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.
| Autor: | Remes-Troche JM; Digestive Physiology and Motility Lab, Instituto de Investigaciones Médico Biológicas, Universidad Veracruzana, Iturbide SN. Col Centro, Veracruz, VER, 91400, Mexico, jose.remes.troche@gmail.com., Sobrino-Cossío S, Soto-Pérez JC, Teramoto-Matsubara O, Morales-Arámbula M, Orozco-Gamiz A, Tamayo de la Cuesta JL, Mateos G |
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| Jazyk: | angličtina |
| Zdroj: | Clinical drug investigation [Clin Drug Investig] 2014 Feb; Vol. 34 (2), pp. 83-93. |
| DOI: | 10.1007/s40261-013-0135-4 |
| Abstrakt: | 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. |
| Databáze: | MEDLINE |
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