Relevance. The «Global Action Plan for the Prevention and Control of Noncommunicable Diseases 2013-2020» approved by the WHO is dedicated to noncommunicable diseases. Among them - diabetes mellitus, which is a consequence of overweight \ obesity and lack of exercise. Pioglitazone is the only drug on the pharmacological market for the treatment of non-alcoholic steatohepatitis (NASH), regardless of diabetic mellitus status. Currently, the treatment of early NASH in the prevention of both type 2 diabetes and CVD, and amelioration of NASH progression is a priority task.
Objective – to study the effectiveness of treatment with pioglitazone in patients with obesity and non-alcoholic fatty liver disease (NAFLD).
Materials that methods. 123 patients with obesity 1, 2, 3 classes in combination with NAFLD were included in our research during 3 months. The randomization method of patients was divided into two groups, comparable in age, sex, and body mass index. All patients were offered drug-free treatment that included lifestyle modification: a reduction in diet of 500 kcal from the physiological daily energy expenditure and its physical activity for 150-200 min per week, the problems of adherence to recommendations were additionally discussed during the visits. The patients of the case group adhered to the basic recommendations and received pioglitazone 15 mg / day additionally as a drug treatment. Patients in the control group adhered only to principles of drug-free treatment. Overall, the program consisted of 5 visits over 3 months period. All patients underwent anthropometric measurements, laboratory and instrumental examinations (Ultrasound steatometry) before and after 12 weeks of treatment. Also studied adherence to treatment in two groups of patients using self-report questionnaire.
Results. A comparative analysis of the data obtained in patients with obesity and NAFLD from the group of pioglitazone (daily dose of 15 mg) revealed the best major metabolic markers, such as significantly decreased values in waist circumference (p<0,0001), uric acid (p=0,001), thriglycerides (p=0,02) and very low density lipoproteins cholesterol(p=0,003), atherogenic coefficient (p=0,002), fasting insulin (p=0,004) and C-peptide, HOMA-IR index (p=0,01) and increased level of high density lipoproteins cholesterol (p=0,009), respectively. A significant association was found between the target reduction of controlled attenuation parameter and treatment with pioglitazone 15 mg (OR 0,27, 95% CI 0,13–0,56, p=0,001). The dynamics of steatosis had a medium correlation with the final adherence level (r=0,52), regardless of the method of treatment.
Conclusions. It was found that in Ukrainians with obesity and NAFLD, moderate steatosis occurs in 73% of cases. Pioglitazone is a significantly highly effective drug for the adjuvant therapy of NAFLD.
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