RESUMO
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.
RESUMO
BACKGROUND: Sustained adherence and persistence with prescription medications is considered essential to achieve maximal treatment benefit for patients with major chronic, noncommunicable diseases such as hyperlipidemia and lipid-associated cardiovascular disease. It is widely documented, however, that many patients with these conditions have poor long-term adherence to their treatments. The population of Russia is affected by poor adherence in the same ways as populations elsewhere and continues to have high rates of cardiovascular disease. OBJECTIVE: The purpose of this study was to examine patient adherence to a prescription-only preparation of highly purified omega-3 polyunsaturated fatty acids (1.2 to 1 eicosapentaenoic acid to docosahexaenoic ratio, 90% purity) in a large sample of patients at risk for cardiovascular diseases using digital technology to monitor patient behavior and as an outreach facility for patient education and engagement. METHODS: We conducted a 6-month prospective observational study (DIAPAsOn) at >100 centers in the Russian Federation. A bespoke electronic data capture and patient engagement system were developed with a well-established Russian technology supplier that enables information obtained during clinic visits to be supplemented by remote patient self-reporting. Other aspects of the program included raising patients' awareness about their condition via educational materials available in personal patient accounts in the electronic system. RESULTS: From an initial cohort of 3000 patients, a safety population of 2572 patients (age: mean 60 years) with an equal proportion of men and women has been characterized. There was widespread concomitant cardiovascular pathology and commensurate use of multiple classes of cardiovascular medication, notably lipid-modifying and antihypertensive drugs. The program was completed by 1975 patients, of whom 780 were prescribed highly purified omega-3 polyunsaturated fatty acid supplements for secondary prevention after myocardial infarction and 1195 were prescribed highly purified omega-3 polyunsaturated fatty acid supplements for hypertriglyceridemia. Data collection and analysis have been completed. CONCLUSIONS: DIAPAsOn will provide insights into patient adherence with prescription-grade omega-3 polyunsaturated fatty acid therapy and perspectives on the role of mobile technology in monitoring and encouraging adherence to therapy.
