Clinical Benefits of Treating Patients with Type 2 Diabetes Mellitus with iGlarLixi: A Patient-Level Simulation Study.

Autor: Chauhan A; Axtria Inc., Berkeley Heights, NJ, USA. ankita.chauhan@axtria.com., Samnaliev M; Axtria Inc., Berkeley Heights, NJ, USA., Ken-Opurum J; Axtria Inc., Berkeley Heights, NJ, USA., Srinivas SSS; Axtria India Pvt. Ltd., Gurgaon, India., Mehta AM; Axtria Inc., Berkeley Heights, NJ, USA., Dex T; Sanofi, Bridgewater, NJ, USA., Charland S; Sanofi US, Golden, CO, USA., Revel A; Sanofi, Bridgewater, NJ, USA., Preblick R; Sanofi, Bridgewater, NJ, USA.
Jazyk: angličtina
Zdroj: Diabetes therapy : research, treatment and education of diabetes and related disorders [Diabetes Ther] 2023 Aug; Vol. 14 (8), pp. 1331-1344. Date of Electronic Publication: 2023 Jun 08.
DOI: 10.1007/s13300-023-01419-z
Abstrakt: Introduction: The fixed-ratio combination of insulin glargine (iGlar) plus lixisenatide (iGlarLixi) has proven efficacious in clinical trials; however, there is limited evidence of its benefits in a variety of real-world patients with type 2 diabetes mellitus (T2DM) who present in routine clinical practice.
Methods: A large integrated claims and EHR database was used to identify two real-world (RW) cohorts (ages ≥ 18) with T2DM who were eligible for treatment with iGlarLixi. At baseline, the first cohort (insulin cohort) received insulin with or without oral antidiabetic drugs (OADs), and the second cohort (OAD-only cohort) received OADs only. A Monte Carlo patient-level simulation was applied to each cohort based on treatment strategies and efficacies from the LixiLan-L and LixiLan-O trials to estimate reductions in glycated hemoglobin A1C (A1C) and the percentage achieving age-based A1C goals (≤ 7% for ages < 65 and ≤ 8% for ages ≥ 65) at 30 weeks.
Results: The RW insulin (N = 3797) and OAD-only (N = 17,633) cohorts differed considerably in demographics, age, clinical characteristics, baseline A1C levels, and background OAD therapies compared to the populations in the Lixilan-L and Lixilan-O trials. Regardless of the cohort description, A1C goals were achieved among 52.6% vs. 31.6% (p < 0.001) of patients in the iGlarLixi vs. the iGlar arms in the insulin cohort simulation, while A1C goals were achieved among 59.9% vs. 49.3% and 32.8% (p < 0.001) of patients in the OAD-only cohort simulation in the iGlarLixi vs. the iGlar and lixisenatide arms, respectively.
Conclusions: Irrespective of the treatment regimen at baseline (insulin vs. OAD only), this patient-level simulation demonstrated that a greater proportion of patients achieved their A1C goals with iGlarlixi compared to iGlar or lixisenatide alone. These findings suggest that the benefits of iGlarLixi extend to clinically distinct RW populations.
(© 2023. The Author(s).)
Databáze: MEDLINE
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