Clinical Therapeutics/Volume ], Number ], 2017 Analysis of 2-Week Data from Two Randomized, Controlled Trials Conducted in Subjects with Frequent Heartburn Treated with Esomeprazole 20 mg Philip O. Katz, MD 1 ; Anne Le Moigne 2 ; and Charles Pollack, MD, PhD 2 1 Albert Einstein Medical Center, Philadelphia, Pennsylvania; and 2 Pfizer Consumer Healthcare, Madison, New Jersey ABSTRACT Purpose: These secondary analyses used data from 2 similarly designed studies in subjects experiencing frequent heartburn to evaluate the efficacy of esome- prazole 20 mg once daily for 2 weeks, which reflects the approved over-the-counter dosage and duration. Methods: Subjects without endoscopically identified erosive esophagitis who were experiencing heartburn for Z6 months and Z4 of 7 days prior to baseline (study 1, N ¼ 368; study 2, N ¼ 349) were randomly assigned to receive double-blind treatment with esome- prazole 40 or 20 mg (administered as esomeprazole magnesium trihydrate 44.5 and 22.3 mg, respectively) or placebo once daily for 4 weeks. Subjects recorded the severity of heartburn in a daily diary, and inves- tigators assessed subjects at each study visit. Two-week assessments were the primary end points of interest in these analyses and included the percentage of subjects with complete heartburn resolution (no episodes during 7 consecutive days), time to sustained complete heart- burn resolution (the first of 7 consecutive episode-free days), and heartburn relief (no episodes other than r1 mild episode during 7 consecutive days). Findings: At week 2, the percentages of subjects who experienced complete heartburn resolution were signifi- cantly greater with esomeprazole 40 mg (study 1, 26.1%; study 2, 35.3%) and 20 mg (study 1, 25.2%; study 2, 35.7%) compared with placebo (study 1, 9.0%; study 2, 3.4%) (all, P r 0.001). Beginning on day 1, the percentages of subjects who experienced sustained heartburn resolution was significantly greater in the groups treated with esomeprazole 40 mg (study 1, 19%; study 2, 19%; P o 0.0001) and 20 mg (study 1, 10%; study 2, 15%; P o 0.05) compared with the group that received placebo (study 1, 2%; study 2, 1%). Additionally, at week 2, the percentages of subjects experiencing heartburn relief were significantly greater with esomeprazole 40 mg (study 1, 35.3%; study 2, 40.5%) and 20 mg (study 1, 34.5%; study 2, 46.4%) compared with placebo (study 1, 16.5%; study 2, 8.6%) (all, P r 0.001). Implications: The results of this study demonstrate that once-daily treatment with esomeprazole 20 mg for 2 weeks effectively resolved subjects' heartburn compared with placebo, beginning on day 1. Studies precede FDA Act 801 clinical trial registration and results submission requirements. (Clin Ther. 2017;]:]]]– ]]]) & 2017 Elsevier HS Journals, Inc. All rights reserved. Key words: esomeprazole, frequent heartburn, gas- troesophageal reflux, over-the-counter, proton pump inhibitor. INTRODUCTION The estimated prevalence of gastroesophageal reflux (GER) symptoms, including heartburn and/or acid regurgitation, ranges from 18% to 28% in North America and 9% to 34% in Europe, while in East Asia the rate is only 7% to 9%. 1,2 The occurrence of heartburn has been increasing each year, particularly in Western countries, and the prevalence increases with age. 1,3,4 The frequency and severity of GER symptoms vary from person to person; therefore, treatment must be tailored toward an individual's given symptom profile. 3,5 Both moderate and severe GER symptoms produce significant impairments in occupational and Accepted for publication March 15, 2017. http://dx.doi.org/10.1016/j.clinthera.2017.03.015 0149-2918/$- see front matter & 2017 Elsevier HS Journals, Inc. All rights reserved. ] 2017 1