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

Troche, José María Remes; Sobrino-Cossío, Sergio; Soto-Pérez, Julio César; Teramoto-Matsubara, Óscar; Morales-Arámbula, M.; Orozco-Gamiz, Antonio; Cuesta, José Luis Tamayo de la; Mateos, Gualberto

doi:10.1007/s40261-013-0135-4

Cited by 6 publications

(4 citation statements)

References 28 publications

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“…Multiple proton pump inhibitors (PPIs) inhibit BCRP in vitro; however, pantoprazole and rabeprazole are the only two that meet the aforementioned criteria for consideration as clinical inhibitors (Tables 6 and 7); however, clinical and/or preclinical proof-of-concept studies have not been reported. Despite clear advantages to using an inhibitor with an acceptable safety profile such as pantoprazole (Remes-Troche et al, 2014) or rabeprazole (ZouboulisVafiadis et al, 2014), these drugs are not as potent BCRP inhibitors as the tyrosine kinase inhibitors (TKIs) with respect to the [I 2 ]/IC 50 values (Table 7), for which preclinical proof of concept has been demonstrated (Zaher et al, 2006 Curcumin also caused a small, but significant, decrease in the clearance of the CYP1A2 substrate caffeine (-29%) (Juan et al, 2007 (Table 6). As such, although using a PPI may minimize the safety risks, other drugs are expected to offer a superior in vivo inhibition profile, rendering data interpretation more straightforward.…”

Section: Orgmentioning

confidence: 99%

Breast Cancer Resistance Protein (ABCG2) in Clinical Pharmacokinetics and Drug Interactions: Practical Recommendations for Clinical Victim and Perpetrator Drug-Drug Interaction Study Design

Lee

O'Connor

Ritchie

et al. 2015

Drug Metabolism and Disposition

126

124

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Breast cancer resistance protein (BCRP; ABCG2) limits intestinal absorption of low-permeability substrate drugs and mediates biliary excretion of drugs and metabolites. Based on clinical evidence of BCRP-mediated drug-drug interactions (DDIs) and the c.421C>A functional polymorphism affecting drug efficacy and safety, both the US Food and Drug Administration and European Medicines Agency recommend preclinical evaluation and, when appropriate, clinical assessment of BCRP-mediated DDIs. Although many BCRP substrates and inhibitors have been identified in vitro, clinical translation has been confounded by overlap with other transporters and metabolic enzymes. Regulatory recommendations for BCRP-mediated clinical DDI studies are challenging, as consensus is lacking on the choice of the most robust and specific human BCRP substrates and inhibitors and optimal study design. This review proposes a path forward based on a comprehensive analysis of available data. Oral sulfasalazine (1000 mg, immediate-release tablet) is the best available clinical substrate for intestinal BCRP, oral rosuvastatin (20 mg) for both intestinal and hepatic BCRP, and intravenous rosuvastatin (4 mg) for hepatic BCRP. Oral curcumin (2000 mg) and lapatinib (250 mg) are the best available clinical BCRP inhibitors. To interrogate the worst-case clinical BCRP DDI scenario, study subjects harboring the BCRP c.421C/C reference genotype are recommended. In addition, if sulfasalazine is selected as the substrate, subjects having the rapid acetylator phenotype are recommended. In the case of rosuvastatin, subjects with the organic anion-transporting polypeptide 1B1 c.521T/T genotype are recommended, together with monitoring of rosuvastatin's cholesterol-lowering effect at baseline and DDI phase. A proof-of-concept clinical study is being planned by a collaborative consortium to evaluate the proposed BCRP DDI study design.

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Section: Orgmentioning

confidence: 99%

Breast Cancer Resistance Protein (ABCG2) in Clinical Pharmacokinetics and Drug Interactions: Practical Recommendations for Clinical Victim and Perpetrator Drug-Drug Interaction Study Design

Lee

O'Connor

Ritchie

et al. 2015

Drug Metabolism and Disposition

126

124

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“…According to their results, no additional improvements of reflux symptoms were observed in the patients who used mosapride combined with PPI compared to those who only received PPI ( 27 ). In the study of Remes-Troche et al, the severity of GERD symptoms decreased by at least 80% from the baseline after the treatment with pantoprazole magnesium ( 28 ). The study of Moraes-Filho et al was designed to compare the efficacy of pantoprazole and esomeprazole in GERD patients.…”

Section: Resultsmentioning

confidence: 99%

Gastrointestinal symptoms associated with gastroesophageal reflux disease, and their relapses after treatment with proton pump inhibitors: A systematic review

et al. 2017

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Gastroesophageal reflux disease (GERD) is a common functional gastrointestinal disorder with significant effects on the quality of life. The burden of GERD is soaring in Asia. Preventing symptom relapse is a therapeutic goal in GERD patients. Since proton pump inhibitors (PPI) are the first-line treatment of GERD, drug failure has become a major problem in the treatment procedure. We reviewed the literature in order to find articles related to comorbidities and symptoms affecting GERD from 1980 to 2015 via PubMed and Google Scholar using keywords such as ‘Gastroesophageal reflux disease’, ‘Gastrointestinal symptoms’ and Boolean operators (such as AND, OR, NOT). Due to the cost of PPI therapy and the high rate of GERD relapse after PPI therapy, demand for continuing this type of treatment is decreasing. Thus, we need to discover new approaches to treat the disease and also investigate the relationship between the treatment of GERD and its comorbidities and symptoms such as functional constipation.

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“…The CSR was defined for persons who specified no episodes of heartburn during the 7 days before the follow-up visit 26. Days to symptoms resolved was defined for the days from initial therapy to reflux symptom <3 points on the Likert scale 27. We defined symptom relapse as (1) ≥2 episodes of troublesome reflux symptoms per week that impair the quality of life, or (2) ingestion of PPIs for >7 days for symptom relapse 21.…”

Section: Methodsmentioning

confidence: 99%

<p>Clinical efficacy of 60-mg dexlansoprazole and 40-mg esomeprazole after 24 weeks for the on-demand treatment of gastroesophageal reflux disease grades A and B: a prospective randomized trial</p>

Chiang

Hsu

et al. 2019

DDDT

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Purpose: Research comparing the clinical efficacy of dexlansoprazole and esomeprazole has been limited. This study aims to compare the clinical efficacy of single doses of dexlansoprazole (modified-release 60 mg) and esomeprazole (40 mg) after 24-week follow-up in patients with mild erosive esophagitis. Methods: We enrolled 86 adult GERD subjects, randomized in a 1:1 ratio to two sequence groups defining the order in which they received single doses of dexlansoprazole (n=43) and esomeprazole (n=43) for 8 weeks as initial treatment. Patients displaying complete symptom resolution (CSR) by the end of initial treatment (8 weeks) were switched to on-demand therapy until the end of 24 weeks. Follow-up endoscopy was performed either at the end of 24 weeks or when severe reflux symptoms occurred. Five patients were lost to follow-up, leaving 81 patients (dexlansoprazole, n=41; esomeprazole, n=40) in the per-protocol analysis. Results: The GERDQ scores at 4-, 8-, 12-, 16-, 20-, and 24-week posttreatment were less than the baseline score. The CSR, rate of symptom relapse, days to symptom resolution, sustained healing rate of erosive esophagitis, treatment failure rate, and the number of tablets taken in 24 weeks were similar in both groups. The esomeprazole group had more days with reflux symptoms than the dexlansoprazole group (37.3±37.8 vs 53.9±54.2; P =0.008). In the dexlansoprazole group, patients exhibited persistent improvement in the GERDQ score during the on-demand period (week 8 vs week 24; P <0.001) but not in the esomeprazole group (week 8 vs week 24; P =0.846). Conclusions: This study suggests that the symptom relief effect for GERD after 24 weeks was similar for dexlansoprazole and esomeprazole. Dexlansoprazole exhibited fewer days with reflux symptoms in the 24-week study period, with better persistent improvement in the GERDQ score in the on-demand period. (ClinicalTrials. gov number: NCT03128736)

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

Cited by 6 publications

References 28 publications

Breast Cancer Resistance Protein (ABCG2) in Clinical Pharmacokinetics and Drug Interactions: Practical Recommendations for Clinical Victim and Perpetrator Drug-Drug Interaction Study Design

Breast Cancer Resistance Protein (ABCG2) in Clinical Pharmacokinetics and Drug Interactions: Practical Recommendations for Clinical Victim and Perpetrator Drug-Drug Interaction Study Design

Gastrointestinal symptoms associated with gastroesophageal reflux disease, and their relapses after treatment with proton pump inhibitors: A systematic review

<p>Clinical efficacy of 60-mg dexlansoprazole and 40-mg esomeprazole after 24 weeks for the on-demand treatment of gastroesophageal reflux disease grades A and B: a prospective randomized trial</p>

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