(172) Feasibility Assessment of Hypertension among Patients with Diabetic Macular Edema using Real World Data

Background: Characterization of hypertension (HT) and worsening HT among patients with diabetic macular edema (DME) in clinical practice is limited. Prior to study initiation to characterize HT in this population, study feasibility including identification of fit-for-purpose data and study design must be assessed (FDA RWE Framework).

Objectives: To assess the feasibility of identifying HT and HT worsening among patients diagnosed with DME in the Truveta database. This includes evaluation of cohort size, capture of HT and HT medication use using various data elements, and frequency assessment of key measurements such as blood pressure (BP).

Methods: All patients diagnosed with DME (index event) between Jan 1 2016 to Oct 20 2023 were identified in Truveta, an electronic medical record database from >30 US health systems. Patients were required to have ≥ 1 medical record in 365+ days before index DME. Demographic and clinical characteristics, and median baseline/follow-up times were described. The number of patients with BP records and mean number of records per patient were captured overall, and by HT diagnosis (ICD code). Elevated BP measures potentially indicative of HT (AHA definition) among patients diagnosed with HT during baseline (DME_HT) and undiagnosed patients without HT medication were evaluated.

Results: Of 59,734 DME patients identified, 75.9% had a baseline HT diagnosis and 81.6% had a HT diagnosis during follow-up. Median age was 64y (IQR 55-72); 60.4% were White, 23.1% Black and 4.2% Asian. Median baseline and follow-up times for DME and DME_HT patients were 4.25 and 4.74 years and 3.02 and 2.84 years, respectively. During follow-up, 39,357 (86.8%) patients with DME_HT were on ≥1 HT medication, of which the most frequently used were beta blockers (60.6%), dihydropyridine calcium channel blockers (50.6%), and ACE inhibitors (42.4%) (not mutually exclusive). There were 50.7 and 63.2 and 94.4 and 105.9 mean BP measurements per person in baseline and in follow-up in the DME and DME_HT, respectively. Median interval (days (IQR)) between BP records was 13.0 (2.0, 45.0) and 12.0 (2.0, 43.0) in baseline, and 8.0 (1.0, 34.0) and 7.0 (1.0, 31.0) in follow-up in the DME and DME_HT, respectively. Of DME patients with 1+ BP measurements, 45.5% and 55.8% had ≥1 record within both 0-6 months and 6-12 months pre- and post-index, respectively. Overall, 795 (31.6%) of patients without DME_HT or HT medication use had ≥1 elevated BP in follow-up. Of DME_HT, 83.3% had a BP record indicative of Stage 1 or 2 HT.

Conclusions: Most DME patients experienced HT, which is consistent with the literature. Frequent BP measurements, coupled with anti-hypertensive medication records, support the use of Truveta in characterizing HT and HT worsening.