Efficacy, Safety, and Tolerability of Pantoprazole Magnesium in the Treatment of Reflux Symptoms in Patients With Gastroesophageal Reflux Disease (GERD): A Prospective, Multicenter, Post-Marketing Observational Study

Clin Drug Investig. 2014 Feb;34(2):83-93. doi: 10.1007/s40261-013-0135-4.

Abstract

Background: To improve proton pump inhibitor effects, pharmacological modifications have been developed such as the use of enantiomer molecules (e.g., S-omeprazole, S-pantoprazole, or dexlansoprazole), or addition of NaHCO3 (for an immediate release) or magnesium (with a lower absorption for a more sustained effect).

Objective: The objective of this study was to assess the efficacy, safety, and tolerability of pantoprazole magnesium 40 mg once daily for 4 weeks, on the relief of reflux symptoms in gastroesophageal reflux disease (GERD) patients.

Methods: A phase IV, open-label, prospective, multicenter study was designed. Patients included were prescribed pantoprazole magnesium 40 mg orally once daily for 28±2 days. All patients had a history of persistent or recurrent heartburn and/or acid regurgitation for at least 3 months. Effectiveness and tolerability data obtained from patients who completed a minimum of 4 weeks of pantoprazole magnesium treatment were considered for analysis.

Results: The account of baseline characteristics and demographics of GERD symptom intensity was made by analyzing the group of 4,343 patients that fulfilled all inclusion criteria; 54% were females (n=2,345) and 46% (n=1,998) males, with a mean age of 36.2±7.5 years. Severity of symptoms, assessed by the physician using the 4-point Likert scale, reduced by at least 80% from baseline intensity after treatment in the per protocol population. In the case of the intention-to-treat population, the improvement in symptom intensity was 73%. The number of patients that experienced any adverse events was 175/5,027 (3.48%).

Conclusions: Pantoprazole magnesium is a safe, effective, and well-tolerated drug that significantly improves GERD symptoms.

Publication types

  • Clinical Trial, Phase IV
  • Multicenter Study
  • Observational Study

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles / adverse effects
  • 2-Pyridinylmethylsulfinylbenzimidazoles / chemistry
  • 2-Pyridinylmethylsulfinylbenzimidazoles / therapeutic use*
  • Adult
  • Anti-Ulcer Agents / adverse effects
  • Anti-Ulcer Agents / chemistry
  • Anti-Ulcer Agents / therapeutic use*
  • Female
  • Gastroesophageal Reflux / drug therapy*
  • Gastroesophageal Reflux / physiopathology
  • Heartburn / drug therapy
  • Humans
  • Male
  • Pantoprazole
  • Prospective Studies
  • Proton Pump Inhibitors / adverse effects
  • Proton Pump Inhibitors / chemistry
  • Proton Pump Inhibitors / therapeutic use*
  • Salts
  • Treatment Outcome

Substances

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Anti-Ulcer Agents
  • Proton Pump Inhibitors
  • Salts
  • Pantoprazole