H2 Blockers Research Articles

Drug utilization pattern of acute poisoning admissions in medicine intensive care unit

Introduction: Acute poisoning is a very common & life threatening crisis and leads to serious conditions and even death of patients. Poisoning may be due to self consumption or accidental of various chemical compounds, medications and poisonous animals. The various drugs used in poisoning and there clinical outcome with different poisoning substances was investigated in this study Material and Methods: The patients which have been diagnosed with acute poisoning in Medical intensive care unit from January 2017 to July 2017 are included in this study. Results: During 7 months of study total 154 patients of acute poisoning were included in this study. Male patients were 111 (72%) while female patients were 43 (28%). Mean age of patients was 34.97 +14.46 years. The commonest cause of poisoning was by use of pesticides followed by venomous snake bite. Drugs prescribed to patients were mainly symptomatic like H2 blockers (99.3%), antiemetics (97.4%), and antimicrobials (90.2%). Specific antidotes prescribed were Atropine (92.8%), pralidoxime (79.8%) and anti-snake venom (17.5%) Conclusions:Organophosphorus compounds were the most common among poisons, followed by Snake bite. Gastroprotective and antiemetic drugs are most commonly prescribed drugs. Keywords: Poisoning, Drug utilization, Intensive care unit

Proton pump inhibitors for the treatment of laryngopharyngeal reflux disease: A protocol for systematic review and meta-analysis.

Background:Laryngopharyngeal Reflux disease refers to abnormal reflux of gastric contents through the esophagus into the throat, which irritates and damages the pharyngeal mucosa, and causes corresponding symptoms. Proton Pump Inhibitors are an important class of gastric acid secretion inhibitors after H2 receptor blockers, which can be used clinically to treat peptic ulcer, abnormal gastric acid secretion and other related diseases. The common clinical drugs include omeprazole, lansoprazole, rabeprazole and so on. Clinical practice has shown that Proton Pump Inhibitors have a good therapeutic effect on Laryngopharyngeal Reflux disease, but evidence of evidence-based medicine is lacking. The purpose of this protocol is to systematically evaluate the efficacy and safety of Proton Pump Inhibitors in the treatment of Laryngopharyngeal Reflux disease and to improve the evidence-based basis for the clinical application of Proton Pump Inhibitors in the treatment of Laryngopharyngeal Reflux disease.Methods:English computer retrieval database (PubMed, Embase, Web of Science, the Cochrane Library) and Chinese computer retrieval database (Wanfang Database, VIP Information Chinese Journal Service Platform, Chinese Biomedical Database) . In addition, Baidu Scholar and Google Scholar were manually searched for randomized controlled clinical studies on the treatment of laryngeal reflux disease with Proton Pump Inhibitors from the establishment of the database to July 2020. Two researchers independently extracted and evaluated the data of the included studies, and meta-analysis was conducted on the included literatures with RevMan5.3 software without language restrictions.Results:In this study, the efficacy and safety of Proton Pump Inhibitors in the treatment of Laryngopharyngeal Reflux disease are evaluated by the overall response rate, clinical symptom remission rate and other indicators.Conclusions:This study will provide reliable evidence-based evidence for the clinical application of Proton Pump Inhibitors in the treatment of Laryngopharyngeal Reflux disease.OSF Registration number: DOI 10.17605 / OSF.IO / NY6SC

Risk of Cancer in Association with Ranitidine and Nizatidine vs Other H2 Blockers: Analysis of the Japan Medical Data Center Claims Database 2005-2018.

In September 2019, ranitidine and nizatidine were suggested to contain N-nitrosodimethylamine, a carcinogenic substance. People have since been concerned about the potential impact of ranitidine/nizatidine use on the risk of cancer. The objective of this study was to investigate the risk of cancer among people receiving ranitidine or nizatidine compared with other histamine 2 receptor antagonists (H2 blockers) [cimetidine, famotidine, roxatidine, and lafutidine]. In the Japan Medical Data Center claims database (comprising people aged < 75years) from 2005 to 2018, we identified new adult users of H2 blockers and classified them into ranitidine/nizatidine users and other H2 blocker users. We estimated the incidence of cancer diagnosis in each group and conducted a multivariable Cox regression analysis. We identified 113,745 new users of ranitidine/nizatidine (median age 41.2years [interquartile range 31.7-51.1]; 49.1% men; median follow-up 2.4years [1.1-4.5]) and 503,982 new users of other H2 blockers (median age 40.9years [31.1-51.2]; 51.0% men; median follow-up 2.3years [0.9-4.2]). The incidence rate of cancer diagnosis was 6.39 (95% confidence interval 6.13-6.66) cases per 1000 person-years (top three sites: breast 14.8%; colorectal 14.6%; and stomach 11.5%) in the ranitidine/nizatidine group and 6.17 (6.05-6.30) cases per 1000 person-years (colorectal 14.7%; breast 13.5%; and stomach 11.2%) in the other H2 blockers group. The adjusted hazard ratio (ranitidine/nizatidine users vs other H2 blocker users) was 1.02 (0.98-1.07). The results were similar by follow-up length, by cancer site, and when ranitidine and nizatidine users were separately compared with the other H2 blockers group. By cumulative dose, the adjusted hazard ratio (95% confidence interval) was 1.03 (0.98-1.08) from 1 to 180 defined daily doses (DDDs), 1.00 (0.73-1.39) from 181 to 365 DDDs, 0.95 (0.61-1.48) from 366 to 730 DDDs, and 0.83 (0.45-1.55) at > 730 DDDs. We found no evidence that ranitidine/nizatidine is associated with an increased risk of cancer, although further studies with more accurate measurement of exposure, inclusion of older people, and longer follow-up may be needed.

Management of Laryngopharyngeal Reflux Around the World: An International Study.

To investigate worldwide practices of otolaryngologists in the management of laryngopharyngeal reflux (LPR). An online survey was sent on the management of LPR to members of many otolaryngological societies. The following aspects were evaluated: LPR definition, prevalence, clinical presentation, diagnosis, and treatment. A total of 824 otolaryngologists participated, spread over 65 countries. The symptoms most usually attributed to LPR are cough after lying down/meal, throat clearing and globus sensation while LPR-related findings are arytenoid erythema and posterior commissure hypertrophy. Irrespective to geography, otolaryngologists indicate lack of familiarity with impedance pH monitoring, which they attribute to lack of knowledge in result interpretation. The most common therapeutic regimens significantly vary between world regions, with a higher use of H2 blocker in North America and a lower use of alginate in South America. The duration of treatment also significantly varies between different regions, with West Asia/Africa and East Asia/Oceania otolaryngologists prescribing medication for a shorter period than the others. Only 21.1% of respondents are aware about the existence of nonacid LPR. Overall, only 43.2% of otolaryngologists believe themselves sufficiently knowledgeable about LPR. LPR knowledge and management significantly vary across the world. International guidelines on LPR definition, diagnosis, and treatment are needed to improve knowledge and management around the world. N.A. Laryngoscope, 131:E1589-E1597, 2021.

Deprescribing: A Tool to Optimize Medications Across the Continuum of Care

Deprescribing: A Tool to Optimize Medications Across the Continuum of Care

Effect of long-term acid suppression therapy with proton pump inhibitors or H2 receptor blockers on serum vitamin B12 levels in elderly population.

Long-term usage of acid suppression drugs like proton pump inhibitors (PPIs) or H2 receptor blockers in the elderly population has been found to result in vitamin B12 deficiency. However, the reports are equivocal. To determine the serum vitamin B12 levels in elderly patients under chronic acid suppression therapy. Patients aged above 60years and on any of the PPIs or H2 blockers for at least 6months were recruited. Out of 77 patients recruited, 60 patients were included for the final analysis. The serum vitamin B12 levels were measured using the AccuDiag™-Vitamin B12 ELISA system. Out of 60 patients, pantoprazole (40%) and omeprazole (37%) were the commonly prescribed acid-suppressing drugs. Nearly 50% of the patients on prolonged acid suppression therapy were either "deficient" (less than 200pg/ml) or "insufficient" (200 to 300pg/ml) in serum vitamin B12 levels. Neither the average serum vitamin B12 levels (p = 0.994) nor the vitamin B12 status (p = 0.226) varied significantly across the drug groups of pantoprazole, omeprazole, and ranitidine. Prolonged acid suppression therapy with PPIs or H2 blockers may result in serum vitamin B12 deficiency. However, there was no class (PPIs vs. H2 receptor blockers)- or drug (pantoprazole vs. omeprazole vs. ranitidine)-based differences found in the vitamin B12 deficiency caused.

Analysis of the long-term economic burden of omalizumab on patients with chronic spontaneous urticaria.

Omalizumab (OMA) is highly effective for refractory chronic spontaneous urticaria (CSU), but its high cost exerts a great economic burden on patients and society. Current knowledge is lacking regarding the economic impact of long-term administration of OMA on patients with CSU in the real-world setting. We retrospectively investigated drug costs relevant to CSU treatment during the period before through to 12months after starting OMA in actual clinical practice. This study involved 32 patients who received at least two injections of OMA (300mg/4weeks) and achieved good responses of urticaria control test score of 12 or more and/or weekly urticaria activity score of 6 or less within 12weeks. Median drug costs of the overall patient cohort increased from ¥14496/month to ¥104522 after starting OMA, but reduced to ¥48810 in 12months along with reduced amount of OMA administration and concomitant medication use. In patients pretreated with antihistamine alone or plus alternative medicines such as H2 blocker and antileukotriene prior to OMA, the increased drug costs by adding OMA decreased to approximately 30% in 12months mainly due to the OMA dose reduction and interval extension of OMA. The drug cost reduction was also observed in patients pretreated with intensive multi-agents, due to discontinuation of expensive immunosuppressants. In conclusion, the introduction of OMA significantly increased the total drug costs relevant to CSU management, but the costs decreased to half in 12months, along with dose-reduced and interval-extended OMA and discontinued concomitant drugs in patients with CSU who responded well to OMA.

S2933 Vanishing Polyps: Can Switching From a PPI to an H2 Blocker Cause Regression of Fundic Gland Polyps?

INTRODUCTION: Fundic gland polyps (FGPs) are identified as a sequalae of prolonged acid suppression. Though some studies show that acid suppression with a proton pump inhibitor (PPI) or Histamine 2 receptor blockers (H2RB) may cause FGPs, stronger evidence supports PPIs as a culprit. Studies have shown improvement of FGPs with cessation of acid suppression, but few studies investigated the effect of changing therapy to an H2RB. This case demonstrates a reduction of polyp size and number upon transition to an H2RB in a patient who developed FGPs as a result of long-term PPI use. CASE DESCRIPTION/METHODS: An 85-year-old female with rheumatoid arthritis on methotrexate and prednisone and on chronic PPI for 15 years for acid reflux presented to the gastroenterology clinic for possible gastritis. Upper endoscopy was performed and showed multiple 5–50 mm pedunculated and sessile polyps throughout the entire stomach. A majority of the polyps were about 3–5 cm. A hot snare and a Roth net were used to remove polyps to confirm histopathology (Figure 1). Gastric biopsies revealed FGPs without evidence of H. pylori, intestinal metaplasia, dysplasia or malignancy. Despite concern for FAP, malignancy, or high-grade dysplasia, the patient elected for continued endoscopic surveillance. She transitioned from a PPI to an H2RB. Serial endoscopies showed marked improvement in the size and number of gastric polyps at 6-months (Figure 2) and at 1-year (Figure 3). DISCUSSION: Some studies have shown a 4 fold increased risk of FGP formation in patients on chronic PPI. These polyps likely form as a response to low acid production causing increased parietal cell growth due to increased gastrin and chromogranin-A circulation causing gland proliferation. Few case reports demonstrate improvement of polyp size and number with transitioning therapy from PPI to H2RB and no large trials support changing therapy to H2RB. Still, H2RBs may be an ideal alternative since studies have shown an improvement in polyp size with cessation of PPI. Though FGPs are benign, PPI may increase the risk of adenomatous polyps and biopsy is necessary to differentiate these, particularly in patients with FAP. Our case demonstrates that discontinuing PPI for H2RB may lead to a sheer reduction in both number of polyps and polyp size, making lesions more amenable to continued resection and sampling and, therefore decreasing and minimizing risk of malignancy.Figure 1.: Initial endoscopy showing multiple large Fundic Gland Polyps in patient on chronic PPI for 15 years.Figure 2.: Repeat Endoscopy 6 months after transitioning from PPI to H2RB and showing smaller and fewer number of Fundic Gland Polyps.Figure 3.: Repeat Endoscopy 1 year after transitioning to H2RB and demonstrating continued, marked improvement in the size and number of Fundic Gland Polyps.

S3306 H2-Blocker Use Is Associated With Acute Kidney Injury Among COVID-19 Patients

INTRODUCTION: The Coronavirus Disease 2019 (COVID-19) has infected over 6.5 million people worldwide, claiming nearly 400,000 lives as of June 2020. Among those hospitalized, acute kidney injury (AKI) occurs in approximately 20–40% of patients. Proton pump inhibitors (PPIs) and H2-blockers (H2Bs) are commonly used medications and have been linked to acute and chronic interstitial nephritis. We assessed the association between PPI or H2B use prior to admission and AKI among patients admitted with COVID-19 infections. METHODS: This was a single center retrospective cohort study. Adult patients with confirmed COVID-19 infection admitted from March to April 2020 were identified. Patients with end-stage renal disease were excluded. Charts were reviewed for patient demographics, outpatient medication list, creatinine at baseline and upon admission, and hospital course. The primary outcome was any association between PPI or H2B use with development of AKI. RESULTS: We reviewed 100 consecutive patients admitted with COVID-19 and 93 patients were included. The mean age of this cohort was 58.9 years and 36.5% were female (Table 1). Sixteen patients were prescribed a PPI prior to admission and 6 patients were on H2B. Of the 93 patients, 84 did not have known chronic kidney disease (CKD). Among patients without CKD, PPI use was not associated with AKI (P = 0.857) but patients taking H2Bs were more likely to develop AKI on admission (P = 0.032) (Figure 1). There were no differences in average BUN-to-creatinine ratios (P = 0.172) or rates of systemic inflammatory response syndrome (P = 0.904) between those who were on H2Bs versus those who were not. CONCLUSION: Among non-CKD patients who were admitted for COVID-19 infection, H2B use was associated with development of AKI whereas PPI use was not. In vitro studies have shown cimetidine to raise serum creatinine theoretically by competitive tubular secretion for creatinine. In the setting of COVID-19 infection and systemic inflammation, reduced renal blood flow adds insult to the kidneys and may synergistically raise serum creatinine with famotidine use. Increased awareness of the relationship between medications and COVID-19 infection may be helpful in providing comprehensive care for critically ill patients.Table 1.: Demographics and clinical characteristicsFigure 1.: Incidence of acute kidney injury (AKI) on admission among patients without chronic kidney disease (CKD).

S1340 Risk of Acute Interstitial Nephritis in Patients on Chronic Proton Pump Inhibitor Therapy

INTRODUCTION: Proton pump inhibitors (PPIs) are commonly prescribed medications. Studies suggest a link between PPI use and acute interstitial nephritis (AIN), however data is limited. Our primary aim was to evaluate the prevalence of AIN in patients on chronic PPI therapy. Our secondary aim was to compare the risk of AIN in patients on PPI compared to H2 blockers and compare adverse events (AE). METHODS: We performed a retrospective analysis in the IBM Explorys database 5 (1999-2020), a pooled, national, de-identified clinical database of over 72 million patients from 26 health care networks and 300 hospitals across the United States. Patient populations were identified using SNOMED and ICD codes. PPI included were esomeprazole, omeprazole, pantoprazole and lansoprazole. The development of AIN was evaluated after at least 6 months of PPI therapy. Patients on medications commonly implicated in AIN including NSAIDs, antibiotics, loop diuretic, H2 blockers, rifampin, and allopurinol were excluded from the study if prescribed within 30 days of development of AIN. Patients with systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, and Sjogren’s were also excluded. The control group was defined as patients on H2 blockers with the above exclusion criteria. AE were defined as ICU admission within 7 days, hemodialysis within 2 weeks, chronic kidney disease within 6 months, and end stage renal disease within 1 year. Odds ratios with 95% CI were calculated for risk of AIN for each PPI compared to the control group. Chi-squared test was used to compare the risk of AEs in the combined PPI group vs H2 blockers. RESULTS: The prevalence of AIN on chronic PPI therapy comprised 6.49% (n = 16130). Prevalence of AIN in lansoprazole was 28 (per 10,000), esomeprazole was 21 (per 10,000), omeprazole was 15 (per 10,000), and pantoprazole was 8 (per 10,000). Esomeprazole, omeprazole, and lansoprazole were associated with an increased risk of AIN when compared to the control. Lansoprazole had the highest associated risk for AIN (OR 2.53, 95% CI 2.38-2.70, followed by esomeprazole (OR 1.9, 95% CI 1.8-2.02), and then omeprazole (OR 1.32, 95% CI 1.26-1.39). Esomeprazole had a higher risk of ICU admission and new-onset CKD. Lansoprazole had a higher risk of ESRD. CONCLUSION: Most PPIs confer a higher risk of AIN compared to H2-blockers. Esomeprazole should be used with caution in patients at high risk for the development of CKD or ESRD. Future prospective studies are needed to validate these findings.Figure 1Figure 2

S1341 Risk of Acute Interstitial Nephritis in Patients on Acute Proton Pump Inhibitor Therapy

INTRODUCTION: Proton pump inhibitors (PPIs) are commonly prescribed medications. Studies suggest a link between PPI and acute interstitial nephritis (AIN), however data is limited. Our primary aim was to evaluate the prevalence of AIN in patients on short-term PPI therapy. Our secondary aim was to compare the risk of AIN in patients on PPI compared to H2-receptor blockers and compare adverse events (AE) . METHODS: We performed a retrospective analysis in the IBM Explorys database 5 (1999-2020), a pooled, national, de-identified clinical database of over 72 million unique patients from 26 health care networks and 300 hospitals across the United States. Patient populations were identified using SNOMED and ICD codes. PPI included were esomeprazole, omeprazole, pantoprazole and lansoprazole. The development of AIN was evaluated within 8 weeks of PPI initiation. Patients on medications commonly implicated in AIN which included NSAIDs, antibiotics, loops diuretic, H2-blockers, rifampin, and allopurinol were excluded from the study if prescribed within 30 days of initiation of PPI. Additionally, patients with systemic lupus erythematous, sarcoidosis, granulomatosis with polyangiitis, and Sjogren’s disease were also excluded from the study. The control group was defined as patients on H2 blockers with the above exclusion criteria. AE were defined as ICU admission within 7 days, hemodialysis within 2 weeks, new chronic kidney disease within 6 months of diagnosis of AIN, and new end stage renal disease within 1 year for PPI group and control group. Prevalence was reported for each PPI. Odds ratio with 95% CI were calculated for risk of AIN for each PPI compared to control group. Chi-squared test was used to compare the risk of AEs in the combined PPI group vs H2-blockers. RESULTS: Acute PPI-induced AIN comprised 0.56% (n = 1410) of total AIN patients. Prevalence of AIN in esomeprazole and omeprazole was 6 (per 10,000), pantoprazole was 18 (per 10,000) and lansoprazole was 4 (per 10,000). Pantoprazole was the only PPI associated with an increased risk of AIN (OR 1.66, 95% CI 1.51-1.84). There was no difference between risk of CKD and ESRD between PPI and control. Patients in PPI group were more likely to be senior, female, have Medicare insurance, hypertension, hyperlipidemia and heart failure. CONCLUSION: Our study shows that AIN is a rare side effect of acute PPI therapy. Pantoprazole should be used with caution perhaps in patients with underlying CKD however this needs to be validated in future studies.Figure 1Figure 2Table 1

S1326 Effect of Gastric Acid Suppression in Gastrointestinal Manifestations of COVID-19

INTRODUCTION: The pandemic caused by the Coronavirus Disease 2019 (COVID-19) has led to over 5 million cases and 340,000 deaths globally as of May 2020. There are increasing reports of gastrointestinal symptoms including diarrhea, nausea, and abdominal pain suggestive of gastrointestinal infection by COVID-19. In vitro studies developed for the safe handling of the COVID-19 virus have reported inactivation of coronavirus in highly acidic conditions (pH < 3) such as the human stomach which has a pH range between 1.0 to 3.5. Proton pump inhibitor (PPI) and H2 receptor blocker (H2B) medications are ubiquitous in clinical practice and have been shown to be highly effective in raising intragastric pH. We hypothesize that acid-suppressing medications taken prior to COVID-19 infection lead to increased gastrointestinal symptoms due to altered gastric pH potentially influencing viral load. METHODS: This was a single center retrospective cohort study. Adult patients with confirmed COVID-19 infection admitted from March to April 2020 were identified and charts were reviewed for patient demographics, outpatient medication list, symptoms associated with COVID-19 infection, and hospital course. The primary outcome was prevalence of gastrointestinal symptoms (abdominal pain, nausea, diarrhea) between the acid-suppressed patients and non-acid-suppressed patients. Secondary outcomes compared need for intensive care, length of stay, and mortality. RESULTS: We reviewed 100 consecutive patients admitted with COVID-19. Twenty-four patients were taking acid-reducing medications prior to admission. There were more females in the acid-suppressed group (41.7%) compared to the non-acid-suppressed group (34.2%) and average age was approximately 59 years for both (Table 1). Overall, GI symptoms occurred in 33.3% of acid-suppressed patients and 34.2% of the non-acid suppressed patients (P = 0.937) (Figure 1). No significant differences in specific GI symptoms were observed between the groups. Need for intensive care, length of stay, and mortality did not differ (Table 1). CONCLUSION: While in vitro studies suggest a potential deleterious effect for patients taking acid-suppressive medications prior to COVID-19 infections, no association was noted in gastrointestinal symptoms, acuity of care, length of stay, or mortality in patients taking PPI or H2 blocker medications prior to admission for COVID-19 infection in our cohort.Table 1.: Demographics and outcomes of COVID-19 patientsFigure 1.: Gastrointestinal Symptoms of Acid-Suppressed Patients vs. Non-Acid-Suppressed Patients.

S0957 Outcome of Stretta in a Tertiary Medical Center: A Safe and Effective Non-Surgical Option for Refractory GERD

INTRODUCTION: GERD is a common chronic condition that can affect quality of life. For a subset of patients, GERD is refractory to lifestyle changes and medications, including PPIs and H2 receptor blockers. Surgical therapies include Nissen fundoplication, but for patients who have already attempted this or do not wish to have surgery, the Stretta procedure is a valuable option. The Stretta procedure delivers radiofrequency energy along the GE junction through an endoscopic catheter. This mechanically alters the GEJ and modulates neural pathways to reduce the frequency of lower esophageal sphincter relaxation. Successful procedures result in symptom resolution, mucosal healing, and/or increased health-related quality of life (HRQoL). METHODS: Retrospective chart review of all patients who underwent the Stretta procedure for GERD from 2005 to 2019 at our center was conducted. Demographics, clinically noted GERD symptoms, including dysphagia heartburn, reflux, and breakthrough symptoms, and PPI usage at baseline and post-procedure were reviewed. RESULTS: Fifty-nine procedures were performed on 56 patients (average age 52.3 years, range 20–82 years, women = 40) from 2005 to 2019. All procedures were performed in an outpatient endoscopy suite. Five patients were lost to follow-up. At 6-month follow-up, 21/51 patients (41%) successfully reduced their PPI dosage by at least half. Symptom resolution was determined by percentage decrease of number of symptoms. Thirty-four out of 51 patients reported symptom improvement, averaging a 78.5% decrease in number of symptoms. The average symptomatic improvement was a 54% decrease in number of symptoms. One patient who had decrease in 1 out of 3 symptoms underwent a second Stretta and had full response after the subsequent procedure. Seventeen patients experience no improvement. Two of these 17 patients underwent a second procedure without improvement. There were no reported long-term procedure-related complications. CONCLUSION: The Stretta procedure can help patients with severe refractory GERD. In our review, two-thirds of patients had meaningful improvement in symptoms. More than two-fifths of patients were able to reduce their PPI dosage. No long-term procedure-related complications were noted. The strength of the review was limited due to the small number of patients and lack of objective markers, such as first-hand HRQoL questionnaires. This can be utilized on future patients to further assess quality of life improvement with the procedure.

S0444 Concomitant TIF With Hiatal Hernia Repair: A Collaborative Single Center Experience

INTRODUCTION: Transoral incisionless fundoplication (TIF) is an attractive alternative to the traditional surgical fundoplications for the treatment of gastroesophageal reflux disease (GERD). Ideal candidates are limited to patients with hiatal hernia (HH), diaphragmatic hiatus (DH) ≤ 2cm, and Hill Grade (HG) I or II because TIF does not address the HH component of GERD. A novel approach of TIF immediately preceded by HH repair, coined concomitant TIF (cTIF), has emerged as a possible solution to address these limitations. The purpose of this study is to assess the efficacy, safety and feasibility of cTIF using a collaborative approach between Interventional Gastroenterology and Foregut Surgery. METHODS: Subjects with a HH or DH too large to undergo TIF (>2 cm), Barrett’s esophagus, LA class C esophagitis or a DeMeester score >50 were selected for cTIF. Subjects underwent HH repair by a surgeon followed by TIF by a gastroenterologist inone combined procedure. Variables studied included age, BMI, HH size, Proton Pump Inhibitor (PPI) or H2 blocker (H2B) use pre and post procedure, and symptoms based on the Reflux Disease Questionnaire (RDQ), GERD Health Related Quality of Life (HRQL) Index and the Reflux Symptom Index (RSI). RESULTS: 34 subjects underwent cTIF, and of those 18 patients had follow up data greater than 6 months. At the time of cTIF, mean age was 59.8 and 17 were male. Mean HH measurement was 2.7 cm. Pre-cTIF, 30 subjects were on PPIs. There was 100% success rate in performing TIF after hiatus repair. 12 months post cTIF, 86% of patients were off PPI. RDQ for symptom frequency was 17.4 pre-cTIF and 4.78 post-cTIF (P < 0.01). RDQ for symptom severity was 16.7 pre-cTIF and 4.56 post-cTIF (P < 0.06). GERD-HRQL for heartburn severity was 23.3 pre-cTIF and 7.37 post-cTIF (P < 0.01). GERD-HRQL for regurgitation severity was 14.3 pre-cTIF and 0 post-cTIF (P = 0.05). RSI was 17.7 pre-cTIF and 8.1 post-cTIF (P < 0.01). CONCLUSION: These early results suggest that concomitant HH repair and TIF appear to be safe and effective in patients with HH or diaphragmatic hiatus too large to undergo TIF alone and severe esophagitis. Many of these patients would not have met traditional criteria for complete or even partial fundoplication and so these patients may be receiving surgical therapy earlier in the disease spectrum. Prospective randomized studies comparing cTIF to laparoscopic Nissen Fundoplication are warranted.

An Herbal Formulation of Jiawei Xiaoyao for the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Placebo-Controlled, Clinical Trial.

INTRODUCTION:To investigate the efficacy and safety of an herbal formulation of Jiawei Xiaoyao (JX) on gastrointestinal symptoms in patients with functional dyspepsia (FD) who had previously rejected standard therapies of proton pump inhibitors, H2 blockers, or Helicobacter pylori eradication.METHODS:A total of 144 adult men and women with FD according to the Rome III criteria were recruited at 9 sites in China from August 2017 to April 2019. Participants were randomized to receive either a JX pill or placebo (12 g/d, 6 g twice a day) for 4 weeks. The primary end point was the change in the total Gastrointestinal Symptom Score (GIS) from baseline to week 4. The secondary end points included the scores on the Hamilton Depression Scale and the Hamilton Anxiety Scale. The safety outcomes included the results of the complete blood count, the liver function test, the renal function test, urinalysis, the fecal occult blood test, and an electrocardiogram.RESULTS:Data from 141 patients (JX pill, n = 70; placebo, n = 71) were statistically analyzed. The mean ± SD of the GIS for the JX pill group at baseline and 4 weeks was 9.3 ± 3.1 and 3.8 ± 3.0, respectively; the mean ± SD of the GIS for the placebo group at baseline and 4 weeks was 9.5 ± 3.4 and 5.3 ± 4.4, respectively (change from baseline to 4 weeks in the JX pill group vs change from baseline in the control group, −1.3 points; P = 0.013). The JX pill group showed greater improvement in both the Hamilton Depression Scale and Hamilton Anxiety Scale scores from baseline to 4 weeks than the placebo group, but the difference was not significant. The total number of adverse events was 30 in the JX pill group vs 20 in the placebo group (P = 0.240).DISCUSSION:The JX pill was superior to the placebo in terms of improving the GIS in patients with FD but did not significantly improve depression or anxiety symptoms. These findings suggest that the JX pill may have a positive effect on the resolution of gastrointestinal symptoms in patients with FD who are seeking alternative therapies.

S0506 Efficacy and Safety of Plecanatide in Patients With Chronic Idiopathic Constipation: Pooled Analysis of Two Phase 3 Trials Stratified by Concomitant Acid Suppression Use

INTRODUCTION: Plecanatide, an approved treatment for chronic idiopathic constipation (CIC), replicates the pH-sensitive activity of uroguanylin in binding to guanylate cyclase-C receptors on intestinal epithelium. Since many individuals with CIC experience reflux and use concomitant acid suppression therapy, we explored the impact of concomitant acid suppressor use on the efficacy and safety of plecanatide in adults with CIC. METHODS: Data on two 12-week, randomized, double-blind, placebo-controlled phase 3 clinical trials of plecanatide were pooled and results were stratified by concomitant acid suppressor use. For each group, durable overall complete spontaneous bowel movement (CSBM) response rates, changes from baseline in bowel movement frequency, stool consistency (Bristol Stool Form Scale), and daily CIC symptom scores (Likert Scale, 0 = none to 4 = very severe) were assessed. Safety was analyzed in patients who received ≥1 dose. RESULTS: The intention-to-treat population (N = 2639) included 12.6% of patients with concomitant acid suppressor use. Patients using acid suppressors were 54.8 years (mean), vs 43.9 years in those not using acid suppressors. Gastroesophageal reflux disease was more common in patients using acid suppressors (83.1%), compared to those not on acid suppressors (6.1%). Proton pump inhibitors (PPIs) were used by 86.4% of patients using acid suppressors with omeprazole as the most common PPI (45.1%); H2 blockers were used by 17.8% of subjects with ranitidine as the most common H2 blocker (9.8%). Regardless of acid suppressor use, plecanatide-treated patients demonstrated significant improvements in the durable overall CSBM responder rates (Figure 1) and greater efficacy across almost all reported endpoints (Table 1) vs placebo, with benefits observed as early as Week 1. Comparisons between acid suppressor use groups (yes vs no) were not significantly different for plecanatide-treated patients (both doses, Table 1). Of the plecanatide-treated patients on acid suppressors, 6.4% experienced diarrhea, 1.4% discontinued due to diarrhea, and 2.3% had ≥ 1 serious adverse event (SAE), compared to 5.0% (diarrhea), 2.1% (discontinued due to diarrhea), and 1.0% (SAE) of patients not using acid suppressors. CONCLUSION: Plecanatide is a safe and effective treatment for CIC when administered with acid suppression therapy. Regardless of acid suppressor use, efficacy responses in plecanatide groups were significantly greater than placebo.Figure 1.: Percentage of Patients With Durable Overall CSBM Response Stratified by Concomitant Acid Suppressor Use (ITT).Table 1.: Change From Baseline in Bowel Movement Frequency, Stool Consistency, and CIC Symptoms in Patients With and Without Concomitant Acid Suppression Therapy (ITT)

INAPPROPRIATE CONTINUATION OF ACID-SUPPRESSION MEDICATION AND BRONCHODILATORS ON DISCHARGE FROM ICU

SESSION TITLE: Late-breaking Abstract Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: October 18-21, 2020 PURPOSE: Failure to reconcile medications at various transitions of care can cause substantial harm to patients and increase the cost to the healthcare system. There is evidence that bronchodilators are administered without clinical indication and that acid-suppressing agents are administered inappropriately in the ICU setting. Prophylactic acid suppression is routinely used for critically ill patients as GI bleed prophylaxis. Studies revealed that hospitalized patients are at risk of being discharged with prescriptions for medications typically used to prevent or treat complications of acute illness, despite having no documented indication for chronic use. We hypothesize that medications such as these may have been started through a ventilator order set and were inappropriately reconciled on discharge from the ICU. METHODS: This was a retrospective, cohort study of adult patients admitted to an intensive care unit (ICU) in 13 hospitals across the HCA North Texas Division during a 6 month period. Demographic data, inpatient medication, clinical data, and discharge diagnosis were extracted using a data extraction tool and recorded. RESULTS: A search of electronic health records yielded 23,204 patients admitted during the time period with 12,930 patients admitted to the ICU. A total of 387 patients were excluded for not receiving at least one bronchodilator, PPI, or H2RA during their ICU stay. Of these 2,557 were started on at least one medication of interest during their ICU stay without having a history of use prior to admission, with 1,912 (75%) receiving a bronchodilator, 1,834 (72%) receiving an H2RAs, 1,225 (48%) receiving PPIs. The highest incidence of inappropriate medication continuation after ICU transfer or discharge occurred in patients receiving PPI(n=366, 26.78%), followed by H2 blockers(n=181, 8.39%), and Bronchodilators(n=105, 5.9%). CONCLUSIONS: Inappropriate discharge of patients on these medications not only poses risk for long term effects on a patient's body but also costs the patients money for a medication they may not require. Studies have shown no benefits of adding PPI/H2RA medications in decreasing morbidity and mortality in the ICU; furthermore, many studies on long-term PPI usage have shown adverse renal side effects. We believe that a multi-disciplinary approach to medication reconciliation during ICU downgrade would prove beneficial in preventing such occurrences. CLINICAL IMPLICATIONS: While utilizing ventilator order sets in an electronic medication administration system (EMAR) may be useful in a clinical setting, it is imperative to update the order sets in keeping up with new evidence-based guidelines. As evident by our findings, continuations of medications that were initiated from an order set may have significant consequences for the patient and add unnecessary costs and diagnosis to the patient's history. DISCLOSURES: Employee relationship with HCA Healthcare Please note: $20001 - $100000 Added 07/23/2020 by Brendon Cornett, source=Web Response, value=Salary No relevant relationships by Marian Gaviola, source=Web Response No relevant relationships by Machaiah Madhrira, source=Web Response No relevant relationships by Anvitha Manduva, source=Web Response no disclosure on file for Ranjit Nair; No relevant relationships by Harsh Patel, source=Web Response no disclosure on file for Prashanth Reddy; No relevant relationships by Karen Singh, source=Web Response No relevant relationships by Muhammad Tola, source=Web Response

S1813 Gut Feeling: Isolated Colonic Histoplasmosis

INTRODUCTION: Histoplasmosis primarily manifests in humans as asymptomatic pulmonary infections and gastrointestinal and hepatic involvement is frequent in disseminated disease. However, isolated involvement is rare and underreported. We present a case of a 65-year-old male with history of hepatitis C that was found to have asymptomatic isolated histoplasmosis on screening colonoscopy and treated with a 6-month course of fluconazole. CASE DESCRIPTION/METHODS: A 65-year-old male with a history of hypertension, GERD, and hepatitis C with completed interferon-Ribavarin treatment was referred from his primary care physician to gastroenterologist for screening colonoscopy. The patient denied any symptoms and previous colonoscopy was unremarkable. EGD was done for previous Barret’s esophagus and showed mild distal esophagitis and gastritis. Colonoscopy showed an ulcerated 3 cm mass in the cecum, multiple colon polyps in ascending colon, rectal ulcer in a polyp, and three sessile polyps of benign appearance ranging from 5 mm to 1 cm. Biopsies were taken of the cecal mass and piece-meal polypectomy was done for rectal ulcer. The ascending colon polyps were not removed as the patient would possibly need right hemicolectomy for the large cecal lesion. Pathology of the antral biopsy showed mild reactive gastropathy with no H. Pylori or intestinal metaplasia. Colon cecum, transverse, and rectal biopsies showed mucosa containing innumerable histiocytic CD68 positive/GMS positive fungal organisms consistent with Histoplasma capsulatum. The patient was referred to infectious disease and started on fluconazole 200 mg BID for 6 months and completed treatment. DISCUSSION: Isolated gastrointestinal histoplasmosis is rare and disseminated disease can present with moderate to severe infections that can be life-threatening. As seen in our patient, it can occurs in immunocompromised patients such as those on immunosuppressant medications including long-term steroids or conditions such as malignancies or chronic infections like HIV or HCV. The role of treatment in isolated histoplasmosis is uncertain, and itraconazole is typically preferred unless there is concomitant use of proton pump inhibitors or H2 blockers that will limit its absorption. Clinicians should be mindful of occult infections in immunocompromised patients and utilizing appropriate evaluation and treatment for these conditions.Figure 1.: Ulcerated mass 3 cm in cecum on colonoscopy.Figure 2.: Rectal ulcer in polyp.Figure 3.: Biopsy of colonic mucosa showing CD 68 positive and GMS positive unnumerable fungal organisms consistent with Histoplasma capsulatum.

Emergence of Vancomycin Resistance after Treatment of Enterococcus: Risk Factors for Subsequent Pathogen Resistance

Background: Vancomycin-resistant Enterococcus (VRE) is a leading cause of nosocomial infections that carries an increased risk of mortality when compared to vancomycin-sensitive Enterococcus (VSE). Data on the frequency of conversion between VSE and VRE in patients are scarce. Among patients presenting with VSE infections, little is known about the subsequent risk of conversion to VRE in the initial treatment period. Methods: A descriptive analysis of VSE to VRE conversion and a retrospective case-control study were performed examining cases of VSE that had subsequent cultures positive for VRE within 90 days within a quaternary healthcare system. Cases were obtained from June 2013 through December 2018. Controls were patients who had VSE culture followed by another VSE culture and were matched by organism (E. faecalis or E. faecium), time between cultures, and initial culture site. Age, gender, healthcare, antibiotic, Clostridiodes difficile, proton pump inhibitor (PPI) exposure, and H2 blocker exposures, and prior VRE infection or colonization were abstracted from the electronic medical record. A univariate analysis with the Fisher exact test was performed with significance considered for P &lt; .05. Results: In total, 8,913 cases of E. faecalis and 2,322 cases of E. faecium were included in the study. Of 8,913 cases of E. faecalis, 51 of 8,503 (0.6%) cultured VRE after VSE, and 47 of 403 (11.7%) cultured VSE after initial VRE. Of E. faecium, 51 of 783 (6.5%) cultured VRE after VSE, and 76 of 1,532 (5.0%) cultured VSE after initial VRE. In total, 76 cases were matched with 99 controls. Patients converting from VSE to VRE were more likely to have prior admission to an intensive care unit (P = .0207), prior positive swab or culture for VRE (P = .0114), previous C. difficile infection (P = .0155), prior vancomycin (P = .0022) and cefepime (P = .0089) exposure. Patients receiving vancomycin after initial VSE culture were more likely to have subsequent cultures positive for VRE (P = .0053). There was no difference in age (P = .966) or male sex (P = .7588). Conclusions: Conversion from VSE to VRE is common, and E. faecium is more likely to become resistant than E. faecalis. Reversion to a vancomycin-sensitive phenotype is also common, and E. faecalis is more likely to show subsequent sensitivity than E. faecium. Previous admission to an intensive care unit, prior colonization or infection with VRE, prior C. difficile infection, and exposure to vancomycin and cefepime are risk factors for emergence of VRE after treatment for vancomycin-sensitive Enterococcus.Funding: NoneDisclosures: None

Desloratadyna i lewocetyryzyna – znaczenie w leczeniu chorób alergicznych

H1-receptor blockers (including levocetirizine and desloratadine) are employed in treatment of multiple allergic diseases. In this review we deliver data regarding efficacy and safety these two drugs. Moreover, we are comparing their properties. The individualization therapy is a mainstay in allergic disorders treatment.