Impact of a tubeless, disposable insulin pump on emergency department visits and inpatient admissions among a Medicare population.

BACKGROUND: A tubeless, disposable insulin pump (Omnipod DASH Insulin Management System, Insulet Corporation) has demonstrated improved glycemic outcomes for people with diabetes who require insulin. The impact of the system on downstream health care events has not been studied. OBJECTIVE: To assess health care resource utilization for a Medicare population before and after starting tubeless, disposable insulin pump therapy. METHODS: This retrospective, observational analysis used data from the Centers for Medicare & Medicaid Services 100% Research Identifiable Files. Study outcomes included change in event rates for diabetes-related emergency department (DRED) visits, all-cause emergency department (ACED) visits, diabetes-related inpatient (DRIP) admissions, and all-cause inpatient (ACIP) admissions among Medicare beneficiaries who started the tubeless, disposable insulin pump in 2020 (postpump observation period) as compared with the same duration and calendar period in 2019 (prepump observation period) with no pump use. Subgroup analyses were performed based on Medicare entitlement reason, diabetes type, and diagnosis status for depressive disorder. RESULTS: A total of 811 users met the criteria for analysis: 46.2% had type 2 diabetes, a majority (59.2%) were aged 65 years or older, and 37.0% had a diagnosis for depressive disorder. Significant reductions were observed for DRED of -46.9% (95% CI = -63% to -23%); ACED of -29.0% (95% CI = -37% to -20%); ACIP of -19.9% (95% CI = -32% to -6%). DRIP rates declined notably (-36.6%; 95% CI = -61% to 4%). Event rates observed across subgroups demonstrated consistent downward trends; however, not all were statistically significant. CONCLUSIONS: These findings demonstrate that use of the tubeless, disposable insulin pump was associated with reductions in DRED, ACED, and ACIP. Our results provide real-world evidence to support the use of the tubeless, disposable insulin pump among Medicare beneficiaries who require insulin, regardless of diabetes type or Medicare entitlement reason. Additional studies are recommended to further evaluate the effect of insulin pumps on health care utilization among the Medicare population and other insurance populations.

Cost-effectiveness of the tubeless automated insulin delivery system vs standard of care in the management of type 1 diabetes in the United States.

BACKGROUND: A tubeless, on-body automated insulin delivery (AID) system (Omnipod 5 Automated Insulin Delivery System) demonstrated improved glycated hemoglobin A1c levels and increased time in range (70 mg/dL to 180 mg/dL) for both adults and children with type 1 diabetes in a 13-week multicenter, single-arm study. OBJECTIVE: To assess the cost-effectiveness of the tubeless AID system compared with standard of care (SoC) in the management of type 1 diabetes (T1D) in the United States. METHODS: Cost-effectiveness analyses were conducted from a US payer's perspective, using the IQVIA Core Diabetes Model (version 9.5), with a time horizon of 60 years and an annual discount of 3.0% on both costs and effects. Simulated patients received either tubeless AID or SoC, the latter being defined as either continuous subcutaneous insulin infusion (86% of patients) or multiple daily injections. Two cohorts (children: <18 years; adults: ≥18 years) of patients with T1D and 2 thresholds for nonsevere hypoglycemia (nonsevere hypoglycemia event [NSHE] <54 mg/dL and <70 mg/dL) were considered. Baseline cohort characteristics and treatment effects of different risk factors for tubeless AID were sourced from the clinical trial. Utilities and cost of diabetes-related complications were obtained from published sources. Treatment costs were derived from US national database sources. Scenario analyses and probabilistic sensitivity analyses were performed to test the robustness of the results. RESULTS: Treating children with T1D with tubeless AID, considering an NSHE threshold of less than 54 mg/dL, brings incremental life-years (1.375) and quality-adjusted life-years (QALYs) (1.521) at an incremental cost of $15,099 compared with SoC, resulting in an incremental cost-effectiveness ratio of $9,927 per QALY gained. Similar results were obtained for adults with T1D assuming an NSHE threshold of less than 54 mg/dL (incremental cost-effectiveness ratio = $10,310 per QALY gained). Furthermore, tubeless AID is a dominant treatment option for children and adults with T1D assuming an NSHE threshold of less than 70 mg/dL compared with SoC. The probabilistic sensitivity analyses results showed that compared with SoC, in both children and adults with T1D, tubeless AID was cost-effective in more than 90% of simulations, assuming a willingness-to-pay threshold of $100,000 per QALY gained. The key drivers of the model were the cost of ketoacidosis, duration of treatment effect, threshold of NSHE, and definition of severe hypoglycemia. CONCLUSIONS: The current analyses suggest that the tubeless AID system can be considered a cost-effective treatment compared with SoC in people with T1D from a US payer's perspective. DISCLOSURES: This research was funded by Insulet. Mr Hopley, Ms Boyd, and Mr Swift are full-time Insulet employees and own stock in Insulet Corporation. IQVIA, the employer of Ms Ramos and Dr Lamotte, received consulting fees for this work. Dr Biskupiak is receiving research support and consulting fees from Insulet. Dr Brixner has received consulting fees from Insulet. The University of Utah has received research funding from Insulet. Dr Levy is a consultant with Dexcom and Eli Lilly and has received grant/research support from Insulet, Tandem, Dexcom, and Abbott Diabetes. Dr Forlenza conducted research sponsored by Medtronic, Dexcom, Abbott, Tandem, Insulet, Beta Bionics, and Lilly. He has been speaker/consultant/advisory board member for Medtronic, Dexcom, Abbott, Tandem, Insulet, Beta Bionics, and Lilly.

Angiotensin-converting enzyme inhibitors reduce community-acquired pneumonia hospitalization and mortality.

BACKGROUND: Pneumonia is a global disorder and a common reason for prolonged hospitalization. Angiotensin-converting enzyme inhibitors (ACEi) have pleiotropic effects that support a role in modulating pneumonia, but results have been controversial. OBJECTIVES: The present study was conducted to elucidate an ACEi-induced pneumonia benefit in at-risk neurologically impaired population and to determine whether a mortality benefit exists. METHODS: A cohort study using a large health-system of 29,011 unique ACEi users and 1635 case patients 65 years of age or older without neurological disorders affecting swallowing who were admitted with community-acquired pneumonia hospitalization and followed up from January 1, 2015 to December 31, 2019 (5 years). The association between ACEi use and pneumonia hospitalization and mortality were determined after propensity score matching using Cox and logistic regression. RESULTS: The experimental cohort was 74.9 ± 7.3 years and 51% were male. ACEi users had lower odds of acquiring pneumonia versus ACEi non-users (odds ratio) 0.72 [95% Confidence Interval (CI) 0.51 to 0.99]; p = 0.048. The risk of short-term mortality (<30 days) (HR) 0.42, p < 0.001 and long-term mortality (≥30 day) (HR) 0.83, p < 0.002 was significantly lower for ACEi users compared with the ACEi non-users. CONCLUSIONS: ACEi use in patients at risk of pneumonia without neurological swallowing disorders is associated with reduction in hospitalization and lowering of short- and long-term mortality. Given the high incidence of morbidity and mortality associated with pneumonia, and the susceptibility in older populations with underlying cardiovascular or renal disease or social dependencies, our data support the prescribing of ACEi in these populations to reduce pneumonia hospitalization risk as well as short- and long-term mortality.

Positive Association between Peri-Surgical Opioid Exposure and Post-Discharge Opioid-Related Outcomes.

Background: Multiple studies have investigated the epidemic of persistent opioid use as a common postsurgical complication. However, there exists a knowledge gap in the association between the level of opioid exposure in the peri-surgical setting and post-discharge adverse outcomes to patients and healthcare settings. We analyzed the association between peri-surgical opioid exposure use and post-discharge outcomes, including persistent postsurgical opioid prescription, opioid-related symptoms (ORS), and healthcare resource utilization (HCRU). Methods: A retrospective cohort study included patients undergoing cesarean delivery, hysterectomy, spine surgery, total hip arthroplasty, or total knee arthroplasty in an academic healthcare system between January 2015 and June 2018. Peri-surgical opioid exposure was converted into morphine milligram equivalents (MME), then grouped into two categories: high (>median MME of each surgery cohort) or low (≤median MME of each surgery cohort) MME groups. The rates of persistent opioid use 30 and 90 days after discharge were compared using logistic regression. Secondary outcomes, including ORS and HCRU during the 180-day follow-up, were descriptively compared between the high and low MME groups. Results: The odds ratios (95% CI) of high vs. low MME for persistent opioid use after 30 and 90 days of discharge were 1.38 (1.24−1.54) and 1.41 (1.24−1.61), respectively. The proportion of patients with one or more ORS diagnoses was greater among the high-MME group than the low-MME group (27.2% vs. 21.2%, p < 0.01). High vs. low MME was positively associated with the rate of inpatient admission, emergency department admissions, and outpatient visits. Conclusions: Greater peri-surgical opioid exposure correlates with a statistically and clinically significant increase in post-discharge adverse opioid-related outcomes. The study findings warrant intensive monitoring for patients receiving greater peri-surgical opioid exposure.

BRCA testing and outcomes in women with breast cancer.

MAIN PURPOSE: Germline BRCA mutations (BRCAm) strongly influence the risk of developing breast cancer. This study aimed to understand the role of BRCAm testing in affected individuals and to assess its impact on the outcome of BRCAm carriers compared to non-carriers (BRCAwt) with breast cancer. RESEARCH QUESTION: The research question is "Does standard of care testing for BRCAm improve survival outcomes of breast cancer patients?" METHODS: In a single institution observational cohort study, demographic and clinical characteristics were compared between breast cancer patients with and without BRCAm. Frequency of BRCA testing was assessed. Survival outcomes were assessed by initial treatment setting stratified by BRCA status. RESULTS: Of 5712 identified women with breast cancer, 14.6% (n = 835) were tested for a BRCA mutation and had a documented result. The total number and proportion of women tested for a BRCAm increased between 2000 and 2014, resulting in an increased number of BRCAm carriers identified. However, the proportion of women who underwent testing and had a BRCAm decreased during the study period from 27.5% in 2000-2004 to 13.3% in 2010-2014. Disease-free survival was similar in the adjuvant and neoadjuvant treatment settings between BRCAm and BRCAwt patients. Progression-free survival on first line treatment and overall survival for patients with metastatic disease was also similar between BRCAm and BRCAwt patients. CONCLUSIONS: The proportion of women tested and the number of BRCAm identified increased during the study period despite a decreasing proportion of positive results among women tested.

Cost-Sharing Requirements for the Herpes Zoster Vaccine in Adults Aged 60.

Background: Rates of zoster vaccination in US adults aged 60+ were approximately 30.6% in 2015. Out-of-pocket cost-sharing has been identified as a major barrier to vaccination for patients. To date, herpes zoster vaccine cost-sharing requirements for adults aged 60 to 64 has not been described. Objective: Compare the cost-sharing requirements for zoster vaccination in adults aged 60 to 64 and adults aged 65+. Methods: A retrospective cohort design examined pharmacy claims for zoster vaccination from the Utah All Payer Claims Database for adults aged 60+. Descriptive statistics and a 2-part cost model compared cost-sharing requirements for adults aged 60 to 64 and adults 65+. Results: Of the 30 293 zoster vaccine claims, 13 398 (45.8%) had no cost-sharing, 1716 (5.9%) had low cost-sharing (defined as $1 to less than $30), and 14 133 (48.3%) had high cost-sharing (defined as $30 or more). In the cost models, adults aged 65+ had higher odds of any cost-sharing (odds ratio = 39.86) and 29% higher cost-sharing as compared with adults aged 60 to 64. Conclusions: Adults aged 60 to 64 encounter lower cost-sharing requirements than adults aged 65+. Providers should be cognizant of this dynamic and encourage zoster vaccination prior to the age of 65.

The effect of a prescription order requirement for pharmacist-administered vaccination on herpes zoster vaccination rates.

OBJECTIVE: To determine the effect of a prescription order requirement for pharmacist-administered zoster vaccination on zoster vaccination in adults aged 60+. METHODS: A 50-state law review of statutes and regulations regarding pharmacists' ability to administer the zoster vaccine with/without a prescription order was performed. States were classified as prescription order required or not required as of January 1, 2014. Data on adults aged 60+ were obtained from the 2014 Behavioral Risk Factor Surveillance System (BRFSS). Chi-square tests and multilevel logistic regression models with and without propensity scores methods were used. RESULTS: Of the 50 states, 39 and the District of Columbia did not require a prescription order. After propensity score matching, zoster vaccination rates for adults ages 60 and older were significantly higher in states that did not require a prescription order (23.0% vs 21.1%, p = 0.0022). The propensity score-matched multilevel logistic regression model for adults aged 60+ found modestly higher odds of HZ vaccination for states that removed the prescription order requirement (OR 1.17, 95% CI 1.01-1.35). Similar estimates were found across other methodologies employed and age strata, although statistical significance varied. CONCLUSIONS: Prescription order requirements are associated with HZ vaccination rates. By removing a prescription order requirement, states may be able to promote increases in HZ vaccination in adults aged 60+.

Projecting the cost, utilization, and patient care impact of prescribing extended release non-abuse-deterrent opioids to chronic pain patients.

OBJECTIVES: To estimate healthcare resource utilization, associated costs, and number needed to harm (NNH) from a physician's decision to prescribe extended-release (ER) non-abuse-deterrent opioids (non-ADO) as compared to ER ADOs in a chronic pain population. DESIGN: A 12-month probabilistic simulation model was developed to estimate the reduction of misuse and/or abuse from a physician's prescribing decisions for 10,000 patients. Model inputs included probabilities for opioid misuse and/or abuse-related events, opioid discontinuation, and switching from ADO to non-ADO. Estimated reductions in abuse associated with ADOs were obtained from positive subjective measures using human abuse liability studies. The model was run separately for commercial, Medicare, Medicaid, and Veterans Administration (VA) populations. The difference in healthcare resource utilization and associated costs (2015 USD) between the ADO and non-ADO simulations was calculated. NNH for non-ADO was also calculated. RESULTS: Misuse and/or abuse-related events for patients prescribed ER non-ADOs ranged from 223-1,410 and associated costs ranged from $20-$98 per patient for commercial and Medicare populations, respectively. Prescribing ER ADOs were associated with 87, 289, 264, and 417 fewer misuse and/or abuse-related events, saving $8, $35, $21, and $29 per patient in commercial, VA, Medicaid, and Medicare populations, respectively. NNH ranged from 185 in the commercial population to 40 in the Medicare population. Results were sensitive to decreases in the probability of misuse and/or abuse events but showed reductions. CONCLUSIONS: A physician's decision to prescribe ER ADOs could lead to large reductions in misuse and/or abuse-related events and associated costs across many patient populations.

Cost of palliative external beam radiotherapy (EBRT) use for bone metastases secondary to prostate cancer.

BACKGROUND: Evaluations of the costs of palliative external beam radiation therapy (EBRT) for treatment of bone metastases are limited. OBJECTIVE: To summarize EBRT lifetime care patterns in deceased men with metastatic prostate cancer treated in a cancer hospital in the United States. METHODS: A retrospective review of electronic health records identified deceased adult prostate cancer (ICD-9 185.xx) patients with bone metastases (ICD-9 198.5) and who were treated for bone pain and metastasis management with EBRT between January 1, 1995 and December 17, 2012. Common Procedural Terminology codes were used to identify all EBRT episodes (total billed EBRT services; initial and final evaluation) to calculate length of EBRT treatments and per episode costs (2011 US$). Bootstrapping approximated the 95% confidence interval for final cost estimates. RESULTS: 176 men were identified; 19 (10.8%) had bone metastases in >1 site. Eighty-nine men (50.6%) received >1 EBRT episode (range, 1-6; median, 2), with first episode length ranging from 1-44 calendar days (mean, 13.4; SD, 8.4) at a mean cost of $7,084 (SD, $4,028). About 70% of costs were attributable to hospital charges and 30% to physician charges. LIMITATIONS: Small sample size limits broad applicability to large populations of men with prostate cancer. CONCLUSION: Care costs for EBRT constitute one of many costs that should be taken into account when planning for palliative care of prostate cancer and bone metastasis.

Research to real-world application: experts weigh in on the underuse of anticoagulants.

Although numerous studies have shown that anticoagulants can reduce the risk of stroke and thromboembolic events in patients with nonvalvular atrial fibrillation, they are underprescribed in the clinical setting. While standardized risk scoring assessments are recommended in treatment guidelines to determine when anticoagulant use may be appropriate, they are not widely used in the real-world clinical setting. Many factors contribute to anticoagulant underuse, including patient characteristics and comorbidities. Reluctance to prescribe an anticoagulant may also stem from concerns about bleeding or other perceived risks. In addition, physicians may be discouraged from prescribing anticoagulant therapy, particularly warfarin, if follow-up care and monitoring is potentially unfeasible. Patient fears of treatment and lack of access to the healthcare system also contribute to underuse. Increased awareness and education, medical therapy management programs, better care coordination, and improvements in monitoring and follow-up programs may help to increase the use of anticoagulant therapies in appropriate patients.

Application of electronic medical record data for health outcomes research: a review of recent literature.

Electronic medical records (EMRs) have become a common source of data for outcomes research. This review discusses trends in EMR data use for outcomes research as well as strengths and limitations, and likely future developments to help optimize value and use of EMR data for outcomes research. EMR-based studies reporting treatment outcomes published between 2007 and 2012 were predominantly from the USA and Europe. There has been a substantial increase in the number of EMR-based outcomes studies published from 2007-2008 (n = 28) to 2010-2011 (n = 55). Many studies evaluated biometric and laboratory test outcomes in common chronic conditions. However, researchers are expanding the scope of evaluated diseases and outcomes using advanced techniques, such as natural language processing and linking EMRs to other patient-level data to overcome issues with missing data or data that cannot be accessed using standard queries. These advances will help to expand the scope and sophistication of outcomes research in the coming years.

Characterization of clinical course and usual care patterns in female metastatic breast cancer patients treated with zoledronic acid.

PURPOSE: To describe usual care received by women with bony metastatic breast cancer (ICD-9: 174.xx and 198.5) treated in a United States specialty cancer hospital, an Electronic Medical Record (EMR)-based retrospective review identified 111 deceased female breast cancer patients ≥18 years of age treated with zoledronic acid (ZOL). RESULTS: Baseline symptoms included bone pain/fracture (58.6%), breathing difficulties (24.3%), or mental status changes (11.7%). ZOL was started at/after metastatic diagnosis for 75.7% of women (N = 84), with average administration of 15.9 months (median 11.3). Nearly 20% required reduced ZOL doses, most (54.5%) due to impaired renal function; 61.3% discontinued ZOL due to patient death/disease progression. Adverse events were reported in 10.8%, while 0.9% (N = 1) had a documented osteonecrosis of the jaw. CONCLUSIONS: Initiation of palliative care should be considered early in patients with a history of metastatic breast cancer who report bone pain or other skeletal-related events.

Implementing CER: what will it take?

BACKGROUND: Comparative effectiveness research (CER) is undeniably changing how drugs are developed, launched, priced, and reimbursed in the United States. But most organizations are still evaluating what CER can do for them and how and when they can utilize the data. A roundtable of stakeholders, including formulary decision makers, evaluated CER's possible effects on managed care organizations (MCOs) and what it may take to fully integrate CER into decision making. OBJECTIVES: To examine the role of CER in current formulary decision making, compare CER to modeling, discuss ways CER may be used in the future, and describe CER funding sources. SUMMARY: While decision makers from different types of organizations, such as pharmacy benefit management (PBM) companies and MCOs, may have varying definitions and expectations of CER, most thought leaders from a roundtable of stakeholders, including formulary decision makers, see value in CER's ability to enhance their formulary decision making. Formulary decision makers may be able to use CER to better inform their coverage decisions in areas such as benefit design, contracting, conditional reimbursement, pay for performance, and other alternative pricing arrangements. Real-world CER will require improvement in the health information technology infrastructure to better capture value-related information. The federal government is viewed as a key driver and funding source behind CER, especially for infrastructure and methods development, while industry will adapt the clinical development and create increasing CER evidence. CER then needs to be applied to determining value (or cost efficacy). CONCLUSIONS: It is expected that CER will continue to grow as a valuable component of formulary decision making. Future integration of CER into formulary decision making will require federal government and academic leadership, improvements in the health information technology infrastructure, ongoing funding, and improved and more consistent methodologies.

Hemorrhagic and thrombotic events associated with generic substitution of warfarin in patients with atrial fibrillation: a retrospective analysis.

BACKGROUND: Substitution of generic warfarin for imprint warfarin (Coumadin; DuPont/Bristol-Myers Squibb) has been a controversial issue due to bioavailability and bioequivalence concerns. OBJECTIVE: To assess the risk of thrombotic and hemorrhagic events following substitution of warfarin formulations in patients with atrial fibrillation (AF). METHODS: Historical cohort analysis was performed using a commercial insurance claims database. Adults with a diagnosis of AF between January 2003 and December 2007, with 16 or more months of continuous eligibility, a warfarin prescription within 30 days after index AF diagnosis, and at least 3 warfarin prescription fills during the follow-up period were included. Individuals with AF diagnosis or warfarin prescription during the pre-index period were excluded. Cox proportional hazard regression models controlling for sex and baseline comorbidities (Charlson comorbidity index, CCI) were used to evaluate the risks of thrombotic and hemorrhagic events following warfarin formulation switches. RESULTS: Of 37,756 subjects included in the analysis (mean age 70.96 years, 42.3% females), 12,996 (34.4%) switched warfarin formulations, 20,292 (53.7%) used only 1 generic product, and 4468 (11.8%) used only Coumadin during follow-up. Compared with continued use of Coumadin, switching from that product to the generic formulation was associated with a significantly higher risk of thrombotic events (HR = 1.81; 95% CI 1.42 to 2.31). Similar findings were observed for switching from generic warfarin to Coumadin (HR = 1.76; 95% CI 1.35 to 2.30), and from 1 generic to another generic product (HR = 1.89; 95% CI 1.57 to 2.29). Similarly, switching from Coumadin to generic warfarin (HR = 1.51; 95% CI 1.17 to 1.93), generic warfarin to Coumadin (HR = 1.60; 95% CI 1.23 to 2.1), and from 1 generic to another generic product (HR = 1.74; 95% CI 1.45 to 2.11) were associated with significantly higher risk of hemorrhage than remaining on Coumadin. CONCLUSIONS: Switching warfarin formulations exposed patients with AF to a higher risk of bleeding events compared to remaining on a single product. Maintaining patients on a product with consistent bioavailability may optimize the risk-benefit balance of anticoagulation therapy.

Prevalence of high-risk cardiovascular conditions and the status of hypertension management among hypertensive adults 65 years and older in the United States: analysis of a primary care electronic medical records database.

This study compared the prevalence of high-risk cardiovascular (CV) conditions, antihypertensive medication treatment patterns, and demographic and clinical characteristics associated with blood pressure (BP) goal attainment between elderly (65 years and older) and nonelderly (younger than 65 years) adults with hypertension. Retrospective cohort study was conducted using an electronic medical record database among patients receiving at least 1 antihypertensive medication. CV risk profiles were assessed by International Classification of Diseases, 9th Revision diagnosis codes. Treatment patterns were assessed by the number of antihypertensive medications prescribed. BP goal attainment was determined by the mean of the last 2 BP readings during 1 year of follow-up. Logistic regression estimated the odds of achieving BP goal. There were 61,355 nonelderly (mean age, 51.8 years) and 47,796 elderly (mean age, 73.2 years) patients in the study. Elderly patients had statistically significant higher levels of isolated systolic hypertension and complicated hypertension. Elderly patients had statistically significant higher levels of prescribing patterns characterized by multiple antihypertensive medications but statistically significant lower levels of BP goal attainment. Age 65 years and older, African American race, body mass index ≥30, and the presence of complicated hypertension were found to be statistically significant factors contributing to a lower likelihood of BP goal attainment. Despite aggressive antihypertensive treatment, elderly patients are less likely to achieve BP goals.

Gastrointestinal complications of over-the-counter nonsteroidal antiinflammatory drugs.

This study assessed the "real-world" risk of serious gastrointestinal (GI) toxicities, defined as perforations, ulcers and bleeds (PUBs) in a U.S. representative population that was using two commonly available over-the-counter (OTC) non-selective nonsteroidal antiinflammatory drugs (NSAIDs), naproxen or ibuprofen with or without concomitant aspirin usage. A retrospective review of a commercially available electronic medical record (EMR) database containing the ambulatory health record data for over 3.2 million individuals was conducted. Subjects were eligible for inclusion in the study if they received an OTC dosage of naproxen (220 mg) or ibuprofen (200 mg). An index date for each subject was defined as the first mention of an OTC NSAID in the medication list of the EMR dataset. Subjects were excluded from the analysis if they met any criteria, which can lead to GI bleeding complications. The dataset was analyzed for PUBs, as indicated by the ICD-9 diagnosis codes for gastric, duodenal, peptic, or gastrojejunal ulcers, or GI hemorrhage, as well as the concomitant use of aspirin. A pre/post-analysis was conducted using a case-crossover design with subjects as their own controls. The index date was the defining event, in order to determine the odds ratio associated with OTC NSAID usage. A pre-index time period of 365 days was used for prior PUBs. For the post-index time period, only PUBs that occurred within 90 days of the OTC NSAID index date were considered. The data set contained 11,957 subjects on naproxen and 38,507 subjects on ibuprofen. In both cases, OTC NSAID usage was associated with a statistically significant increase in the odds ratio for PUBs. Subjects on ibuprofen had an odds ratio of 1.38 (95% CI 1.07-1.78, P=0.01). Naproxen subjects exhibited an odds of 1.54 (95% CI 1.04-2.28, P=0.03). The concomitant aspirin population consisted of 2,328 naproxen subjects and 4,843 ibuprofen subjects. Concomitant aspirin usage was also associated with a significantly higher risk for PUBs than the corresponding monotherapy. Subjects taking both ibuprofen and aspirin had an odds ratio of 3.36 (2.36-4.80, P<.00001), while those on naproxen and aspirin had an odds ratio of 2.07 (1.23-3.49, P=.005) relative to those subjects on ibuprofen and naproxen monotherapy, respectively. Utilizing a national electronic medical record database representing patients seen predominantly in a primary care setting, this study has documented the "real-world" risk associated with the use of two common OTC NSAIDs, as well as the increased risk associated with concomitant aspirin use in this population.