A Randomized Open-Label Study of Two Methods of Proton Pump Inhibitors Discontinuation
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Background Proton pump inhibitors (PPIs) are effective in treating gastroesophageal reflux disease (GERD). Unfortunately, they are often inappropriately prescribed and long-term use has potential adverse effects. A single best method for discontinuation of PPIs does not currently exist. The objective of this study was to determine if there is a significant difference in successfully discontinuing PPI use at 12 months between patients discontinuing abruptly or tapering first. Methodology We conducted a randomized trial with 38 patients diagnosed with GERD. We collected six weekly and then monthly surveys of symptoms based on the Dyspepsia Symptom Severity Index. Chart review at 12 months determined whether the patient was able to discontinue PPI. Results A Kaplan-Meier survival analysis at 12 months did not show a statistically significant difference between the abrupt and taper groups for discontinuation of PPI medication (p = 0.75). Cox regression analysis showed no association of alcohol use, smoking, or caffeine use with failure to discontinue PPI, but H2 blocker use was associated with a 79% reduction in risk of failure to discontinue PPI (p = 0.004). The taper group had significantly less symptoms 14, 18, 22, and 30 weeks after discontinuation. Conclusions Our study suggests that there is no difference in successful discontinuation of PPIs between abrupt and taper methods at 12 months; however, there are less symptoms in the taper method, and H2 blocker use is associated with success. Further study is needed with larger numbers of participants and randomization of H2 blocker use.Keywords:
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Objective Clinically, patients with proton pomp inhibitor (PPI)-resistant gastroesophageal reflux disease (GERD) are very challenging to treat. The aim of this study was to determine the rates of symptom relief and adverse events among PPI-resistant GERD patients that changed their therapy from a PPI to vonoprazan.
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Gastroesophageal reflux disease (GERD) affects 10–20% of adults in Western countries (1,2) and 13% of Americans use medications for GERD at least twice weekly (3). In the USA alone, it is estimated that the annual direct and indirect costs incurred due to GERD is approximately $10 billion (4).
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Purpose: The aim of this study was to describe GERD patients who initiated dexlansoprazole (DEX), a new proton pump inhibitor (PPI) with dual delayed release (DDR)TM technology. Methods: Using the HealthCore Integrated Research Database (HIRDTM), patients with ≥ 1 medical claim for GERD (ICD-9 codes 530.10, 530.11, 530.12, 530.19, 530.81, 530.12 or 787.1x) and ≥ 1 pharmacy claim for DEX 30 mg or 60 mg between 01/01/2009 to 12/31/2009 and continuous eligibility for 6 months prior to the index date were identified. The index date was defined as date of the first pharmacy claim for DEX. Baseline demographic, clinical and treatment characteristics were described for GERD patients initiating DEX. Results: 6,520 GERD patients were on DEX during the study period, with a mean (±SD) age of 48.7 (±12) years, and 60% were female. Almost all patients (99%) were on the indicated once-a-day dosing regimen. The treating physician specialties for the DEX users were: 34% primary care providers, 33% gastroenterologists, 7% otolaryngology, 7% non-physician, 11% were other physician specialties and 10% had missing data. Among DEX users, 55% did not have any claim for a prescription PPI in the previous 6 months. Of the 45% of DEX users (n=2,692) who used a PPI immediately prior to initiation of DEX, 41% switched from lansoprazole, 33% from esomeprazole, 21% from omeprazole and 3% from rabeprazole. Eleven percent (n=716) of DEX users switched from previous twice a day (BID) PPI regimen (35% were on BID lansoprazole, 26% on BID esomeprazole, 22% on BID omeprazole, and 14% on BID pantoprazole) to once-a-day DEX. Among DEX users, who were previously on BID PPIs, 7% had claims for Barrett's esophagus compared to 4.5% among overall DEX users (p<0.05). In the 6 month follow-up period for 1,379 DEX users, 70% of patients had ≥2 prescription fills for DEX [Mean (SD) fills=3.4 (2.1)]. Conclusion: More than half of GERD patients initiating DEX did not have recorded prescription PPI use within the last 6 months. 99% of patients were on the indicated once-a-day dosing regimen. 11% of DEX users were previously on BID PPI regimens. Future studies should evaluate symptom relief and potential cost savings associated with switching patients from BID PPI regimen to DEX.
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Purpose: To assess patient and physician perceptions and knowledge regarding proton pump inhibitor (PPI) use with emphasis on mealtime dosing directions (i.e., taken 30-60 minutes before meals). Methods: In this ongoing, nationally-representative, survey coupled with a longitudinal medical chart review study, primary care physicians (PCP) and gastroenterologists (GE) treating GERD patients, and patients with GERD taking a prescription PPI, were asked about their perceptions regarding the use of PPIs. Based on a modified Health Belief Model, perceived importance and inconvenience of mealtime-related dosing directions (7-point Likert scale) and perceived susceptibility of worsened GERD when PPI dosing directions were/were not followed (5-point scale) were collected. Results: For this interim analysis, 267 patients (mean age 52 years, 40% male, 80% Caucasian, 43% with college degree) and 105 physicians (83 PCP, 22 GE) completed the survey. Patients had physician-diagnosed GERD for an average of 2 years, with 17% erosive, 54% nonerosive GERD (29% undocumented). Physicians were 76% male, 47% solo vs group practice, with an average of 369 GERD patients managed in the past 6 months. For the 6 PPIs studied, many physicians incorrectly identified mealtime-related dosing directions (from 23% for esomeprazole to 69% for pantoprazole). Correspondingly, 36% of patients taking PPIs with mealtime-related dosing directions reported they did not receive such directions. Patients perceived mealtime dosing directions as less inconvenient than physicians [mean/SD scores 1.6/1.1 vs. 4.7/1.5, p<0.001]. Both groups indicated taking PPIs as directed was important, with physicians indicating greater importance than patients (mean/SD: 5.2/1.2 vs. 4.5/1.6, p<0.001). 81% of physicians believed PPI mealtime-related dosing directions would reduce adherence. Patients receiving specific mealtime-related dosing directions were more likely to perceive that PPIs would not work if not taken as directed, compared to those not receiving such direction (56% vs. 48%, p<0.05). Patients, compared with physicians, perceived a greater chance of GERD worsening if PPIs were not taken as directed (74% patients reporting high/very high vs. 37%, p<0.001). Conclusion: A sizeable proportion of physicians were unaware of mealtime dosing directions for PPIs, which may affect patients' proper administration of their PPI and consequently PPI effectiveness. Understanding the knowledge gaps between patients and physicians on GERD and PPI use may inform future interventions to improve patient adherence to specific dosing instructions. Disclosure: Dr. Solem - Contracted research vendor for Takeda Pharmaceuticals International, Dr. Mody - Employee: Takeda Pharmaceuticals International, Dr. Stephens - Contracted research vendor for Takeda Pharmaceuticals International, Mrs. Macahilig - Contracted research vendor for Takeda Pharmaceuticals International, Dr. Tran Carpiuc - Contracted research vendor for Takeda Pharmaceuticals International, Dr. Gao - Contracted research vendor for Takeda Pharmaceuticals International. This research was supported by an industry grant from Takeda Pharmaceuticals International, Inc. funded this project.
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This article reviews the available endoscopic treatments for gastroesophageal reflux disease (GERD). Plicating gastric folds methods, like Bard's EndoCinch method (Endoscopic Gastroplication, ELGP method), NDO Surgical's Full-thickness Plicator method, and Wilson-Cook Medical's Endoscopic Suturing Device (ESD) method, are used to form new plications in the cardia. Alternatively, thermal tissue remodeling/neurolysis methods, like Curon Medical's Stretta System, can be used to denature the muscular layer of the lower esophageal sphincter (LES) region. Finally, bulking injection methods, like Boston Scientific's Enteryx Procedure and Medtronic's Gatekeeper Reflux Repair System, can be used to insert a foreign body into the LES region. All six methods resulted in the improvement of symptoms and acid reflux, but only the bulking injection methods caused an improvement of the manometric findings. Nevertheless, the improvement of symptoms and acid reflux seems to be much more important than the improvement of the manometric findings. The overall discontinuation of proton-pump inhibitor (PPI) use was about 70%. Thus, endoscopic treatments for GERD are still in the development phase. The efficacy, safety, durability, cost-effectiveness, indications, and possible combination with other treatments must be thoroughly assessed in randomized controlled trials. If the usefulness of endoscopic treatment is confirmed, however, a new minimally invasive treatment strategy for GERD will have been established.
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