Evaluating time to treatment intensification among drug naïve type 2 diabetes patients: a comparison of initial combination therapy vs step-therapy approaches

Abstract Background Emerging evidence from clinical trial data on glycemic control in type 2 diabetes (T2D) patients suggests that early use of combination therapy provides more durable effects on glycated hemoglobin (HbA1c) levels. Real-world research on the early use of combination therapy vs. step-therapy, using longitudinal data, is scant. Therefore, we have undertaken this study to fill the gap in the literature. Aim To evaluate the impact of initial pharmacotherapy approach— initial combination therapy vs. traditional step-therapy— on time to treatment intensification (TI) among drug naïve type 2 diabetes (T2D) patients during 12 months of follow-up. Method A retrospective cohort study was conducted from 2017 to 2019 using the Merative™ MarketScan®. We included drug naïve T2D patients ≥ 18 years old who received dual therapy, either as their initial treatment regimen or add-on treatment. TI was defined as either add-on of third noninsulin ADM or the initiation of insulin. A multivariable Cox regression model was conducted to assess time to TI between the two study groups, adjusting for the baseline covariates. Results Out of 23,253 patients, 8103 were in step-therapy, and 15,150 were in the initial combination cohort. About 16% of patients received TI during the follow-up period. The average time to TI was 145 and 147 days for the step-therapy and initial combination cohort, respectively. Unadjusted survival analysis showed a worse survival rate for step-therapy compared to the initial combination group. The multivariable Cox model indicated that receiving step-therapy was associated with significantly higher hazard for TI (HR 1.20, 95% CI 1.05–1.36). Conclusion Patients who received step-therapy had a higher risk and shorter time to TI during the 12-month follow-up vs the initial combination.