Use Of Gastroprotective Agents Research Articles

Drug Utilization Study of Gastroprotective Agents in Medicine and Surgery Wards of a Tertiary Care Teaching Hospital.

Introduction Drug utilization research (DUR) is "the marketing, distribution, prescription, and use of drugs in a society, with special emphasis on the resulting medical, social, and economic consequences" as per the definition of the World Health Organization (WHO). The ultimate goal of DUR is to evaluate whether the drug treatment is rational or not. Various gastroprotective agents are available today, such as proton pump inhibitors, antacids, and histamine 2A receptor antagonists (H2RAs). Proton pump inhibitors block the gastric H+/K+-adenosine triphosphatase (ATPase) via covalent binding to cysteine residues of the proton pump to inhibit gastric acid secretion. Antacids are compounds containing different combinations, such as calcium carbonate, sodium bicarbonate, aluminum, and magnesium hydroxide. Histamine 2A receptor antagonists (H2RAs) decrease gastric acid secretion by reversibly binding to histamine H2 receptors located on gastric parietal cells, thereby inhibiting the binding and action of the endogenous ligand histamine. A recent literature review has shown that inappropriate use of gastroprotective agents has increased the risk for adverse drug reactions (ADRs) and drug interactions. Methods A total of 200 inpatient prescriptions were analyzed. The extent of prescribing, dosing information given, and cost incurred on the use of gastroprotective agents in both surgery and medicine inpatient departments was assessed. Prescriptions were also analyzed using WHO core indicators and for drug-drug interactions. Results Proton pump inhibitors were prescribed to 112 male patients and 88 female patients. The most common diagnosis was diseases of the digestive system with 54 (27.5%) cases, followed by diseases of the respiratory tract with 48 (24%) cases. Out of 200 patients, 51 comorbidities were reported from 40 patients. Among all prescriptions, injection of pantoprazole was the most common route of administration (181 (90.5%)),followed by tablets of pantoprazole (19 (9.5%)). The most common dose prescribed of pantoprazole was 40 mg in 191 (95.5%)patients in both departments. The frequency of therapy was also most commonly prescribed twice daily (BD) in 146 (73%) patients. Potential drug interaction was most commonly found with aspirin in 32 (16%) patients. The total cost incurred on proton pump inhibitor therapy of the medicine and surgery departments was 20,637.4 Indian Rupees (INR). Of this, the cost for patients admitted in the medicine ward was 11,656.12 INR and in the surgery department was 8,981.28 INR. Conclusion Gastroprotective agents are a group of drugs that are used to protect the stomach and the gastrointestinal tract (GIT) from acid-related injury. Our study found that proton pump inhibitors were the most commonly prescribed gastroprotective agents among inpatient prescriptions, with pantoprazole being the most frequently used. The most common diagnosis among patients was diseases of the digestive system, and most of the prescriptions were for injection administration at a dose of 40 mg twice daily. These findings suggest that there may be opportunities for improvement in the rational use of gastroprotective agents to reduce the risk of adverse drug reactions and interactionsand lower healthcare costs. Overall, the study highlights the need for healthcare providers to be aware of the appropriate use of gastroprotective agents to minimize irrational prescriptions and reduce polypharmacy.

Association between gastroprotective agents and risk of incident interstitial lung disease in systemic sclerosis

ObjectivesAlthough interstitial lung disease (ILD) occurs in over half of systemic sclerosis (SSc) patients and represents a leading cause of mortality, there are currently no preventative strategies. We evaluated if gastroprotective agents were associated with a lower incident risk of SSc-ILD. MethodsAn SSc cohort without clinically apparent ILD at baseline was constructed from the Canadian Scleroderma Research Group registry. The primary exposure was any use of gastroprotective agents. Treatment with promotility agents was assessed as a secondary exposure. Time to development of clinically apparent ILD was compared between exposed and unexposed person-time, using a multivariable marginal structural Cox model incorporating inverse probability of treatment weights to address time-varying confounding. ResultsIn total, 798 subjects met inclusion criteria. At cohort entry, median disease duration was 7.6 (IQR 3.9–15.6) years. During a median 4.4 (IQR 2.6–7.2) years of follow-up, 158 new ILD cases were diagnosed, for a crude incidence of 4.4 (95% CI 3.8–5.1) events per 100 person-years. Most (2085, 73.4%) person-visits were exposed to gastroprotective agents, 579 (20.4%) were exposed to promotility agents, and 554 (19.5%) were exposed to both agents. The marginal structural weighted hazard ratio (HR) for incident ILD related to gastroprotective agents was 0.86 (95% CI 0.52–1.41). When exposure was defined as treatment with promotility agents, the weighted adjusted HR was 0.79 (95% CI: 0.35–1.77). ConclusionIn this large retrospective cohort study, we were unable to demonstrate a protective role for gastroprotective and promotility agents in preventing clinically apparent SSc-ILD.

Comparative Effectiveness of Machine Learning Approaches for Predicting Gastrointestinal Bleeds in Patients Receiving Antithrombotic Treatment

Anticipating the risk of gastrointestinal bleeding (GIB) when initiating antithrombotic treatment (oral antiplatelets or anticoagulants) is limited by existing risk prediction models. Machine learning algorithms may result in superior predictive models to aid in clinical decision-making. To compare the performance of 3 machine learning approaches with the commonly used HAS-BLED (hypertension, abnormal kidney and liver function, stroke, bleeding, labile international normalized ratio, older age, and drug or alcohol use) risk score in predicting antithrombotic-related GIB. This retrospective cross-sectional study used data from the OptumLabs Data Warehouse, which contains medical and pharmacy claims on privately insured patients and Medicare Advantage enrollees in the US. The study cohort included patients 18 years or older with a history of atrial fibrillation, ischemic heart disease, or venous thromboembolism who were prescribed oral anticoagulant and/or thienopyridine antiplatelet agents between January 1, 2016, and December 31, 2019. A cohort of patients prescribed oral anticoagulant and thienopyridine antiplatelet agents was divided into development and validation cohorts based on date of index prescription. The development cohort was used to train 3 machine learning models to predict GIB at 6 and 12 months: regularized Cox proportional hazards regression (RegCox), random survival forests (RSF), and extreme gradient boosting (XGBoost). The performance of the models for predicting GIB in the validation cohort, evaluated using the area under the receiver operating characteristic curve (AUC), sensitivity, specificity, positive predictive value, and prediction density plots. Relative importance scores were used to identify the variables that were most influential in the top-performing machine learning model. In the entire study cohort of 306 463 patients, 166 177 (54.2%) were male, 193 648 (63.2%) were White, the mean (SD) age was 69.0 (12.6) years, and 12 322 (4.0%) had experienced a GIB. In the validation data set, the HAS-BLED model had an AUC of 0.60 for predicting GIB at 6 months and 0.59 at 12 months. The RegCox model performed the best in the validation set, with an AUC of 0.67 at 6 months and 0.66 at 12 months. XGBoost was similar, with AUCs of 0.67 at 6 months and 0.66 at 12 months, whereas for RSF, AUCs were 0.62 at 6 months and 0.60 at 12 months. The variables with the highest importance scores in the RegCox model were prior GI bleed (importance score, 0.72); atrial fibrillation, ischemic heart disease, and venous thromboembolism combined (importance score, 0.38); and use of gastroprotective agents (importance score, 0.32). In this cross-sectional study, the machine learning models examined showed similar performance in identifying patients at high risk for GIB after being prescribed antithrombotic agents. Two models (RegCox and XGBoost) performed modestly better than the HAS-BLED score. A prospective evaluation of the RegCox model compared with HAS-BLED may provide a better understanding of the clinical impact of improved performance.

A Study of Prescribing Patterns for Non-Steroidal Anti-Inflammatory Drugs in a Tertiary Care Teaching Hospital

Analgesics, including nonsteroidal anti-inflammatory drugs, are a commonly prescribed group of drugs in clinical practice for the management of pain and inflammation. This study was carried out to evaluate the prescribing pattern for nonsteroidal anti-inflammatory drugs in the tertiary care teaching hospital. A prospective cross sectional study was conducted in the orthopaedic department of a tertiary care teaching hospital from February to December 2017. The institutional ethical committee approved the study. Patients of both genders were included in the study. Patients treated with at least one nonsteroidal anti-inflammatory drug in the outpatient department of orthopaedics were included. The prescription was compared with World Health Organization drug prescribing indicators to compare selective and nonselective nonsteroidal anti-inflammatory drugs associated with the treatment also concurrent prescription of gastro protective agents. The data collected was analysed by descriptive statistics. Chi-Square test was used to compare the difference between the two groups. A p value of <0.05 was considered significant. Out of 500 prescriptions included in the study, the total number of drugs prescribed was 1098, of which were nonsteroidal anti-inflammatory drugs. Based on the World Health Organization’s drug use indicators, the average number of drugs per encounter was 2.19 % and the average number of nonsteroidal antiinflammatory drugs per encounter was 1.38 %. Out of all the nonsteroidal anti-inflammatory drugs prescribed, 428 (62.20 %) were from National List of Essential Medicine India 2015 and 678 (98.5 %) nonsteroidal anti-inflammatory drugs were prescribed by generic name. Among the study population, only 40 % of patients were prescribed Proton Pump Inhibitors along with nonsteroidal anti-inflammatory drugs. Proton Pump Inhibitors are effective in ulcer prophylaxis in their standard dose. The present study concluded that among cyclooxygenase-1 inhibitors, Diclofenac was the most commonly prescribed nonsteroidal anti-inflammatory drugs from the national list of essential medicine. The most frequently prescribed cyclooxygenase-2 inhibitor in this study was Etoricoxib. The percentage of analgesic prescribed by generic name was excellent. However, the average number of drugs per prescription deviated from the World Health Organization’s rational drug use indicator. The use of gastro protective agents needs to be rationalised with nonsteroidal anti-inflammatory drugsy

Underutilization of gastrointestinal prophylaxis in high-risk chronic nonsteroidal anti-inflammatory drug users in Korea.

Background The increasing use of antithrombotic therapies in older patients has led to an increased risk of gastrointestinal (GI) bleeding in chronic nonsteroidal anti-inflammatory drug (NSAID) users. Therefore, there is a pressing need for GI prophylaxis in these high-risk patients. Objective To analyze prescribing patterns and factors associated with the use of gastroprotective agents (GPAs) among high-risk, chronic NSAID users. Setting National claims database including 20% of the total Korean population aged ≥ 65years. Method In this cross-sectional study, we identified older adults prescribed traditional NSAIDs for > 90days and classified them into high- and ultra-high-risk groups if they had one or two or more GI risk factors, respectively. Proton pump inhibitors or misoprostol prescribed for more than 80% of traditional NSAID treatment days was regarded as appropriate GI prophylaxis. Main outcome measure Prevalence and associated factors with appropriate GI prophylaxis. Results Among 69,992 chronic traditional NSAID users, 38.8% and 9.4% belonged to the high and ultra-high-risk groups; 13.2% and 19.9% received appropriate GI prophylaxis, respectively. The most frequently used GPA was histamine H2 antagonists. Multiple NSAID use, concomitant antiplatelets and anticoagulants, and prior GI ulcer history increased the likelihood of receiving appropriate GI prophylaxis. Advanced age (≥ 85years), indications other than arthritis, and neurology specialists negatively affected appropriate GI prophylaxis use. Conclusion Approximately one in five chronic NSAID users, considered ultra-high risk, are prescribed appropriate GI prophylaxis in Korea. Advanced age, indications, and specialties of the prescriber all need to be considered when selecting target populations for interventions.

Only full adherence to proton pump inhibitors protects against drug-induced upper gastrointestinal bleeding.

The use of gastroprotective agents has allowed significant progress in the prevention of upper gastrointestinal bleeding (UGIB) associated with non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelet agents. Nevertheless, some concerns remain regarding the gastroprotective dosage and treatment duration. Our aim was to study the effect of gastroprotective agents in UGIB induced by NSAIDs and single- or dual-antiplatelet therapy. A multicenter case-control study was conducted including 577 cases diagnosed with UGIB and 1343 sex-, age-, and hospital-matched controls. To estimate exposure to NSAIDs and gastroprotective agents, consumption was calculated for the 4weeks prior to hospital admission in terms of defined daily doses (DDDs). Risk groups for UGIB induced by NSAIDs and single- or dual-antiplatelet therapy were defined as a function of each drug dose, use of gastrointestine-damaging drugs, and risk factors for UGIB. Odds ratios (ORs) with 95% confidence intervals (CIs) were adjusted for single- (model 1) and dual- (model 2) antiplatelet therapy. Full adherence (> 0.80DDD) to proton pump inhibitors (PPIs) was the only gastroprotective therapy that significantly reduced the risk of UGIB, considering NSAID risk (OR: 0.53; 95% CI: 0.30-0.95) and dose (OR: 0.48; 95% CI: 0.27-0.87) with ORs adjusted for single-antiplatelet therapy (model 1) and NSAID risk (OR: 0.55; 95% CI: 0.31-0.98) and dose (OR: 0.49; 95% CI: 0.28-0.89) with ORs adjusted for dual-antiplatelet therapy (model 2). These results reinforce the recommendation of adding a PPI at effective doses (full adherence) to prevent UGIB induced by NSAIDs, or single- or dual-antiplatelet therapy.

Cost of Ulcerative Colitis in Quebec, Canada: A Retrospective Cohort Study.

Ulcerative colitis (UC) is associated with significant health care utilization and costs. We assessed UC direct medical costs in Quebec, Canada, in 2 time periods (1998-2004 and 2005-2011) and determined changes over time. Because the introduction of anti-tumor necrosis factor α may have influenced the UC cost, we used the Quebec health services administrative databases and the same inclusion criteria to create 2 separate UC cohorts, before (1998-2004) and after (2005-2011) anti-tumor necrosis factor α introduction. The postcohort included 801 patients and the precohort 716 patients. Overall, cohorts were predominately women and were comparable in terms of patient's demographics and comorbidities. Corticosteroid use, emergency department visits and hospitalizations for colectomies, and other gastrointestinal disorders were fewer in the postcohort versus precohort. The median daily cost (interquartile range) was $16.96 ($6.80-$48.16) for the postcohort and $18.65 ($7.82-$53.31) for the precohort. In generalized linear models with log link and gamma distribution, the adjusted daily cost ratios (95% confidence interval) in the postcohort versus precohort was 0.75 (0.67-0.85). Older age at inclusion, low income, lower socioeconomic status, and previous use of gastroprotective agents, antidepressants, and sulfasalazine, methotrexate, or cyclosporine were associated with increased costs. Women and those who visited a gastroenterologist in the previous year incurred lower costs. The mean UC daily cost decreased from 2005 to 2011 as compared to 1998 to 2004 because of a decrease in rates of colectomy and other gastrointestinal hospitalizations and emergency department visits. Further investigation is required to determine the reasons for these changes.

Evaluation of rational nonsteroidal anti-inflammatory drugs and gastro-protective agents use; association rule data mining using outpatient prescription patterns

BackgroundNonsteroidal anti-inflammatory drugs (NSAIDs) and gastro-protective agents should be co-prescribed following a standard clinical practice guideline; however, adherence to this guideline in routine practice is unknown. This study applied an association rule model (ARM) to estimate rational NSAIDs and gastro-protective agents use in an outpatient prescriptions dataset.MethodsA database of hospital outpatients from October 1st, 2013 to September 30th, 2015 was searched for any of following drugs: oral antacids (A02A), peptic ulcer and gastro-oesophageal reflux disease drugs (GORD, A02B), and anti-inflammatory and anti-rheumatic products, non-steroids or NSAIDs (M01A). Data including patient demographics, diagnoses, and drug utilization were also retrieved. An association rule model was used to analyze co-prescription of the same drug class (i.e., prescriptions within A02A-A02B, M01A) and between drug classes (A02A-A02B & M01A) using the Apriori algorithm in R. The lift value, was calculated by a ratio of confidence to expected confidence, which gave information about the association between drugs in the prescription.ResultsWe identified a total of 404,273 patients with 2,575,331 outpatient visits in 2 fiscal years. Mean age was 48 years and 34% were male. Among A02A, A02B and M01A drug classes, 12 rules of associations were discovered with support and confidence thresholds of 1% and 50%. The highest lift was between Omeprazole and Ranitidine (340 visits); about one-third of these visits (118) were prescriptions to non-GORD patients, contrary to guidelines. Another finding was the concomitant use of COX-2 inhibitors (Etoricoxib or Celecoxib) and PPIs. 35.6% of these were for patients aged less than 60 years with no GI complication and no Aspirin, inconsistent with guidelines.ConclusionsAround one-third of occasions where these medications were co-prescribed were inconsistent with guidelines. With the rapid growth of health datasets, data mining methods may help assess quality of care and concordance with guidelines and best evidence.

GPs' views and experiences of prescribing non-steroidal anti-inflammatory drugs: a qualitative study.

BackgroundNon-steroidal anti-inflammatory drugs (NSAIDs) are widely prescribed in primary care despite being a high-risk drug group causing significant adverse events, yet little is known about GPs’ perceptions of NSAID risks and benefits.AimTo explore GPs’ experiences with NSAID prescribing and views about the risks and benefits of this group of medicines.Design & settingA qualitative, inductive study in general practice.MethodIndividual interviews with 15 GPs using a semi-structured interview guide. Interviews were audiorecorded and transcribed. An inductive, thematic approach was used for analysis. Sampling continued until data saturation was achieved.ResultsThree main themes illustrate GPs’ key concerns with managing NSAID risks. The first theme was perceptions of risks and benefits of NSAIDs: GPs expressed differing attitudes towards prescribing medication generally. GPs were aware of the general risks of NSAIDs but weighed these up against specific risk factors and potential benefits for particular patients. They were most concerned about long-term use, risks for children, older people, and patients with comorbidities. The second theme was assessing and mitigating risks when prescribing NSAIDs: GPs considered gastric, cardiac, and renal risks of patients as well as drug interactions. Mitigation strategies included alternative treatment, choice and dose of NSAID, and use of gastroprotective agents. The final theme was other factors impacting on NSAID risks: particularly patient expectations and over-the-counter (OTC) availability.ConclusionNSAID prescribing is a complex balance between pragmatism and potential adverse events. Given the costs of morbidity, hospitalisation, and patient demand there is an urgent need to secure a more detailed evidence base and develop practical pathways to support safer prescribing.

Bariatric Embolization: Pilot Study on the Impact of Gastroprotective Agents and Arterial Distribution on Ulceration Risk and Efficacy in a Porcine Model

PurposeTo assess whether the number of fundal arteries embolized and use of gastroprotective agents have an impact on ghrelin suppression and gastric ulceration rates. Materials and MethodsTwenty-two healthy, growing swine (mean, 38.4 kg; range, 30.3–47.0 kg) were evaluated. Six control swine underwent a sham procedure. Gastric embolization was performed by the infusion of 40-µm microspheres selectively into some or all gastric arteries supplying the gastric fundus. In group 1, 6 swine underwent embolization of all 4 arteries to the gastric fundus. In group 2, 5 swine underwent embolization of 2 gastric fundal arteries. In group 3, 5 swine underwent embolization of 1 gastric fundal artery. Animals in groups 2 and 3 were treated with gastroprotective agents (sucralfate and omeprazole). Weight and fasting plasma ghrelin levels were analyzed at baseline and at week 4. Upon animal euthanasia, gross analysis was performed for identification of ulcers. ResultsOnly group 1 animals exhibited changes in serum ghrelin levels that rendered them significantly lower than those in control animals (P = .049). Group 3 animals exhibited marked elevations in serum ghrelin levels compared with control animals (P = .001). Gross pathologic evaluation revealed 0 ulcers in the control animals, 3 ulcers (50%) in group 1, 2 ulcers (40%) in group 2, and 2 ulcers (40%) in group 3. ConclusionsAdministration of gastroprotective agents and embolization of fewer arteries to the gastric fundus did not prevent gastric ulceration in treated animals. Only animals that underwent embolization of all gastric arteries exhibited significant decreases in serum ghrelin levels.

Gastrointestinal risk assessment in patients requiring non-steroidal anti-inflammatory drugs for osteoarthritis: The GIRANO study.

To evaluate gastrointestinal risk profiles in patients with osteoarthritis who are currently being treated, or who are candidates for treatment, with a non-steroidal anti-inflammatory drug. Patients with osteoarthritis treated by primary care physicians or physical and rehabilitation medicine (PRM) specialists in Belgium and Luxembourg were scored for gastrointestinal risk profile, low, moderate or high, based on the presence of gastrointestinal risk factors. These included advanced age, gastrointestinal history, comorbidities, medication use, smoking, and alcohol consumption. Use of gastro-protective agents (proton pump inhibitors) was also assessed. A total of 190 primary care physicians and PRM specialists provided data on 885 patients. A large majority of patients were rated high-risk gastrointestinal (77.8%), with fewer moderate (19.4%) or low (2.8%) risk. The proportion of high-risk patients treated by PRM specialists was significantly lower than that treated by primary care physicians (64.7% vs 79.9%; p < 0.0001). Only 37.0% of high-risk patients received proton pump inhibitors co-prescription with a non-steroidal anti-inflammatory drug. A high prevalence of elevated gastrointestinal risk was found in this survey of patients with osteoarthritis who were current or candidate users of non-steroidal anti-inflammatory drugs. This appears to be insufficiently recognized, as preventative gastro-protective co-treatment was infrequently prescribed. Careful assessment of gastrointestinal risk factors should be made before prescribing non-steroidal anti-inflammatory drugs, with treatment tailored to the patient's gastrointestinal risk profile.

Prevention of Dabigatran-Related Gastrointestinal Bleeding With Gastroprotective Agents: A Population-Based Study

Use of dabigatran, an inhibitor of thrombin, increases the risk of gastrointestinal bleeding (GIB). However, it is not clear whether gastroprotective agents (GPAs) prevent GIB in dabigatran users. We investigated the risk of GIB and the role of gastroprotective agents (including proton pump inhibitors and histamine type-2-receptor antagonists) in patients using dabigatran. We performed a retrospective cohort study using a population-wide database managed by the Hong Kong Hospital Authority. Patients newly prescribed dabigatran from 2010 through 2013 were included in the analysis. Poisson regression was used to assess the risk of GIB in dabigatran users by incidence rate ratio (IRR), adjusted for patient characteristics, comorbidities, and concurrent medications. Among the 5041 patients newly prescribed dabigatran, 124 (2.5%) developed GIB during follow-up evaluation (4.2/100 patient-years). The risk of GIB in this population increased among patients 75 years and older (IRR, 2.47; 95% confidence interval [CI], 1.66-3.68), patients with a history of peptic ulcers or GIB (IRR, 2.31; 95% CI, 1.54-3.46), and patients who used aspirin (IRR, 1.52; 95% CI, 1.03-2.24). Concomitant use of gastroprotective agents was associated with a reduced risk of GIB (IRR, 0.52; 95% CI, 0.35-0.77). Subcategory analysis showed that use of proton pump inhibitors (IRR, 0.53; 95% CI, 0.31-0.91) or histamine type-2-receptor antagonists (IRR, 0.61; 95% CI, 0.40-0.94) were associated with a lower risk of GIB. Further analysis showed that the risk reduction by gastroprotective agents was significant for only upper GIB (IRR, 0.29; 95% CI, 0.15-0.54), and only for patients with a prior history of peptic ulcers or GIB (IRR, 0.14; 95% CI, 0.06-0.30). In the Hong Kong population, use of gastroprotective agents was associated with a reduced risk of GIB in patients taking dabigatran. The association was stronger for upper GIB than lower GIB, and in patients with a prior history of peptic ulcers or GIB.

Effectiveness of interventions by community pharmacists to reduce risk of gastrointestinal side effects in nonselective nonsteroidal anti‐inflammatory drug users

Upper gastrointestinal (UGI) complications in elderly users of nonselective nonsteroidal anti-inflammatory drugs (ns-NSAIDs) without concomitant use of gastroprotective agents (GPAs) were a leading cause of potentially avoidable drug-related hospital admissions in the Netherlands. We aimed to determine the effectiveness of community pharmacists' interventions to improve safety in ns-NSAID use in patients at UGI risk. In this prospective cohort study, pharmacists in participating pharmacies (intervention group, IG) received feedback on drug dispensing in ns-NSAID users of ≥60 years of age at risk for UGI damage and were instructed to select patients to improve ns-NSAID prescribing, in collaboration with primary care physicians. Ns-NSAID users from other pharmacies without concomitant GPA use were followed in parallel as a control group (CG). Changes in the UGI risk of ns-NSAID users between baseline and follow-up measurement, assessed either by the addition of GPAs or the cessation of ns-NSAIDs, were compared between the two study arms. At baseline, 14% of ns-NSAID users at UGI risk did not receive GPAs. Persistent ns-NSAID users from the selected IG patients had an additional 7% likelihood of reduced UGI risk at follow-up (odds ratio 0.93, 95% confidence interval 0.89-0.97) compared with CG patients. In the IG, 91% of selected IG patients at UGI risk from ns-NSAIDs at baseline were no longer at increased risk at follow-up because of cessation of ns-NSAIDS or to concomitant GPA use. Although concomitant gastroprotection use in susceptible ns-NSAID users in the Netherlands is high, pharmacist-led interventions could further improve prescribing of ns-NSAIDs.

Factors associated with warfarin discontinuation, including bleeding patterns, in atrial fibrillation patients

Objective:To determine risk factors for both warfarin discontinuation and bleeding in patients with atrial fibrillation (AF).Methods:Data from the MarketScan database (January 2005–June 2008) were retrospectively analyzed for patients ≥18 years old who used warfarin continuously (≥2 prescriptions for 6 months) subsequent to an AF diagnosis. Patients were followed until one of the following endpoints occurred: warfarin discontinuation or end of the 30 month study period (whichever happened first). Recent bleeding was defined as occurring within 90 days before discontinuation. Drug interactions related to bleeding were defined as occurring within 120 days prior to bleeding.Results:The study included 7971 eligible patients (mean age 67.8 years; 41.2% female). During follow-up, 51.7% of patients discontinued warfarin (P < .001). More patients with recent bleeding (61.8%) discontinued warfarin compared to patients without recent bleeding (51.3%). After adjustment, patients with recent bleeding were 35% more likely to discontinue warfarin compared to those without recent bleeding (relative risk = 1.35; CI: 1.16–1.58). Age >85 years and a history of ≥1 hospitalizations/emergency room visits were associated with an increased likelihood of discontinuation (P < .001). Female gender, daily dosage >5 mg, concomitant use of gastroprotective agents, and CHADS2 scores ≥1 were associated with a decreased likelihood of discontinuation (P < .05).Conclusions:Risk factors for warfarin discontinuation include older age, recent bleeding, and a high number of concomitant medications. Risk factors associated with bleeding events are older age, use of a warfarin-potentiating medication, previous bleeding, and higher CHADS2 scores.

Commentary: improving the use of gastroprotective agents among high‐risk NSAID users – authors’ reply

Commentary: improving the use of gastroprotective agents among high‐risk NSAID users – authors’ reply

Commentary: improving the use of gastroprotective agents among high‐risk NSAID users

Commentary: improving the use of gastroprotective agents among high‐risk NSAID users

Differences in utilisation of gastroprotective drugs between 2001 and 2005 in Australia and Nova Scotia, Canada

This study aimed to compare use of histamine H2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs), 2001-2005, in the elderly and social security beneficiaries in Australia (AUS) and Nova Scotia, Canada (NS). Prescription dispensing data were collected for all subsidised H2RAs and PPIs. In AUS, dispensing data for concession beneficiaries were obtained from the Pharmaceutical Benefits Scheme database. In NS, data were sourced from the Pharmacare database. Relevant population data were used to convert to World Health Organisation Anatomic Therapeutic Chemical defined daily doses (2005) per 1000 beneficiaries per day (DDD/1000/day). Overall use of gastroprotective agents was similar and rising in NS and AUS (100-160 DDD/1000/day) over this 5-year time window. However, the proportion of this use accounted for by PPIs was far higher in AUS (over 85% by 2005) than in NS (23% rising to 35% over the 5 years). In AUS, PPI use rose from 50 to about 140 DDD/1000/day over the 5 years, whereas PPI use in NS rose slowly to less than 60 DDD/1000/day by 2005. H2RA use in NS was always high (over 100 DDD/1000/day), whereas in AUS, H2RA use fell from 54 to around 24 DDD/1000/day over this period. AUS had much higher use of PPIs than NS over 2001-2005. The proportion of PPIs in all gastroprotective agents rose in AUS to be nearly 90%. The differences in utilisation during this time window could lead to differences in health outcomes from either lower gastro-intestinal bleeding risk or higher long-term adverse effects of PPIs.

The use of prophylactic gastroprotective therapy in patients with nonsteroidal anti‐inflammatory drug‐ and aspirin‐associated ulcer bleeding: a cross‐sectional study

Poor adherence to gastroprotective agents (GPAs) is common among users of nonsteroidal anti-inflammatory drugs (NSAIDs) or low-dose aspirin (ASA). There are little data on the utilization of GPAs among NSAID and ASA users complicated by ulcer bleeding. To study the utilization of GPA among NSAID and ASA ulcers before the onset of ulcer bleeding. We conducted a cross-sectional study to determine the exposure to NSAIDs, ASA, and GPAs within 4 weeks before endoscopically confirmed ulcer bleeding. Sensitivity analysis was performed to study how improving adherence to GPA use would reduce the risk of ulcer bleeding in high-risk users. Between 2000 and 2009, 1093 and 2277 patients had NSAID- and ASA-associated ulcer bleeding respectively. The incidence of NSAID-associated ulcer bleeding declined by 40%, whereas that of ASA-associated ulcer bleeding increased by 46%. Thirty-nine per cent of NSAID users and 75% of ASA users belonged to high ulcer risk category. Although GPA prescription rate has increased over time, only 41.6% and 30.6% of high-risk NSAID and ASA users received GPAs before ulcer bleeding respectively. Sensitivity analysis showed that if GPAs could reduce bleeding risk by 50%, improving adherence would prevent up to 35% of ulcer bleeding in high-risk users. A substantial proportion of high-risk NSAID and ASA users had not received prophylaxis with gastroprotective agents before ulcer bleeding. These bleeding episodes may be preventable with better adherence to gastroprotective agent use.

Factors Associated with Gastroprotective Agent Use and Adherence among Adults with Arthritis Taking NSAIDs in the United States

Purpose: To examine factors associated with gastroprotective agent (GPA) use and adherence among adults with arthritis taking NSAIDs. Methods: A Web-based community panel of US men and women age ≥40 with self-reported arthritis was invited via e-mail to participate in a Web survey. Interested panelists consented and completed the screening questions. Respondents who reported NSAID use in the last 30 days were eligible to continue the survey. NSAID and GPA use were asked, as were questions about comorbid conditions, gastrointestinal (GI) history, and other risk factors. Logistic regressions were performed to assess the associations of predictor variables with GPA use and adherence. Results: Invitations were sent to 7,605 adults with arthritis; 4,108 (54%) responded; 2,208 completed. The final sample consisted of 2,000 participants: 1,525 (76%) with osteoarthritis, 354 (18%) with rheumatoid arthritis and 121 (6%) with both. Mean age was 62.0 years; 64% were female; 83% were white; 25% worked full-time and 39% were retired. Mean duration with arthritis was 13.0 years; 47% and 19% experienced arthritis symptoms “daily” and “almost always”, respectively. The most frequently-used NSAIDs were ibuprofen (54%), aspirin (35%) and naproxen (33%). GPA use was more frequent among higher frequency NSAID users; 36% of single NSAID users and 43% of participants taking 4+ NSAIDs reported taking GPAs. The most frequently-used GPAs were omeprazole (48%), esomeprazole (17%), and ranitidine (17%); 39% of daily NSAID users reported taking a GPA. Variables significantly associated with GPA use were: older age (odds ratio (OR) 1.02); male gender (OR 0.76); being white (vs. Hispanic) (OR 0.24); taking an NSAID at least daily (OR 1.5 for daily use; 2.2 for 2x daily use; and 1.8 for use ≥ 3 times per day); taking fewer NSAIDs (OR 0.83); taking a COX-2 inhibitor (OR 1.6) or a prescription NSAID (OR 1.9); history of ulcer (OR 2.2), Barrett's esophagus (OR 8.8), or GERD (OR 12.6); prescription antiplatelet use (OR 1.9); and more frequent GI symptoms as indicated by GSRS total score (OR 1.5). Variables significantly associated with GPA adherence were: (OR 1.02); inflammatory bowel disease (OR 1.57); GERD (OR 1.72); less frequent GI symptoms (OR 0.62); prescription antiplatelet use (OR 1.97); and prescription NSAID use (OR 1.65). Conclusion: Slightly more than 1/3 of daily NSAID users routinely take GPAs. Older age; taking a prescription NSAID; history of GERD; prescription antiplatelet use; and GI symptoms were all associated with GPA use and adherence to GPA regimen in this sample of adults with arthritis using NSAIDs. These data may be useful for clinicians treating patients with arthritis. Disclosure: Karin S. Coyne, Mary Kay Margolis, and Ray Hsieh are employees of United BioSource Corporation who were paid scientific consultants to Pfizer in connection with this research. Joseph C. Cappelleri, Margaret Noyes Essex, Peter W. Park and Ashish V. Joshi are employees and stockholders of Pfizer Inc. This study was funded by Pfizer Inc. This research was supported by an industry grant from Pfizer Inc.

Gastroprotective Therapy Does Not Improve Outcomes of Patients With Helicobacter pylori–Negative Idiopathic Bleeding Ulcers

We performed a prospective cohort study to investigate the effects of gastroprotective agents (such as proton pump inhibitors or histamine-2 receptor antagonists) on long-term clinical outcomes of patients with Helicobacter pylori-negative idiopathic bleeding ulcers. Patients with H pylori-negative idiopathic bleeding ulcers were recruited from a single center from April 2002 to March 2009 (n = 663). Age- and sex-matched patients with H pylori-positive bleeding ulcers were used as controls (n = 633). After ulcers had healed, 566 patients in the H pylori-negative idiopathic ulcer cohort received gastroprotective agents at clinicians' discretion, whereas controls received no gastroprotective agent after H pylori eradication therapy. Patients were followed until September 2011 for end points that included recurrent ulcer bleeding and all-cause mortality. During the exposed period of 534 person-years, the incidence rates of recurrent ulcer bleeding and death were 3.8 (95% confidence interval [CI], 2.6-5.4) and 21.8 (95% CI, 18.8-25.3) per 100 person-years among the patients given gastroprotective agents, compared with incidence rates of 2.4 (95% CI, 1.6-3.5; P = .08) and 13.8 (95% CI, 11.9-16.0; P < .001) per 100 person-years, respectively, during the unexposed period of 1588 person-years. Use of gastroprotective agents was not associated with mortality, after adjusting for confounders (hazard ratio, 1.1; 95% CI, 0.6-1.7). Incident rates of recurrent ulcer bleeding and death were significantly higher in patients with H pylori-negative idiopathic ulcers (2.9 and 17.0 per 100 person-years, respectively) than in controls (1.1 and 5.9 per 100 person-years, respectively; P < .001). Gastroprotective agents do not reduce the risk of recurrent bleeding or mortality for patients with H pylori-negative idiopathic bleeding ulcers.