Charlotte Area Health Education Center, Charlotte, NC.
Skaggs College of Pharmacy, University of Utah, Salt Lake City.
J Manag Care Spec Pharm. 2022 Jun;28(6):592-603. doi: 10.18553/jmcp.2022.21436. Epub 2022 Mar 30.
People with type 2 diabetes (T2D) who change their basal insulin (BI) may have variable persistence with therapy. Compared with first-generation (long-acting) BI analogs (insulin glargine 100U/mL [Gla-100]; insulin detemir [IDet]), second-generation (longer-acting) BI analogs (insulin glargine 300U/mL [Gla-300]; insulin degludec) have similar glycated hemoglobin (HbA1c) attainment and lowered hypoglycemia risk, which could impact treatment persistence. To compare persistence, adherence, health care resource utilization (HRU), and costs for individuals switching from neutral protamine Hagedorn insulin or a first-generation BI analog with either the second-generation BI, Gla-300, or an alternative first-generation BI analog (Gla-100 or IDet). We used Optum Clinformatics claims data from adults (aged ≥ 18 years) with T2D who had received BI (neutral protamine Hagedorn, Gla-100, IDet) in the 6-month baseline period, and switched to either Gla-300 or an alternative first-generation BI (Gla-100 or IDet; treatment switch = index date) between April 1, 2015, and August 31, 2019. Participants were followed for 12 months, until plan disenrollment, or until death, whichever occurred first. Cohorts were propensity score matched (PSM) on baseline characteristics. The primary outcome was the proportion who were persistent with therapy at 12 months. Secondary outcomes were adherence (proportion of days covered); change in HbA1c; and all-cause, diabetes-related, and hypoglycemia-related HRU and costs. PSM generated 3,077 participants/group (mean age: 68 years, 52% female). Cohorts were well balanced except for hospitalization, which was adjusted in models as a covariate. During the 12-month follow-up period, participants who received Gla-300 vs first-generation BI had greater persistence with (45.5% vs 42.1%; adjusted = 0.0001), and adherence to (42.8% vs 38.2%; adjusted = 0.0006), BI therapy and a statistically larger reduction in HbA1c at 12 months (-0.65% vs -0.45%; adjusted = 0.0040). The proportion of participants achieving HbA1c less than 8% (47.2% vs 40.9%; < 0.0001), but not less than 7% (21.2% vs 20.8%), was significantly higher for Gla-300 vs first-generation BI. All-cause (45.3 vs 65.9 per 100 patient-years [P100PY]) and diabetes-related (21.5 vs 29.1 P100PY), but not hypoglycemia-related, hospitalizations (1.0 vs 1.5 P100PY) were significantly (P < 0.0001) lower for Gla-300 vs first-generation BI. Similarly, all-cause (111.9 vs 148.8 P100PY), diabetes-related (54.8 vs 74.2 P100PY), and hypoglycemia-related (2.9 vs 5.7 P100PY) emergency department (ED) visits were significantly lower for Gla-300 (all < 0.0001). Costs for all-cause hospitalizations and hypoglycemia-related ED visits were significantly lower for Gla-300 vs first-generation BI. Although pharmacy costs were significantly higher for Gla-300 vs first-generation BI, all-cause total health care costs were not significantly different: $41,255 vs $45,316 per person per year, respectively. In this claims-based analysis of people with T2D receiving BI, switching to Gla-300 was associated with significantly better persistence, adherence, and HbA1c reduction compared with switching to an alternative first-generation BI analog. All-cause HRU was significantly lower; despite significantly higher pharmacy costs, total health care costs were similar. This study was funded by Sanofi US. Medical writing support was provided by Helen Jones, PhD, CMPP, of Evidence Scientific Solutions and funded by Sanofi US. Dr Wright is on the speakers' bureau and sits on the advisory boards for Abbot Diabetes, Bayer, Boehringer Ingelheim, Eli Lilly, and Sanofi; sits on the advisory board for Medtronic; and is a consultant for Abbot Diabetes, Bayer, Boehringer Ingelheim, and Eli Lilly. Dr Malone is on advisory boards for Novartis and Avalere and consults for Pear Therapeutics, Sarepta, and Strategic Therapeutics. Dr Trujillo sits on advisory boards for Novo Nordisk and Sanofi. Drs Gill, Zhou, and Preblick and Mr Li are employees and stockholders of Sanofi. Mr Huse is an employee of Evidera and a contractor for Sanofi. Dr Reid is a speaker and consultant for Novo Nordisk and Sanofi-Aventis and is a consultant for AstraZeneca and Intarcia.
患有 2 型糖尿病(T2D)的患者改变其基础胰岛素(BI)的使用可能会对治疗的持续时间产生不同的影响。与第一代(长效)BI 类似物(甘精胰岛素 100U/mL[Gla-100];地特胰岛素[IDet])相比,第二代(更长效)BI 类似物(甘精胰岛素 300U/mL[Gla-300];德谷胰岛素)在糖化血红蛋白(HbA1c)达标率和降低低血糖风险方面具有相似的效果,这可能会影响治疗的持续时间。本研究旨在比较从中性鱼精蛋白锌胰岛素或第一代 BI 类似物(甘精胰岛素 100U/mL、地特胰岛素)转换为第二代 BI(甘精胰岛素 300U/mL)或另一种第一代 BI 类似物(甘精胰岛素 100U/mL 或地特胰岛素)的患者在持续性、依从性、医疗资源利用(HRU)和成本方面的差异。我们使用 Optum Clinformatics 理赔数据,纳入了基线期(6 个月)内接受 BI(中性鱼精蛋白锌胰岛素、甘精胰岛素 100U/mL、地特胰岛素)治疗的年龄≥18 岁的 T2D 患者,这些患者在 2015 年 4 月 1 日至 2019 年 8 月 31 日期间转换为甘精胰岛素 300U/mL 或另一种第一代 BI 类似物(甘精胰岛素 100U/mL 或地特胰岛素)(治疗转换为索引日期)。参与者随访 12 个月,直至计划退出或死亡,以先发生者为准。使用倾向评分匹配(PSM)对基线特征进行匹配。主要结局是 12 个月时治疗持续性的比例。次要结局包括依从性(覆盖率);糖化血红蛋白的变化;以及全因、糖尿病相关和低血糖相关的 HRU 和成本。PSM 生成了 3077 名患者/组(平均年龄 68 岁,52%为女性)。除了住院治疗,其他情况两组均平衡。在 12 个月的随访期间,与第一代 BI 相比,接受甘精胰岛素 300U/mL 治疗的患者具有更高的持续性(45.5% vs. 42.1%;校正值=0.0001)和依从性(42.8% vs. 38.2%;校正值=0.0006),BI 治疗的糖化血红蛋白降低幅度也更大(-0.65% vs. -0.45%;校正值=0.0040)。HbA1c 水平低于 8%(47.2% vs. 40.9%;<0.0001)的患者比例显著高于第一代 BI,而 HbA1c 水平低于 7%(21.2% vs. 20.8%)的患者比例则无显著差异。甘精胰岛素 300U/mL 组全因(每 100 患者年[P100PY]45.3 例 vs. 65.9 例)和糖尿病相关(每 100 患者年[P100PY]21.5 例 vs. 29.1 例)住院率显著低于第一代 BI,但低血糖相关住院率(每 100 患者年[P100PY]1.0 例 vs. 1.5 例)则无显著差异。同样,甘精胰岛素 300U/mL 组全因(每 100 患者年[P100PY]111.9 例 vs. 148.8 例)、糖尿病相关(每 100 患者年[P100PY]54.8 例 vs. 74.2 例)和低血糖相关(每 100 患者年[P100PY]2.9 例 vs. 5.7 例)急诊就诊率也显著低于第一代 BI(均<0.0001)。甘精胰岛素 300U/mL 组全因住院和低血糖相关急诊就诊的费用均显著低于第一代 BI。虽然甘精胰岛素 300U/mL 组的药费显著高于第一代 BI,但全因总医疗费用并无显著差异:每人每年分别为 41255 美元和 45316 美元。在这项基于 BI 治疗的 T2D 患者的医保理赔数据分析中,与转换为另一种第一代 BI 类似物相比,转换为甘精胰岛素 300U/mL 与更好的持续性、依从性和糖化血红蛋白降低有关。全因 HRU 显著降低;尽管药费显著增加,但总医疗费用相似。本研究由赛诺菲美国公司资助。医学写作支持由 Evidence Scientific Solutions 的 Helen Jones,PhD,CMPP 提供,由赛诺菲美国公司资助。Wright 博士是演讲者和顾问委员会成员,服务于 Abbott Diabetes、Bayer、Boehringer Ingelheim、Eli Lilly 和 Sanofi;是 Medtronic 顾问委员会成员;是 Abbott Diabetes、Bayer、Boehringer Ingelheim 和 Eli Lilly 的顾问。Malone 博士是 Novartis 和 Avalere 的顾问委员会成员,为 Pear Therapeutics、Sarepta 和 Strategic Therapeutics 提供咨询。Trujillo 博士是 Novo Nordisk 和 Sanofi 的顾问委员会成员。Gill 博士、Zhou 博士和 Preblick 博士以及 Li 先生是 Sanofi 的员工和股东。Huse 先生是 Evidera 的员工,也是 Sanofi 的承包商。Reid 博士是 Novo Nordisk 和 Sanofi-Aventis 的演讲者和顾问,是 AstraZeneca 和 Intarcia 的顾问。