Effectiveness of patient-oriented intervention in primary prevention of cardiovascular diseases with statins: Open-label randomized study.

Background: Poor adherence to treatment is an obstacle to reach the target level of lipids. The purpose of the study was to investigate the impact of patient-oriented intervention with primary focus on patients' adherence to lipid-lowering therapy on low-density lipoprotein cholesterol (LDL-C) in patients with dyslipidemia and receiving statins for primary prevention of cardiovascular diseases (CVD).

Methods: A prospective, open-label, randomized, multicenter study in parallel groups. Data was collected from 11 study sites. 2,912 patients were recruited between June 2018 and August 2019. Test Intervention: extended consultation on drug compliance, patient-oriented printed materials about CVD prevention, SMS- and phone reminders. The primary endpoint was LDL-C. Chi-square test or Fisher's exact test was used for qualitative variables. Paired Wilcoxon test was used to compare the variables between patient visits. The odds ratio (OR) at 95% confidence interval (CI) was defined as the ratio of the chance of fulfilling the criterion in the group or subgroup (subpopulation).

Results: At 12 month, the number of patients achieving target levels of LDL-C, total cholesterol (TC) and blood pressure (BP) was significantly higher in the intervention group vs control (LDL-C: 80% vs. 70%, OR: 1.68, 95% CI: 1.40 to 2.01, p<0.001; TC: 80% vs. 67%, OR: 1.92, 95% CI: 1.60 to 2.29, p<0.001; BP: 85% vs 79%, OR: 1.49, 95% CI:1.22 to 1.83, p=0.0001).

Conclusion: Proposed patient-oriented intervention helps to achieve the target level of LDL-C, TC and supports better control of BP in patients receiving statins for primary prevention of CVD.