Abstract
Purpose: Nocturnal heartburn (HB) and sleep disturbances commonly occur in patients with GERD and may have a significantly negative impact on quality of life and work productivity. This study evaluated the effects of dexlansoprazole MR (DEX), a PPI with a Dual Delayed ReleaseTM formulation, on work productivity and regular daily activities in GERD patients with nighttime symptoms and GERD-related sleep disturbances. Methods: A multicenter, randomized, double-blind, placebo controlled, parallel group trial in patients aged 18-66 with symptomatic GERD, a history of nocturnal HB and GERD associated sleep disturbances, with no esophageal erosions based on endoscopy. Patients enrolled had moderate to very severe nocturnal HB and GERD-related sleep disturbances for at least 3 of 7 nights based on twice daily diary entries, and were randomized within 4 days after this 7 night diary qualification. Patients received DEX 30mg or placebo (PBO) orally, every morning for 4 weeks. At baseline and at the end of week 4, patients completed the Work Productivity Activity Impairment-Specific Health Problem (WPAI-SHP) questionnaire, a validated 6-item questionnaire. The WPAI-SHP was used to assess the impact of GERD-related sleep disturbances on impairment of work productivity and regular activities. Subscales were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. Changes from baseline to week 4 in WPAI-SHP endpoints were analyzed using analysis of covariance with treatment as the factor and the baseline value as a covariate. Results: 305 patients were randomized into the study, mean age 44 yrs, 110 men (36%) and 195 women (64%). Baseline characteristics were similar between the treatment groups. For each subscale, only patients with baseline and Week 4 data available were included in each analysis. 184 patients reported being employed at both baseline and week 4. As measured by change from baseline, DEX patients had a significantly greater decrease in impairment of regular daily activities compared to PBO. Among those employed, DEX patients had a significantly greater decrease in impairment of overall work productivity compared to PBO (Table).TableConclusion: DEX 30 mg is effective in improving overall work productivity and decreasing impairment of regular daily activities in patients with significant complaints of nighttime HB and associated sleep disturbances. Sponsored by Takeda Global Research & Development Center, Inc., Deerfield, IL, USA. Disclosure: David Johnson - Consultant: Takeda, AstraZeneca, Esai, Novartis; Research Support: Takeda, AstraZeneca; Clinical Investigator; Takeda, AstraZeneca, Novartis. William Orr-Speaker, Consultant, Research Support: Takeda Ronnie Fass - Consultant: Takeda, Xenoport, Vecta, Eisai, Salix; Research Support: Takeda, Wyeth, AstraZeneca, Sucampo; Speakers Bureau: Eisai, Takeda. M Claudia Perez, Cong Han, Reema Mody, Kathleen Stern - Employee: Takeda.
Published Version
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