Division of Endocrinology and Metabolism, University of California School of Medicine, San Diego; Veterans Affairs Medical Center, San Diego, California; and Taking Control of Your Diabetes, Del Mar, California.
Becton, Dickinson and Co., Franklin Lakes, New Jersey.
J Manag Care Spec Pharm. 2019 Dec;25(12):1420-1431. doi: 10.18553/jmcp.2019.19097. Epub 2019 Sep 24.
Persistence with multiple daily insulin injections (MDI) may be challenging for patients with type 2 diabetes (T2DM). However, limited information is available regarding the effect of persistence with MDI on outcomes.
To evaluate persistence with basal and bolus insulin therapy and assess its relationship with clinical and economic outcomes in a real-world setting.
This retrospective matched cohort study used 2012-2015 data from multiple U.S. commercial health plans (IBM MarketScan). Patients with T2DM aged 18-64 years with ≥ 2 basal and ≥ 2 bolus insulin claims during a 12-month period were eligible for inclusion if they had 18 months of continuous health plan enrollment (6-month baseline and 12-month post-index). Persistence during 12 months post-index was defined using 2 methods: (a) method 1, ≤ 90-day gaps in both basal and bolus insulin claims and (b) method 2, ≥ 1 basal and ≥ 1 bolus insulin claim every quarter (every 90 days) for 4 consecutive quarters after index bolus claim. Propensity score matching was used to match persistent and nonpersistent method 2 cohorts. Mean per-patient all-cause and diabetes-related medical costs (2015 U.S. dollars, excluding outpatient drugs) and health care resource use (HCRU) were calculated. For patients with hemoglobin A1c (A1c) values during baseline and post-index months 10-12, treatment success was defined as (a) A1c decrease from baseline of ≥ 1% and/or (b) baseline A1c ≥ 7% with post-index A1c < 7%. Baseline characteristics of matched cohorts were compared using standardized mean differences (SMDs). Outcome variables were compared using t-tests, chi-square tests, and generalized linear models.
Characteristics of 12,882 eligible patients and 12-month persistence rates were similar as defined by method 1 (22.4%) and method 2 (21.1%). After matching, the method 2 cohorts included 2,723 and 8,169 persistent and nonpersistent patients, respectively, with well-balanced baseline characteristics (mean age 53 years; 58% men; all SMDs < 0.1). All-cause annual medical costs were lower for the persistent cohort (mean $13,499 vs. $17,362; < 0.0001), as were annual diabetes-related costs (mean $6,392 vs. $8,376; < 0.0001). In persistent versus nonpersistent cohorts, 11% versus 15% of patients, respectively, experienced ≥ 1 hospitalization; 21% versus 24%, respectively, had ≥ 1 ED visit; 9% versus 12%, respectively, experienced ≥ 1 diabetes-related hospitalization; and 13% versus 15%, respectively, had ≥ 1 diabetes-related ED visit ( ≤ 0.005 for all). Mean baseline A1c was similar in persistent and nonpersistent cohorts (9.7% vs. 9.6%, respectively; = 0.63). Persistence with MDI was associated with greater mean reduction in A1c (-1.3% vs. -0.8%, respectively; = 0.006) and greater percentages of patients achieving treatment success (55% vs. 39%, respectively, for nonpersistent; = 0.009).
Poor persistence with basal-bolus insulin therapy over 12 months of follow-up was prevalent and was associated with greater medical costs, greater HCRU, and poorer glycemic control than for patients who were persistent. Interventions are needed to improve persistence with insulin therapy and aid patients with T2DM to achieve glycemic control.
Funding for this study was provided by Becton, Dickinson and Company (BD). All authors except Edelman are employees and stockholders of BD. Edelman reports board membership at Senseonics and participation in advisory board/speakers bureau at Lilly USA, MannKind, Novo Nordisk, Sanofi-Aventis U.S., Merck, and AstraZeneca, all unrelated to this study. A poster for this study was presented at the AMCP Managed Care & Specialty Pharmacy Annual Meeting 2018; April 23-26, 2018; Boston MA.
对于 2 型糖尿病（T2DM）患者而言，坚持每日多次胰岛素注射（MDI）可能具有挑战性。然而，关于坚持 MDI 治疗对结局的影响，相关信息有限。
评估基础和餐时胰岛素治疗的坚持情况，并在真实环境中评估其与临床和经济结局的关系。
本回顾性匹配队列研究使用了来自美国多个商业健康计划（IBM MarketScan）的 2012-2015 年数据。在 12 个月内有≥2 次基础和≥2 次餐时胰岛素索赔的年龄在 18-64 岁的 T2DM 患者，如果在索引前 6 个月和索引后 12 个月连续参加健康计划，则有资格纳入研究。通过以下 2 种方法来定义索引后 12 个月的坚持情况：（a）方法 1，基础和餐时胰岛素索赔之间的差距≤90 天，（b）方法 2，在索引餐时胰岛素索赔后 4 个连续季度每季度（每 90 天）至少有 1 次基础和 1 次餐时胰岛素索赔。使用倾向评分匹配来匹配方法 2 中持续和非持续的队列。计算每位患者的全因和糖尿病相关医疗费用（2015 年美元，不包括门诊药物）和医疗保健资源利用（HCRU）。对于基线和索引后 10-12 个月期间有血红蛋白 A1c（A1c）值的患者，治疗成功定义为：（a）A1c 从基线下降≥1%，和/或（b）基线 A1c≥7%，但索引后 A1c<7%。使用标准化均差（SMD）比较匹配队列的基线特征。使用 t 检验、卡方检验和广义线性模型比较结局变量。
符合条件的 12882 名患者的特征和 12 个月的坚持率与方法 1（22.4%）和方法 2（21.1%）定义的相似。匹配后，方法 2 队列分别包括 2723 名和 8169 名持续和非持续患者，两组基线特征均衡（平均年龄 53 岁；58%为男性；所有 SMDs<0.1）。持续组的全因年度医疗费用（平均$13499 美元 vs. $17362 美元；<0.0001）和糖尿病相关年度医疗费用（平均$6392 美元 vs. $8376 美元；<0.0001）均较低。与非持续组相比，持续组分别有 11%和 15%的患者发生≥1 次住院；分别有 21%和 24%的患者发生≥1 次急诊就诊；分别有 9%和 12%的患者发生≥1 次糖尿病相关住院；分别有 13%和 15%的患者发生≥1 次糖尿病相关急诊就诊（所有 P 值均<0.005）。持续组和非持续组的平均基线 A1c 相似（分别为 9.7%和 9.6%；=0.63）。与非持续组相比，MDI 治疗的坚持与 A1c 平均降低幅度更大（-1.3% vs. -0.8%；=0.006）和治疗成功的患者比例更高（非持续组分别为 55%和 39%；=0.009）。
在 12 个月的随访中，基础-餐时胰岛素治疗的坚持情况不佳较为普遍，与坚持治疗的患者相比，该组患者的医疗费用更高、HCRU 更多、血糖控制更差。需要采取干预措施来提高胰岛素治疗的坚持率，帮助 T2DM 患者实现血糖控制。
本研究的资金由 Becton，Dickinson and Company（BD）提供。除 Edelman 外，所有作者均为 BD 的员工和股东。Edelman 报告在 Lilly USA、MannKind、Novo Nordisk、Sanofi-Aventis U.S.、Merck 和 AstraZeneca 担任董事会成员，并参与了 Lilly USA、MannKind、Novo Nordisk、Sanofi-Aventis U.S.、Merck 和 AstraZeneca 的顾问委员会/发言人局，所有这些都与本研究无关。该研究的海报在 2018 年 4 月 23 日至 26 日举行的 AMCP 管理式医疗和专科药房年度会议上进行了展示；地点为美国马萨诸塞州波士顿。
