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Phase 4 study reveals promising efficacy and safety of dexlansoprazole to treat GERD

Phase 4 study reveals promising efficacy and safety of dexlansoprazole to treat GERD Phase 4 study reveals promising efficacy and safety of dexlansoprazole to treat GERD
Phase 4 study reveals promising efficacy and safety of dexlansoprazole to treat GERD Phase 4 study reveals promising efficacy and safety of dexlansoprazole to treat GERD

A phase IV, non-randomized, multicenter, open-label, uncontrolled, multi-country study was carried to investigate the safety and efficacy of dexlansoprazole modified-release in individuals suffering from erosive esophagitis and non-erosive reflux disease (NERD).

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Key take away

In gastroesophageal reflux disease (GERD) subjects, dexlansoprazole modified-release therapy depicts a positive efficacy and safety profile to treat both daytime and nighttime acid regurgitation and heartburn symptoms.

Background

A phase IV, non-randomized, multicenter, open-label, uncontrolled, multi-country study was carried to investigate the safety and efficacy of dexlansoprazole modified-release in individuals suffering from erosive esophagitis and non-erosive reflux disease (NERD).

Method

The trial enrolled 296 Asian participants (age ≥ 20 years) having typical GERD symptoms for at least six months and underwent endoscopy. Considering the endoscopic outcomes, participants were allocated to either (i) NERD arm (n=208): Participants received dexlansoprazole modified-release 30 mg once daily for four weeks, or (ii) EE arm (n=88): Participants received dexlansoprazole modified-release 60 mg once daily for eight weeks. The percentage of days that individuals did not witness any 24-hour acid regurgitation or heartburn was the major outcome.

Result

The therapy showed good tolerability with a low incidence of treatment-associated adverse events in both groups. During the therapeutic period, the median percentage of days that individuals did not witness any 24-hour and nighttime acid regurgitation or heartburn in both arms is shown in the table below:


Conclusion

Management of GERD patients with dexlansoprazole modified-release is effective and safe to relieve heartburn and acid regurgitation symptoms.

Source:

Journal of Neurogastroenterology and Motility

Article:

Phase 4 Study in Patients From Asia With Gastroesophageal Reflux Disease Treated With Dexlansoprazole

Authors:

Justin C Y Wu et al.

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