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基于达到临床相关治疗目标评估德谷胰岛素利拉鲁肽与基础胰岛素和基础-餐时胰岛素强化方案治疗 2 型糖尿病的短期成本-效果。

Evaluation of the Short-Term Cost-Effectiveness of IDegLira Versus Basal Insulin and Basal-Bolus Therapy in Patients with Type 2 Diabetes Based on Attainment of Clinically Relevant Treatment Targets.

机构信息

Endocrinology, Jefferson Health NJ, Voorhees, New Jersey.

Department of Endocrinology and Metabolic Diseases, University Hospital of Larissa, Larissa, Greece.

出版信息

J Manag Care Spec Pharm. 2020 Feb;26(2):143-153. doi: 10.18553/jmcp.2019.19035. Epub 2019 Dec 19.

Abstract

BACKGROUND

Effective glycemic control can reduce the risk of complications and their related costs in patients with type 2 diabetes (T2D). Many patients fail to reach hemoglobin A1c (HbA1c) ≤ 6.5% or < 7.0%, often due to adverse effects of treatment, such as hypoglycemia and weight gain. Glycemic targets should be individualized and consider multiple factors, including the risk of adverse events and the patient's characteristics and comorbid conditions.

OBJECTIVE

To compare the odds and annual cost of achieving treatment targets, which incorporate HbA1c targets of < 7.5%, < 8.0%, and ≤ 9.0%, with insulin degludec/liraglutide (IDegLira) versus basal insulin and basal-bolus therapy.

METHODS

This is a post hoc analysis of the DUAL V and DUAL VII 26-week trials, which randomized patients with T2D uncontrolled (HbA1c 7%-10%) on insulin glargine 100 units/mL (IGlar U100) and metformin to IDegLira or continued IGlar U100 titration (DUAL V) or IGlar U100 + insulin aspart (DUAL VII), all with metformin. Proportions of patients achieving HbA1c targets (< 7.5%, < 8.0%, and ≤ 9.0%) by the end of trial were assessed via 3 outcomes: alone, without either hypoglycemia or weight gain (double composite outcome), or without a combination of hypoglycemia and weight gain (triple composite outcome). The cost per patient achieving the triple composite outcome at each HbA1c target (< 7.5%, < 8.0%, and ≤ 9.0%) was calculated by dividing the annual cost of treatment by the proportion of patients achieving the target. This short-term (1-year) cost-effectiveness analysis was conducted from the perspective of a U.S. health care payer.

RESULTS

More patients achieved HbA1c < 7.5% ( < 0.0001) and < 8.0% ( = 0.0003), and a similar percentage achieved HbA1c ≤ 9.0% with IDegLira versus IGlar U100 (DUAL V). Similar proportions of patients achieved all 3 HbA1c targets with IDegLira compared with basal-bolus therapy (DUAL VII). The odds of achieving double or triple composite outcomes were significantly higher for IDegLira versus IGlar U100 or basal-bolus for all 3 HbA1c targets ( < 0.0001 in each case) in both trials. For each $1 spent on IDegLira, the equivalent annual costs per patient to achieve HbA1c targets of < 7.5%, < 8.0%, or ≤ 9.0% without hypoglycemia and without weight gain were $2.43, $2.10, and $2.05, respectively, for IGlar U100 and $6.33, $5.80, and $6.06, respectively, for basal-bolus therapy.

CONCLUSIONS

Based on data from DUAL V and DUAL VII, this analysis showed that a greater or similar proportion of patients with T2D reached HbA1c targets with IDegLira compared with IGlar U100/basal-bolus therapy. Odds of achieving double or triple composite outcomes of HbA1c reduction without hypoglycemia and/or without weight gain were greatest for IDegLira. Short-term cost analyses based on the triple composite outcomes suggest that IDegLira is a cost-effective treatment option in the United States compared with either uptitration of IGlar U100 or basal-bolus therapy.

DISCLOSURES

This study was supported by Novo Nordisk A/S. The analysis was based on the DUAL V (NCT01952145) and DUAL VII (NCT02420262) trials, which were funded and conducted by Novo Nordisk. This post hoc analysis was conceived and interpreted by the authors and drafted with medical writing support that was funded by Novo Nordisk. Novo Nordisk also reviewed the manuscript for medical accuracy. Hunt and Malkin are employees of Ossian Health Economics and Communications, which received consulting fees from Novo Nordisk during the conduct of this study and has received consulting fees from Novo Nordisk, unrelated to this study. Mocarski, Ranthe, and Schiffman are employees of Novo Nordisk and Novo Nordisk A/S. Cannon has received speaker fees/honoraria from Abbvie, Amgen, and Janssen; speaker fees from Novo Nordisk; and has stock ownership in Novo Nordisk. Bargiota has received speaker fees/honoraria from AstraZeneca, Eli Lilly, MSD, Novo Nordisk, Sanofi, Boehringer Ingelheim, and Novartis. Billings has received personal fees from Novo Nordisk, Sanofi, and Dexcom, unrelated to this study. Leiter reports grants and personal fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck, Novo Nordisk, Sanofi, Servier, and GSK, unrelated to this study. Doshi has no relevant conflicts of interest to disclose. Parts of this study were presented as a poster at the AMCP Managed Care & Specialty Pharmacy Annual Meeting; April 23-26, 2018; Boston, MA.

摘要

背景

有效的血糖控制可以降低 2 型糖尿病(T2D)患者发生并发症及其相关费用的风险。许多患者未能达到血红蛋白 A1c(HbA1c)≤6.5%或<7.0%,这通常是由于治疗的不良反应,如低血糖和体重增加。血糖目标应个体化,并考虑多种因素,包括不良事件的风险以及患者的特征和合并症情况。

目的

比较实现治疗目标的几率和年度成本,这些目标包含 HbA1c 目标<7.5%、<8.0%和≤9.0%,使用德谷胰岛素/利拉鲁肽(IDegLira)与基础胰岛素和基础-餐时胰岛素方案相比。

方法

这是 DUAL V 和 DUAL VII 26 周试验的事后分析,该试验将血糖控制不佳(HbA1c 7%-10%)的 T2D 患者随机分配至接受德谷胰岛素/利拉鲁肽或继续滴定甘精胰岛素 100U/mL(IGlar U100)和二甲双胍(DUAL V)或甘精胰岛素 U100+门冬胰岛素(DUAL VII),所有患者均合用二甲双胍。通过 3 种结局评估试验结束时达到 HbA1c 目标(<7.5%、<8.0%和≤9.0%)的患者比例:单独、无低血糖或体重增加(双重复合结局)或无低血糖和体重增加的组合(三重复合结局)。通过将治疗年度成本除以达到目标的患者比例,计算出每位患者达到每个 HbA1c 目标(<7.5%、<8.0%和≤9.0%)时达到三重复合结局的成本。这是一项基于美国医疗保健支付者视角的短期(1 年)成本-效果分析。

结果

与 IGlar U100 相比,IDegLira 更能达到 HbA1c<7.5%(<0.0001)和<8.0%(=0.0003),并且达到 HbA1c≤9.0%的患者比例相似(DUAL V)。与基础-餐时胰岛素方案相比,IDegLira 达到所有 3 个 HbA1c 目标的患者比例相似(DUAL VII)。与 IGlar U100 或基础-餐时胰岛素方案相比,IDegLira 达到双重或三重复合结局的几率更高(每种情况下均<0.0001)。对于每个花费在 IDegLira 上的美元,IGlar U100 达到 HbA1c 目标<7.5%、<8.0%或≤9.0%且无低血糖和无体重增加的等效年度成本分别为 2.43 美元、2.10 美元和 2.05 美元,而基础-餐时胰岛素方案的等效年度成本分别为 6.33 美元、5.80 美元和 6.06 美元。

结论

基于 DUAL V 和 DUAL VII 的数据,本分析表明,与 IGlar U100/基础-餐时胰岛素方案相比,更多的 T2D 患者达到了 IDegLira 的 HbA1c 目标。与低血糖和/或体重增加无关的 HbA1c 降低的双重或三重复合结局的几率,IDegLira 最大。基于三重复合结局的短期成本分析表明,与 IGlar U100 或基础-餐时胰岛素方案相比,IDegLira 是美国一种具有成本效益的治疗选择。

披露

本研究由诺和诺德公司资助。该分析基于 DUAL V(NCT01952145)和 DUAL VII(NCT02420262)试验,这些试验由诺和诺德公司资助和开展。这一事后分析由作者提出并解释,草稿由 Novo Nordisk 资助的医学写作支持撰写。诺和诺德还审查了该手稿的医学准确性。Hunt 和 Malkin 是 Ossian Health Economics and Communications 的员工,在本研究进行期间,他们从 Novo Nordisk 获得咨询费,并且与这项研究无关,他们从 Novo Nordisk 获得咨询费。Mocarski、Ranthe 和 Schiffman 是 Novo Nordisk 的员工和 Novo Nordisk A/S 的员工。Cannon 曾因 Abbvie、Amgen 和 Janssen、Novo Nordisk 和 Novo Nordisk A/S 获得演讲费/酬金;因 AstraZeneca、Eli Lilly、MSD、Novo Nordisk、Sanofi、Boehringer Ingelheim 和 Novartis 获得演讲费/酬金;并拥有 Novo Nordisk 的股票所有权。Bargiota 因 AstraZeneca、Boehringer Ingelheim、Eli Lilly、Janssen、Merck、Novo Nordisk、Sanofi、Servier 和 GSK 获得与本研究无关的个人酬金。Leiter 报告说,他因 AstraZeneca、Boehringer Ingelheim、Eli Lilly、Janssen、Merck、Novo Nordisk、Sanofi、Servier 和 GSK 获得了与本研究无关的资助和个人酬金。Doshi 没有与本研究相关的利益冲突。本研究的部分内容作为海报在 2018 年 4 月 23 日至 26 日于波士顿举行的 AMCP 管理式医疗和专科药房年度会议上展示。

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