Aim. To determine the features and main problems of statin therapy, as well as assess the possibility of achieving the target level of lipid pattern in patients with high and very high cardiovascular risk (CVR) in real clinical practice.Material and methods. The design of the “PRIORITET” observational program is an open observational study. Patients with high and very high CVR were divided into 3 groups in accordance with the initial data: (1) not taking statins, (2) taking statins, but not reaching the target low-density lipoprotein cholesterol (LDL-C) level, (3) taking statins with the achievement of the target LDL-C level, which is justified in replacing the statin inside the class — adverse effects (AE), high price, etc. Within 12 weeks 3 visits of patients to hospitals were carried out: baseline visit (B0), visit 1 month after the study initiation (B1) and visit 3 months after the study initiation (B3). The choice of atorvastatin or rosuvastatin was assessed by the doctors.Results. Groups 1, 2 and 3 included 112, 170 and 16 people, respectively. At B0, 145 (48,7%) patients were prescribed atorvastatin, and 153 (51,3%) — rosuvastatin. Three people dropped out of the study to B3, 295 patients completed the program. Lipid pattern of 285 patients were analyzed: 121 (41%) people (101 with very high CVR and 20 with high CVR) achieved the target LDL-C level, the remaining 164 (59%) patients (CVR — 156 and 8, respectively) — no. The most pronounced dynamics of LDL=C level was revealed in group 1, the differences between group 1 and groups 2 and 3 are highly statistically significant (p<0,0001). There were no differences in the frequency of reaching the target LDL-C level between patients taking atorvastatin or rosuvastatin. The target level of LDL-C (p=0,003) in the treatment of rosuvastatin in patients with high CVR was reached significantly more often than in patients with very high CVR. Also 3 non-serious AEs were reported. On average, in 9% of cases, reaching the target level of LDL-С during visits B1 and B3 was wrong interpreted by the attending physicians.Conclusion. The main problems of statin therapy in real clinical practice are the wrong interpretation of reaching the target level of LDL-C, inertness of doctors in titrating of statins doses and achieving the target level of lipid pattern. It may be the cause of reduced efficiency and deterioration of lipid-lowering therapy results in patients with high and very high CVR. The results of the “PRIORITET” study demonstrated the possibility of improving the practice of statins use and its accordance with clinical guidelines.Skibitsky V. V. on behalf of the working group of the “PRIORITET” researchWorking Group of the “PRIORITET” study: Voronina V. P. (Moscow), Zelenova T. I. (Moscow), Sladkova T.A. (Moscow), Alekseeva A. I. (Tula), Barabanova T. Yu. (Tula), Zotova A. S. (Tula), Kolomeitseva T. M. (Tula), Prikhod’ko T. N. (Tula), Pazelt E. A. (Nizhny Novgorod), Khramushev N. Yu. (Nizhny Novgorod), Skibitsky A. V. (Krasnodar), Alekseeva V. V. (Saratov), Lazareva E. V. (Saratov).
Приверженность лечению -это степень, с кото-рой пациент готов выполнять предписания врача, причем подразумевается добровольное активное взаимоприемлемое взаимодействие пациента и врача для достижения терапевтического эффекта. Низкая приверженность выполнению врачебных назначений и рекомендаций является основным барьером на пути успешного лечения и проблемой, которую должны пытаться решить медицинские ра-ботники [1][2][3].По данным литературы, каждый четвертый пациент не придерживается предписанной лечащим врачом те-рапии [4]. Очевидно, что недостаточная (низкая) при-верженность лечению может иметь серьезные и доро-гостоящие последствия. Подсчитано, что она является причиной значительного количества смертельных слу-чаев при сердечно-сосудистых заболеваниях (в ре-зультате сердечной недостаточности и инсульта). Кро-ме того, предполагается, что до 23% вызовов на дом, 10% госпитализаций и частых визитов в медучрежде-ния, диагностических мероприятий можно было бы из-бежать при соблюдении пациентами всех предписаний врача [3]. Цель. Изучить влияние приверженности рекомендованной терапии пациентов, перенесших ОКС, на риск развития сердечно-сосудистых осложнений в течение одного года после госпитализации; выявить основные причины низкой приверженности предписанной терапии. Методы исследования. В исследование включены пациенты с ОКС (n=271), последовательно поступавшие в отделение неотложной кардиологии. Всем пациентам проводили комплексную терапию (ацетилсалициловая кислота (АСК), бета-адреноблокаторы (БАБ), ингибиторы АПФ, статины). Анализировали частоту назначения препаратов, потенци-ально улучшающих прогноз ИБС. В течение 12 мес отслеживали развитие сердечно-сосудистых осложнений (смерть, инфаркт миокарда, инсульт, эпизоды нестабильной стено-кардии, декомпенсация сердечной недостаточности). Оценивали приверженность пациентов рекомендованной терапии. Результаты. При выписке из стационара терапия АСК была рекомендована 98% пациентам, БАБ -95%, ингибиторами АПФ -97%, статинами -63%. Через 12 мес только 73% пациентов продолжили терапию АСК, 66% -БАБ, 74% -ингибиторами АПФ, 44% -статинами. Среди пациентов, прерывавших прием рекомендованных препаратов, частота повторных госпитализаций была достоверно выше: 80% (n=32) против 24% (n=55) среди приверженных терапии пациентов. Основными причинами госпитализаций становились декомпенсированная форма сердечной недостаточности (46%), возобновление клиники стенокардии напряжения (32%), повторные случаи ОКС (19%). Заключение. Значимая часть пациентов (около 1/3) прекращает рекомендованную терапию в течение 12 мес после развития ОКС. Низкая приверженность терапии, чаще все-го обусловленная субъективными причинами, ассоциируется с трехкратным повышением риска развития сердечно-сосудистых осложнений (относительный риск=3,27; 95% ДИ 2,49-4,30; p=0,05). Ключевые слова: ишемическая болезнь сердца, острый коронарный синдром, приверженность терапии, прогноз, эффективность терапии. Aim. In patients after acute coronary syndrome (ACS) to study the effect of adherence to recommended therapy on t...
Aim. To study adherence to treatment with generic statins prescribed to patients with high and very high cardiovascular risk in routine clinical practice, as well as the possible impact of educational training of doctors on compliance with clinical guidelines and changes in patient adherence to treatment. Material and methods. The study was prospective, with educational training for physicians on the main provisions of current clinical guidelines prior to the program. It included 3 visits over 12 weeks: inclusion visit (V0), and visits after 1 and 3 months of follow-up (V1 and V3). The use of generic atorvastatin or rosuvastatin was recommended for all patients. To assess adherence the following surveys were used: medical survey (all visits), the original questionnaire to assess the potential and the actual commitment to taking statins and the causes of non-adherence, and the Morisky-Green 8-question test (visits V0 and V3) to evaluate overall adherence to drug treatment. The patients who started the drug taking according to the medical recommendations and continued it during the study were considered as adherents. Patients who started but stopped taking the drug for 12 weeks were considered as partially non-adherent. Patients who refused to take the recommended statin were considered as non-adherents. The prescribed doses of statins and medical tactics in the titration of doses, as well as the achievement of the target level of low-density lipoprotein cholesterol (LDL cholesterol) were evaluated. Results. 112 (37.5%) of the 298 patients with baseline indications for taking statins did not take these drugs. According to the medical survey at V0 a total of 286 (96%) patients were potential adherents to medical recommendations; at V3 262 (88%) patients were adherent to statin treatment; 34 patients were partially non-adherent, 1 – was non-adherent, and 1 – dropped out of the study immediately after V0. According to the original questionnaire, potential adherence was assessed in 281 patients: 244 (86.8%) were potentially adherent, 37 (13.2%) – partially non-adherent. At V3, out of 294 patients who filled in the original questionnaire, 260 (88.5%) were adherent, 26 (8.8%) – partly non-adherent, 8 (2.7%) – nonadherent. The Morisky-Green questionnaire was filled in by 292 patients: at V0, 106 patients (36.3%) had treatment adherence, non-adherence – 186 patients (63.7%). By V3, an increase in total adherence was found: 159 patients (54.5%) were adherent, and 133 (45.5%) – non-adherent. The lipid profile was evaluated in 231 patients in V1 and in 285 ones – in V3. The target LDL cholesterol level was reached by V1 in 47 (20.3%) patients, and in 184 (79.7%) patients – was not. Dose titration occurred in 56 patients. By V3, 121 (42.4%) patients reached the target level of LDL cholesterol, and 164 – did not. The results of the lipid profile analysis were erroneously interpreted in 21 patients. Conclusion The results of the medical survey and the original questionnaire for assessing adherence predominantly coincided. The Morisky-Green test does not accurately reflect patients' commitment to taking a particular drug. Clinical inertness of doctors in the titration of statin doses and achievement of target LDL cholesterol levels were found as well as erroneous interpretation of the LDL cholesterol level. Educational trainings for doctors had a positive effect on the implementation of clinical guidelines, and also contributed to increasing patient adherence to medical recommendations.
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