TRUST Study: Participation in Randomized Controlled Trials and Subsequent Adherence to Visiting Medical Institutions and Taking Medications in Patients with Cardiovascular Diseases. Part II. Assessment of the Quality of Therapy

Abstract

Aim. Based on the data of the TRUST study (Influence of Participation in Randomized Controlled Trials on adheRence to Medicines' Intake and regUlar viSits to the docTor) to assess the quality of drug therapy and patients' awareness of achieving target blood counts and blood pressure (BP) among patients with coronary artery disease (CAD), diabetes mellitus (DM), hypertension.Material and methods. 102 patients are enrolled in the study group of the TRUST study who participated in one or more randomized clinical trials (RCT) in the period from 2011 to 2018. A control group (n=109) included patients who had never participated in an RCT was selected. From January to April 2020, face-to-face or telephone contact was established with patients from both groups. In the study group, the response was 86.3%, in the control group - 81.7%. The adherence to drug therapy accordingly to current clinical guidelines was analyzed in patients with coronary artery disease in both groups.Results. Patients with CAD who previously participated in RCTs take drugs with proven efficacy significantly more often than patients who did not participate in clinical trials. All groups of drugs intake was significantly more frequent in the study group than in the control group: angiotensin-converting-enzyme inhibitors/angiotensin receptor blockers (odds ratio [OR] 7.66, 95% confidence interval [CI] 2.5-22.6; p=0.006), statins (OR 5.12, 95%CI 1.8-14.5; p=0.002), beta-blockers (OR 2.96, 95%CI 1.03-8.5; p=0.038), antiplatelet agents (OR 2.94, 95%CI 1.1-7.7; p=0.026). In the main group, 54.3% of patients with CAD knew about their level of low-density lipoprotein cholesterol (LDL-c), and 68% of them had an LDL level of ≤ 1.8 mmol/l. Patients with DM in 92.9% of cases were aware of their glucose level, and in 76.9% of them had the fasting glucose level <7 mmol/L. Hypertensive patients in 92.8% of cases controlled their blood pressure twice a day and 89.2% of them had a target blood pressure level (<140/90 mm Hg).Conclusion. Patients who participated in RCTs showed better adherence to treatment and health awareness compared to the control group. Partly, the approach to patient management, as it takes place in the RCTs model, can be implemented in real clinical practice to improve the quality of therapy in patients with cardiovascular disease.