Increasing Body Mass Index Does Not Diminish Heartburn Relief in Patients Who Are Treated with Dexlansoprazole for NERD or Erosive Esophagitis: 6
Abstract
Purpose: To determine the effect of body mass index (BMI) on heartburn symptom severity and frequency in patients with nonerosive gastroesphophageal reflux disease (NERD) or erosive esophagitis (EE) treated with dexlansoprazole MR (DEX), lansoprazole (LAN), or placebo (PLB) once daily. Methods: This was a post hoc analyses of patients enrolled in phase 3 studies either assessing the efficacy and safety of DEX vs PLB for 24-hour heartburn relief of NERD or comparing DEX to LAN in EE healing. DEX 30 mg and PLB were administered to 315 and 317 endoscopically confirmed NERD patients in a randomized, double-blind, 4-week study. NERD patients were to have a ≥6-month history of heartburn and experiencing heartburn symptoms 4 out of 7 days prior to randomization. In two 8-week, double-blind, randomized healing studies, 2737 endoscopically confirmed EE patients received DEX 60 mg or LAN 30 mg. In all studies, the percentage of 24-hour heartburn free days was assessed by daily diary entries and heartburn severity was rated using a 5-point scale (0 = none to 4 = very severe). Patients with evaluable diary data and heartburn symptom severity data at baseline and during treatment were included in this analysis. Results are summarized by baseline BMI (kg/m2) and treatment group using descriptive statistics. Results: The distribution of patients with baseline BMI of <25, 25 to <30, and ≥30 in the NERD study was 190, 193, and 238, respectively, and 547, 1013, and 1132, respectively, in the…
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.
Read the paper
Related studies
- Improving sleep quality leads to better mental health: A meta-analysis of randomised controlled trials
- Tocilizumab in patients with severe COVID-19: a retrospective cohort study
- A new aging measure captures morbidity and mortality risk across diverse subpopulations from NHANES IV: A cohort study
- Fruit, vegetable, and legume intake, and cardiovascular disease and deaths in 18 countries (PURE): a prospective cohort study
- Are noise and air pollution related to the incidence of dementia? A cohort study in London, England
- Long COVID symptoms and duration in SARS-CoV-2 positive children — a nationwide cohort study
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.