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.

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.

Digital Technology Tools to Examine Patient Adherence to a Prescription-Only Omega-3 Polyunsaturated Fatty Acid Therapy To Mitigate Cardiovascular Risk: Protocol for a Prospective Observational Study and Preliminary Demographic Analysis.

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.

Prognostic value of changes in arterial stiffness in men with coronary artery disease.

BACKGROUND: Men with coronary artery disease (CAD) have been shown to have enhanced arterial stiffness. Arterial function may change over time according to treatment, but the prognostic value of these changes has not been investigated. OBJECTIVES: The aim of the present study was to assess whether an improvement in large artery rigidity in response to treatment, could predict a more favorable prognosis in a population of men with CAD. METHODS: A total of 161 men with CAD (mean age 56.8 ± 10.9 years) being treated with conventional therapy underwent brachial-ankle pulse wave velocity (PWVba) measurements at baseline and after six months. Follow-up period was 3.5 years. End-points were major adverse cardiac events (MACE): acute myocardial infarction, unstable angina, coronary intervention, or cardiac death. RESULTS: During the three-year follow-up period (since initial six-month follow-up), 30 patients experienced MACE. After six-month follow-up, PWVba had not improved (ΔPWVba ≥ 0%, relative to baseline) in 85 (52.8%) of 161 men (Group 1), whereas it had improved (ΔPWVba < 0%) in the remaining 76 men (47.2%) (Group 2). During follow-up, we noticed 24 cardiovascular events in Group 1 and six events in Group 2 (P < 0.001). Cox proportional hazards analyses demonstrated that independent of conventional risk factor changes, absence of PWVba decrease was a predictor of MACE (RR 3.99; 95% CI:1.81-8.78; P = 0.004). The sensitivity of ΔPWVba was 80% and its specificity was 54%. CONCLUSIONS: This study demonstrates that an improvement in arterial stiffness may be obtained after six months of conventional therapy and clearly identifies patients who have a more favorable prognosis.

Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial.

PURPOSE: The purpose of this analysis was to investigate trastuzumab-associated cardiac adverse effects in breast cancer patients after completion of (neo)adjuvant chemotherapy with or without radiotherapy. PATIENTS AND METHODS: The Herceptin Adjuvant (HERA) trial is a three-group, multicenter, open-label randomized trial that compared 1 or 2 years of trastuzumab given once every 3 weeks with observation in patients with HER-2-positive breast cancer. Only patients who after completion of (neo)adjuvant chemotherapy with or without radiotherapy had normal left ventricular ejection fraction (LVEF > or = 55%) were eligible. A repeat LVEF assessment was performed in case of cardiac dysfunction. RESULTS: Data were available for 1,693 patients randomly assigned to 1 year trastuzumab and 1,693 patients randomly assigned to observation. The incidence of trastuzumab discontinuation due to cardiac disorders was low (4.3%). The incidence of cardiac end points was higher in the trastuzumab group compared with observation (severe congestive heart failure [CHF], 0.60% v 0.00%; symptomatic CHF, 2.15% v 0.12%; confirmed significant LVEF drops, 3.04% v 0.53%). Most patients with cardiac dysfunction recovered in fewer than 6 months. Patients with trastuzumab-associated cardiac dysfunction were treated with higher cumulative doses of doxorubicin (287 mg/m(2) v 257 mg/m(2)) or epirubicin (480 mg/m(2) v 422 mg/m(2)) and had a lower screening LVEF and a higher body mass index. CONCLUSION: Given the clear benefit in disease-free survival, the low incidence of cardiac adverse events, and the suggestion that cardiac dysfunction might be reversible, adjuvant trastuzumab should be considered for treatment of breast cancer patients who fulfill the HERA trial eligibility criteria.