History of Respiratory Events Prior to a First COPD Diagnosis and Future Exacerbations: A Longitudinal Observational Cohort Database Study in Japan.

Background: Little is known about the association between respiratory events prior to diagnosis of chronic obstructive pulmonary disease (COPD) and future clinical outcomes in Japan. We investigated the association between pre-COPD diagnosis respiratory events and the incidence of exacerbations in a cohort of newly diagnosed COPD patients in Japan. Patients and Methods: Data were retrieved from the JMDC claims database. Patients ≥40 years old with a first COPD diagnosis (≥1 hospitalization or ≥2 outpatient claims for COPD) between 2010 and 2016 were included. The incidence rate (IR) of exacerbations in patients with or without any respiratory event (including lower respiratory tract infection and respiratory failure) in the year preceding diagnosis was compared. A negative binomial model explored the association between pre-diagnosis respiratory event and IR ratio (IRR) of exacerbations. Results: A total of 20,212 patients newly diagnosed with COPD were identified: 61% male, mean age 55 years (SD 9); of these, 955 (4.7%) had experienced ≥1 respiratory event in the year preceding diagnosis. Median duration of follow-up was 3.3 years during which the IR of exacerbations was 0.31 per patient-year (95% confidence interval [CI] 0.29-0.33) in patients with respiratory event, and 0.11 (95% CI 0.10-0.13) in patients without. The IR for severe exacerbation was nearly 10 times greater in patients with respiratory event versus without. Experiencing respiratory event pre-diagnosis was independently associated with an increased IRR of future moderate-to-severe exacerbation (adjusted IRR, 2.7; 95% CI 2.3-3.1). Conclusion: Patients experiencing respiratory events in the year preceding COPD diagnosis should be considered at-risk of worse clinical COPD outcomes.

Real-world persistence, adherence, health care resource utilization, and costs in people with type 2 diabetes switching from a first-generation basal insulin to a second-generation (insulin glargine 300 U/mL) vs an alternative first-generation basal insulin.

BACKGROUND: People with type 2 diabetes (T2D) who change their basal insulin (BI) may have variable persistence with therapy. Compared with first-generation (long-acting) BI analogs (insulin glargine 100U/mL [Gla-100]; insulin detemir [IDet]), second-generation (longer-acting) BI analogs (insulin glargine 300U/mL [Gla-300]; insulin degludec) have similar glycated hemoglobin (HbA1c) attainment and lowered hypoglycemia risk, which could impact treatment persistence. OBJECTIVE: To compare persistence, adherence, health care resource utilization (HRU), and costs for individuals switching from neutral protamine Hagedorn insulin or a first-generation BI analog with either the second-generation BI, Gla-300, or an alternative first-generation BI analog (Gla-100 or IDet). METHODS: We used Optum Clinformatics claims data from adults (aged ≥ 18 years) with T2D who had received BI (neutral protamine Hagedorn, Gla-100, IDet) in the 6-month baseline period, and switched to either Gla-300 or an alternative first-generation BI (Gla-100 or IDet; treatment switch = index date) between April 1, 2015, and August 31, 2019. Participants were followed for 12 months, until plan disenrollment, or until death, whichever occurred first. Cohorts were propensity score matched (PSM) on baseline characteristics. The primary outcome was the proportion who were persistent with therapy at 12 months. Secondary outcomes were adherence (proportion of days covered); change in HbA1c; and all-cause, diabetes-related, and hypoglycemia-related HRU and costs. RESULTS: PSM generated 3,077 participants/group (mean age: 68 years, 52% female). Cohorts were well balanced except for hospitalization, which was adjusted in models as a covariate. During the 12-month follow-up period, participants who received Gla-300 vs first-generation BI had greater persistence with (45.5% vs 42.1%; adjusted P = 0.0001), and adherence to (42.8% vs 38.2%; adjusted P = 0.0006), BI therapy and a statistically larger reduction in HbA1c at 12 months (-0.65% vs -0.45%; adjusted P = 0.0040). The proportion of participants achieving HbA1c less than 8% (47.2% vs 40.9%; P < 0.0001), but not less than 7% (21.2% vs 20.8%), was significantly higher for Gla-300 vs first-generation BI. All-cause (45.3 vs 65.9 per 100 patient-years [P100PY]) and diabetes-related (21.5 vs 29.1 P100PY), but not hypoglycemia-related, hospitalizations (1.0 vs 1.5 P100PY) were significantly (P < 0.0001) lower for Gla-300 vs first-generation BI. Similarly, all-cause (111.9 vs 148.8 P100PY), diabetes-related (54.8 vs 74.2 P100PY), and hypoglycemia-related (2.9 vs 5.7 P100PY) emergency department (ED) visits were significantly lower for Gla-300 (all P < 0.0001). Costs for all-cause hospitalizations and hypoglycemia-related ED visits were significantly lower for Gla-300 vs first-generation BI. Although pharmacy costs were significantly higher for Gla-300 vs first-generation BI, all-cause total health care costs were not significantly different: $41,255 vs $45,316 per person per year, respectively. CONCLUSIONS: In this claims-based analysis of people with T2D receiving BI, switching to Gla-300 was associated with significantly better persistence, adherence, and HbA1c reduction compared with switching to an alternative first-generation BI analog. All-cause HRU was significantly lower; despite significantly higher pharmacy costs, total health care costs were similar. DISCLOSURES: This study was funded by Sanofi US. Medical writing support was provided by Helen Jones, PhD, CMPP, of Evidence Scientific Solutions and funded by Sanofi US. Dr Wright is on the speakers' bureau and sits on the advisory boards for Abbot Diabetes, Bayer, Boehringer Ingelheim, Eli Lilly, and Sanofi; sits on the advisory board for Medtronic; and is a consultant for Abbot Diabetes, Bayer, Boehringer Ingelheim, and Eli Lilly. Dr Malone is on advisory boards for Novartis and Avalere and consults for Pear Therapeutics, Sarepta, and Strategic Therapeutics. Dr Trujillo sits on advisory boards for Novo Nordisk and Sanofi. Drs Gill, Zhou, and Preblick and Mr Li are employees and stockholders of Sanofi. Mr Huse is an employee of Evidera and a contractor for Sanofi. Dr Reid is a speaker and consultant for Novo Nordisk and Sanofi-Aventis and is a consultant for AstraZeneca and Intarcia.

Healthcare resource utilization in patients with newly diagnosed atrial fibrillation in the United States.

OBJECTIVES: To summarize healthcare resource utilization (HCRU) in patients with newly diagnosed (incident) paroxysmal or persistent atrial fibrillation (AF). METHODS: This retrospective, observational cohort study assessed HCRU among patients with incident paroxysmal or persistent AF using data from 1 January 2015 to 30 September 2019 in the IBM MarketScan® Research Databases. RESULTS: A total of 50,796 patients were identified in the overall incident AF cohort. Rates of all-cause inpatient hospital stays, all-cause emergency room visits, and all-cause outpatient visits in the overall incident cohort were 46.8, 114.7, and 2,752.7 events per 100 patient-years (PY), respectively. Rates of cardiovascular-related inpatient stays for the overall population were 11.3 events per 100 PY. During follow-up, 50.4% of the overall cohort filled prescriptions for direct-acting oral anticoagulants and 5.0% had catheter ablation. CONCLUSIONS: Advances in anticoagulation and ablation have been realized since previously published HCRU analyses of patients with atrial fibrillation. This update suggests that HCRU among patients with incident AF in the US remains high with some subgroups of patients receiving more specialized care.

Comparative Safety and Effectiveness of Sotalol Versus Dronedarone After Catheter Ablation for Atrial Fibrillation.

Background Atrial tachyarrhythmias are common after atrial fibrillation ablation, so adjunctive antiarrhythmic drug therapy is often used. Data on the effectiveness and safety of dronedarone and sotalol after AF ablation are limited. Here, we compared health outcomes of ablated patients treated with dronedarone versus sotalol. Methods and Results A comparative analysis of propensity score-matched retrospective cohorts was performed using IBM MarketScan Research Databases. Patients treated with dronedarone after atrial fibrillation ablation were matched 1:1 to patients treated with sotalol between January 1, 2013 and March 31, 2018. Outcomes of interest included cardiovascular hospitalization, proarrhythmia, repeat ablation, and cardioversion. This study was exempt from institutional review board review. Among 30 696 patients who underwent atrial fibrillation ablation, 2086 were treated with dronedarone and 3665 with sotalol after ablation. Propensity-score matching resulted in 1815 patients receiving dronedarone matched 1:1 to patients receiving sotalol. Risk of cardiovascular hospitalization was lower with dronedarone versus sotalol at 3 months (adjusted hazard ratio [aHR], 0.77 [95% CI, 0.61-0.97]), 6 months (aHR, 0.76 [95% CI, 0.63-0.93]), and 12 months after ablation (aHR, 0.70 [95% CI, 0.66-0.93]). Risk of repeat ablation and cardioversion generally did not differ between the 2 groups. A lower risk of proarrhythmia was associated with dronedarone versus sotalol at 3 months (aHR, 0.76 [95% CI, 0.64-0.90]), 6 months (aHR, 0.80 [95% CI, 0.70-0.93]), and 12 months (aHR, 0.83 [95% CI, 0.73-0.94]) after ablation. Conclusions These data suggest that dronedarone may be a more effective and safer alternative after ablation than sotalol.

Development and validation of algorithms to identify newly diagnosed type 1 and type 2 diabetes in pediatric population using electronic medical records and claims data.

PURPOSE: To develop and validate algorithms to classify diabetes type in newly diagnosed pediatric patients with DM. METHOD: Data from the United States Department of Defense health system were used to identify patients aged 10 to 18 years with incident DM. Two independent sets of 200 children were randomly sampled for algorithm development and validation. Algorithms were developed based on clinical insight, published literature, and quantitative approaches. The actual DM type was ascertained via chart review. Finally, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were evaluated. RESULTS: Among the 400 patients, mean age was 14.2 (±2.5 years), and 50% were female. The best performing algorithms were based on data available in claims. They consisted of several logical expressions based on one predictor or more, which classified patients by use of glucose-lowering drugs or testing, DM ICD-9 diagnosis codes, and comorbidities. The best performing T2DM and T1DM algorithms achieved 90% and 98% sensitivity, 95% and 95% specificity, 87% and 98% PPV, and 96% and 96% NPV, respectively. CONCLUSIONS: Our results suggest that claims algorithms can accurately identify newly diagnosed T1DM and T2DM pediatric patients, which can facilitate large database studies in children with T1DM and T2DM. However, external validation in other data sources is needed.

Replication of Mini-Sentinel Study Assessing Mirabegron and Cardiovascular Risk in Non-Mini-Sentinel Databases.

BACKGROUND: In 2014, the US Food and Drug Administration (FDA) initiated a prospective routine surveillance using the Mini-Sentinel (M-S) program to assess potential signals of acute myocardial infarction (AMI) and stroke with use of mirabegron, indicated for the treatment of overactive bladder (OAB), compared with oxybutynin. PURPOSE: To replicate the FDA M-S analysis of mirabegron using datasets that did not contribute to the M-S program. METHODS: IMS PharMetrics Plus and Truven MarketScan claims data from 2012-2015 were converted to the M-S Common Data Model. New and non-new users of mirabegron and oxybutynin were analyzed per the publicly available M-S protocol, and propensity score-matched 1:1 using the M-S PROMPT 2 module. Incidence rates (IR) were calculated per 1000 person-years (PY). Adjusted hazard ratios (aHRs) for mirabegron versus oxybutynin were calculated using Cox regression models. RESULTS: In PharMetrics, 12,429 new mirabegron users and 61,548 new oxybutynin users were identified. The aHR was 0.67 (95% confidence interval (CI)] 0.33-1.37) for AMI (mirabegron IR 4.4/1000 PY), and 0.62 (95% CI 0.34-1.13) for stroke (mirabegron IR 6.3/1000 PY). In MarketScan, 17,182 new mirabegron users and 63,962 new oxybutynin users were identified. The aHR was 0.57 (95% CI 0.17-1.95) for AMI, and 0.69 (95% CI 0.30-1.62) for stroke; IRs were similar to those from PharMetrics. Neither dataset suggested an increased risk of AMI or stroke associated with mirabegron in non-new users. CONCLUSIONS: Using the publicly-available M-S protocol and analysis programs with alternative (non M-S) data sources, no statistically significant increased risk of AMI or stroke was found among new or non-new users of mirabegron compared with oxybutynin. These findings were consistent with the FDA M-S mirabegron study.

Economic burden of relapsed or refractory multiple myeloma: Results from an international trial.

OBJECTIVE: The direct cost of relapsed or refractory multiple myeloma (RRMM) is documented; indirect costs are being explored. Healthcare payers seek cost-offsets from therapies that improve clinical outcomes but challenge budgets; employers seek lower absenteeism and better productivity. Study goals were to: (i) identify direct and indirect economic factors of RRMM, and (ii) explore longitudinal relationships between clinical, economic, and health-related quality of life (HRQoL) assessments. METHODS: Economic questionnaire, clinical, and HRQoL data from a multisite, international, randomized, controlled study in RRMM were analyzed. RESULTS: Patients (n=263) were 53.6% male, 91.6% Caucasian; mean age of 62.9 years, median Eastern Cooperative Oncology Group status of 1 (56.3%). Moderate to severe pain or fatigue was reported by 30.4% and 70.6%, respectively. At baseline, ≥1 hospitalization was reported by 107 (41.8%); 182 (71.1%) and 86 (33.6%) reported specialist and family physician visits, respectively. A total of 28 (10.8%) were working: 10 (37.0%) of which reported RRMM-driven absenteeism ≥1 day. Of those who were not working, 110 (48.2%) indicated that it was due to RRMM. Multivariate modeling showed lower hospitalization with a major tumor response (ß=-1.44, CI: -2.89 to 0.01, P=.05). CONCLUSIONS: Substantial RRMM indirect, social costs were observed. Better major tumor response may reduce hospital visits.