在DIAPAsOn研究中使用数字技术工具来描述心肌梗死后或高甘油三酯血症患者对处方级ω-3多不饱和脂肪酸治疗的依从性：前瞻性观察研究。

Use of Digital Technology Tools to Characterize Adherence to Prescription-Grade Omega-3 Polyunsaturated Fatty Acid Therapy in Postmyocardial or Hypertriglyceridemic Patients in the DIAPAsOn Study: Prospective Observational Study.

作者信息

Arutyunov Gregory P, Arutyunov Alexander G, Ageev Fail T, Fofanova Tatiana V

机构信息

Department of Internal Medicine, Pirogov Russian National Research Medical University, Moscow, Russian Federation.

Department of Outpatient Medical and Diagnostic Technologies of the Research Institute of Cardiology named after A.L. Myasnikov, Federal State Budgetary Institution National Medical Research Center of Cardiology named after Academician E.I. Chazov, Ministry of Health of the Russian Federation, Moscow, Russian Federation.

出版信息

JMIR Cardio. 2022 Jul 25;6(2):e37490. doi: 10.2196/37490.

DOI:10.2196/37490

PMID:35877173

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9361151/

Abstract

BACKGROUND

Maintaining sustained adherence to medication for optimal management of chronic noninfectious diseases, such as atherosclerotic vascular disease, is a well-documented therapeutic challenge.

OBJECTIVE

The DIAPAsOn study was a 6-month, multicenter prospective observational study in the Russian Federation that examined adherence to a preparation of highly purified omega-3 polyunsaturated fatty acids (Omacor) in 2167 adult patients with a history of recent myocardial infarction or endogenous hypertriglyceridemia.

METHODS

A feature of DIAPAsOn was the use of a bespoke electronic patient engagement and data collection system to monitor adherence. Adherence was also monitored by enquiry at clinic visits. A full description of the study's aims and methods has appeared in JMIR Research Protocols.

RESULTS

The net average reduction from baseline in both total and low-density lipoprotein cholesterol was approximately 1 mmol/L and the net average increase in high-density lipoprotein cholesterol was 0.2 (SD 0.53) mmol/L (P<.001 for all outcomes vs baseline). The mean triglyceride level was 3.0 (SD 1.3) mmol/L at visit 1, 2.0 (SD 0.9) mmol/L at visit 2, and 1.7 (SD 0.7) mmol/L at visit 3 (P<.001 for later visits vs visit 1). The percentage of patients with a triglyceride level <1.7 mmol/L rose from 13.1% (282/2151) at baseline to 54% (1028/1905) at the end of the study. Digital reporting of adherence was registered by 8.3% (180/2167) of patients; average scores indicted poor adherence. However, a clinic-based enquiry suggested high levels of adherence. Data on health-related quality of life accrued from digitally engaged patients identified improvements among patients reporting high adherence to study treatment, but patient numbers were small.

CONCLUSIONS

The lipid and lipoprotein findings indicate that Omacor had nominally favorable effects on the blood lipid profile. Less than 10% of patients enrolled in DIAPAsOn used the bespoke digital platform piloted in the study, and the level of self-reported adherence to medication by these patients was also low. Reasons for this low uptake and adherence are unclear. Better adherence was recorded in clinical reports.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03415152; https://clinicaltrials.gov/ct2/show/NCT03415152.

摘要

背景

对于慢性非传染性疾病（如动脉粥样硬化性血管疾病）的优化管理，维持对药物的持续依从性是一个有充分文献记载的治疗挑战。

目的

DIAPAsOn研究是在俄罗斯联邦进行的一项为期6个月的多中心前瞻性观察性研究，该研究在2167例近期有心肌梗死病史或内源性高甘油三酯血症的成年患者中，考察了对高纯度ω-3多不饱和脂肪酸制剂（Omacor）的依从性。

方法

DIAPAsOn研究的一个特点是使用定制的电子患者参与和数据收集系统来监测依从性。在门诊就诊时通过询问也对依从性进行监测。该研究的目的和方法的完整描述已发表在《JMIR研究方案》中。

结果

总胆固醇和低密度脂蛋白胆固醇较基线的净平均降低约为1 mmol/L，高密度脂蛋白胆固醇的净平均升高为0.2（标准差0.53）mmol/L（所有结果与基线相比，P<0.001）。第1次就诊时甘油三酯平均水平为3.0（标准差1.3）mmol/L，第2次就诊时为2.0（标准差0.9）mmol/L，第3次就诊时为1.7（标准差0.7）mmol/L（与第1次就诊相比，后续就诊时P<0.001）。甘油三酯水平<1.7 mmol/L的患者百分比从基线时的13.1%（282/2151）升至研究结束时的54%（1028/1905）。8.3%（180/2167）的患者进行了依从性的数字报告；平均得分表明依从性较差。然而，基于门诊的询问显示依从性较高。从参与数字互动的患者中收集的与健康相关的生活质量数据表明，报告对研究治疗依从性高的患者有改善，但患者数量较少。