Impact of Weight Change on Glycemic Control and Metabolic Parameters in T2D: A Retrospective US Study Based on Real-World Data.

INTRODUCTION: Weight loss has been identified as a key strategy for improving glycemic and metabolic outcomes in people with type 2 diabetes (T2D). However, the long-term, real-world impact of weight loss on these outcomes remains unclear. This study aimed to investigate (1) the association between weight loss and glycemic control, (2) association between weight loss and metabolic parameters, and (3) predictors of weight loss and how weight change trajectory varies based on index body mass index (BMI). METHODS: A retrospective, longitudinal cohort study using the linked IQVIA Ambulatory electronic medical records and PharMetrics® Plus databases was performed from January 1, 2010 through December 31, 2019 in adults with T2D. Participants were categorized into 1-year and 5-year follow-up cohorts based on their observed weight change over time. Longitudinal values for vital signs and laboratory parameters, including BMI, weight, glycated hemoglobin (HbA1c), and metabolic parameters (liver enzymes and cholesterol), were reported at index date and every 6 months post index date. Multivariable logistic regression analysis was used to evaluate the factors associated with weight loss. RESULTS: Of 1,493,964 people evaluated, 1,061,354 (71%) and 308,320 (20.6%) were classified into the 1-year and 5-year follow-up cohorts. Average HbA1c reductions of 1.2% and 0.5% were observed among people who lost ≥ 15% of index weight in the 1-year and 5-year follow-up cohorts, respectively. Higher weight loss percentages were associated with numerically greater improvements in metabolic parameters. The presence of bariatric surgery and higher index BMIs were identified as the strongest predictors of ≥ 15% and ≥ 10% weight loss in both follow-up cohorts. CONCLUSION: Results from this study suggest that modest and sustained weight loss can lead to clinically meaningful improvements in glycemic and metabolic parameters among people with T2D. These findings highlight the importance of weight management in managing T2D and preventing its associated complications.

Characteristics, treatment patterns, health care resource utilization and costs in patients with bullous pemphigoid: A retrospective analysis of US health insurance claims data.

Background: Real-world data describing the impact of incident bullous pemphigoid (BP) on patients and health care resource utilization (HCRU) are limited. Objective: To examine characteristics, treatment patterns, HCRU, and costs for incident BP. Methods: Retrospective analysis of 2015 to 2019 US health insurance claims for patients ≥18 years with an incident BP diagnosis. Patients with BP were matched to those without on demographic and clinical characteristics. Statistics were descriptive. Results: The mean Charlson Comorbidity Index score was higher for patients with BP (n = 1108) than without (n = 4621) at baseline (mean [SD]: 3.3 [2.7] vs 2.8 [2.4]) and during follow-up (5.0 [4.9] vs 3.7 [3.0]). Hypertension, diabetes, skin ulcers, chronic pulmonary disease, dyslipidemia, sleep disorders, and congestive heart failure were higher with BP. Most patients with BP received antibiotics (>80%) and/or corticosteroids (>90%). Hospitalizations were more common (44.0% vs 17.1%) and monthly all-cause health care costs more than double ($3214 vs $1353) in patients with BP than without. Limitations: Diagnoses were based on billing codes. HCRU claims data may not reflect the true number of encounters. Conclusion: Incident BP is associated with considerable morbidity, HCRU, and costs. More effective, targeted treatments are needed to improve quality of life, while minimizing exposure to systemic corticosteroids.

Retrospective Analysis of the Burden of Illness of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Versus Asthma in Commercially Insured US Patients.

Background and aim Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare inflammatory disorder associated with the presence of blood and tissue eosinophilia, extravascular granulomas, and asthma. Currently, the burden of EGPA on the patient and the healthcare system is not well characterized. This study aimed to assess the real-world clinical and economic burden of disease in adult patients with EGPA compared with matched patients with asthma without EGPA. Methods This retrospective cohort study used medical, pharmacy, enrolment, and demographic data from a US administrative claims database (PharMetrics Plus). Patients ≥18 years old, with ≥six months of continuous health plan enrolment in the baseline period, and ≥12 months of continuous health plan enrolment in the follow-up period were eligible for this analysis. Patients with EGPA and patients with asthma without EGPA were identified using diagnosis codes and were subsequently matched 1:5 (e.g., one patient with EGPA matched with five patients with asthma, without EGPA) based on baseline characteristics. The primary outcome measure was all-cause healthcare costs; secondary outcomes included healthcare resource utilization, medication usage, and clinical characteristics. Results In the final matched cohorts, there were 7183 patients with EGPA and 35,915 patients with asthma without EGPA. During the follow-up period, mean total all-cause healthcare costs were significantly higher in patients with EGPA than in those with asthma without EGPA (mean {standard deviation}: $44,405 {$82,060} vs $24,487 {$54,691}; p<0.0001). Patients with EGPA had mean total all-cause healthcare costs that were 73.9% greater than those in patients with asthma without EGPA, even after applying a multivariable analysis to adjust for differences in demographic and clinical characteristics. Medication usage was consistently higher in the EGPA population than in the asthma population (excepting short-acting ß2-agonists). The majority of patients in the EGPA population (83.1%) also experienced ≥one relapse during the study period, with 26.3% of patients in the EGPA population experiencing a major relapse. Conclusions There is a significantly greater economic and clinical burden associated with EGPA compared with asthma without EGPA in adults. These results underscore the unmet need in this patient population for improved disease control strategies that will reduce the burden of EGPA on patients and the healthcare system.

A real-world study of treatment patterns among patients with osteoporotic fracture: analysis of a Japanese hospital database.

Health records of patients hospitalized for osteoporotic fracture were analyzed. Prior to the index hospital admission, most patients were not receiving any antiosteoporotic treatment. During the index hospitalization visit, 25.5% of patients received antiosteoporotic treatment. The most common treatment regimens were active vitamin D3, bisphosphonates, and teriparatide. PURPOSE: To examine the real-world treatment patterns and factors associated with receipt of treatment among Japanese patients with osteoporotic fracture. METHODS: We retrospectively analyzed health records of patients who were hospitalized for osteoporotic fracture between February 2016 and February 2018 in Japan. The type and duration of treatment with antiosteoporotic medications prescribed during hospital stays and after discharge were examined using descriptive statistics. Demographic and clinical factors (e.g., age, previous diagnoses, Charlson Comorbidity Index scores) associated with osteoporotic treatment were explored using multivariable logistic regression. RESULTS: A total of 112,275 patient medical records were evaluated, including 56,574 records from patients with hip fracture, 26,681 records from patients with vertebrae fracture, and 29,020 patients with non-vertebral non-hip fractures. Prior to the index hospital admission, most patients (91.7%, n = 102,919) were not receiving any antiosteoporotic treatment. For those receiving treatment, active vitamin D3 (51.1%, n = 4778) and bisphosphonates (47.5%, n = 4441) were the most common. During the index hospitalization visit, 25.5% (n = 28,678) of patients received treatment for their fracture, including active vitamin D3 (n = 17,074), bisphosphonates (n = 10,007), and teriparatide (n = 4561). Upon discharge, 41.5% (n = 46,536) of patients returned to their home and 34.3% (n = 38,542) of patients were transferred to a different hospital or medical care facility. Variables associated with receipt of treatment at follow-up included older age, previous diagnoses of osteoporosis and fracture, and higher Charlson Comorbidity Index scores. CONCLUSION: Despite osteoporotic fracture being a major health concern within older Japanese populations, treatment with antiosteoporotic medication regimens remains generally low.

Herpes Zoster Incidence and Burden in Adults With Type 2 Diabetes in the U.S.: A Retrospective Database Analysis.

OBJECTIVE: Data on the real-world burden of herpes zoster (HZ) in adults with type 2 diabetes (T2D) in the U.S. are limited. We assessed HZ in patients with and without T2D and measured the impact of HZ on health care resource use (HCRU) and costs. RESEARCH DESIGN AND METHODS: This retrospective cohort analysis used U.S. commercial claims data (sourced from claims incurred between 1 January 2012 and 31 July 2018). HZ incidence rates/1,000 person-years (PYs) were calculated in patients with and without T2D. HZ risk was evaluated using Poisson regression to generate adjusted incidence rate ratios (aIRRs). Patients with T2D with HZ were propensity score matched to patients with T2D only and to patients with HZ without T2D. HCRU and costs were compared across cohorts during a 1-year follow-up period. Cox proportional hazards analyses evaluated factors associated with HZ-related complications. RESULTS: Crude HZ incidence rates in patients with and without T2D were 9.8/1,000 PY and 2.6/1,000 PY, respectively. T2D patients were almost twice as likely to be diagnosed with HZ (aIRR 1.84; 95% CI 1.82-1.85). HZ was associated with increased HCRU and health care costs. At 12 months, unadjusted incremental all-cause health care costs for patients with T2D with HZ versus patients with T2D without HZ were $5,216. The unadjusted incremental HZ-related health care costs for patients with T2D with HZ versus patients with HZ without T2D were $2,726. Age was the most important predictor for HZ-related complications. CONCLUSIONS: Given the increased risk of HZ and HCRU and cost burden in patients with T2D, HZ prevention in patients with T2D may be beneficial.

Are we there yet? Increasing use of cardioprotective antihyperglycemic agents in patients with T2D and CVD or CV risk in the United States.

OBJECTIVE: To report on the use of antihyperglycemic agents (AHAs) by age (i.e. <65, ≥65 years) in patients with type 2 diabetes (T2D) and cardiovascular disease (CVD) or cardiovascular risk (CV risk) factors in the United States. METHODS: Patients with T2D and CVD (CVD cohort) or T2D and an additional CV risk factor without pre-existing CVD (CV risk cohort) were identified from 2015 to 2019 in a claims database. Patients were followed from their first observed CVD diagnosis or CV risk factor for each year they were continuously enrolled or until occurrence of a CVD diagnosis (CV risk cohort only). Classes of AHAs received were reported by year, cohort, and age group. RESULTS: From 2015 to 2019, the percentage of patients <65 years on glucagon-like peptide-1 receptor agonists (GLP-1 RAs) increased (CVD: 9-17%, CV risk: 9-17%) and was approximately twice that of those ≥65 years (CVD: 4-8%, CV risk: 4-8%); the percentage of patients <65 years on sodium-glucose cotransporter-2 (SGLT2) inhibitors increased (CVD: 11-16%, CV risk: 11-17%) and was approximately triple that of those ≥65 years (CVD: 3-6%, CV risk: 4-7%). CONCLUSIONS: The use of GLP-1 RAs and SGLT2 inhibitors increased during the study period; however, most patients did not receive these medications. Patients aged ≥65 years were particularly disadvantaged.

Burden of opioid use for pain management among adult herpes zoster patients in the US and the potential impact of vaccination.

PLAIN LANGUAGE SUMMARYWhat is the context? Herpes zoster or shingles and its complications such as postherpetic neuralgia - a painful condition that affects the nerve fibers and skin - may lead to complex pain that can be addressed using opioids in some patients.The recombinant zoster vaccine (RZV) vaccine prevents shingles and, therefore, may reduce the use of opioids and the negative health outcomes and costs associated with it.What is new? In this retrospective medical claims study, including patients between 2012 and 2017, we evaluated the receipt of pain medication including opioids in herpes zoster patients, and assessed factors associated with opioid prescription.estimated health care resource utilization and costs associated with opioid use among patients with herpes zoster.assessed the impact of vaccination on opioid prescriptions.Among subjects receiving opioids, 78.5% started with a weak opioid dose. Dose escalation was uncommon.Postherpetic neuralgia, immunocompromised status, and comorbidities are the main risk factors associated with opioid prescription.Health care costs are almost double in patients with herpes zoster receiving opioids compared with patients without an opioid prescription.In a population of 1 million adults aged 50 years or older, vaccination with the recombinant zoster vaccine could prevent over 19,000 patients from receiving opioids.What is the impact? Prevention of herpes zoster through vaccination may be a highly effective strategy to reduce opioid prescriptions and costs related to pain management in a susceptible population.Increasing RZV vaccination coverage in adults aged ≥50 years may further reduce potential opioid prescriptions through a decrease in shingles incidence.

An evaluation of costs associated with overall organ damage in patients with systemic lupus erythematosus in the United States.

INTRODUCTION: Approximately 33-50% of patients with systemic lupus erythematosus (SLE) develop organ damage within 5 years of diagnosis. Real-world studies that capture the healthcare resource utilization (HCRU) and costs associated with SLE-related organ damage are limited. The aim of this study was to evaluate HCRU and costs associated with organ damage in patients with SLE in the USA. METHODS: This retrospective study (GSK study 208380) used the PharMetrics Plus administrative claims database from 1 January 2008 to 30 June 2019. Patients with SLE and organ damage were identified using International Classification of Diseases (ICD)-9/10 codes derived from the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index. The first observed diagnosis of organ damage was designated as the index date. Selection criteria included: ≥18 years of age; ≥1 inpatient or ≥2 outpatient claims for SLE (≥30 days apart before the index date; ICD-9: 710.0 or ICD-10: M32, excluding M32.0); ≥1 inpatient or ≥3 outpatient claims for organ damage within 6 months for the same organ system code; continuous enrollment of 12 months both pre- and post-index date. The proportion of patients with new organ damage, disease severity, SLE flares, SLE-related medication patterns, HCRU and all-cause costs (2018 US$) were assessed 12 months pre- and post-index date. RESULTS: Of the 360,803 patients with a diagnosis of SLE, 8952 patients met the inclusion criteria for the presence of new organ damage. Mean (standard deviation (SD)) age was 46.4 (12.2) years and 92% of patients were female. The most common sites of organ damage were neuropsychiatric (22.0%), ocular (12.9%), and cardiovascular (11.4%). Disease severity and proportion of moderate/severe flare episodes significantly increased from pre- to post-index date (p < 0.0001). Overall, SLE-related medication patterns were similar pre- versus post-index date. Inpatient, emergency department and outpatient claims increased from pre- to post-index date and mean (SD) all-cause costs were 71% higher post- versus pre-index date ($26,998 [57,982] vs $15,746 [29,637], respectively). CONCLUSIONS: The economic impact associated with organ damage in patients with SLE is profound and reducing or preventing organ damage will be pivotal in alleviating the burden for patients and healthcare providers.

The Health Care Resource Utilization and Costs Among Patients With Type 2 Diabetes and Either Cardiovascular Disease or Cardiovascular Risk Factors An Analysis of a US Health Insurance Database.

PURPOSE: Health care costs and cardiovascular (CV) outcomes were evaluated among US patients with type 2 diabetes (T2D) and cardiovascular disease (CVD) or CV risk factors. METHODS: Patients with ≥24 months of continuous enrollment were selected from the MarketScan Commercial and Medicare databases from January 1, 2014, to September 30, 2018. For the first qualifying 24-month period, months 1 to 12 defined the baseline period and months 13 to 24 defined the follow-up period. All patients had ≥2 T2D diagnoses during baseline. Two cohorts were created: (1) patients with ≥1 CVD diagnosis during baseline ("CVD cohort"); and (2) patients with ≥1 CV risk factor ("CV risk cohort") and no diagnosed CVD during baseline. The percentage of patients with subsequent CVD diagnoses and annual all-cause, T2D-related, and CV-related costs in baseline and follow-up periods were reported. FINDINGS: In total, 1,106,716 patients met inclusion criteria: CVD cohort, 224,018 patients; CV risk cohort, 812,144 patients; and no diagnosed CVD or CV risk factors, 70,554. During baseline, 40.2% of the CVD cohort had 2 or more CVD diagnoses. During follow-up, 10.5% of the CV risk cohort had evidence of CVD (ie, emergent CVD). During baseline, the CVD cohort had mean (SD) all-cause costs of $38,985 ($69,936); T2D-related costs, $16,208 ($34,104); and CV-related annual costs, $18,842 ($44,457). The CV risk cohort had mean all-cause costs of $13,207 ($27,057); T2D-related costs, $5226 ($12,268); and CV-related costs, $2754 ($10,586). During follow-up, the CV risk cohort with emergent CVD had higher mean all-cause, T2D-related, and CV-related annual costs than costs among patients without CVD (all-cause, $39,365 [$67,731] vs $13,401 [$27,530]; T2D related, $18,520 [$37,256] vs $5732 [$12,540]; and CV related, $18,893 [$43,584] vs $2650 [$10,501], respectively). IMPLICATIONS: Costs for patients with T2D and either CVD or CV risk are substantial. In this analysis, ∼10% of patients with CV risk were diagnosed with emergent CVD. All-cause costs among patients with emergent CVD were nearly 3 times higher than those among patients with CV risk only. Because costs associated with CVD in the T2D population are high, preventing CVD events in patients with T2D has the potential to decrease overall health care costs and avoid additional disease burden for these patients.

Long-Term Pain Management and Health Care Resource Use Among an Employed Population in Japan with Knee Osteoarthritis Combined with Low Back Pain.

OBJECTIVE: Assess long-term comorbidity burden and pain management patterns among working-age patients with knee osteoarthritis (KOA) only without low back pain (LBP) (KOA-noLBP) and patients with KOA plus LBP (KOA+LBP) in Japan. METHODS: Retrospective claims data analyses were conducted on data from the Japan Medical Data Center (JMDC) database. Adult patients (≥40 years) with a diagnosis of knee osteoarthritis (KOA) (January 1, 2011-December 31, 2012) and 5 years of follow-up were evaluated. The first claim with a KOA diagnosis defined the index date. Longitudinal pain management patterns were assessed in both cohorts. RESULTS: Overall, 1,828 patients met study criteria (717 with KOA-noLBP; 1,111 with KOA+LBP). The mean age of patients with KOA-noLBP was 52.1 years, and that of patients with KOA+LBP was 53.1 years, with more females in the KOA+LBP cohort (49.4% vs. 55.0%). Regardless of cohort, >90% of patients received pharmacological intervention during the 5-year follow-up period. The most common regimen first received was either topical or oral nonsteroidal anti-inflammatory drugs. A higher mean number of pharmaceutical treatments were received by patients in the KOA+LBP cohort (3.6) than by patients in the KOA-noLBP cohort (2.7) during the follow-up period. Regardless of cohort, most of the direct medical cost was derived from medication. CONCLUSION: This study demonstrates that a greater proportion of the JMDC population of working individuals with KOA were comorbid with LBP and received pain-related treatment in the long-term perspective relative to patients with KOA without LBP. Appropriate pain management for both KOA and LBP would be key for effective resource utilization in an aging society facing socioeconomic burdens.

Longitudinal Assessment of Pain Management Among the Employed Japanese Population with Knee Osteoarthritis.

PURPOSE: To assess comorbidity burden and pain-management patterns among working-aged patients with knee osteoarthritis only (KOA/O) and patients with knee osteoarthritis plus osteoarthritis at another site (KOA/+) in Japan. PATIENTS AND METHODS: Retrospective claims data analysis was conducted using the Japan Medical Data Center database. Working-aged adults (aged 40 to 71 years) with 5 years of follow-up and diagnosed with knee osteoarthritis (KOA) between January 1, 2011, and December 31, 2012, were evaluated. The first claim with a KOA diagnosis defined the index date. Patients were divided into two mutually exclusive cohorts: KOA/O and KOA/+. Longitudinal pain-management patterns during each year of follow-up were analyzed. RESULTS: A total of 2542 patients met study criteria: 1575 KOA/O and 967 KOA/+. Mean age and number of comorbidities were higher among the KOA/+ versus KOA/O cohort. Pharmaceutical treatment was received by 91.5% of patients in the KOA/+ compared with 85.1% of patients in the KOA/O cohort during the first year of follow-up. The most common pharmacological treatment received during the first year of follow-up was either topical or oral nonsteroidal anti-inflammatory drugs for both cohorts. During each year of follow-up, the KOA/+ cohort had greater proportion of patients with at least one health-care encounter (ie, hospital admissions, outpatient and pharmacy visits) and higher direct medical costs compared with the KOA/O cohort. CONCLUSION: This study demonstrates that a greater proportion of the working population with KOA/+ received pain-related treatment compared with patients with KOA/O. Further studies are necessary to evaluate appropriate pain management for both KOA only and KOA with other sites.

Corrigendum to: Longitudinal, Nationwide, Cohort Study to Assess Incidence, Outcomes, and Costs Associated With Complicated Urinary Tract Infection.

[This corrects the article DOI: 10.1093/ofid/ofz446.].

Clinical implications of prolonged hyperglycaemia before basal insulin initiation in type 2 diabetes patients: An electronic medical record database analysis.

AIMS: To assess the effect of duration of hyperglycaemia before basal insulin (BI) initiation on clinical outcomes in type 2 diabetes (T2D). MATERIALS AND METHODS: Patients with T2D who initiated BI during 2009-2013, had continuous enrolment for ≥2 years preceding and ≥1 year following BI initiation ("index date"), and had ≥1 glycated haemoglobin (A1C) measure not at target (ie, ≥7.0%) within 6 months preindex date were included in the study. Patients were stratified by preindex-date duration of A1C ≥7.0%. Longitudinal A1C, weight, BMI, and diabetes medication were compared between cohorts for up to 15-month follow-up. RESULTS: Of 37 053 patients who initiated BI, 40.7%, 15.3%, 16.0%, and 28.0%, respectively, had uncontrolled A1C for <6, 6-<12, 12-<18 and 18-24 months preindex date. Baseline characteristics were similar between cohorts. Baseline A1C values were similar across cohorts (9.2%-9.6%). Mean follow-up A1C values were higher with longer preindex-date duration of uncontrolled A1C (8.0 ± 1.7%, 8.2 ± 1.6%, 8.5 ± 1.7%, and 8.6 ± 1.7% for <6, 6-<12, 12-<18, and 18-24 months); attainment of A1C <7.0% worsened with increasing preindex-date duration of A1C ≥7.0% (29.6%, 20.0%, 14.6%, and 11.5% for <6, 6-<12, 12-<18, and 18-24 months). CONCLUSIONS: These data suggest that longer duration of uncontrolled A1C before BI initiation increases the risk of not reaching glycaemic targets. However, target attainment was poor in all cohorts, highlighting inadequate glycaemic control as an important unmet need in US patients with T2D.

Achievement of Target A1C <7.0% (<53 mmol/mol) by U.S. Type 2 Diabetes Patients Treated With Basal Insulin in Both Randomized Controlled Trials and Clinical Practice.

OBJECTIVE: Many patients with type 2 diabetes do not reach glycemic goals despite basal insulin treatment. This study assessed the achievement of a target A1C <7.0% (<53 mmol/mol) after initiation of basal insulin in two settings. METHODS: This was a retrospective analysis of pooled randomized controlled trial (RCT) data, from 11 24-week studies of patients initiating basal insulin performed between 2000 and 2005 and of outpatient electronic medical record (EMR) data from the General Electric Centricity database for insulin-naive patients initiating basal insulin between 2005 and 2012. Baseline characteristics stratified by target A1C and fasting plasma glucose (FPG) attainment were compared descriptively. RESULTS: In the RCT dataset, 49.0% of patients failed to achieve the target A1C at 6 months versus 72.4% and 72.9% at 6 and 12 months in the EMR dataset, respectively. Despite this, in the RCT dataset, 79.4% of patients achieved the target A1C and/or an FPG <130 mg/dL. In the EMR dataset, only 47.6% and 47.3% of patients achieved an A1C <7.0% and/or FPG <130 mg/dL at 6 and 12 months, respectively. Overall, patients with an A1C >7.0% had a longer diabetes duration and were more likely to be female, nonwhite, and self-funding or covered by Medicaid. Among patients with an A1C >7.0%, more RCT patients (58.0%) had an FPG <130 mg/dL than EMR patients at 6 months (27.8%) and 12 months (27.7%). CONCLUSION: Unmet needs remain after basal insulin initiation, particularly in real-world settings, where many patients require further insulin titration. In both populations, patients failing to achieve the target A1C despite attaining an FPG <130 mg/dL require interventions to improve postprandial control.

Treatment patterns and characteristics of patients with migraine in Japan: A retrospective analysis of health insurance claims data.

OBJECTIVE: To describe treatment patterns of migraine patients in the Japan Medical Data Center (JMDC) database. METHODS: Patients aged ≥18 years with ≥1 inpatient or ≥2 outpatient migraine diagnoses, ≥1 outpatient diagnosis and ≥1 migraine-specific acute treatment (triptan or ergotamine), or ≥2 migraine-specific acute treatments from 1 May 2011 to 30 April 2014 were identified. Patients were required to be enrolled in a health plan for ≥1 year before and after the index date. The first migraine diagnosis or acute treatment defined the index date. Patients were stratified by the migraine treatments observed after the index date (i.e. migraine-specific acute treatment only [AT], prophylactic with or without migraine-specific acute treatment [PT], or no treatment [NT]) and described regarding the first migraine treatment regimen and subsequent treatment patterns during up to 1 year of follow-up. RESULTS: A total of 16,443 patients met the eligibility criteria (9873 AT, 3022 PT, and 3548 NT). AT patients had mean (SD) 10.3 (20.5) acute treatment days during 1-year follow-up, and 81.9% received triptans. When assessing the first migraine treatment regimen during follow-up in PT patients, 29.2% received prophylactic treatment only and 51.7% received both acute and prophylactic treatment. Calcium-channel blockers with or without concomitant triptans (34.4%) were the most common first regimen. Approximately 62.2% discontinued initial prophylactic treatment after an average of 61.2 days (SD = 65.3) of persistent treatment. Among discontinuers, 15.2% reinitiated original treatment and 7.0% switched treatment post-discontinuation within a year, while the remaining patients did not receive prophylactic therapy following discontinuation. CONCLUSIONS: Among Japanese migraine patients, prophylactic use was low and associated with a high rate of discontinuation following a brief treatment period. Many patients reinitiated or switched treatment following discontinuation, while a significant proportion of patients remained discontinued from prophylactic therapy, suggesting a high unmet need.

The Economic Burden of Congenital Cytomegalovirus Disease in the First Year of Life: A Retrospective Analysis of Health Insurance Claims Data in the United States.

PURPOSE: Congenital cytomegalovirus (cCMV) infection is the most common congenital infection in the United States; however, limited data exist regarding the economic burden of cCMV disease (cCMVd) among newborns and infants. The purpose of this study was to compare health care resource utilization and costs between infants with cCMVd at birth and during the first year of life versus matched infants without diagnosed cCMVd. METHODS: Retrospective analyses of health insurance claims data from the MarketScan Commercial Claims and Encounters and Multi-State Medicaid databases (January 1, 2011-December 31, 2016) were conducted. Infants with cCMV diagnosis (International Classification of Diseases, Ninth Revision, Clinical Modification code 771.1 or 078.5; International Classification of Diseases, Tenth Revision, Clinical Modification code P35.1 or B25) were included. Two mutually exclusive periods were examined: initial hospital stay at birth ("birth" analysis) and subsequent 12 months ("postbirth" analysis). Infants with cCMVd in both periods were matched 1:1 to infants without cCMVd based on demographic and clinical characteristics. All-cause costs for cCMVd in infants versus matched control infants were reported in 2016 US dollars. Multivariable regression analyses controlled for additional confounding factors. FINDINGS: In the birth analysis, 397 of 404 newborns with cCMVd (167 vaginal deliveries, 230 cesarean deliveries) were matched to control infants; newborns with cCMVd had an additional mean (95% CI) of 9.1 (5.8-12.3) and 9.0 (4.6-13.5) inpatient days and $24,274 (10,082-38,466) and $31,770 (9911-53,630) more unadjusted inpatient costs versus control infants for vaginal and cesarean deliveries, respectively. In the postbirth analysis, 678 of 679 infants with cCMVd were matched with control infants; infants with cCMVd had an additional $58,806 (95% CI, 41,247-76,365) in unadjusted costs versus control infants, with inpatient visits accounting for 85% of the difference. Newborns with cCMVd accrued costs at birth averaging 1.5 to 2.1 times greater than control infants for cesarean and vaginal deliveries. During the first year of life, infants with cCMVd had costs averaging 7 times greater than control infants. IMPLICATIONS: cCMVd is associated with substantial economic burden from birth and during the first year of life. Our findings support the notion that developing effective prevention of cCMVd and increasing awareness of the disease among women should be a public health priority, given the economic burden of cCMVd.

Costs of herpes zoster complications in older adults: A cohort study of US claims database.

BACKGROUND/OBJECTIVES: Herpes zoster (HZ) incidence increases with age, and the burden of HZ is expected to grow with aging of populations worldwide. We aim to determine the incremental healthcare resource utilization and associated costs of patients with common HZ-related complications other than postherpetic neuralgia (cutaneous, neurologic and ophthalmic) compared to uncomplicated HZ. METHODS: We conducted a retrospective cohort study of commercial health insurance claims covering about 40 million immunocompetent individuals aged ≥50 years at study entry from all over the US, from 2008 to 2013, with follow-up for one year after HZ onset. All-cause healthcare resource utilization and direct healthcare costs were recorded and calculated from six months before until 12 months after HZ onset. The mean costs for HZ patients with complications were compared to the mean costs for patients with uncomplicated HZ. Multivariable regression analyses estimated mean incremental costs adjusted for demographics, comorbidities, type of complication and time period. RESULTS: Over the five-year study period, 22,948 HZ patients (60% women, median age 62 years) who experienced at least one of the selected complications were compared to 213,232 patients (63% women, median age 61 years) with uncomplicated HZ. Overall, the mean annual incremental unadjusted costs for the patients with HZ-related complications were US$4716, ranging from US$2173 for ophthalmic to US$18,323 for neurologic complications. Most of the incremental costs associated with HZ complications were accrued during the first quarter after HZ onset. For each complication type the incremental costs increased with age up to, but not including the oldest group, aged ≥80 years. CONCLUSIONS: Approximately 10% of immunocompetent older patients with HZ develop complications which considerably increase the economic burden of HZ. Vaccination of older adults will offset some of the burden of HZ, including costs associated with HZ-related complications.

Cost of herpes zoster and herpes zoster-related complications among immunocompromised individuals.

Herpes zoster (HZ) is a painful dermatomal rash caused by reactivation of latent varicella-zoster virus. The incidence of HZ is increased for immunocompromised (IC) individuals. The objective of this study is to assess the healthcare costs incurred by IC individuals who develop HZ with or without associated complications. We conducted a retrospective case-control study across the US over a 5-year period, based on health insurance claims data for individuals aged ≥50 years identified as IC by disease or immunosuppressive treatment. A cohort of 30,107 IC individuals who experienced HZ was matched to a cohort of 113,875 IC individuals without HZ. Average all-cause healthcare costs over 18 months were calculated and compared between IC individuals with and without HZ. In addition, the costs of HZ in IC individuals with HZ-related complications were compared to the costs of those with uncomplicated HZ. During the year following HZ onset, IC individuals with HZ had on average total unadjusted costs that were US$3879 higher than the controls. After adjusting costs, controlling for comorbidities and healthcare costs before the onset of HZ, the average annual costs for HZ cases and controls without HZ were similar. HZ-related complications led to increases in average adjusted annual costs compared to uncomplicated HZ ranging from US$612 for eye complications to US$4535 for neurologic complications. In conclusion, in IC individuals, episodes of HZ lead to substantially increased unadjusted annual healthcare costs. HZ-related complications add considerably to adjusted annual healthcare costs compared to uncomplicated HZ.

Treatment Intensification in Type 2 Diabetes: A Real-World Study of 2-OAD Regimens, GLP-1 RAs, or Basal Insulin.

INTRODUCTION: Treatment guidelines recommend a stepwise approach to glycemia management in patients with type 2 diabetes (T2D), but this may result in uncontrolled glycated hemoglobin A1c (HbA1c) between steps. This retrospective analysis compared clinical and economic outcomes among patients with uncontrolled T2D initiating two oral antidiabetes drugs (OADs), glucagon-like peptide-1 receptor agonists (GLP-1 RAs), or basal insulin in a real-world setting. METHODS: Adults with T2D on OAD monotherapy were identified in the MarketScan claims database (2007-2014). Those initiating two OADs (simultaneously or sequentially), GLP-1 RAs, or basal insulin were selected (date of initiation was termed the 'index date'); patients were required to have HbA1c > 7.0% in the 6 months pre-index date. HbA1c was compared from 6 months pre- to 1-year post-index. Annual all-cause healthcare utilization and costs were reported over the 1-year follow-up period. RESULTS: Data for 6054 patients were analyzed (2-OAD, n = 4442; GLP-1 RA, n = 361; basal insulin, n = 1251). Baseline HbA1c was high in all cohorts, but highest in the basal-insulin cohort. Treatment initiation resulted in reductions in HbA1c in all cohorts, which was generally maintained throughout the follow-up period. Average HbA1c reductions from the 6 months pre- to 1 year post-index date were -1.2% for GLP-1 RA, -1.6% for OADs, and -1.8% for basal insulin. HbA1c < 7.0% at 1 year occurred in 32.6%, 47.5%, and 41.1% of patients, respectively. Annual healthcare costs (mean [SD]) were lowest for OAD (US$10,074 [$22,276]) followed by GLP-1 RA (US$14,052 [$23,829]) and basal insulin (US$18,813 [$37,332]). CONCLUSION: Despite robust HbA1c lowering following treatment initiation, many patients did not achieve HbA1c < 7.0%. Basal insulin, generally prescribed for patients with high baseline HbA1c, was associated with a large reduction in HbA1c and with higher costs. Therapy intensification at an appropriate time could lead to clinical and economic benefits and should be investigated further. FUNDING: Sanofi U.S., Inc.

Treatment Patterns, Statin Intolerance, and Subsequent Cardiovascular Events Among Japanese Patients With High Cardiovascular Risk Initiating Statin Therapy.

BACKGROUND: This study examined treatment patterns, possible statin intolerance, and incidence of cardiovascular events (CVEs) in 2 cohorts of patients with high cardiovascular risk (i.e., patients with atherosclerotic cardiovascular disease [ASCVD] and patients with diabetes mellitus).Methods and Results:A retrospective cohort study examined adults initiating either a statin or ezetimibe from 1 January 2006 to 31 May 2014 in the Japan Medical Data Center database. The first observed statin or ezetimibe prescription defined the index date. Patients had ≥12 months of pre- and post-index date plan enrollment. Two high-risk cohorts, the ASCVD cohort and diabetes cohort, were created based on diagnoses observed during the 12 months' pre-index date. Treatment patterns, possible statin intolerance, and incidence of CVEs were reported. In the ASCVD cohort (n=5,302), 32.9% discontinued therapy, 7.7% switched to a non-index statin or non-statin lipid-lowering therapy, and 11.2% augmented index therapy in the 12 months' post-index date; only 0.3% were using high-intensity statins and 10% had possible statin intolerance. Also, 8.1% had any new CVE during the follow-up period. Treatment patterns and incidence of CVEs among the diabetes cohort were similar to those of the ASCVD cohort. CONCLUSIONS: High cardiovascular risk Japanese patients had frequent treatment modifications, although use of high-intensity statin doses was rare. These patterns may indicate that alternative therapies for lipid lowering are needed.