Clinical Trajectories, Healthcare Resource Use, and Costs of Diabetic Nephropathy Among Patients with Type 2 Diabetes: A Latent Class Analysis

Abstract

Introduction: Patients with type 2 diabetes mellitus (T2DM) are clinically heterogeneous in terms of disease severity, treatment, and comorbidities, potentially resulting in differential diabetic nephropathy (DN) progression courses. In this exploratory study we used latent class analysis (LCA) to identify patient groups with distinct clinical profiles of T2DM severity and explored the association between disease severity, DN progression or reversal, and healthcare resource use (HRU) and costs.

Methods: Latent class analysis was used to group adults with ≥ 2 medical claims with a diagnosis of T2DM and ≥ 2 urine albumin tests within the Truven MarketScan database (2004-2014), based on T2DM-related complications, comorbidities, and therapies. DN severity categories (normoalbuminuria, moderately increased albuminuria, and severely increased albuminuria) were determined based on urine albumin measure. The risks of DN progression and reversal (change to a more/less severe DN category) were compared among all identified latent classes using Kaplan-Meier analyses and log-rank tests. All-cause and DN-related costs and HRU were assessed and compared during the study period among the identified latent classes.

Results: Four clinically distinct profiles were identified among the 23,235 eligible patients: low comorbidity/low treatment (46.5%), low comorbidity/high treatment (29.0%), moderate comorbidity/high insulin use (9.7%), and high comorbidity/moderate treatment (14.8%). The 5-year DN progression rates for these clinically distinct profiles were 11.8, 18, 16.5, and 27.7%, respectively. Compared with the low comorbidity/low treatment group, all other groups were associated with an increased risk of DN progression (all p < 0.001). Increasing comorbidity was significantly associated with higher all-cause and DN-related HRU and costs, primarily driven by higher pharmacy and inpatient costs.

Conclusion: Patients with T2DM who have more comorbidities experienced higher rates of DN progression and HRU and incurred higher healthcare costs compared with patients with low comorbidity profiles. Future prospective studies are needed to confirm the significance of these groups on DN progression, HRU, and costs.

Funding: Takeda Development Center Americas, Inc.

Keywords: Clinical outcomes; Costs; Diabetic nephropathy; Healthcare resource use; Type 2 diabetes.

Fig. 1

Sample selection. ESRD End-stage renal disease, T2DM type 2 diabetes mellitus

Fig. 2

Time to progression to a more severe diabetic nephropathy (DN) disease stage. The respective 1-, 3-, 5-year DN progression rates were 9.27, 20.79, and 27.70% for the high comorbidity/moderate treatment group (purple); 5.86, 13.26, and 16.46% for the moderate comorbidity/high insulin group (green); 5.60, 13.93, and 17.97% for the low comorbidity/high treatment group (red); and 3.95, 9.54, and 11.78% for the low comorbidity/low treatment group (blue)

Fig. 3

Time to reversal to a less severe DN disease stage. The respective 1-, 3-, 5-year DN reversal rates were 7.09, 11.99, and 13.92% for the high comorbidity/moderate treatment group (purple); 5.00, 8.91, and 8.91% for the moderate comorbidity/high insulin group (green); 6.11, 9.90, and 10.54% for the low comorbidity/high treatment group (red); and 4.51, 7.88, and 8.89% for the low comorbidity/low treatment group (blue)