Eli Lilly and Company, Indianapolis, Indiana.
HealthCore Inc, Wilmington, Delaware.
Clin Ther. 2022 Jun;44(6):873-887. doi: 10.1016/j.clinthera.2022.04.005. Epub 2022 May 24.
To describe clinical characteristics and treatment outcomes for early or late initiation of dulaglutide therapy in patients with type 2 diabetes.
This retrospective, claims-based analysis evaluated adults with type 2 diabetes, ≥1 claim for dulaglutide 0.75 mg or 1.5 mg once-weekly injection (between November 2014 and August 2019), and no prior use of glucagon-like peptide 1 receptor agonists or insulin. Cohorts were defined based on the number of oral antidiabetic drug (OAD) classes used within the 24-month baseline period before dulaglutide therapy initiation: 1 OAD, 2 OADs, or ≥3 OADs. The number of OAD classes used before dulaglutide therapy initiation served as a proxy for timing of initiation, with a higher number of OAD classes indicating a longer duration of T2D. Baseline demographic and clinical characteristics were compared across each cohort. Six-month follow-up outcomes, including change in glycosylated hemoglobin (HbA) and treatment patterns, were descriptively assessed within each cohort.
The study population consisted of 18,121 patients across the 1 OAD (n = 4822), 2 OADs (n = 6293), and ≥3 OADs (n = 7006) cohorts. Mean age at baseline was 54.7 years. Males were more prevalent in the ≥3 OADs cohort. Most patients (67%-70%) initiated treatment with dulaglutide 0.75 mg. Dose escalation to 1.5 mg was uncommon (15%-20%) but trended higher in the ≥3 OAD cohort. Adherence to dulaglutide at 6-month follow-up (61%-67%) increased with higher baseline OAD use. The HbA assessment (n = 3178) included 761 patients in the 1 OAD cohort, 1088 patients in the 2 OADs cohort, and 1329 patients in the ≥3 OADs cohort. Baseline mean [SD] HbA level increased with number of OAD classes (1 OAD: 8.18% [1.80]; 2 OADs: 8.56% [1.66]; and ≥3 OADs: 8.73% [1.51]). Patients in the early dulaglutide therapy initiator group experienced larger reductions in HbA levels (1 OAD: -1.39%; 95% CI, -1.50 to -1.27; 2 OADs: -1.30%; 95% CI, -1.39 to -1.20; and ≥3 OADs: -1.01%; 95% CI, -1.09 to -0.93) versus the patients in the delayed initiator group. Patients in the early dulaglutide therapy initiator group also achieved HbA <7% at 6-month follow-up more frequently than those in the later initiator group (1 OAD: 68%; 2 OADs: 51%; and ≥3 OADs: 33%).
Cohorts of dulaglutide therapy initiators, defined by prior OAD use as a proxy of timing of initiation, differed in their baseline characteristics and short-term follow-up outcomes. Earlier dulaglutide therapy initiation was associated with lower mean HbA levels and increased probability of achievement of HbA <7% during the 6-month follow-up period.
描述 2 型糖尿病患者接受度拉鲁肽早期或晚期起始治疗的临床特征和治疗结局。
这项回顾性、基于索赔的分析评估了患有 2 型糖尿病的成年人，这些患者在 2014 年 11 月至 2019 年 8 月期间至少有 1 次度拉鲁肽 0.75mg 或 1.5mg 每周 1 次注射的索赔，并且之前没有使用过胰高血糖素样肽 1 受体激动剂或胰岛素。队列是根据在度拉鲁肽治疗开始前 24 个月的基线期内使用的口服降糖药 (OAD) 类别的数量定义的：1 种 OAD、2 种 OAD 或 ≥3 种 OAD。OAD 治疗开始前使用的 OAD 类别数量作为起始时间的代表，使用的 OAD 类别数量越多，2 型糖尿病的持续时间越长。在每个队列中比较了基线人口统计学和临床特征。在每个队列中描述性评估了 6 个月随访的结果，包括糖化血红蛋白 (HbA) 的变化和治疗模式。
研究人群包括来自 1 种 OAD (n=4822)、2 种 OAD (n=6293)和 ≥3 种 OAD (n=7006)队列的 18121 名患者。基线时的平均年龄为 54.7 岁。≥3 种 OAD 队列中男性更为常见。大多数患者 (67%-70%) 开始接受度拉鲁肽 0.75mg 治疗。剂量升级至 1.5mg 并不常见 (15%-20%)，但在 ≥3 种 OAD 队列中呈上升趋势。在 6 个月随访时，对度拉鲁肽的依从性 (61%-67%)随着基线 OAD 使用量的增加而增加。HbA 评估 (n=3178)包括 1 种 OAD 队列中的 761 名患者、2 种 OAD 队列中的 1088 名患者和 ≥3 种 OAD 队列中的 1329 名患者。基线平均[标准差]HbA 水平随 OAD 类别数量的增加而升高 (1 种 OAD：8.18%[1.80]；2 种 OAD：8.56%[1.66]；≥3 种 OAD：8.73%[1.51])。早期度拉鲁肽治疗启动者组的 HbA 水平下降幅度更大 (1 种 OAD：-1.39%；95%CI，-1.50 至-1.27；2 种 OAD：-1.30%；95%CI，-1.39 至-1.20；≥3 种 OAD：-1.01%；95%CI，-1.09 至-0.93)，与延迟启动者组相比。早期度拉鲁肽治疗启动者组在 6 个月随访时达到 HbA<7%的患者也更为常见 (1 种 OAD：68%；2 种 OAD：51%；≥3 种 OAD：33%)。
根据 OAD 使用作为起始时间的替代指标定义的度拉鲁肽治疗启动者队列在基线特征和短期随访结果方面存在差异。早期开始度拉鲁肽治疗与较低的平均 HbA 水平相关，并在 6 个月随访期间增加了 HbA<7%的可能性。
