Effect of Dexlansoprazole MR on Improving Work Productivity and Daily Activities in Patients with Symptomatic Nonerosive GERD: 31
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 305 participants or records.
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