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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

https://doi.org/10.20996/1819-6446-2020-12-06

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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.

About the Authors

N. O. Vasyukova
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Natalia O. Vasyukova - MD, Postgraduate Student, Department of Preventive Pharmacotherapy, National Medical Research Center for Therapy and Preventive Medicine.
Petroverigsky per. 10, Moscow, 101990.



N. P. Kutishenko
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Natalia P. Kutishenko - MD, PhD, Head of Laboratory for Pharmacoepidemiological Studies, Department of Preventive Pharmacotherapy, National Medical Research Center for Therapy and Preventive Medicine.
Petroverigsky per. 10, Moscow, 101990.



Yu. V. Lukina
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Yulia V. Lukina - MD, PhD, Leading Researcher, Laboratory for Pharmacoepidemiological Studies, Department of Preventive Pharmacotherapy, National Medical Research Center for Therapy and Preventive Medicine.
Petroverigsky per. 10, Moscow, 101990.



O. I. Zvonareva
Siberian State Medical University
Russian Federation

Olga I. Zvonareva - PhD, Researcher, Central Research Laboratory, Siberian State Medical University.
Moskovsky trakt 2, Tomsk, 634050.



S. Yu. Martsevich
National Medical Research Center for Therapy and Preventive Medicine
Russian Federation

Sergey Yu. Martsevich - MD, PhD, Professor, Head of Department of Preventive Pharmacotherapy, National Medical Research Center for Therapy and Preventive Medicine.
Petroverigsky per. 10, Moscow, 101990.



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For citation:


Vasyukova N.O., Kutishenko N.P., Lukina Yu.V., Zvonareva O.I., Martsevich S.Yu. 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. Rational Pharmacotherapy in Cardiology. 2020;16(6):977-983. (In Russ.) https://doi.org/10.20996/1819-6446-2020-12-06

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ISSN 1819-6446 (Print)
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