Цель. Изучить частоту и характер употребления алкоголя у амбулаторных больных с сердечно-сосудистыми заболеваниями и выяснить предпочтения этих пациентов относительно помощи в ограничении потребления алкоголя. Материал и методы. Добровольное анонимное анкетирование с использованием опросников АУДИТ-С и CAGE проведено среди 199 пациентов. В анализ включены данные 182 пациентов (82 женщины и 100 мужчин; средний возраст 56,4±5,8 лет). Результаты. Среди нозологических форм преобладали артериальная гипертензия (70%), нарушения ритма сердца (25%), ишемическая болезнь сердца (20%), хроническая сердечная недостаточность I-II ФК (21%). Положительный тест AUDIT-С выявлен у 30% мужчин и у 7,3% женщин. Совсем не употребляли алкоголь 17% мужчин и 23,2% женщин. По CAGE положительные ответы на все 4 вопроса дали 3% мужчин и никто из женщин, положительные ответы на 3 вопроса-15% мужчин и никто из женщин, на два вопроса-17% мужчин и 11% женщин. Из всех опрошенных мужчин положительный ответ на вопрос о необходимости сокращения потребления алкоголя дали 36%, и 13,4% от всех опрошенных женщин. Заключение. Одновременное тестирование по опросникам AUDIT-C и CAGE амбулаторных больных с сердечно-сосудистыми заболеваниями позволяет выявить подгруппу пациентов (больше-мужчины), которые имеют возможную проблему с избыточным потреблением алкоголя и нуждаются в сокращении потребления спиртных напитков. Ключевые слова: сердечно-сосудистые заболевания, этанол, алкогольная зависимость. Рациональная фармакотерапия в кардиологии 2015;11(6):582-589 Alcohol consumption in patients with cardiovascular diseases (results of the survey of cardiac patients in outpatient practice)
The prolonged release tablets form of alimemazine is seen as a promising agent for the long-term treatment of generalized anxiety disorder (GAD).Objective: to investigate the efficacy and safety of therapy with alimemazine (Teraligen® retard, prolonged release film-coated tablets) in patients with GAD.Material and methods. The study design was a multicentre, open-label, non-comparative clinical trial (CT) with two doses of alimemazine 20 and 40 mg (Teraligen® retard, prolonged-release film-coated tablets). 129 patients diagnosed with GAD (criteria according to the ICD-10 classification), 86 women and 43 men were included, mean age 38.0±11.1 years. The level of anxiety, assessed by the Hamilton HARS scale, at Week 0 (Visit 1) was 24.8±7.3 points.Results. By Week 6, the level of anxiety statistically significantly decreased to a mean score of 10.8±6.6, while the dynamics of the mean score relative to baseline was -14.0±6.27 (p<0.0001). The proportion of patients with a decrease in the total score on the HARS scale by 50% or more compared with the initial value was: after 1 week of therapy – 10.3% (n=13); after 3 weeks of therapy – 60.5% (n=75; compared to baseline, p<0.0001); after 6 weeks of therapy – 69.4% (n=86; compared to baseline, p<0.0001). The therapy was well tolerated, among the adverse events (AEs) patients noted: morning sleepiness (7.8%; n=10); dry mouth (7.8%; n=10); general weakness (4.7%; n=6). Other AEs (dizziness, headache, impaired concentration, muscle weakness, memory impairment, tinnitus, tachycardia) were much less common. From the side of the liver, no AEs were detected, including changes in the activity of liver enzymes.Conclusion. Prolonged release alimemazine tablets 20 mg and 40 mg for six weeks resulted in a statistically significant reduction in anxiety levels, with at least two-thirds of patients experiencing more than half their anxiety. The effect increases with each week as you continue to take the drug. The prolonged release form of alimemazine is well tolerated, the treatment of GAD with the drug is effective and safe and may represent a rational alternative to antidepressant therapy.
Objective: to evaluate the pharmacokinetic parameters, safety and tolerability of Vespireit® (INN buspirone), prolonged-release tablets, 15 mg (JSC “Valenta Pharm”, Russia), which is being developed as a drug for the treatment of functional vertigo, in healthy volunteers with a single oral dose of 15 and 30 mg on an empty stomach or after meals and multiple doses in a daily dose of 15 mg.Material and methods. JSC “Valenta Pharm” conducted an open-label, three-stage, randomized, two-periods, cross-over comparative clinical trial of Vespireit®. At stages 1 and 2, healthy volunteers were screened and randomized into two equal groups (Group 1 and Group 2), as well as the distribution of participants in Group 3. Then, at stage 1, healthy volunteers (n=24) took Vespireit® once at a dose of 15 mg on an empty stomach or after meals, at stage 2, volunteers (n=24) took Vespireit® once at a dose of 30 mg on an empty stomach or after meals. Stage 3 was conducted in 18 volunteers as a non-randomized, non-comparative study with Vespireit® 15 mg on an empty stomach once daily for 5 days. During the study, blood samples were collected from each subject to determine the concentration of test compounds in blood plasma and subsequently calculate their pharmacokinetic parameters. Quantitative determination of buspirone and its two metabolites, 6-hydroxybuspirone (6OH-bus) and 1-(2-pyrimidinyl)-piperazine (1-PP), was performed by a validated high-performance liquid chromatography method with tandem mass spectrometric detection. During the study, tolerability and safety were also evaluated: adverse events, vital signs, laboratory parameters and electrocardiogram parameters were recorded.Results. When the study drug Vespireit®, prolonged-release tablets, was administered once at a dose of 15 mg to healthy volunteers after a meal, an increase in the relative bioavailability and relative degree of absorption of buspirone was observed compared with the fasting state, which was accompanied by a 1.5- and 2.5-fold increase in the AUC0–t and Cmax of buspirone, respectively. In addition, the Cmax of 6-OH-bus increased 1.4-fold and the Cmax of 1-PP increased 1.2-fold. Meal had no effect on the AUC0–t of 6-OH-bus and 1-PP. When the study drug was administered once at a dose of 30 mg after a meal, an increase in the relative bioavailability and relative degree of absorption of buspirone was observed compared with fasting, which was accompanied by an increase in the AUC0–t and Cmax by 1.5- and 2.1-fold, respectively. A 1.2-fold increase in the Cmax of 6-OH-bus was also observed. Food had no effect on the AUC0–t of 6-OH-bus and on the AUC0–t and Cmax of 1-PP. No accumulation of buspirone and its metabolites was observed with repeated dosing.Conclusion. In the study, the values of pharmacokinetic parameters of the new drug Vespireit® in the prolonged-release tablets dosage form were determined both with single administration on an empty stomach and after meals and with multiple administration. The differences and advantages over buspirone preparations in the form of immediate-release tablets are shown: higher relative bioavailability of buspirone with a reduction in interindividual differences in bioavailability and Cmax, more stable plasma concentration of buspirone with reduced peak values of the active substance and metabolite 1-PP, a 1.2-fold increase in AUC0–∞, a 2-fold increase in T1/2, and a 2-fold increase in the degree of retardation (MRT) for buspirone, a 1.4-fold increase in Cmax and MRT of 6-OH-bus, a decrease in AUC0–∞, AUC0–t, and T1/2 of metabolite 1-PP, and a decrease in the ratio of the concentration of 1-PP to the concentration of buspirone and to 6-OH-bus. A favorable safety profile of Vespireit® was demonstrated.
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