JMIR Publications

ABSTRACT

Background:

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

Objective:

A full description of the study’s aims and methods has appeared in JMIR Res Protoc.

Methods:

A feature of DIAPAsOn was the use of a bespoke electronic patient engagement and data collection system.

Results:

The net average reduction from baseline in both total and low-density lipoprotein cholesterol was approximately 1 mmol/L and the net average increment in high-density lipoprotein cholesterol was 0.2+/-0.53 mmol/L. Mean triglyceride levels declined by ~1.3 mmol/, from an initial level of 2.99+/-1.29 mmol/L to 1.67+/- 0.67 mmol/L. The percentage of patients with triglyceride <1.7 mmol/L rose from 13.1% at baseline to 54% at study-end. Digital reporting of adherence was registered by 8.3% of patients (n=180) and average scores indicted poor adherence. However, 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 those patients was also low. Reasons for this low uptake and adherence are unclear. Better adherence was recorded by clinical report. Clinical Trial: NCT03415152