Single-Pill vs. Monotherapy in Achieving, Maintaining HbA1c Goal Compared
This article is written live from the American Association of Clinical Endocrinologists (AACE) 2017 Annual Meeting in Austin, TX. MPR will be reporting news on the latest findings from leading experts in endocrinology. Check back for more news from AACE 2017.
According to results of a study presented at the AACE 2017 Annual Meeting, treatment with a single-pill combination (SPC) of empagliflozin/linagliptin (EMPA/LINA) was more effective for obtaining HbA1c goals at 12 and 52 weeks compared to monotherapy in patients with type 2 diabetes (T2D).
Angelo Del Parigi, MD, of Boehringer Ingelheim Pharmaceuticals Inc., in Ridgefield, CT, stated that the study “aimed to identify characteristics associated with achieving an HbA1c target of ≤7% at week 12 and maintaining target at week 52” in patients treated with the SPC compared to monotherapy.
To do this, Dr. Del Parigi and colleagues pooled data from two Phase 3 studies analyzing patients with T2D that were treatment-naïve (n=677) or taking metformin (n=686). Patients from these studies were then randomized to the following treatment groups: EMPA/LINA 25mg/5mg, EMPA/LINA 10mg/5mg, EMPA 25mg, EMPA 10mg, or LINA 5mg. The authors explained, “target attainment groups were defined as patients at HbA1c target of ≤7% at weeks 12 and 52 (AT12&52), those at target at week 12 but above target at week 52 (AT12-only), and those with HbA1c above target at week 12 (ABT12).”
Results of the study found significant differences in the SPC groups vs. monotherapy groups (c2 test, P<0.0001). The respective proportions of AT12&52 and AT12-only were reported as 43.3% and 22.4% for the EMPA/LINA 25mg/5mg group, 45.9% and 17.8% for the EMPA/LINA 10mg/5mg group, 31.3% and 11.4% for the EMPA 25mg group, 30.5% and 11.5% for the EMPA 10mg group, and 21.8% and 15.3% for the LINA 5mg group.
Analysis also found that values such as baseline HbA1c and fasting plasma glucose (FPG) were the “strongest predictors of goal attainment.” On the other hand, values such as body weight, waist circumference, and systolic and diastolic blood pressure “did not contribute to the outcome.”
Findings from the descriptive analysis showed that lower mean baseline HbA1c and FPG were both associated with achieving and maintaining HbA1c target with mean baseline values across treatment groups ranging AT12&52: HbA1c 7.4–7.6%, FPG 137.9–145.7mg/dL; AT12-only: HbA1c 7.5–7.8%, FPG 136.7–149.6mg/dL; ABT12: HbA1c 8.3–8.5%, FPG 167.4–177.1mg/dL.
Results of this analysis found that more patients treated with EMPA/LINA SPC were more likely to reach and maintain an HbA1c target of ≤7% vs. patients treated with monotherapy. For the specific patient population studied, baseline glucose control was tied to reaching and maintaining the HbA1c target.
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