Bochkareva Elena V, Boytsov Sergey A, Drapkina Oxana M, Melikhov Oleg G, Butina Ekaterina K, Kim Irina V
National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russia.
National Medical Research Center of Cardiology, Moscow, Russia.
Caspian J Intern Med. 2025 Jun 23;16(3):458-467. doi: 10.22088/cjim.16.3.458. eCollection 2025 Summer.
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).
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).
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).
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.
治疗依从性差是达到血脂目标水平的一个障碍。本研究的目的是调查以患者为导向的干预措施（主要关注患者对降脂治疗的依从性）对血脂异常且接受他汀类药物进行心血管疾病（CVD）一级预防的患者的低密度脂蛋白胆固醇（LDL-C）的影响。
一项前瞻性、开放标签、随机、多中心平行组研究。数据从11个研究地点收集。2018年6月至2019年8月招募了2912名患者。试验干预：关于药物依从性的延长咨询、关于CVD预防的以患者为导向的印刷材料、短信和电话提醒。主要终点是LDL-C。卡方检验或费舍尔精确检验用于定性变量。配对威尔科克森检验用于比较患者就诊之间的变量。95%置信区间（CI）的比值比（OR）定义为组或亚组（亚人群）中达到标准的机会之比。
在12个月时，干预组中达到LDL-C、总胆固醇（TC）和血压（BP）目标水平的患者数量显著高于对照组（LDL-C：80%对70%，OR：1.68，95%CI：1.40至2.01，p<0.001；TC：80%对67%，OR：1.92，95%CI：1.60至2.29，p<0.001；BP：85%对79%，OR：1.49，95%CI：1.22至1.83，p = 0.0001）。
所提出的以患者为导向的干预措施有助于接受他汀类药物进行CVD一级预防的患者达到LDL-C、TC目标水平，并有助于更好地控制血压。
