Esomeprazole Treatment of Frequent Heartburn: Two Randomized, Double-Blind, Placebo-Controlled Trials

Abstract

A 14-day regimen of esomeprazole 20 mg once daily was effective for treating frequent heartburn in subjects who are likely to self-treat with over-the-counter medications.

Analysis of 2-Week Data from Two Randomized, Controlled Trials Conducted in Subjects with Frequent Heartburn Treated with Esomeprazole 20 mg

“…16 The current findings are consistent with those from 2 recently published clinical studies of esomeprazole 20 mg given over 2 weeks in subjects with frequent heartburn who were likely to use an OTC PPI. 18 Likewise, these data are consistent with those from 2-week studies of other OTC PPIs, including omeprazole and lansoprazole, available in some countries. Those studies demonstrated the efficacy of OTC PPI treatment using many of the end points included in the present analyses.…”

A 14-day regimen of esomeprazole 20 mg/day for frequent heartburn: durability of effects, symptomatic rebound, and treatment satisfaction

“…[8] Similar results were seen for heartburn-free days and nights. These effects were observed with esomeprazole 20 mg as early as the first four days of treatment, with significantly more subjects experiencing heartburn-free 24-hour days during this period (P = 0.0053 and P < 0.0001 vs. placebo in Study 1 and Study 2, respectively).…”

“…The conduct of these studies has been published in detail previously [8] and is summarized here briefly. Both studies were conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and are consistent with International Council for Harmonisation and Good Clinical Practice.…”

“…[8] An important concern associated with a 2-week treatment course with a PPI is the loss of treatment effects after the medication is stopped at the end of the treatment period, an effect that has been observed with another OTC PPI. [9] Additionally, there is the potential for experiencing symptomatic rebound or acid hypersecretion following the cessation of PPI treatment, which has been observed in asymptomatic volunteers following withdrawal of a PPI, [10,11] but these effects have not been consistently reported and have primarily been observed with long-term treatment.…”

“…[6,7] Esomeprazole has been shown to be an effective remedy for frequent heartburn in two identical randomized, double-blind, placebo-controlled studies in a population of subjects who are likely to self-treat with OTC medications without consulting a healthcare provider. [8] In both studies, the active treatment phase was followed by a 7-day placebo follow-up phase, which allowed for evaluating the duration of effect after treatment was stopped. Results of the primary and secondary efficacy endpoints relating to heartburn from these trials have been published elsewhere and are briefly summarized below.…”