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

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.

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.

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.

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.

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.