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

Imran Sheikh MD; Abhijeet Waghray MD; Nisheet Waghray MD; Chunrong Dong PhD; M Michael Wolfe MD

Disclosures

Am J Gastroenterol. 2014;109(6):789-794. 

In This Article

Abstract and Introduction

Abstract

Objectives. Optimal administration of proton pump inhibitor (PPI) for the treatment of gastroesophageal reflux disease (GERD) requires consideration of meal timing. Since becoming available over the counter (OTC), no studies have assessed treatment patterns and symptom control in OTC consumers. The objective of this study was to survey dosing patterns and symptom control in OTC and prescription PPI users.

Methods. Patients at five clinics were surveyed regarding diagnosis of GERD, use of OTC or prescription PPIs, information on time of day dosing, demographics, and Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS; 2001, Johnson & Johnson).

Results: Of the 1,959 patients surveyed, 610 (31%) used PPIs for GERD. Of these, 190 (31%) and 223 (37%) received prescriptions from gastroenterologists (GIs) and primary care physicians (PCPs), respectively; 197 (32%) purchased OTC PPIs. Of the patients prescribed PPIs by GIs, 71% were optimal users, whereas 47% of patients receiving prescriptions from PCPs and 39% of consumers used PPIs optimally (P<0.001 compared with GIs). GSAS symptom, frequency, and severity scores were significantly better in patients prescribed PPIs by GIs (all P<0.001, GI compared with PCP and consumer). GSAS symptom, frequency, and severity scores were also significantly better in patients using PPIs optimally (P<0.001 for all parameters) compared with those taking PPIs suboptimally or excessively.

Conclusions: 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.

Introduction

Gastroesophageal reflux disease (GERD) accounts for a substantial number of physician office visits, with a very high prevalence in Western countries.[1] In the United States, it is estimated that 44% of the adult population experience heartburn at least once a month, with 7% experiencing symptoms daily.[2] Direct costs of GERD amount to $10 billion/year, with indirect costs related to lost work productivity estimated as high as $75 billion/year.[3,4] Several forms of medical treatment are available, including prokinetic, mucosal protecting, and antisecretory agents. Proton pump inhibitors (PPIs) are superior in providing symptomatic relief and healing of mucosal injury;[5,6] and although they have a relatively safe profile, their long-term safety has recently been questioned.[7]

PPIs are prodrugs that require acid activation for maximum effectiveness, resulting in a delayed onset of acid inhibition. They noncompetitively antagonize H+,K+ adenosinetriphosphatase (H+,K+ ATPase), the enzyme in gastric parietal cells responsible for transporting H+ ions into the gastric lumen. PPIs are thus potent inhibitors of acid secretion, thereby increasing intragastric pH while decreasing gastroesophageal reflux. Sequential doses of PPIs result in decreased acid secretion until a steady state is reached by day 7 of use; therefore, "as needed" dosing of these agents should not be expected to effectively relieve symptoms. PPIs control acid secretion optimally when parietal cells have been stimulated, which occurs after food consumption, and they should thus only be taken before a meal, generally the first dose administered before breakfast and a second dose, if indicated, before dinner.[8–11]

Since their introduction in the late 1980s, PPIs are increasingly prescribed by primary care providers and are readily available over the counter (OTC). Prior studies have demonstrated that primary care physicians (PCPs) infrequently instruct patients about optimal time dosing of PPIs,[6] but to date no study has compared either dosing practices of OTC and prescription PPI users or the drugs' effectiveness in these groups. This study compares OTC with prescription PPI users, evaluating treatment patterns and symptom control in each group.

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