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.
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.