Publication:

A multicenter and post-marketing surveillance study to evaluate the safety and effectiveness of a sodium alginate-based raft-forming antacid oral suspension in Indian patients with heartburn and indigestion

Background This study evaluated the safety and effectiveness of a sodium alginate-based raft-forming antacid oral suspension in Indian patients with heartburn and indigestion.

Methods This multicenter post-marketing surveillance study, conducted across five centers in India, included adult patients with heartburn and indigestion prescribed a sodium alginate-based antacid suspension (10-20 ml after meals and at bedtime) for 7 days. Patients were evaluated on day 8 (±2). Effectiveness was assessed by adequate symptom relief, improvement in RDQ frequency and severity scores, reduction in symptom duration, and improvement in night-time symptoms. Safety was evaluated based on reported adverse drug reactions and global tolerability assessments by patients and investigators.

Results Of 319 enrolled patients, 297 completed the study. After 7 days, adequate relief was reported by 95.6% for heartburn and 96.6% for indigestion. RDQ frequency and severity scores significantly improved (both ~74-76% reduction; p<0.0001), with marked reductions in daily symptom duration and nighttime episodes. Only one non-serious, unrelated ADR was reported, and tolerability was rated “good” by ~90% of patients and investigators.

Conclusions The sodium alginate-based raft-forming antacid oral suspension provided effective relief of heartburn and indigestion, reflected by greater than 95% adequate relief rates, over 74% reductions in RDQ scores and marked decreases in symptom duration, with an acceptable safety and tolerability profile during the course of the study.