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Background Myotonic dystrophy (DM) is a rare, inherited disorder with multi-systemic effects that impact the skeletal muscles, eyes, heart, skin and gastrointestinal, endocrine, respiratory, and central nervous systems. DM is divided into two subtypes: DM1 can present from early childhood through adulthood and also has a congenital form (cDM) while DM2 typically manifests during mid-adulthood. Both forms are progressive with no approved treatments, and unmet need for disease-modifying therapies remains high. This study interrogated health insurance claims data to explore the clinical experience, healthcare resource utilization (HCRU), and all-cause costs for DM. Results A total of 8541 patients with DM and 242 patients with cDM and their matched controls were selected from a database of over 200 million claimants. HCRU and all-cause costs, including pharmacy, outpatient, and inpatient services, were analyzed across four years in 12-month follow-up periods. Mean all-cause costs per DM patient were high in each of the four periods (range $14,640–$16,704) and showed a steady increase from 13 to 23 months on, while the control group mean costs declined from $9671 in the first 12 months after the index event, to approach the US population average ($5193) over time. For cDM, the highest mean costs were in the first 12-months ($66,496 vs. $2818 for controls), and remained high (above $17,944) across all subsequent periods, while control mean costs approached $0. For DM and cDM, HCRU was higher compared to controls across all study periods and all-cause healthcare costs were mostly driven by inpatient and outpatient encounters. Analysis of all diagnosis codes over the study period (comorbidities) demonstrated an elevated comorbidity profile consistent with the clinical profile of DM. Conclusions This study is among the first to utilize claims data to increase understanding of the clinical experience and health economic outcomes associated with DM. The markedly elevated HCRU patterns and comorbidity profile presented here add to the broad body of scientific and clinical knowledge on DM. These insights can inform clinical care and support the development of disease modifying and/or symptom-targeting therapies that address the multi-systemic, progressive nature of DM.

BACKGROUND:Despite their long-term risks, corticosteroids are often used in the management of ulcerative colitis (UC) to help patients achieve and maintain disease remission. The aim of this study was to describe the frequency of high-level corticosteroid exposure and the association between this exposure and both clinical and economic outcomes.METHODS:This retrospective analysis used the IQVIA Real-World Data Adjudicated Claims—US database from January 1, 2006 to June 30, 2017. Patients aged ≥18 years with ≥2 medical claims for UC (ICD9:556.* or ICD10 K51.*) who initiated their first UC therapy (considered the “index” date) between July 1, 2006 and June 30, 2013 and had continuous enrollment 6 months prior to (pre-index) and 4 years after (post-index) this therapy were included. The first 3 years of the post-index window was the corticosteroid exposure observation period; the fourth (and last) year was the outcomes assessment period. Patients were categorized into one of 2 corticosteroid use cohorts: “frequent” (>30 days of continuous corticosteroid exposure in at least 2 of the 3 observation years) versus “infrequent” (all others). Cohorts were compared with respect to the incidence of clinical outcomes (known disease and corticosteroid-related sequelae including infections, osteoporosis etc.), healthcare resource utilization, and costs in the outcomes assessment period. Analyses included chi-square tests and 2-sample t tests.RESULTS:A total of 22,841 patients with UC were included (53.1% female; mean age = 45.2 years [SD = 11.5]). Among them, 4,098 (17.9%) patients met criteria for frequent corticosteroid use. Compared with patients in the infrequent cohort, patients in the frequent cohort were significantly more likely to be younger (28.0% vs 22.7% were 18–39 years), male (48.9% vs 46.5%), and had greater total pre-index costs ($17,294 vs $8,257) (all P < 0.05). Patients in the frequent cohort were significantly more likely to develop gastrointestinal conditions (e.g., ulcers, gastrointestinal bleeding; 87.5% vs 74.0%), infections (e.g., herpes zoster; 53.5% vs 44.3%), musculoskeletal conditions (e.g., osteoporosis; 59.7% vs 51.5%), and dermatologic conditions (e.g., acne, abdominal striae; 34.9% vs 29.8%) (all P < 0.05) during the subsequent outcomes assessment period compared with patients in the infrequent cohort. Patients in the frequent cohort were also more likely to experience a future emergency room visit (24.8% vs 17.9%), an inpatient hospitalization (16.9% vs 8.2%), longer average length of hospital stays (5.9 vs 5.4 days), and higher costs (pharmacy: $17,243 vs $7,939; outpatient: $9,998 vs $6,363; inpatient: $7,299 vs $2,769) compared with patients in the infrequent cohort (all P < 0.05).CONCLUSION(S):Frequent corticosteroid exposure was common among patients with UC and subsequently associated with an increased likelihood of adverse clinical outcomes and greater healthcare resource utilization, and costs.

Background Prior studies have found that patients taking single-pill amlodipine/atorvastatin (SPAA) have greater likelihood of adherence at 6 months than those taking 2-pill calcium-channel blocker and statin combinations (CCB/statin). This study examines whether this adherence benefit results in fewer cardiovascular (CV) events. Methods A retrospective cohort study was conducted using administrative claims data from the IMS LifeLink: US Health Plan Claims database, identifying adults already taking CCB or statin (but not both) who had an index event of either initiating treatment with SPAA or adding CCB to statin (or vice versa) between April 1, 2004 to August 31, 2005. Inclusion criteria included age 18+ years, continuously enrolled for minimum of 6 months prior and 18 months following treatment initiation, >1 diagnosis of hypertension, and no prescription claims for SPAA or added CCB or statin for 6 months prior. Exclusion criteria included >1 claim with missing or invalid days supplied, age 65+ years and not enrolled in Medicare Advantage, or history of prior CV events, cancer diagnosis, or chronic renal failure. The primary outcome measure was the rate of CV events (myocardial infarction, heart failure, angina, other ischemic heart disease, stroke, peripheral vascular disease, or revascularization procedure) from 6 to 18 months following index date, analyzed at three levels: 1) all adherent vs. non-adherent patients, 2) SPAA vs. dual-pill patients (regardless of adherence level), and 3) adherent SPAA, adherent dual-pill, and non-adherent SPAA patients vs. non-adherent dual-pill patients. Results Of 1,537 SPAA patients, 56.5% were adherent at 6 months, compared with 21.4% of the 17,910 CCB/statin patients (p < 0.001). Logistic regression found SPAA patients more likely to be adherent (OR = 4.7, p < 0.001) than CCB/statin patients. In Cox proportional hazards models, being adherent to either regimen was associated with significantly lower risk of CV event (HR = 0.77, p = 0.003). A similar effect was seen for SPAA vs. CCB/statin patients (HR = 0.68, p = 0.02). In a combined model, the risk of CV events was significantly lower for adherent CCB/statin patients (HR = 0.79, p = 0.01) and adherent SPAA patients (HR = 0.61, p = 0.03) compared to non-adherent CCB/statin patients. Conclusions Patients receiving SPAA rather than a 2-pill CCB/statin regimen are more likely to be adherent. In turn, adherence to CCB and statin medications is associated with lower risk of CV events in primary prevention patients.

The aim of this analysis was to implement a claims-based algorithm to estimate biologic cost per effectively treated patient for biologics approved for moderate to severe rheumatoid arthritis (RA). This retrospective analysis included commercially insured adults (aged 18–63 years) with RA in a commercial database, who initiated biologic treatment with abatacept, adalimumab, etanercept, golimumab, or infliximab between 2007 and 2010. The algorithm defined effectiveness as having all of the following: high adherence, no biologic dose increase, no biologic switching, no new nonbiologic disease-modifying antirheumatic drug, no increased or new oral glucocorticoid use, and no more than 1 glucocorticoid injection. For each biologic, cost per effectively treated patient was defined as total drug and administration costs (from allowed amounts on claims), divided by the number of patients categorized as effectively treated. Of 15,351 patients, 12,018 (78.3%) were women, and the mean (SD) age was 49.7 (9.6) years. The algorithm categorized treatment as effective in the first year for 30% (1899/6374) of etanercept, 30% (1396/4661) of adalimumab, 20% (560/2765) of infliximab, 27% (361/1338) of abatacept, and 29% (62/213) of golimumab treated patients. The 1-year biologic cost per effectively treated patient, as defined by the algorithm, was nominally lower for subcutaneously injected biologics than for infused biologics. The 1-year biologic cost per effectively treated patient, as defined by the algorithm, was lowest for etanercept ($49,952), followed by golimumab ($50,189), adalimumab ($52,858), abatacept ($71,866), and infliximab ($104,333). Algorithm-defined effectiveness was similar for biologics other than infliximab. The 1-year biologic cost per effectively treated patient, as defined by the algorithm, was nominally lower for subcutaneously injected biologics than for infused biologics.

IntroductionWe sought to examine real-world treatment patterns and healthcare resource utilization (HCRU) for patients receiving an antipsychotic (AP) and subsequently prescribed benztropine.MethodsA retrospective analysis was conducted among patients with evidence of benztropine initiation using claims data from IQVIA’s New Data Warehouse from January 2017–March 2020. Patients were indexed on the date of first pharmacy claim for benztropine and had continuous enrollment in the 6 months prior (pre-index) and minimum 12 months post-index date, up to 24 months. Patients also had ≥1 pharmacy claim for an AP either pre-index or on the index date.ResultsA total of 112,542 patients were included; 59% were female with mean age of 46 years. The most common comorbidities were bipolar disorder (BD; 28.3%), schizophrenia (SCZ; 28.3%), and depression (26.3%). Over half of the cohort (54.1%) had ≥2 comorbid conditions. Nearly 20% of patients had ≥20 medications (median 10–14) and medications with anticholinergic (AC) properties were used by 87.9%. Approximately 80% of patients had mild AC burden at baseline (using AC burden calculator). The median number of benztropine prescription fills was 5 with treatment duration <3 months in 44.3% of patients and <6 months in 61.7%. All-cause mean healthcare costs in the 12-month cohort (24-month cohort) were $11,755 ($23,128), mean costs for pharmacy were $9,229 ($18,148), and mean costs for inpatient stays were $34,669 ($41,280). Emergency room (ER) visits occurred in 47.3% and physician office visits in 78.9% of the cohort. In patients with available inpatient 12-month data (n=33,717), inpatient stays occurred in 4.0% (13.3% when extrapolated to total cohort). In patients with 24-month data (n=73,836), ER visits occurred in 61% of the cohort and inpatient stays in 6.6% (21.9% when extrapolated to the total cohort). Multivariate analyses showed baseline SCZ was associated with a significantly increased risk of ER visit of 30% and inpatient stay of 50%. Similarly, substance abuse was associated with an increased risk of ER visit of 85% and inpatient stay of about 40%. Other significant associations with ER visits included falls/accidents at baseline (148% increased risk), abnormal movement disorders (38% increased risk), and orthostatic hypotension (38% increased risk).ConclusionsIn this real-world analysis of patients initiating benztropine, polypharmacy and AC burden were frequently observed. BD, SCZ, and depression were the most common comorbidities. Healthcare costs and HCRU were high for the entire cohort; inpatient stays contributed to high costs. Baseline SCZ, falls/accidents (ER only), and substance abuse were significantly associated with ER and inpatient admissions. The comorbidity and medication profiles of this cohort may have influenced the high healthcare costs and HCRU observed in the study.FundingNeurocrine Biosciences, Inc.

Rates of abdominopelvic surgery, with a particular focus on gallbladder procedures, were measured in patients with irritable bowel syndrome (IBS) (n = 108,936) and compared with those in a general population sample (n = 223,082). The patient sample was selected from persons who were members of a managed care organization during the years 1995-2000. Medical records from a randomly selected subset of IBS patients were reviewed to confirm the diagnosis. Crude and standardized rates and adjusted rate ratios for surgery were calculated. The incidence of abdominopelvic surgery, excluding gallbladder procedures, was 87% higher in patients with IBS than that for the general population. The incidence of gallbladder surgery was threefold higher in IBS patients than the general population. Patients with IBS have an increased risk for abdominopelvic and gallbladder surgery and, thus, an associated risk for experiencing morbidity and mortality associated with these surgical procedures.

This study compared all-cause health care resource use (HCRU) and costs between patients with acute oropharyngeal infections and respiratory tract infections (RTIs) receiving targeted syndromic real-time polymerase chain reaction (RT-PCR) tests with next-day results vs matched patients receiving other/no diagnostic tests. Propensity-matched, retrospective study. Two cohorts with International Classification of Diseases, Tenth Revision, Clinical Modification codes for diagnosis or symptom(s) of oropharyngeal infection or RTI (first diagnosis = index) on an outpatient claim were identified in the IQVIA PharMetrics Plus database (July 2020-October 2023). HCRU and costs were examined over 6 months post index across 5 subcohorts: patients receiving syndromic RT-PCR and 4 matched subcohorts (other PCR, point-of-care [POC] only, culture, or no test). The mean (SD) costs for postindex total outpatient services ($2598 [$7564] vs $2970 [$8417]; P < .0001), physician office visit ($624 [$1150] vs $689 [$1082]; P = .0002), emergency department (ED) ($290 [$1145] vs $397 [$1630]; P = .0192), and other medical services ($1684 [$6799] vs $1883 [$7568]; P < .0001) were significantly lower for the oropharyngeal RT-PCR subcohort than the matched culture subcohort. The mean (SD) postindex costs for any outpatient medical services ($2796 [$11,453] vs $3221 [$7873]; P < .0001), physician office visits ($525 [$974] vs $703 [$2635]; P = .0057), ED visits ($253 [$1036] vs $355 [$1300]; P = .0011), and other medical services ($2018 [$10,986] vs $2163 [$6458]; P < .0001) were significantly lower for the RTI RT-PCR subcohort than the matched culture subcohort. Patients in both RT-PCR subcohorts had lower utilization of other medical services and any outpatient services compared with all matched comparator subcohorts. This propensity-matched study provides evidence on the economic impact of syndromic RT-PCR tests for respiratory infections, highlighting their advantages over traditional diagnostic methods.

The current study assessed the impact of urinary incontinence (UI) on residents, staff, care processes, and quality measures in long-term care (LTC) settings. A 70-question quantitative online survey was sent to directors of nursing (DONs) who had worked for ≥1 year in a ≥100-bed facility (≥80% LTC beds). Of the 62% of residents with UI, 40% were always incontinent, and 81% used incontinence products for UI. Overall, 59% of DONs reported that UI management contributes to certified nursing assistant turnover. Approximately 36% of resident falls occurred while trying to get to the bathroom. LTC quality measures reported as significantly impacted by UI included urinary tract infection and falls with major injury. Only 14% of residents with UI were treated with medication. Most (75%) DONs were unaware of any link between anticholinergic medications and risk of cognitive side effects. These results highlight the need for improved UI treatment, awareness, and management in this population. [Journal of Gerontological Nursing, 48(7), 38–46.]

Esophagogastric varices (EGV) and upper gastrointestinal bleeding are common and potentially fatal complications in patients with advanced hepatocellular carcinoma (aHCC). We aimed to evaluate the real-world prevalence of EGV among the aHCC population in the United States. This retrospective cohort study utilized IQVIA's PharMetrics Plus Health Plans Claims database between January 1, 2016, and July 31, 2021 (study period). Adult patients with an aHCC diagnosis who initiated systemic therapies were included, while those with any secondary malignancies or prior liver transplant at baseline were excluded. The date of therapy initiation was the index date; baseline characteristics, prior procedures, and clinical events of interest were captured during the 12-month pre-index (baseline) period. Patients were followed for clinical outcomes (EGV- or bleeding-related emergency room [ER] visits or hospitalization) during the 6-month post-index period. Logistic regression was conducted to identify key predictors of post-index EGV- or bleeding-related ER visit or hospitalization. 904 patients with aHCC were included in the study (mean age: 61.3 years; 75.3% male). Sorafenib (423 patients, 46.8%) was the most prescribed aHCC treatment. During the entire study period, 458 patients (50.7%) underwent an esophagogastroduodenoscopy (EGD), of whom 209 (45.6%) had post-index EGV. Among 327 patients (36.2%) with a baseline EGD, 175 (53.5%) were diagnosed with EGV and 50 (15.3%) had variceal bleeding; 141 patients (15.6% of all patients) experienced ≥1 EGV- or bleeding-related ER visit or hospitalization post-index. There is a high prevalence of EGV in patients with aHCC. The presence of EGV, gastrointestinal bleeding, and portal hypertension-related comorbidities was associated with an increased risk of subsequent EGV- or bleeding-related ER visits or hospitalizations in patients with aHCC. Assessment and stratification of varices should be considered in patients with aHCC before initiating systemic therapies to inform treatment decisions.