Introduction: OCS use is associated with adverse outcomes, including type II diabetes (DM-T2). Individualized models to estimate risks from prior and future OCS use could facilitate clinical planning. Objective: Develop a model to estimate risk of DM-T2 in patients with asthma. Methods: A historical cohort study of adults with asthma at index date with ≥2 years of baseline (pre-index) and ≥3 years of follow-up data (post-index) from the Optimum Patient Care Research Database. Primary outcome was time to DM-T2 diagnosis in those with no prior DM-T2 history. Cox regression models were used to model known DM-T2 risk factors selected from literature and included based on backwards stepwise selection, including change in average annual OCS use over time (decreased, no change, increased, Figure). The model was evaluated in 75% of patients and validated in the remainder. Kaplan Meier curves were used to evaluate separation between stratified risk groups. Results: Overall, 104,461 patients met all inclusion criteria (7452 developed DM-T2). The model validation showed a consistently higher predicted DM-T2 risk among patients who increased their OCS use compared to baseline (HR for 1-step increase = 1.551). In an example patient, 20-year DM-T2 risks were 7.3%, 8.9%, and 13.4% for decreased, no change, and increased OCS usage, post-index date, respectively (Figure). Conclusion: Risk for DM-T2 can be moderated by lowering OCS usage in asthma patients.

Rationale: To improve COPD management in primary care, it is first necessary to describe these patients using clinically-relevant variables that can be collected practically and monitored longitudinally.Our aim was to describe the demographic and clinical characteristics of COPD patients managed in U.S. primary care. Methods: This is an observational, patient registry study using data from the COPD Optimum Patient care DARTNet Research Database (COPD-RD) from which the Advancing the Patient Experience (APEX) COPD registry is derived.The APEX in COPD registry is the first U.S. primary care, based registry, to collect both retrospective and prospective electronic health record (EHR) data and patient reported information/outcomes and plans to include 3,000 COPD patients.COPD patients included in the registry were aged ≥35 years at diagnosis with a COPD diagnosis code [ICD9CM, ICD10CM].Baseline demographic and clinical EHR data for all available patients were accessed (Dec 2019-Jan 2020) from 5 U.S. large primary care medical groups located in TX, CO, NC, OH and NY.Most data extend back as far as 2009.pg. 2 Results: Baseline data from 17,192 available patients (mean age (SD): 67.4 years (11.3)) were included.Patients were predominantly female (n=9,689/17,192; 56.4%), white (n=9,732/15,216; 56.6%), current-(n=6,428/17,192; 37.4%) and ex-smokers (n=7,356/17,192; 42.8%) and over-weight/obese (n=8,620/12,475; 69.1% ).Overall, 38.3% of patients (n=6,579/17,192) experienced ≥1 (acute lower respiratory event) in the last 12 months; 22.3%, 8.4% and 7.6% experienced 1, 2 and ≥3 exacerbations, respectively.Of those patients with a blood eosinophil count (BEC) reading (n=8,882/17,192; 51.7%) most had a BEC (ever) in the range 150-300 cells/µL (n=4,062/8,882; 45.7%) and >300 cells/µL (n=3,102/8,882; 34.9%).Overall, 2.9% of patients (n=494/17,192) received no therapy (last 12 months), 9.2% (n=1,587/17,192) were on short-acting bronchodilators only, 12.4% (n=2,127/17,192) were on LAMA, 13.2% (n=2,265/17,192) on LABA/LAMA, 5.7% (n=979/17,192) on ICS monotherapy, 28.9% (n=4,970/17,192) on ICS/LABA and 27.1% (n=4,658/17,192) on ICS/LAMA/LABA therapy.The most common comorbidities were hypertension (n=12,488/17,192; 72.6%), diabetes mellitus (7,724/17,192; 44.9%), depression (n=7,240/17,192; 42.1%), osteoarthritis (n=7,098/17,192; 41.3%), anxiety (n=5,403/17,192; 31.4%),obstructive sleep apnea (n=6,295/17,192; 36.6%),GERD (n=6,758/17,192; 39.3%), and asthma (5,713/17,192; 33.2%). Conclusion:These data comprehensively describe patients diagnosed with COPD managed in U.S. primary care, emphasizing the high exacerbation and co-morbidity burden.Approximately 20% of patients coded as COPD are not treated with correct maintenance medication.