Improving blood pressure control, organoprotection and metabolic disorders correction in patients with hypertension switching from diuretic-based combinations to fixed combination lisinopril + amlodipine + rosuvastatin

The aim of the study was to assess the possibility of fixed combination Lisinopril + amlodipine + rozuvastatin to improve arterial elesticity in patients with hypertension and high pulse wave velocity, despite previous diuretic-based combination antihypertensive therapy. Materials and methods. In an open, observational study duration of 24 weeks was included 60 patients on previous diuretic-based combination antihypertensive therapy. All participants underwent 24-hour blood pressure monitoring, applanation tonometry (augmentation index and central blood pressure), pulse wave velocity measurement, laboratory tests (lipid profile, fasting glucose, insulin resistance index - NOMA), leptin, high-sensitivity C-reactive protein before and after the switching to a fixed combination of lisinopril + amlodipine + rosuvastatin. Results. According to measurements of office blood pressure switching of patients on double combinations based on diuretics to a fixed combination of lisinopril + amlodipine + rosuvastatin, a further decrease in systolic blood pressure (SBP) by 13.7% and diastolic BP (DBP) by 18.8% was observed. According to the ABPM, the decline in the average daily SBP was 15.8%, DBP - 22.5%, average SBP - 16.2%, DBP - 19.8%. The combination of lisinopril + amlodipine + rosuvastatin reduced PWV by 15.9%, augmentation index by 13.5%, central SBP by 8.4% (

Сравнительный клинико-экономический анализ интенсификации терапии базальным инсулином или дапаглифлозином у пациентов с неконтролируемым сахарным диабетом 2-го типа

Objective. Determine if dapagliflozin use is pharmacoeconomically reasonable option for patients with inadequate glycemic control compared with basal insulin.Materials and Methods. The study was conducted according to standard pharmacoeconomic methods: cost-utility analysis (CUA), budget impact analysis (BIA).Results. The use of dapagliflozin as an alternative to basal insulin can reduce health system costs, improves the quality of life of patients, adding 0.73 QALY per patient. Modelling suggests that dapagliflozin introduction could delay the start of insulin treatment by an average of 6.5 years that in turn will allow achieving cost savings and improving the quality of life of patients.Conclusions. Dapagliflozin therapy is the preferred alternative to basal insulins, due to lower costs and improvement in the quality of life of patients.Цель – определить, является ли выбор дапаглифлозина фармакоэкономически обоснованным при включении его в терапию у пациентов с недостаточным гликемическим контролем в сравнении с базальными инсулинами.Материалы и методы. Исследование проводилось по стандартным фармакоэкономическим методикам анализа полезности затрат (CUA), оценки влияния на бюджет.Результаты. Применение дапаглифлозина в качестве альтернативного базальному инсулину препарата при интенсификации терапии СД 2-го типа позволяет сократить затраты системы здравоохранения, а также повышает качество жизни пациентов, добавляя 0,73 QALY в расчете на одного пациента и позволяет отложить старт инсулинотерапии в среднем на 6,5 лет, что позволит достичь экономии бюджетных средств и улучшить качество жизни пациентов.Выводы. Терапия дапаглифлозином является предпочтительной альтернативой в сравнении с использованием базальных инсулинов, поскольку сопровождается наименьшими затратами и позволяет улучшить качество жизни пациентов

THE USE OF MULTI-COMPONENT THERAPY IN THE MANAGEMENT OF METABOLIC SYNDROME

Background: The metabolic syndrome (MS) is a cluster of hormonal and metabolic abnormalities arising from insulin resistance. It is associated with high risk of diabetes and cardiovascular disease. To reduce this risk, correction of the key pathophysiological factor of MS is recommended, namely, abdominal obesity. However, conventional non-medical treatment approaches (lifestyle changes and diet), as well as medical therapy with metformin frequently do not provide significant and consistent reduction in body weight. With all this, the use of sibutramine, a centrally active anti-obesity agent, looks promising. Being a selective inhibitor of re-uptake of neurotransmitters serotonin and norepinephrine, this agent promotes decreased appetite and weight loss in combination with diet and exercise.Aim: To compare efficacy of lifestyle intervention only to that of lifestyle intervention plus metformin monotherapy or lifestyle intervention plus combination therapy with sibutramine and metformin with regard to anthropometric and metabolic parameters in MS patients. Materials and methods: This was a prospective, open-label, randomized, comparative study in 3 parallel groups. Sixty patients (mean age 45.4 ± 7.5 years) with MS (according to IDF 2005 criteria) were enrolled and randomized into 3 groups at 1:1:1 ratio. For 24 weeks, patients in the group 1 (n = 20) were on metformin monotherapy, those in the group 2 (n = 20) on combined therapy with sibutramine and metformin and patients from the group 3 (control group, n = 20) were given recommendations on lifestyle change only. The groups were matched for baseline clinical characteristics and demographics. All patients were instructed on diet, physical activity, and lifestyle changes. Anthropometric and metabolic parameters were assessed at baseline, weeks 4, 12 and 24. Results: The group on combination therapy with sibutramine/metformin showed the highest mean percentage of decrease in body mass, body mass index and waist circumference. Under combination therapy, waist circumference decreased by 2.3 ±0.57 cm (р < 0.05), waist/hip ratio by 2.72% (р < 0.05). Serum ALT activity in both groups on medical treatment decreased significantly (by 27.5% in group 1 and by 28.07% in group 2, p < 0.05 for comparison with baseline values) which indicates an improvement of liver function in MS patients. At week 24, there were clinically significant improvements of lipid profile in both medical treatment groups. In group 2, there was more advanced decrease in triglyceride levels, compared to group 1 (by 24.5% vs. 11.2%, p < 0.05). There were no serious adverse events related to the drugs during the study.Conclusion: Combination of sibutramine with metformin is effective, safe and well tolerated for correction of excess weight in patients with MS, in whom metformin monotherapy is ineffective

COMPARATIVE CLINICAL AND ECONOMIC ANALYSIS OF THE INTENSIFICATION THERAPY IN PATIENTS WITH UNCONTROLLED DIABETES TYPE 2 USING BASAL INSULIN OR DAPAGLIFLOZIN

Objective. Determine if dapagliflozin use is pharmacoeconomically reasonable option for patients with inadequate glycemic control compared with basal insulin.Materials and Methods. The study was conducted according to standard pharmacoeconomic methods: cost-utility analysis (CUA), budget impact analysis (BIA).Results. The use of dapagliflozin as an alternative to basal insulin can reduce health system costs, improves the quality of life of patients, adding 0.73 QALY per patient. Modelling suggests that dapagliflozin introduction could delay the start of insulin treatment by an average of 6.5 years that in turn will allow achieving cost savings and improving the quality of life of patients.Conclusions. Dapagliflozin therapy is the preferred alternative to basal insulins, due to lower costs and improvement in the quality of life of patients

WAYS OF MENOPAUSAL HORMONAL THERAPY IN CORRECTION OF METABOLIC DISORDERS AND ANGIOPROTECTION IN POSTMENOPAUSAL WOMEN

Aim. To compare effectiveness of non-drug therapy together with menopausal hormonal therapy (MHT) — estradiol hemihydrate 1 mg/drospirenon 2 mg (Angeliq® Bayer Pharma AG (Germany)) related to normalization of anthropometric and metabolic parameters, elasticity values and vascular age in women with metabolic syndrome (MS) in postmenopause.Material and methods. The open-label prospective comparative controlled randomized study in 2 parallel groups. Sixty female patients (mean age 55,26±5,63 y.) with MS (according to IDF 2005 criteria) were randomized equally 1:1 into 2 groups. During 36 weeks patients of 1st group (n=30) received life style modification recommendations and monotherapy by Angeliq® , patients from 2nd group (controls, n=30) only followed life style modification. Groups were comparable by baseline clinical and demographic parameters. All patients received instructions for diet, physical activity and life style changes. Anthropometric, metabolic and instrumental assessments were done at baseline, in 12 and 36 weeks of therapy.Results. Prescription of MHT in MS patients in postmenopause led to body weight decrease, decrease of percent composition of visceral fat, improvement of metabolic parameters, vascular elasticity and decrease of vascular age. There were no adverse events related to the drug during the study.Conclusion. Angeliq® is effective and safe medication for low-dosage continuous combination MHT in menopausal MS that facilitates improvement of anthropometric parameters, vascular elasticity and vascular ageing

SLOW RELEASE MELATONINE IN METABOLIC SYNDROME SYMPTHOMATICS CORRECTION

Aim. To compare effectiveness of metformin monotherapy (Mf) and combination of metformin with slow release melatonine (MfM) from the perspective of correction of anthropometric, hemodynamical parameters, premature vascular ageing and somnological status in patients with metabolic syndrome (MS).Material and methods. An open label prospective comparative study conducted, in 3 parallel groups: 238 MS patients (IDF, 2005) having, at the moment of prescreening, sleep disorders (less than 19 points in Questionnaire of self sleep evaluation), were randomized to 3 groups. During 12 weeks all patients underwent life style correction that included regimen of meal intake, normalization of “sleepwakefulness” rhythm, physical activity. In addition to this, first group patients (n=80) received Mf, and second (n=78) — combination MfM (Circadin 2 mg). Controls (n=80) were patients without pharmaceutical interventions. Groups were comparable by the baseline clinical and demographic characteristics. Sleep quality, anthropometric and metabolic parameters, adipocytokine level and vascular elasticity parameters were assessed at baseline and in 12 weeks after treatment.Results. The results of the study performed have proved the feasibility of melatonine slow release addition to standard MS therapy in circadian disorders (CD). MfM no only normalizes the rhythm “sleep-wakefulness”, but also retards vascular ageing, has positive profile of cardiovasular and metabolic effects, acting on insulin resistance as trigger of MS development. Serious adverse events were not marked during the study. Conclusion. Combination therapy by MfM is more effective than monotherapy by Mf in correction of body overweight, carbohydrate and lipid metabolism disorders in MS with CD

ADDITIONAL ANGIOPROTECTION AND METAbOLIC DISORDERS CORRECTION IN TREATMENT OF ARTERIAL HYPERTENSION PATIENTS REACHED TARGET bLOOD PRESSURE LEVELS, WITH FIxED COMbINATION OF PERINDOPRIL AND INDAPAMIDE

Aim. Evaluation of the ability of fixed combination of perindopril and indapamide (Noliprel Bi Forte) to achieve additional angioprotection in patients with arterial hypertension already reached target blood pressure (BP) at previous antihypertension therapy with losartan and hydrochlorothiazide (HCT).Material and methods. To open observational study, lasting 12 weeks, 25 patients included, those who had been taking losartan+HCT 100/12,5 mg. Results. During the study, all patients underwent 24 hour BP monitoring, applanation tonometry (augmentation index assessment and of central BP), measurement of pulse wave velocity (PWV), laboratory tests (lipids, fasting glucose, HOMA index, homocystein, leptin, adiponectin, high-sensitive C-reactive protein (hsCRP), vascular age assessment). After shifting the therapy with losartan and HCT to combination perindopril and indapamide, BP decreased additionally by 3,9%, and diastolic BP — 5,4% (p<0,05). There was decrease of augmentation index by 9,4% and vascular age by 6,0% (p<0,05). There was also decrease of leptin level by 14,5%, hsCRP by 11,0%, and increase of adiponectin by 9,9% (p<0,05).Conclusion. The fixed combination perindopril and indapamide does have advantages for losartan and HCT combination in BP control, vascular elasticity improvement, and facilitates the decrease of body mass index, insulin resistance and non-infectious inflammation