Real-world treatment patterns in drug naïve type 2 diabetes population: Initial combination therapy vs. sequential step-therapy.

Background: Despite evidence-based guidelines and available therapies, many patients with type 2 diabetes (T2D) have suboptimal glycemic control. The current standard of care suggests initial monotherapy followed by add-on therapy to achieve and maintain target HbA1c. However, clinical trials revealed that intensive glycemic control, especially at the early stages of the disease, could result in earlier and better long-term glycemic control in addition to reducing diabetes-related complications and mortality risk.

Objective: This population-based study aimed to investigate treatment initiation patterns among newly diagnosed drug-naïve patients with T2D in real-world clinical settings, focusing on two recommended approaches: initial combination therapy and step-therapy.

Methods: A retrospective study was conducted using claims data from the Merative MarketScan Research Databases between 2017 and 2019. The study included drug-naïve patients with T2D with continuous enrollment in medical and pharmacy plans. Patients were categorized into the initial combination therapy or step-therapy cohorts based on their initial treatment regimen. Baseline characteristics of the cohorts were recorded, and logistic regression analysis was performed to identify factors associated with receiving each approach.

Results: The study included a total of 117,419 patients in the Commercial/Medicare population and 18,574 patients in the Medicaid population. About 10% to 12% of patients received initial combination therapy as their initial pharmacotherapy regimen. Several patient demographic and clinical characteristics were significantly associated with the use of initial combination therapy vs. step-therapy. Results also showed a greater usage of loose-dose combination pills over fixed-dose combinations.

Conclusion: Given the lack of real-world studies on combination vs. step-therapy, the study findings provide insights into the current treatment initiation patterns and associated factors among drug-naïve patients with T2D. These findings contribute to understanding the real-world clinical practices in diabetes management and may help guide clinicians in making informed decisions regarding pharmacotherapy approaches.