Consumer Use of Over-the-Counter Proton Pump Inhibitors in Patients With Gastroesophageal Reflux Disease

Sheikh, Imran; Waghray, Abhijeet; Waghray, Nisheet; Dong, Chunrong; Wolfe, M. Michael

doi:10.1038/ajg.2013.421

Cited by 42 publications

(28 citation statements)

References 15 publications

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“…However, more than 50% of GERD patients do not adhere to proper timing of PPI consumption when prescribed by a primary care physician. 88 Gunaratnam et al 89 showed that only 46% of refractory GERD patients were dosing their PPI optimally. Of those who dosed suboptimally, 39% took their PPI at bedtime, and 4% took it as needed.…”

Section: Dependency On Food For Efficacymentioning

confidence: 99%

Unmet Needs in the Treatment of Gastroesophageal Reflux Disease

Dickman

Maradey–Romero

Gingold‐Belfer

et al. 2015

J Neurogastroenterol Motil

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Gastroesophageal reflux disease (GERD) is a highly prevalent gastrointestinal disorder. Proton pump inhibitors have profoundly revolutionized the treatment of GERD. However, several areas of unmet need persist despite marked improvements in the therapeutic management of GERD. These include the advanced grades of erosive esophagitis, nonerosive reflux disease, maintenance treatment of erosive esophagitis, refractory GERD, postprandial heartburn, atypical and extraesophageal manifestations of GERD, Barrett's esophagus, chronic protein pump inhibitor treatment, and post-bariatric surgery GERD. Consequently, any future development of novel therapeutic modalities for GERD (medical, endoscopic, or surgical), would likely focus on the aforementioned areas of unmet need.

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Section: Dependency On Food For Efficacymentioning

confidence: 99%

Unmet Needs in the Treatment of Gastroesophageal Reflux Disease

Dickman

Maradey–Romero

Gingold‐Belfer

et al. 2015

J Neurogastroenterol Motil

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“…Although the proportion of patients taking OTC PPIs internationally is unknown, it may well represent the majority of use globally. A recent US survey [433] found that 32 % of patients with GERD symptoms were using OTC PPIs, with only 39 % of consumers using them optimally, with better symptom relief. Besides patients, 50 % of US gastroenterologists also use (i.e., suggest to patients) OTC PPIs [434].…”

Section: Discussionmentioning

confidence: 99%

Effective and safe proton pump inhibitor therapy in acid-related diseases – A position paper addressing benefits and potential harms of acid suppression

Scarpignato

Gatta

Zullo³

et al. 2016

BMC Med

351

288

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BackgroundThe introduction of proton pump inhibitors (PPIs) into clinical practice has revolutionized the management of acid-related diseases. Studies in primary care and emergency settings suggest that PPIs are frequently prescribed for inappropriate indications or for indications where their use offers little benefit. Inappropriate PPI use is a matter of great concern, especially in the elderly, who are often affected by multiple comorbidities and are taking multiple medications, and are thus at an increased risk of long-term PPI-related adverse outcomes as well as drug-to-drug interactions. Herein, we aim to review the current literature on PPI use and develop a position paper addressing the benefits and potential harms of acid suppression with the purpose of providing evidence-based guidelines on the appropriate use of these medications.MethodsThe topics, identified by a Scientific Committee, were assigned to experts selected by three Italian Scientific Societies, who independently performed a systematic search of the relevant literature using Medline/PubMed, Embase, and the Cochrane databases. Search outputs were distilled, paying more attention to systematic reviews and meta-analyses (where available) representing the best evidence. The draft prepared on each topic was circulated amongst all the members of the Scientific Committee. Each expert then provided her/his input to the writing, suggesting changes and the inclusion of new material and/or additional relevant references. The global recommendations were then thoroughly discussed in a specific meeting, refined with regard to both content and wording, and approved to obtain a summary of current evidence.ResultsTwenty-five years after their introduction into clinical practice, PPIs remain the mainstay of the treatment of acid-related diseases, where their use in gastroesophageal reflux disease, eosinophilic esophagitis, Helicobacter pylori infection, peptic ulcer disease and bleeding as well as, and Zollinger–Ellison syndrome is appropriate. Prevention of gastroduodenal mucosal lesions (and symptoms) in patients taking non-steroidal anti-inflammatory drugs (NSAIDs) or antiplatelet therapies and carrying gastrointestinal risk factors also represents an appropriate indication. On the contrary, steroid use does not need any gastroprotection, unless combined with NSAID therapy. In dyspeptic patients with persisting symptoms, despite successful H. pylori eradication, short-term PPI treatment could be attempted. Finally, addition of PPIs to pancreatic enzyme replacement therapy in patients with refractory steatorrhea may be worthwhile.ConclusionsOverall, PPIs are irreplaceable drugs in the management of acid-related diseases. However, PPI treatment, as any kind of drug therapy, is not without risk of adverse effects. The overall benefits of therapy and improvement in quality of life significantly outweigh potential harms in most patients, but those without clear clinical indication are only exposed to the risks of PPI prescription. Adhering with evidence-based ...

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“…These results suggest that azeloprazole sodium may be more effective when administered before a meal, as in the report about other PPIs. 13,14 Further study should be performed to show a definite difference or similarity before and after a meal.…”

Section: Discussionmentioning

confidence: 99%

“…Although the labels of most PPIs do not provide a recommended dosing time, PPIs should be taken before meals because they optimally suppress acid secretion when parietal cells are activated after food intake. 13,14 However, the preferred dosing time should be determined based on evidence; therefore, it is important to assess the effect of food on the pharmacokinetics (PK) and pharmacodynamics (PD) of PPIs. Azeloprazole sodium was synthesized to overcome issues associated with the metabolism of marketed PPIs by CYP2C19.…”

mentioning

confidence: 99%

Pharmacokinetics and Pharmacodynamics of Azeloprazole Sodium, a Novel Proton Pump Inhibitor, in Healthy Japanese Volunteers

Toda

Shiramoto

Komai

et al. 2017

The Journal of Clinical Pharma

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The pharmacokinetics (PK) and pharmacodynamics (PD) of proton pump inhibitors differ among cytochrome P450 (CYP) 2C19 genotypes. Therefore, we developed azeloprazole sodium (Z-215), a novel proton pump inhibitor, whose metabolism is not affected by CYP2C19 activity in vitro. However, the PK and PD of azeloprazole sodium have not been evaluated in Japanese subjects. We conducted an open-label, crossover study in healthy Japanese male volunteers to evaluate the plasma concentration and intragastric pH with respect to CYP2C19 genotype after repeated administration of 10, 20, and 40 mg azeloprazole sodium and 10 and 20 mg rabeprazole sodium (rabeprazole). The plasma concentration profile of azeloprazole sodium was similar among genotypes, whereas that of rabeprazole differed. The 24-hour intragastric pH ≥ 4 holding time ratio (pH ≥ 4 HTR) of azeloprazole sodium was similar among genotypes. The pH ≥ 4 HTR was 52.5%-60.3%, 55.1%-65.8%, and 69.4%-77.1% after administration of 10, 20, and 40 mg azeloprazole sodium, respectively, and 59.2%-72.3% and 64.4%-91.2% after administration of 10 and 20 mg rabeprazole, respectively, on the fifth day of dosing. The maximum plasma concentration (C ), area under the plasma concentration-time curve (AUC), and pH ≥ 4 HTR of azeloprazole sodium were proportional to dose. The C , AUC, and pH ≥ 4 HTR on day 5 were slightly higher following administration of 20 mg azeloprazole sodium before comparison with after a meal. No serious adverse events were observed. These results suggest that azeloprazole sodium is useful for treating gastroesophageal reflux disease in all CYP2C19 genotypes.

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Consumer Use of Over-the-Counter Proton Pump Inhibitors in Patients With Gastroesophageal Reflux Disease

Abstract: Patients receiving prescription PPI from a GI are more likely to be optimal users with better symptom control. Conversely, consumers are more likely to be suboptimal users with inadequate symptom control.

Cited by 42 publications

References 15 publications

Unmet Needs in the Treatment of Gastroesophageal Reflux Disease

Unmet Needs in the Treatment of Gastroesophageal Reflux Disease

Effective and safe proton pump inhibitor therapy in acid-related diseases – A position paper addressing benefits and potential harms of acid suppression

Pharmacokinetics and Pharmacodynamics of Azeloprazole Sodium, a Novel Proton Pump Inhibitor, in Healthy Japanese Volunteers

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