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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

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.

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Acknowledgments

The current study was sponsored by Nykomed, Mexico. Nykomed did not participate in the writing of this article or in the decision to submit the article for publication. José M. Remes-Troche has received consultancy honoraria from Takeda, Janssen, and AstraZeneca. Antonio Orozco-Gamiz has worked as a speaker for Takeda, GlaxoSmithKline, and Bristol-Myers Squibb. Julio César Soto-Pérez, Oscar Teramoto-Matsubara, Gualberto Mateos, Sergio Sobrino-Cossío, Miguel Morales-Arámbula, and José Luis Tamayo de la Cuesta have no conflicts of interest that are directly relevant to the content of this study.

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Correspondence to José María Remes-Troche.

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Remes-Troche, J.M., Sobrino-Cossío, S., Soto-Pérez, J.C. et al. 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 34, 83–93 (2014). https://doi.org/10.1007/s40261-013-0135-4

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Keywords

  • Omeprazole
  • Clostridium Difficile Infection
  • Pantoprazole
  • Rabeprazole
  • Reflux Symptom