1 IBM Watson Health, Bethesda, Maryland.
2 Novo Nordisk A/S, Søborg, Denmark.
J Manag Care Spec Pharm. 2019 Jun;25(6):669-680. doi: 10.18553/jmcp.2019.18429. Epub 2019 Mar 21.
Treatment adherence and persistence are crucial to achieve glycemic control in patients with type 2 diabetes (T2D). Early response to a new therapy may lead to improved treatment adherence and associated outcomes.
To assess the effect of early response to glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy, as indicated by reduced hemoglobin A1c (A1c) and body weight, on long-term adherence and persistence.
Adults aged ≥ 18 years with T2D initiated with GLP-1 RA therapy after January 1, 2010, were identified from the IBM Explorys Therapeutic Dataset. Patients were required to have health care utilization ≥ 6 months before and ≥ 18 months after the index prescription. Changes in A1c and body weight from baseline through 6 months were assessed for all patients; early response was defined by > 1% reduction in A1c and > 3% reduction in body weight within 3-6 months. Adherence (assessed as the proportion of days covered [PDC] ≥ 80%) and nonpersistence/discontinuation (indicated by a gap in therapy ≥ 60 days) over 18 months were evaluated among early responders versus nonresponders. Multivariable logistic regression was used to assess the effect of early response to GLP-1 RA therapy on adherence and discontinuation over 18 months.
Among 8,329 identified patients, 33.3% and 31.2% experienced early response as indicated by reductions in A1c > 1% point and in body weight > 3% from baseline, respectively. Significantly higher proportions ( < 0.001) of early responders in both reduced A1c and body weight were adherent over 18 months compared with patients without an early response (A1c: 45.0% vs. 37.1%; body weight: 43.3% vs. 38.0%). Significantly lower proportions ( < 0.001) of early responders discontinued over 18 months compared with patients without an early response (A1c: 61.4% vs. 67.9%; body weight: 61.9% vs. 67.5%). After controlling for baseline demographic and clinical characteristics including baseline weight, baseline A1c, oral antidiabetes drug use, insulin use, and the presence of comorbidity of diabetes, patients were more likely to be adherent over 18 months if they had reductions in A1c > 1% (OR = 1.59, 95% CI = 1.36-1.85) or body weight reduction > 3% (OR = 1.18, 95% CI = 1.02-1.36) at 3-6 months compared with those without an early response. Similarly, the early responders had significantly lower likelihood of discontinuation compared with those without early response (A1c > 1%; OR = 0.62, 95% CI = 0.53-0.72; body weight > 3%; OR = 0.81, 95% CI = 0.70-0.94).
Early response to GLP-1 RA therapy was associated with significantly increased adherence and reduced likelihood of discontinuation.
Funding to conduct this study was provided to IBM Watson Health by Novo Nordisk A/S. The analysis was conducted independently by IBM Watson Health. Novo Nordisk A/S and IBM Watson Health collaborated on study design and interpretation of results. At the time of this study, Durden and Laing were employed by IBM Watson Health and received funding from Novo Nordisk to conduct this study. Fowler is employed by IBM Watson Health. Panton and Mocevic were employed by Novo Nordisk while this study was conducted. A portion of these results were presented at the AMCP Managed Care & Specialty Pharmacy Annual Meeting 2018; April 23-26, 2018; Boston, MA, where it was awarded with a bronze ribbon.
对于 2 型糖尿病（T2D）患者，治疗依从性和持久性对于实现血糖控制至关重要。新疗法的早期反应可能会改善治疗依从性和相关结果。
评估 GLP-1 受体激动剂（GLP-1RA）治疗早期反应（表现为糖化血红蛋白（A1c）和体重降低）对长期依从性和持久性的影响。
从 IBM Explorys 治疗数据集确定了 2010 年 1 月 1 日后开始 GLP-1RA 治疗的年龄≥18 岁的成年人。要求患者在指数处方前至少有 6 个月的医疗保健使用，并且在处方后至少有 18 个月的医疗保健使用。评估所有患者基线至 6 个月期间 A1c 和体重的变化；早期反应定义为 3-6 个月内 A1c 降低>1%和体重降低>3%。在 18 个月时，评估早期反应者与无反应者的依从性（评估为 PDC≥80%）和非持续性/停药（治疗中断≥60 天表示）。使用多变量逻辑回归评估 GLP-1RA 治疗早期反应对 18 个月时依从性和停药的影响。
在 8329 名确定的患者中，分别有 33.3%和 31.2%的患者在 A1c 降低>1%和体重降低>3%方面表现出早期反应。与无早期反应的患者相比，在 A1c 和体重均有早期反应的患者中，在 18 个月时的依从性比例明显更高（<0.001）（A1c：45.0% vs. 37.1%；体重：43.3% vs. 38.0%）。与无早期反应的患者相比，在 18 个月时的停药比例明显更低（<0.001）（A1c：61.4% vs. 67.9%；体重：61.9% vs. 67.5%）。在控制基线人口统计学和临床特征（包括基线体重、基线 A1c、口服抗糖尿病药物使用、胰岛素使用和糖尿病合并症的存在）后，与无早期反应的患者相比，如果患者在 3-6 个月时 A1c 降低>1%（OR=1.59，95%CI=1.36-1.85）或体重降低>3%（OR=1.18，95%CI=1.02-1.36），则更有可能在 18 个月时保持依从性。同样，与无早期反应的患者相比，早期反应者的停药可能性明显更低（A1c>1%；OR=0.62，95%CI=0.53-0.72；体重>3%；OR=0.81，95%CI=0.70-0.94）。
GLP-1RA 治疗的早期反应与依从性显著提高和停药可能性降低相关。
开展这项研究的资金由 Novo Nordisk A/S 提供给 IBM Watson Health。IBM Watson Health 独立开展了这项分析。Novo Nordisk A/S 和 IBM Watson Health 合作开展了研究设计和结果解释。在进行这项研究时，Durden 和 Laing 受雇于 IBM Watson Health，并获得 Novo Nordisk 的资助进行这项研究。Fowler 受雇于 IBM Watson Health。Panton 和 Mocevic 在进行这项研究时受雇于 Novo Nordisk。这项研究的部分结果在 2018 年 AMCP 管理式医疗和专科药房年度会议上进行了介绍；2018 年 4 月 23-26 日，波士顿，马萨诸塞州，该会议授予其铜带奖。
