The current state of the Russian and foreign regulatory framework for off-label prescription of medicines is presented in the article. The existing problems of this specific drug therapy and possible solutions are described. Unfortunately, there are some gaps in the Russian legislation regarding the off-label medication use. Based on the clinical reality, in some cases, the “off-label” drugs prescription can be justified by the clinical condition of the patient, the lack of alternative approved drugs, and the availability of published scientific data that create the prerequisites for the effectiveness of this approach. When off-label drug prescribing as a forced measure, the doctor must provide a rationale for this prescription in the medical documentation, the conclusion of the consultation (with the participation of relevant specialists and the clinical pharmacologist) or the medical commission (with the participation of the administration representative), and the written informed consent of the patient or his legal representative. This information should be actively communicated to doctors in order to increase their legal literacy and prevent possible negative and legal consequences.
Aim. To evaluate the therapeutic efficacy of a combination of ivabradine and beta-blockers (BAB) in patients with stable angina, initially taking only BAB and not reaching the target heart rate (HR) due to the risk of hypotension.Material and methods. A prospective observational post-registration study was performed at the Research Institute for Complex Issues of Cardiovascular Diseases. The study included 50 patients with stable angina pectoris (diagnosed by coronary angiography in combination with clinical manifestations of angina of functional class II-III according to the Canadian classification) and an initial sinus rhythm with a heart rate of more than 70 beats per minute. These patients have already taken BAB. Heart rate, the number of angina attacks, nitrate intake and quality of life indicators according to the questionnaire were evaluated as criteria for therapeutic efficacy.Results. Taking the study drug in combination with BAB led to a significant decrease the average heart rate at rest by 20%, as well as after a six-minute walk test (TLC) in most patients (p<0.050), and a decrease in the total number of angina attacks per week from 5 to less than 1 (p<0.050) and the frequency of nitrate intake for the relief of angina attacks from 58% to 20% (p=0.001). Therapy with ivabradine (Bravadin) was well tolerated by patients: there were no adverse events in the observed sample of patients, patients had a high adherence to treatment (100% of the contents of handed out blisters were used). During the 3 months of follow-up, according to the EQ-5D-5L quality of life questionnaire, patients improved their perception of their own health level (p<0.050), the number of patients experiencing mild (p=0.034) and strong (p=0.041) mobility limitations decreased; strong (p=0.024) restriction in self-care, mild (p=0.041) and strong (p=0.024) restriction of daily activities, mild manifestation of pain (p=0.009) and mild anxiety (p=0.027) also were reduced compared with the initial questionnaires.Conclusion. Ivabradine (Bravadin) in addition to BAB is an effective and safe antianginal therapy for the prevention of angina attacks by reducing the initially high heart rate in patients with angina pectoris of functional class II-III.
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