New insights into real-world use of combination versus step therapy may help refine early glycemic management and improve long-term outcomes.

According to a study recently published in the Journal of the American Pharmacists Association, despite the availability of evidence-based guidelines and various treatment options, patients with type 2 diabetes continue to experience worsening glycemic control.

Current treatment guidelines typically recommend starting with monotherapy and adding additional medications as necessary to achieve target HbA1c levels. However, research suggests that initiating intensive glycemic control early in the disease course can improve long-term outcomes, including better glycemic control and a reduction in diabetes-related complications and mortality.

“The main advantages associated with step-therapy include better assessment of desired and undesired effects of each medication in the patient’s treatment regimen, better control of adverse effects, and lower medication costs,” Zahra Majd, PharmD, PhD, University of Houston, and colleagues wrote in the study. “On the other hand, several pivotal clinical trials in diabetes management have demonstrated 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 the risks for diabetes-related complications and mortality.”

The researchers categorized patients as those who started with combination therapy and those who followed the step-therapy approach to investigate treatment initiation patterns among newly diagnosed drug-naive patients with type 2 diabetes in real-world clinical settings

To investigate treatment initiation patterns, Majd and colleagues conducted a population-based study consisting of 117,419 patients from the commercial insurance/Medicare population and 18,574 patients from the Medicaid population. Most patients in the commercial insurance/Medicare group were male (53.5%) and 45-64 years of age (69.1%). In the Medicaid group, most patients were female (62.2%) and aged 45-64 years (60.6%).

Among the patients included in the study, approximately 10%-12% received initial combination therapy as their first pharmacotherapy regimen. Various demographic and clinical factors such as gender, health plan type, and comorbid conditions were significantly associated with the use of initial combination therapy versus step therapy.

In the commercial insurance/Medicare group, patients aged 18-34 years had significantly higher odds of receiving initial combination therapy than other age groups. Women were less likely than men to receive initial combination therapy (odds ratio [OR] = 0.67; 95% CI, 0.64-0.69).

Similarly, in the Medicaid group, females were less likely to receive initial combination therapy than males (OR 0.77, 95% CI 0.70-0.85). Race was a significant factor correlated with pharmacotherapy approach, with White people and Hispanics being more likely to receive initial combination therapy than Black individuals (OR 1.18, 95% CI 1.05-1.31 and OR 1.57, 95% CI 1.17-2.12, respectively).

The researchers also noted a higher prevalence of loose-dose combination pills compared with fixed-dose combinations in the treatment regimens.

Because real-world data on the comparison between combination and step therapy are limited, Majd and colleagues suggest that their study provides valuable insights into current treatment initiation patterns for drug-naive patients with type 2 diabetes.

“Understanding differences in treatment patterns may help healthcare providers identify potential barriers, make informed decisions, and develop tailored and effective strategies for managing diabetes across diverse patient populations,” they concluded.

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Disclosures: No authors declared financial ties to drugmakers. See full study for details.

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