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.