Glycemic Control and Obesity Among People With Type 2 Diabetes in Europe and Australia: A Retrospective Cohort Analysis.

INTRODUCTION: In people with type 2 diabetes (PwT2D) who also have obesity, efforts targeting weight loss, including lifestyle, medication and surgical interventions, are recommended. The objective of this study was to explore the relationship between glycemic control and obesity among PwT2D in Europe and Australia using recent real-world data and applying consistent methodology across countries. METHODS: Retrospective study utilizing IQVIA electronic medical records (EMR) databases grouped into panels based on specialty of contributing physicians. General practitioner (GP) and endocrinologist/diabetologist (E/D) panels were used in Germany and France, while GP panels were used in Italy, UK and Australia. The Spanish database included all physician specialties. The sample included PwT2D with glycated hemoglobin A1c (HbA1c) and body mass index (BMI) values measured within 90 days of each other between January 2015 and December 2018 (second record termed the 'index date'). PwT2D had a 1-year baseline period and a recorded HbA1c at the end of the 1-year post-index period. RESULTS: The final sample comprised 194,729 PwT2D. At baseline, across countries/panels, 36.8-58.0% were above HbA1c target (HbA1c ≥ 7%) and 39.4-56.7% had obesity (BMI ≥ 30.0 kg/m2). Mean HbA1c ranged from 6.9 to 7.6% and mean BMI ranged from 29.3-31.6 kg/m2. At baseline, a higher proportion of PwT2D with obesity (40.8-64.2%) were above HbA1c target compared to their counterparts without obesity (32.2-52.4%). A higher proportion of patients with obesity at baseline (38.1-60.6%) had post-index HbA1c above target compared to their counterparts without obesity (30.9-56.0%). In logistic regression, patients with obesity had substantially lower odds of post-index HbA1c below target compared to those without obesity in all countries/panels except for France (E/D), Spain and Australia. CONCLUSIONS: This study presents data on HbA1c and BMI among type 2 diabetes (T2D) populations in Europe and Australia. A notable proportion of PwT2D had obesity and were above HBA1c target. Higher BMI was associated with poorer glycemic control.

Healthcare resource utilization of patients with warm autoimmune hemolytic anemia initiating first line therapy of oral corticosteroids with or without rituximab.

This retrospective cohort study described real-world treatment patterns and healthcare resource utilization (HCRU) of patients with warm autoimmune hemolytic anemia (wAIHA) initiating treatment with first-line (1L) oral corticosteroids (OCS) + rituximab (R) compared to 1L OCS. Patients with a wAIHA diagnosis code (D59.11) between 8/2020-3/2022 were identified using US pharmacy and medical claims databases. Patients initiating 1L OCS ± R were identified (date of initiation = 'index date') with a 1-year pre-index period and a variable (minimum 1-year) follow-up period. The final sample comprised 77 1L OCS + R patients and 400 1L OCS patients (~ 60% female, mean age > 64 years). Over the 1-year follow-up, HCRU was higher in the OCS + R cohort with higher mean number of physician office visits (22.9 and 14.4; p < 0.01), including hematology/oncology office visits, and higher utilization of rescue therapy (59.7% and 33.3%; p < 0.01), driven by higher use of injectable corticosteroids. Patients in OCS + R and OCS groups completed 1L therapy after a similar mean duration of 103.5 and 134.6 days, respectively (p = 0.24). In the majority of patients, second-line (2L) therapy was initiated at a similar timepoint: 66.2% OCS + R and 72.0% OCS cohorts (p = 0.31) initiated 2L in a mean of 218.3 and 203.2 days (p = 0.76) after the end of 1L treatment, respectively. The addition of rituximab in 1L did not extend the remission period, with most patients in both cohorts initiating 2L therapy within less than 1 year of completing 1L treatment. 1L OCS + R patients also had substantial HCRU burden. More effective novel therapies are needed to address the high unmet need in wAIHA.

A clinical and economic assessment of adjuvanted trivalent versus standard egg-derived quadrivalent influenza vaccines among older adults in the United States during the 2018-19 and 2019-20 influenza seasons.

BACKGROUND: Clinical evidence supports use of enhanced influenza vaccines in older adults. Few economic outcome studies have compared adjuvanted trivalent inactivated (aIIV3) and standard egg-derived quadrivalent inactivated influenza vaccines (IIV4e). RESEARCH DESIGN AND METHODS: A retrospective cohort study was conducted leveraging deidentified US hospital data linked to claims data during the 2018-19 and 2019-20 influenza seasons. Relative vaccine effectiveness (rVE) was compared in adults aged ≥ 65 years receiving aIIV3 or IIV4e using inverse probability of treatment weighting (IPTW) and Poisson regression. An economic assessment quantified potential real-world cost savings. RESULTS: The study included 715,807 aIIV3 and 320,991 IIV4e recipients in the 2018-19 and 844,169 aIIV3 and 306,270 IIV4e recipients in the 2019-20 influenza seasons. aIIV3 was significantly more effective than IIV4e in preventing cardiorespiratory disease (2018-19 rVE = 6.2%; and 2019-20 rVE = 6.0%) and respiratory disease (2018-19 rVE = 8.9%; and 2019-20 rVE = 10.1%). During the 2018-19 influenza season cardiorespiratory hospitalization cost savings for the aIIV3 population were $392 M, and $221 M for the 2019-20 season. Respiratory hospitalization cost savings for the aIIV3 population were $145 M and $97 M, respectively. CONCLUSIONS: Our findings suggest that aIIV3 provides clinical and economic advantages versus IIV4e in the elderly.

Flu vaccines do not work as well in older adults due to the aging of their immune system. One approach to improving vaccine efficacy is the addition of a substance, or adjuvant, to the vaccine in order to boost an individual's immune response. This study evaluated an adjuvanted vaccine compared to an unadjuvanted vaccine for preventing cardiorespiratory hospitalizations and hospitalization costs. The findings demonstrated that the adjuvanted flu vaccine, compared to the unadjuvanted vaccine, prevented more hospitalizations and greatly reduced associated hospital costs.

Aquacel Ag Advantage/Ag+ Extra and Cutimed Sorbact in the management of hard-to-heal wounds: a cohort study.

OBJECTIVE: To compare Aquacel Ag Advantage/Ag+ Extra (Aquacel Ag+) (Convatec, UK) and Cutimed Sorbact (Sorbact) (Essity, US) dressings indicated for the treatment of patients with venous leg ulcers (VLUs), diabetes foot ulcers (DFUs) and pressure injuries (PIs) for clinical performance and outcomes using real-world evidence in Germany and the US. METHOD: This study was a chart audit review of patients who used either Aquacel Ag+ or Sorbact dressings in the 24 months prior to October 2022. Healthcare providers with access to electronic medical records and charts were asked to capture data via patient record forms. The quantitative data were analysed. RESULTS: Findings in Germany were comparable between Aquacel Ag+ and Sorbact with regards to wound description, management and treatment outcomes, including percent area reduction and wound closure. A difference was that a greater proportion of Sorbact patients required surgery (0% versus 11%; p=0.039). In the US, a greater proportion of wounds were worsening before dressing in the Aquacel Ag+ cohort (49% versus 34%; p=0.010). A multinomial logistic regression yielded the result that patients who received Aquacel Ag+ were 3.53 times more likely to have the wound completely healed (p=0.033). CONCLUSION: Both Aquacel Ag+ and Sorbact dressings are widely used in Germany and the US for patients with VLUs, DFUs and PIs. Our study found two important differences: patients who used Aquacel Ag+ were less likely to need further surgery in Germany; and in the US, there were significantly higher odds that wounds would completely heal with Aquacel Ag+ dressings compared to Sorbact.

Health-Care Resource Utilization and Treatment Patterns in Men with Erectile Dysfunction and Benign Prostatic Hyperplasia-Associated Lower Urinary Tract Symptoms in the United States: A Retrospective Database Study.

Objective: To compare health-care resource utilization (HCRU) outcomes in patients with erectile dysfunction (ED) and benign prostatic hyperplasia-associated lower urinary tract symptoms (BPH-LUTS) treated with tadalafil or non-phosphodiesterase-5 inhibitor (PDE5i), adherence to and persistence with tadalafil by dose in the United States (US). Methods: This was a noninterventional, real-world evidence study of men (aged ≥45 years) with ED and BPH-LUTS treated with tadalafil or non-PDE5i. The IQVIA US PharMetrics Plus claims database was used. Outcomes included all-cause and disease-specific HCRU over a 12-month follow-up. Persistence with and adherence to tadalafil were evaluated stratified by dose (10 or 20 mg as needed; 2.5 or 5 mg as once daily [OD]). Results: The final sample comprised 11,351 tadalafil and 48,722 non-PDE5i patients. For all-cause and disease-specific HCRU, including prescription fills, physician office visits, emergency room visits, laboratory tests, radiology examinations, outpatient surgical services, ancillary services, hospitalizations, mean number of utilizations, and proportions of patients with one or more utilizations, were lower for tadalafil compared with non-PDE5i patients. For all-cause HCRU, proportions of patients with one or more emergency room visits (18.6% vs 21.7%, p<0.0001) and outpatient surgical visits (63.0% vs 68.8%, p<0.0001) were significantly lower for tadalafil compared with non-PDE5i patients. For disease-specific HCRU, the proportion with one or more disease-specific physician office visits (55.1% vs 91.4%), laboratory tests (34.8% vs 58.2%), outpatient surgery (24.3% vs 38.9%), or outpatient ancillary services (18.0% vs 29.8%) were significantly lower for tadalafil compared with non-PDE5i patients (all comparisons, p<0.0001). Mean persistence days (179.8 vs 61.2), proportion persistence (35.8% vs 6.5%), and mean adherence (0.5 vs 0.2) were higher for tadalafil OD doses than as-needed tadalafil doses. Conclusion: Patients on tadalafil demonstrated less HCRU and higher persistence and adherence (OD versus as-needed tadalafil) than non-PDE5i patients, which demonstrates its benefit in the management of ED and BPH-LUTS in the US.

A Real-World Evaluation of Primary Medication Nonadherence in Patients with Nonvalvular Atrial Fibrillation Prescribed Oral Anticoagulants in the United States.

BACKGROUND: Nonadherence to oral anticoagulants (OACs) is a challenge to stroke risk reduction in patients with nonvalvular atrial fibrillation (NVAF). Data on primary medication nonadherence (PMN) in NVAF are lacking. OBJECTIVES: Our aim was to assess the rates and predictors of PMN among NVAF patients who were newly prescribed an OAC. METHODS: This was a retrospective database analysis of linked healthcare claims and electronic health record data. Adult NVAF patients with a prescription order for an OAC (apixaban, rivaroxaban, dabigatran, or warfarin) between January 2016 and June 2019 were identified (date of first prescription order = index date). Patients had a 1-year baseline and a 6-month post-index period to assess the rates of PMN, defined as having a prescription order but no paid claim for any OAC on or within 30 days after the index date. Sensitivity analyses explored 60-, 90- and 180-day PMN thresholds. Logistic regression models were used to examine the predictors of PMN. RESULTS: Among 20,393 patients, the overall 30-day PMN rate was 28.4%; PMN rates decreased to 17% with a 180-day threshold. PMN was numerically lowest for warfarin among OACs and numerically lowest for apixaban among direct OACs. A CHA2DS2-VASc score of ≥ 3, commercial insurance, and African American race were associated with higher odds of PMN. CONCLUSIONS: More than one-quarter of patients experienced PMN within 30 days of their initial prescription order. This rate decreased over a longer period, suggesting a delay in fills. Understanding the factors associated with PMN is warranted to develop effective interventions for improving OAC treatment rates in NVAF.

Eight-year trends in obesity-related complications and health care cost progression in a US population with obesity: A retrospective cohort study.

AIMS: Obesity-related complications (ORCs) impose a substantial health burden on affected individuals, and economic costs to health care systems. We examined ORCs and the progression of direct health care costs over 8 years, stratified by obesity class. MATERIALS AND METHODS: Adults with obesity were identified in linked US medical records and administrative claims databases. The index date was the first body mass index measurement of 30 to <70 kg/m2 between 1 January 2007 and 31 March 2012; a ≥8-year continuous enrolment post-index was required for inclusion. Diagnosis codes for five specific ORCs and total health care costs were recorded in each year of follow-up. Costs adjusted for clinical and demographic factors were also estimated. RESULTS: Of 28 583 eligible individuals, 17 892 had class I obesity, 6550 had class II obesity and 4141 had class III obesity. From baseline to year 8, the presence of type 2 diabetes and knee osteoarthritis doubled in all obesity classes, with even larger increases for chronic kidney disease and heart failure. Observed and adjusted total health care costs generally increased from the baseline year to year 8. The difference in costs between obesity classes increased over time: at year 1, individuals with class III obesity had 26.8% higher costs than those in class I, but at year 8, this difference was 40.7%. Outpatient costs constituted half of the total observed costs across obesity classes. CONCLUSIONS: ORC rates and health care costs increase over time, and are greater in higher obesity classes. This could be mitigated by approaches that limit obesity progression.

Association of Daily Growth Hormone Injection Adherence and Height Among Children With Growth Hormone Deficiency.

OBJECTIVE: Recombinant human growth hormone (somatropin) is recommended for children with growth hormone deficiency (GHD) to normalize adult height. Prior research has indicated an association between adherence to somatropin and height velocity. Further research is needed using real-world data to quantify this relationship; hence the objective of this study was to investigate the association between adherence to somatropin and change in height among children with GHD. METHODS: This retrospective cohort study included patients in the IQVIA PharMetrics Plus and Ambulatory Electronic Medical Records databases aged 3 to 15 years, with ≥1 GHD diagnosis code claim and newly initiated on somatropin between January 1, 2007 and November 30, 2019. Adherence was measured over the follow-up using the medication possession ratio (MPR); patients were classified as adherent (MPR ≥ 0.8) or nonadherent (MPR < 0.8). RESULTS: Among 201 patients initiated on somatropin, 74.6% were male, mean age was 11.4 years, and the mean follow-up was 343.3 days. Approximately 76.6% of patients were adherent to somatropin over the follow-up period. Adjusted growth trajectories were similar between adherent and nonadherent patients pre-treatment initiation (P = .15). Growth trajectories post-initiation were significantly different (P = .001). On average, adherent patients gained an additional 1.8 cm over 1 year compared with nonadherent patients, adjusted for covariates. CONCLUSION: Greater adherence to somatropin therapy is associated with improved height velocity. As suboptimal adherence to daily somatropin therapy is an issue for children with GHD, novel strategies to improve adherence may improve growth outcomes.

A Real-World Clinical and Economic Analysis of Cell-Derived Quadrivalent Influenza Vaccine Compared to Standard Egg-Derived Quadrivalent Influenza Vaccines During the 2019-2020 Influenza Season in the United States.

BACKGROUND: Cell-derived influenza vaccines are not subject to egg-adaptive mutations that have potential to decrease vaccine effectiveness. This retrospective analysis estimated the relative vaccine effectiveness (rVE) of cell-derived quadrivalent influenza vaccine (IIV4c) compared to standard egg-derived quadrivalent influenza vaccines (IIV4e) among recipients aged 4-64 years in the United States during the 2019-2020 influenza season. METHODS: The IQVIA PharMetrics Plus administrative claims database was utilized. Study outcomes were assessed postvaccination through the end of the study period (7 March 2020). Inverse probability of treatment weighting (IPTW) was implemented to adjust for covariate imbalance. Adjusted rVE against influenza-related hospitalizations/emergency room (ER) visits and other clinical outcomes was estimated through IPTW-weighted Poisson regression models for the IIV4c and IIV4e cohorts and for the subgroup with ≥1 high-risk condition. Sensitivity analyses modifying the outcome assessment period as well as a doubly-robust analysis were also conducted. IPTW-weighted generalized linear models were used to estimate predicted annualized all-cause costs. RESULTS: The final sample comprised 1 150 134 IIV4c and 3 924 819 IIV4e recipients following IPTW adjustment. IIV4c was more effective in preventing influenza-related hospitalizations/ER visits as well as respiratory-related hospitalizations/ER visits compared to IIV4e. IIV4c was also more effective for the high-risk subgroup and across the sensitivity analyses. IIV4c was also associated with significantly lower annualized all-cause total costs compared to IIV4e (-$467), driven by lower costs for outpatient medical services and inpatient hospitalizations. CONCLUSIONS: IIV4c was significantly more effective in preventing influenza-related hospitalizations/ER visits compared to IIV4e and was associated with significantly lower all-cause costs.

Return-to-Function Following Treatment of Dupuytren Contracture With Collagenase Clostridium Histolyticum Versus Fasciectomy.

Background: Dupuytren contracture (DC) treatment with collagenase clostridium histolyticum (CCH) has lower associated treatment costs than fasciectomy, but real-world, postprocedure return-to-function data are limited. Methods: This retrospective study used a US claims database and included adults treated for DC with CCH or fasciectomy (first treatment = index date), who had continuous health plan enrollment ≥360 days preindex and ≥90 days postindex (ie, 90-day follow-up). Analgesic use and physical therapy (PT) and occupational therapy (OT) visits during the follow-up were used as surrogate markers for return-to-function. Results: Overall, 1654 and 2745 patients were included in the CCH and fasciectomy cohorts, respectively. A significantly lower percentage of patients in the CCH versus fasciectomy cohort used opioid analgesics (32.3% vs 82.7%; P < .0001), used nonsteroidal anti-inflammatory drugs (8.6% vs 17.2%; P < .0001), or had ≥1 DC-specific PT or OT visit during follow-up (PT, 38.9% vs 45.3% [P < .0001]; OT, 32.8% vs 38.0% [P = .0006]). The mean number of DC-specific PT and OT visits (PT, 2.5 vs 6.4 [P < .0001]; OT, 1.4 vs 1.9 [P < .0001]) per patient was significantly lower in the CCH versus fasciectomy cohort. Conclusions: This analysis using surrogate markers suggests that CCH treatment may allow earlier return-to-function than fasciectomy in adults treated for DC.

Health Care Resource Utilization and Costs for Adults With Mild Traumatic Brain Injury With Chronic Vestibular Impairment.

OBJECTIVE: To quantify the economic burden of all-cause health care resource utilization (HCRU) among adults with and without chronic vestibular impairment (CVI) after a mild traumatic brain injury (mTBI). DESIGN: Retrospective matched cohort study. SETTING: IQVIA Integrated Data Warehouse. PARTICIPANTS: People with mTBI+CVI (n=20,441) matched on baseline age, sex, year of mTBI event, and Charlson Comorbidity Index (CCI) score to people with mTBI only (n=20,441) (N=40,882). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: All-cause health HCRU and costs at 12 and 24 months post mTBI diagnosis. RESULTS: People with mTBI+CVI had significantly higher all-cause HCRU and costs at both time points than those with mTBI only. Multivariable regression analysis showed that, when controlling for baseline variables, costs of care were 1.5 times higher for mTBI+CVI than mTBI only. CONCLUSIONS: People who developed CVI after mTBI had greater overall HCRU and costs for up to 2 years after the injury event compared with people who did not develop CVI after controlling for age, sex, region, and CCI score. Further research on access to follow-up services and effectiveness of interventions to address CVI is warranted.

Comparing the Clinical and Economic Outcomes Associated with Adjuvanted versus High-Dose Trivalent Influenza Vaccine among Adults Aged ≥ 65 Years in the US during the 2019-20 Influenza Season-A Retrospective Cohort Analysis.

The burden of influenza is disproportionally higher among older adults. We evaluated the relative vaccine effectiveness (rVE) of adjuvanted trivalent (aIIV3) compared to high-dose trivalent influenza vaccine (HD-IIV3e) against influenza and cardio-respiratory disease (CRD)-related hospitalizations/ER visits among adults ≥65 years during the 2019-2020 influenza season. Economic outcomes were also compared. A retrospective cohort analysis was conducted using prescription, professional fee claims, and hospital data. Inverse probability of treatment weighting (IPTW) was used to adjust for confounding. IPTW-adjusted Poisson regression was used to evaluate the adjusted rVE of aIIV3 versus HD-IIV3e. All-cause and influenza-related healthcare resource utilization (HCRU) and costs were examined post-IPTW. Recycled predictions from generalized linear models were used to estimate adjusted costs. Adjusted analysis showed that aIIV3 (n = 798,987) was similarly effective compared to HD-IIV3e (n = 1,655,979) in preventing influenza-related hospitalizations/ER visits (rVE 3.1%; 95% CI: -2.8%; 8.6%), hospitalizations due to any cause (-0.7%; 95% CI: -1.6%; 0.3%), and any CRD-related hospitalization/ER visit (0.9%; 95% CI: 0.01%; 1.7%). Adjusted HCRU and annualized costs were also statistically insignificant between the two cohorts. The adjusted clinical and economic outcomes evaluated in this study were comparable between aIIV3 and HD-IIV3e during the 2019-2020 influenza season.

Economic Impact of Preoperative Meloxicam IV Administration in Total Knee Arthroplasty: A Randomized Trial Sub-Study.

We evaluated the economic impact associated with preoperative meloxicam IV 30 mg vs placebo administration among adult total knee arthroplasty (TKA) recipients enrolled in Phase IIIB NCT03434275 trial. Data on total hospital costs and length of stay (LOS) obtained from the trial were compared between meloxicam IV 30 mg and placebo groups. Patients in the meloxicam IV 30 mg vs placebo group (n = 93 vs 88) incurred an adjusted $2,266 (95% CI: -$1,035, $5,116; p = 0.1689) lower total hospital costs and an adjusted 8.6% (95% confidence interval [CI]: -2.0%, 18.1%; p = 0.1082) shorter LOS. While statistically non-significant, based on 95% CIs, the results from this sub-study may suggest a favorable impact associated with meloxicam IV 30 mg on hospital costs and LOS.

Treatment Patterns and Persistence With GLP-1 RA Treatments Among Patients With Type 2 Diabetes in France: A Retrospective Cohort Analysis.

INTRODUCTION: In type 2 diabetes (T2D), persistence with injectable glucose-lowering therapy is associated with better outcomes. This study used real-world pharmacy data to report on persistence with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in patients with T2D in France. METHODS: This retrospective cohort analysis presents longitudinal data from approximately 7500 French retail pharmacies that filled GLP-1-RA prescriptions for GLP-1 RA-naïve patients with T2D ('index therapy': dulaglutide; once-weekly exenatide [exenatide QW]; twice-daily exenatide [exenatide BID]; liraglutide) between January 2015 and December 2016 (follow-up ≥ 12 months). The main outcome was treatment persistence (absence of discontinuation [gap following index therapy prescription ≥ 2-fold the expected duration of that prescription] or switch [new non-index glucose-lowering prescription issued ≤ 30 days before/after index therapy discontinuation]). Persistence was calculated as the median duration through Kaplan-Meier survival analysis over the variable follow-up period and as the proportion of patients persistent at 12 months. In addition to persistence outcomes (discontinuation/switch), three other treatment modifications were assessed: augmentation/intensification with a new non-index glucose-lowering therapy; off-label dose increase (daily dose > 20 µg for exenatide BID; two consecutive prescriptions with daily dose > 1.8 mg for liraglutide); and off-label dose decrease (two consecutive prescriptions with average daily dose lower than the index dose). Off-label dose changes were not assessed for dulaglutide or exenatide QW (as single-dose, prefilled pens). RESULTS: Median persistence was longest for dulaglutide (373 days) versus liraglutide (205 days), exenatide QW (184 days) and exenatide BID (93 days). Twelve months after treatment initiation, the percentage of persistent patients ranged from 51% (dulaglutide) to 21% (exenatide BID). Overall, treatment modification occurred less commonly for dulaglutide than for the other index GLP-1 RAs. CONCLUSION: This analysis revealed marked differences in persistence among GLP-1 RAs, which was highest for dulaglutide and lowest for exenatide BID. The prospective TROPHIES study will provide additional information about persistence with dulaglutide and liraglutide, including reasons for treatment modifications.

Patients with type 2 diabetes (T2D) who continue to take injectable glucose-lowering therapy for the duration of time recommended by their physician (i.e. those who are 'persistent') usually have better outcomes than those who do not. Persistence may be quantified as the "the duration of time from initiation to discontinuation of therapy". Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are glucose-lowering agents that are often used as the first injectable drug if oral treatments are no longer effective. The aim of the current study was to use data from approximately 7500 retail pharmacies to report persistence with each of four GLP-1 RAs (dulaglutide, once-weekly exenatide [exenatide QW], twice-daily exenatide [exenatide BID] or liraglutide) in GLP-1 RA-naïve patients with T2D in France. Patients (N = 15,074) initiated treatment between January 2015 and December 2016 and were followed for ≥ 12 months. The total duration of follow-up varied among patients. Among patients, persistence over the variable follow-up period was highest for dulaglutide and lowest for exenatide BID: median persistence was longer for dulaglutide (373 days) than for liraglutide (205 days), exenatide QW (184 days) or exenatide BID (93 days). Twelve months after treatment initiation, the percentage of persistent patients ranged from 51% (dulaglutide) to 21% (exenatide BID), with intermediate values for exenatide QW (35%) and liraglutide (36%). This analysis has revealed marked differences in the persistence of patients for various GLP-1 RAs, with patients on dulaglutide showing the highest persistence and those on exenatide BID the lowest.

Healthcare Resource Utilization Among Patients with Focal Seizures Treated with Eslicarbazepine Acetate in the US Long-Term Care Setting: A Retrospective Claims Database Analysis.

INTRODUCTION: The aim of this study was to compare healthcare resource utilization (HCRU) before and after initiation of eslicarbazepine acetate (ESL) in the long-term care (LTC) setting (rehabilitation center, mental health center, LTC non-skilled nursing facility/assisted-living facility, home health, assisted living, nursing home, other/unknown). METHODS: This retrospective analysis used IQVIA's New Data Warehouse, which includes deterministically linked LTC, prescription, and professional fee claims data and IQVIA Hospital Charge Data Master database. The study period was 1 April 2013 to 31 December 2019. The index date was the date of ESL initiation in the LTC setting. Inclusion criteria were: (1) ≥ 1 new ESL prescription between 1 April 2014 and 31 December 2018; (2) diagnosis of focal seizure (FS) during the 12 months pre-index date; and (3) no ESL prescription during the 12-month period pre-index. A 12-month pre-post analysis compared epilepsy-specific and all-cause HCRU before and after ESL initiation. Categorical variables were compared with McNemar's tests. RESULTS: A total of 307 patients (mean age 52.2 years, 57.7% male) with FS were included, of whom 24.8% were in nursing homes. Patients used a mean of 3.1 antiseizure drugs prior to initiation of ESL, and 87.9% of patients initiated ESL as adjunctive treatment. There were significant reductions in proportion of patients with epilepsy specific physician office visits, emergency department (ED) visits, hospitalizations, and all-cause physician office visits and hospitalizations in the post-index period compared to the pre-index period (P < 0.05). Similar results were observed in sensitivity (patients with an epilepsy diagnosis) and subgroup analyses [presence or absence of intellectual developmental disorders or age (≥ 65 and < 65 years)]. CONCLUSION: Proportion of patients with epilepsy-specific physician office visits, ED visits, hospitalizations, and all-cause physician office visits and hospitalizations were significantly reduced following initiation of ESL in patients with FS in LTC.

A retrospective cohort study assessing relative effectiveness of adjuvanted versus high-dose trivalent influenza vaccines among older adults in the United States during the 2018-19 influenza season.

PURPOSE: To evaluate the relative vaccine effectiveness (rVE) against influenza-related hospitalizations/emergency room (ER) visits, influenza-related office visits, and cardio-respiratory disease (CRD)-related hospitalizations/ER visits and compare all-cause and influenza-related costs associated with two vaccines specifically indicated for older adults (≥65 years), adjuvanted (aTIV) and high-dose trivalent influenza vaccine (TIV-HD), for the 2018-19 influenza season. METHODS: A retrospective analysis of older adults was conducted using claims and hospital data in the United States. For clinical evaluations, adjusted analyses were conducted following inverse probability of treatment weighting (IPTW) to control for selection bias. Poisson regression was used to estimate the adjusted rVE against influenza-related hospitalizations/ER visits, influenza-related office visits, and any CRD-related hospitalizations/ER visits. For the economic evaluation, treatment selection bias was adjusted through 1:1 propensity score matching (PSM). All-cause and influenza-related costs associated with hospitalizations/ER, physician office and pharmacy visits were adjusted using generalized estimating equation (GEE) models. RESULTS: After IPTW and Poisson regression, aTIV (n = 561,315) was slightly more effective in reducing influenza-related office visits compared to TIV-HD (n = 1,672,779) (6.6%; 95% CI: 2.8-10.3%). aTIV was statistically comparable to TIV-HD (2.0%; 95% CI: -3.7%-7.3%) in preventing influenza-related hospitalizations/ER visits but more effective in reducing hospitalizations/ER visits for any CRD (2.6%; 95% CI: 2.0-3.2%). In the PSM-adjusted cohorts (n = 561,243 pairs), following GEE adjustments, predicted mean annualized all-cause and influenza-related total costs per patient were statistically similar between aTIV and TIV-HD (US$9676 vs. US$9625 and US$18.74 vs. US$17.28, respectively; both p > 0.05). Finally, influenza-related pharmacy costs were slightly lower for aTIV as compared to TIV-HD ($1.75 vs $1.85; p < 0.0001). CONCLUSIONS: During the 2018-19 influenza season, influenza-related hospitalization/ER visits and associated costs among people aged ≥ 65 were comparable between aTIV and TIV-HD. aTIV was slightly more effective in preventing influenza-related office visits and any CRD event as compared to TIV-HD in this population.

Quality of life in patients with type 2 diabetes after switching to insulin degludec: results from a cross-sectional survey.

PURPOSE: Five quality of life (QoL) domains are particularly important to patients with type 2 diabetes (T2D) using basal insulin-sense of physical well-being, sense of safety regarding hypoglycemia, sense of diabetes as burdensome, feelings of freedom and flexibility, and sleep quality. METHODS: An online survey assessed these QoL domains in adult patients with T2D in the USA who had switched from a previous basal insulin to insulin degludec (IDeg): modified versions of the World Health Organization (Five) Well-Being Index (WHO-5), Hypoglycemia Attitudes and Behavior Scale (HABS; confidence and anxiety subscales only), and Diabetes Distress Scale (DDS; emotional burden and regimen-related distress subscales only); three items assessing feelings of freedom and flexibility; and one item assessing sleep quality (hours of restful sleep). Patients rated each item for their previous basal insulin and currently while using IDeg. Correlations between sleep quality and the other QoL scales were also assessed. RESULTS: In total, 152 patients completed the survey and were included in the study sample. Patients reported significantly improved scores while using IDeg on all WHO-5, DDS, HABS, feelings of freedom and flexibility item scores, and total raw/mean subscale scores (P < 0.0001). Patients also reported a significantly greater number of hours of restful sleep [mean (SD) 6.6 (2.0) vs. 5.5 (1.8); P < 0.0001]. Better sleep quality statistically significantly correlated with improved QoL in all other domains assessed. CONCLUSIONS: Treatment with IDeg after switching from a previous basal insulin was associated with statistically significant improvements in all QoL domains assessed.

Clinical and Economic Outcomes Associated with Cell-Based Quadrivalent Influenza Vaccine vs. Standard-Dose Egg-Based Quadrivalent Influenza Vaccines during the 2018-19 Influenza Season in the United States.

Non-egg-based influenza vaccines eliminate the potential for egg-adapted mutations and potentially increase vaccine effectiveness. This retrospective study compared hospitalizations/emergency room (ER) visits and all-cause annualized healthcare costs among subjects aged 4-64 years who received cell-based quadrivalent (QIVc) or standard-dose egg-based quadrivalent (QIVe-SD) influenza vaccine during the 2018-19 influenza season. Administrative claims data (IQVIA PharMetrics® Plus, IQVIA, USA) were utilized to evaluate clinical and economic outcomes. Adjusted relative vaccine effectiveness (rVE) of QIVc vs. QIVe-SD among overall cohort, as well as for three subgroups (age 4-17 years, age 18-64 years, and high-risk) was evaluated using inverse probability of treatment weighting (IPTW) and Poisson regression models. Generalized estimating equation models among the propensity score matched sample were used to estimate annualized all-cause costs. A total of 669,030 recipients of QIVc and 3,062,797 of QIVe-SD were identified after IPTW adjustments. Among the overall cohort, QIVc had higher adjusted rVEs against hospitalizations/ER visits related to influenza, all-cause hospitalizations, and hospitalizations/ER visits associated with any respiratory event compared to QIVe-SD. The adjusted annualized all-cause total costs were higher for QIVe-SD compared to QIVc ((+$461); p < 0.05).

Healthcare resource utilization and exacerbations in patients with chronic obstructive pulmonary disease treated with nebulized glycopyrrolate in the USA: a real-world data analysis.

AIMS: This study compared medication use, healthcare resource utilization (HRU), and exacerbations among individuals with chronic obstructive pulmonary disease (COPD) who initiated glycopyrrolate/eFlow Closed System nebulizer 25 mcg/mL glycopyrrolate (hereafter GLY) in a real-world setting before and after treatment initiation. MATERIALS AND METHODS: Retrospective claims and hospital charge master data were used to identify individuals ≥ 40 years of age diagnosed with COPD who initiated GLY between 1 April 2018 and 28 February 2019 (first prescription claim = index date). Patients were excluded if they had ≥1 asthma diagnosis in the 6-month pre-index period. The proportion of patients with COPD-related medications, other outpatient HRU, hospitalizations, and exacerbations were compared between the 6-month pre-index and 6-month follow-up periods. Among patients utilizing the service, per-person utilization rates were compared between the two periods. RESULTS: Among patients initiating GLY (n = 767), the mean age was 71.4 years, 56.1% were female, and the mean Charlson Comorbidity Index score was 2.0. The mean number of GLY claims per person was 3.8 during the follow-up period. Compared to the pre-index period, a lower proportion of patients had claims for COPD medications including oral corticosteroids (62.1% vs. 69.1%, p = .0001) and fixed-dose SAMA/SABA (26.1% vs. 33.0%, p < .0001) and a higher proportion of patients had claims for LABA (29.7% vs. 22.6%, p < .0001) during the follow-up period. Fewer patients had ≥1 COPD-related physician office visit (42.4% vs. 49.8%, p < .0001), radiology test (40.7% vs. 46.5%, p = .005), or moderate exacerbation (48.0% vs. 53.2%, p = .01) after initiating GLY. Among patients with linkage to inpatient data (n = 316), fewer were hospitalized (7.9% vs. 13.0%, p = .037) and hospital length of stay was shorter (1.9 vs. 3.6 days, p = .017) after initiating GLY/eFlow. CONCLUSIONS: Among patients initiating GLY in a real-world setting, COPD medications, hospitalizations, other HRU, and exacerbations decreased after treatment initiation compared with the 6-month pre-index period.

Complication-specific direct medical costs by body mass index for 13 obesity-related complications: a retrospective database study.

BACKGROUND: Obesity, a multifactorial disease associated with many severe complications, affects more than 40% of adults in the United States. OBJECTIVE: To quantify the cost burden of 13 obesity-related complications (ORCs), overall and by body mass index (BMI) class. METHODS: Adult patients (aged ≥ 18 years) with ≥ 1 medical claim with an ICD-9/10 diagnosis code for the ORC of interest were identified using linked data from IQVIA's Ambulatory Electronic Medical Records and PharMetrics Plus. Thirteen ORCs were separately assessed (asthma, dyslipidemia, gastroesophageal reflux disease [GERD], heart failure with preserved ejection fraction [HFpEF], hypertension, musculoskeletal pain, obstructive sleep apnea [OSA], osteoarthritis [OA] of the knee, polycystic ovary syndrome [PCOS], prediabetes, psoriasis, type 2 diabetes mellitus [T2DM], and urinary incontinence); ORC cohorts were not mutually exclusive. For each ORC, the first claim identified for the ORC from January 2010-December 2016 was termed the index date. Patients had continuous enrollment in the 1-year pre-index (without a diagnosis code of the specific ORC under study) and the 1-year post-index, with ≥ 1 BMI value in the 6-months pre-index. Patients with underweight (BMI < 18.5 kg/m2) and those with cancer or pregnancy were excluded. Complication-specific costs were identified as claims with a diagnosis code for the ORC (primary position only for hospitalizations) or ORC-specific medications or procedures. Baseline demographic/clinical characteristics and complication-specific costs over the 1-year follow-up were assessed for each ORC cohort, overall and by BMI class (18.5-24.9; 25.0-29.9; 30.0-34.9; 35.0-39.9; ≥ 40 kg/m2). The association between total complication-specific costs and BMI class was assessed by generalized linear regression model for each ORC, adjusting for baseline characteristics. RESULTS: The total number of patients that comprised the ORC cohorts ranged from 1,275 (HFpEF) to 101,784 (musculoskeletal pain). Across ORC cohorts, 41.6% (musculoskeletal pain) to 73.5% (OSA) had obesity (BMI ≥ 30 kg/m2). For 4 ORC cohorts, more than one fifth of patients had class III obesity (BMI ≥ 40 kg/m2): T2DM, OSA, PCOS, and HFpEF. Baseline mean Charlson Comorbidity Index score increased with increasing BMI class for most ORC cohorts. The most costly ORCs overall based on mean total 1-year cost were: OA of the knee ($3,697 [range from normal weight (BMI: 18.5-24.9 kg/m2) to class III obesity: $2,453-$4,518]), HFpEF ($3,586 [range: $3,402-$4,685]), OSA ($2,768 [$2,442-$2,974]), and psoriasis ($2,711 [$2,131-$3,292]). The highest cost differences (≥20%) were observed among those with class III obesity versus those with normal weight for these aforementioned ORCs, as well as for GERD ($1,719 [$1,484-$1,893]) and asthma ($1,531 [$1,361-$1,780]). Following adjustment, most cost comparisons by BMI class were significantly higher versus those for normal weight for 6 ORCs. CONCLUSIONS: ORCs are important drivers of the economic burden of obesity, indicating an unmet need for the treatment of obesity. Appropriate weight management may reduce ORC-associated costs. DISCLOSURES: This study and its publication were supported by Novo Nordisk. Divino, Anupindi, and DeKoven are employed by IQVIA, which received funding from Novo Nordisk for this study. Ramasamy, Eriksen, Olsen, and Meincke are employed by and shareholders of Novo Nordisk. Material reported in this manuscript was presented in an abstract accepted by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2020, to be published in Value in Health. There was no presentation at ISPOR 2020.