca Raton, FL.