27 research outputs found
ΠΡΠ²Π΅ΡΠ΅Π½ΠΈΠ΅ ΡΠ΅ΠΌΠ΅ΠΉΠ½ΡΡ ΡΠ΅Π½Π½ΠΎΡΡΠ΅ΠΉ Π² ΡΠΎΡΡΠΈΠΉΡΠΊΠΈΡ ΠΌΠ°ΡΡ-ΠΌΠ΅Π΄ΠΈΠ°
The problems of promotion of family values in the Russian mass media were analyzed in the article. Popularization of family values through the media should contribute to strengthening the family institution and become an effective tool in the fight against the demographic crisis. The results of the content analysis confirms that the media neglect of family problems. In this situation, promotion of family values among young people is ineffective
Π Π½Π΅ΡΡΠΎΠΉΠΊΠΎΡΡΠΈ Π΄Π²ΡΡ ΡΠΈΠΌΠΌΠ΅ΡΡΠΈΡΠ½ΡΡ Π³ΠΎΠΌΠΎΠΌΠΎΡΡΠ½ΡΡ ΠΊΡΠΈΠΏΡΠΎΡΠΈΡΡΠ΅ΠΌ, ΠΎΡΠ½ΠΎΠ²Π°Π½Π½ΡΡ Π½Π° ΡΠΈΡΡΠ΅ΠΌΠ΅ ΠΎΡΡΠ°ΡΠΎΡΠ½ΡΡ ΠΊΠ»Π°ΡΡΠΎΠ²
ΠΠ΄Π½ΠΎΠΉ ΠΈΠ· Π½Π°ΠΈΠ±ΠΎΠ»Π΅Π΅ Π°ΠΊΡΡΠ°Π»ΡΠ½ΡΡ
Π·Π°Π΄Π°Ρ, ΡΠ²ΡΠ·Π°Π½Π½ΡΡ
Ρ Π·Π°ΡΠΈΡΠΎΠΉ ΠΎΠ±Π»Π°ΡΠ½ΡΡ
Π²ΡΡΠΈΡΠ»Π΅Π½ΠΈΠΉ, ΡΠ²Π»ΡΠ΅ΡΡΡ Π°Π½Π°Π»ΠΈΠ· ΠΊΡΠΈΠΏΡΠΎΡΡΠΎΠΉΠΊΠΎΡΡΠΈ Π³ΠΎΠΌΠΎΠΌΠΎΡΡΠ½ΡΡ
ΡΠΈΡΡΠΎΠ². ΠΠ°Π½Π½Π°Ρ ΡΡΠ°ΡΡΡ ΠΏΠΎΡΠ²ΡΡΠ΅Π½Π° ΠΈΠ·ΡΡΠ΅Π½ΠΈΡ Π²ΠΎΠΏΡΠΎΡΠ° ΠΎ Π·Π°ΡΠΈΡΠ΅Π½Π½ΠΎΡΡΠΈ Π΄Π²ΡΡ
Π½Π΅Π΄Π°Π²Π½ΠΎ ΠΏΡΠ΅Π΄Π»ΠΎΠΆΠ΅Π½Π½ΡΡ
Π³ΠΎΠΌΠΎΠΌΠΎΡΡΠ½ΡΡ
ΠΊΡΠΈΠΏΡΠΎΡΠΈΡΡΠ΅ΠΌ, ΠΊΠΎΡΠΎΡΡΠ΅, Π² ΡΠ²ΡΠ·ΠΈ Ρ ΠΈΡ
Π²ΡΡΠΎΠΊΠΎΠΉ Π²ΡΡΠΈΡΠ»ΠΈΡΠ΅Π»ΡΠ½ΠΎΠΉ ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΡΡ, ΠΌΠΎΠ³ΡΡ Π±ΡΡΡ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½Ρ Π΄Π»Ρ ΡΠΈΡΡΠΎΠ²Π°Π½ΠΈΡ Π΄Π°Π½Π½ΡΡ
Π½Π° ΠΎΠ±Π»Π°ΡΠ½ΡΡ
ΡΠ΅ΡΠ²Π΅ΡΠ°Ρ
. ΠΠ±Π΅ ΠΊΡΠΈΠΏΡΠΎΡΠΈΡΡΠ΅ΠΌΡ ΠΎΡΠ½ΠΎΠ²Π°Π½Ρ Π½Π° ΡΠΈΡΡΠ΅ΠΌΠ°Ρ
ΠΎΡΡΠ°ΡΠΎΡΠ½ΡΡ
ΠΊΠ»Π°ΡΡΠΎΠ², ΡΡΠΎ ΠΏΠΎΠ·Π²ΠΎΠ»ΡΠ΅Ρ ΡΠ°ΡΡΠΌΠΎΡΡΠ΅ΡΡ ΠΈΡ
Ρ Π΅Π΄ΠΈΠ½ΡΡ
ΠΏΠΎΠ·ΠΈΡΠΈΠΉ. ΠΠΌΠ΅Π½Π½ΠΎ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ΠΈΠ΅ ΡΠΈΡΡΠ΅ΠΌ ΠΎΡΡΠ°ΡΠΎΡΠ½ΡΡ
ΠΊΠ»Π°ΡΡΠΎΠ² Π΄Π΅Π»Π°Π΅Ρ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΠ΅ ΡΡΠΈΡ
ΠΊΡΠΈΠΏΡΠΎΡΠΈΡΡΠ΅ΠΌ Π² ΡΠ΅Π°Π»ΡΠ½ΡΡ
ΠΏΡΠΈΠ»ΠΎΠΆΠ΅Π½ΠΈΡΡ
Π·Π°ΠΌΠ°Π½ΡΠΈΠ²ΡΠΌ Ρ ΡΠΎΡΠΊΠΈ Π·ΡΠ΅Π½ΠΈΡ ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ ΠΏΠΎ ΡΡΠ°Π²Π½Π΅Π½ΠΈΡ Ρ Π΄ΡΡΠ³ΠΈΠΌΠΈ Π³ΠΎΠΌΠΎΠΌΠΎΡΡΠ½ΡΠΌΠΈ ΡΠΈΡΡΠ°ΠΌΠΈ, ΡΠ°ΠΊ ΠΊΠ°ΠΊ ΠΏΠΎΡΠ²Π»ΡΠ΅ΡΡΡ Π²ΠΎΠ·ΠΌΠΎΠΆΠ½ΠΎΡΡΡ Π»Π΅Π³ΠΊΠΎ ΡΠ°ΡΠΏΠ°ΡΠ°Π»Π»Π΅Π»ΠΈΡΡ Π²ΡΡΠΈΡΠ»Π΅Π½ΠΈΡ. ΠΠ΄Π½Π°ΠΊΠΎ ΠΈΡ
ΠΊΡΠΈΠΏΡΠΎΡΡΠΎΠΉΠΊΠΎΡΡΡ Π½Π΅ Π±ΡΠ»Π° Π² Π΄ΠΎΡΡΠ°ΡΠΎΡΠ½ΠΎΠΉ ΠΌΠ΅ΡΠ΅ ΠΈΠ·ΡΡΠ΅Π½Π° Π² Π»ΠΈΡΠ΅ΡΠ°ΡΡΡΠ΅ ΠΈ Π½ΡΠΆΠ΄Π°Π΅ΡΡΡ Π² Π°Π½Π°Π»ΠΈΠ·Π΅.
ΠΡΠΌΠ΅ΡΠΈΠΌ, ΡΡΠΎ ΡΠ°Π½Π΅Π΅ ΠΏΡΠ΅Π΄ΡΠ΅ΡΡΠ²Π΅Π½Π½ΠΈΠΊΠ°ΠΌΠΈ Π±ΡΠ»Π° ΡΠ°ΡΡΠΌΠΎΡΡΠ΅Π½Π° ΠΊΡΠΈΠΏΡΠΎΡΠΈΡΡΠ΅ΠΌΠ° ΠΏΠΎΡ
ΠΎΠΆΠ°Ρ Π½Π° ΠΎΠ΄ΠΈΠ½ ΠΈΠ· ΡΠΈΡΡΠΎΠ², ΠΊΡΠΈΠΏΡΠΎΡΡΠΎΠΉΠΊΠΎΡΡΡ ΠΊΠΎΡΠΎΡΠΎΠ³ΠΎ ΠΈΡΡΠ»Π΅Π΄ΡΠ΅ΡΡΡ. ΠΡΠ»Π° ΠΏΡΠ΅Π΄Π»ΠΎΠΆΠ΅Π½Π° ΠΈΠ΄Π΅Ρ Π°Π΄Π°ΠΏΡΠΈΠ²Π½ΠΎΠΉ Π°ΡΠ°ΠΊΠΈ ΠΏΠΎ Π²ΡΠ±ΡΠ°Π½Π½ΡΠΌ ΠΎΡΠΊΡΡΡΡΠΌ ΡΠ΅ΠΊΡΡΠ°ΠΌ Π½Π° ΡΡΡ ΠΊΠΎΠ½ΡΡΡΡΠΊΡΠΈΡ ΠΈ Π΄Π°Π½Π° ΠΎΡΠ΅Π½ΠΊΠ° Π½Π΅ΠΎΠ±Ρ
ΠΎΠ΄ΠΈΠΌΠΎΠ³ΠΎ Π΄Π»Ρ ΡΠ°ΡΠΊΡΡΡΠΈΡ ΠΊΠ»ΡΡΠ° ΠΊΠΎΠ»ΠΈΡΠ΅ΡΡΠ²Π° ΠΏΠ°Ρ >. ΠΠ΄Π΅ΡΡ ΠΏΡΠΎΠ²ΠΎΠ΄ΠΈΡΡΡ Π°Π½Π°Π»ΠΈΠ· ΡΡΠΎΠΉ Π°ΡΠ°ΠΊΠΈ ΠΈ ΠΏΠΎΠΊΠ°Π·ΡΠ²Π°Π΅ΠΌ, ΡΡΠΎ ΠΈΠ½ΠΎΠ³Π΄Π° ΠΎΠ½Π° ΠΌΠΎΠΆΠ΅Ρ ΡΠ°Π±ΠΎΡΠ°ΡΡ Π½Π΅ΠΊΠΎΡΡΠ΅ΠΊΡΠ½ΠΎ. Π’Π°ΠΊΠΆΠ΅ ΠΎΠΏΠΈΡΡΠ²Π°Π΅ΡΡΡ Π±ΠΎΠ»Π΅Π΅ ΠΎΠ±ΡΠΈΠΉ Π°Π»Π³ΠΎΡΠΈΡΠΌ Π°ΡΠ°ΠΊΠΈ Ρ ΠΈΠ·Π²Π΅ΡΡΠ½ΡΠΌΠΈ ΠΎΡΠΊΡΡΡΡΠΌΠΈ ΡΠ΅ΠΊΡΡΠ°ΠΌΠΈ. ΠΡΠΈΠ²ΠΎΠ΄ΡΡΡΡ ΡΠ΅ΠΎΡΠ΅ΡΠΈΡΠ΅ΡΠΊΠΈΠ΅ ΠΎΡΠ΅Π½ΠΊΠΈ Π²Π΅ΡΠΎΡΡΠ½ΠΎΡΡΠΈ ΡΡΠΏΠ΅ΡΠ½ΠΎΠ³ΠΎ ΡΠ°ΡΠΊΡΡΡΠΈΡ ΡΠ΅ΠΊΡΠ΅ΡΠ½ΠΎΠ³ΠΎ ΠΊΠ»ΡΡΠ° Ρ Π΅Π³ΠΎ ΠΏΠΎΠΌΠΎΡΡΡ ΠΈ ΠΏΡΠ°ΠΊΡΠΈΡΠ΅ΡΠΊΠΈΠ΅ ΠΎΡΠ΅Π½ΠΊΠΈ ΡΡΠΎΠΉ Π²Π΅ΡΠΎΡΡΠ½ΠΎΡΡΠΈ, ΠΏΠΎΠ»ΡΡΠ΅Π½Π½ΡΠ΅ Π² Ρ
ΠΎΠ΄Π΅ Π²ΡΡΠΈΡΠ»ΠΈΡΠ΅Π»ΡΠ½ΠΎΠ³ΠΎ ΡΠΊΡΠΏΠ΅ΡΠΈΠΌΠ΅Π½ΡΠ°.
ΠΠ°ΡΠΈΡΠ΅Π½Π½ΠΎΡΡΡ Π²ΡΠΎΡΠΎΠΉ ΠΊΡΠΈΠΏΡΠΎΡΠΈΡΡΠ΅ΠΌΡ Π½Π΅ Π±ΡΠ»Π° ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½Π° ΡΠ°Π½Π΅Π΅ Π² Π»ΠΈΡΠ΅ΡΠ°ΡΡΡΠ΅. ΠΠ·ΡΡΠ΅Π½Π° Π΅Ρ ΡΡΠΎΠΉΠΊΠΎΡΡΡ ΠΊ Π°ΡΠ°ΠΊΠ΅ Ρ ΠΈΠ·Π²Π΅ΡΡΠ½ΡΠΌΠΈ ΠΎΡΠΊΡΡΡΡΠΌΠΈ ΡΠ΅ΠΊΡΡΠ°ΠΌΠΈ. ΠΡΠΎΠ°Π½Π°Π»ΠΈΠ·ΠΈΡΠΎΠ²Π°Π½Π° Π·Π°Π²ΠΈΡΠΈΠΌΠΎΡΡΡ Π½Π΅ΠΎΠ±Ρ
ΠΎΠ΄ΠΈΠΌΠΎΠ³ΠΎ Π΄Π»Ρ Π²Π·Π»ΠΎΠΌΠ° ΠΊΠΎΠ»ΠΈΡΠ΅ΡΡΠ²Π° ΠΏΠ°Ρ > ΠΎΡ ΠΏΠ°ΡΠ°ΠΌΠ΅ΡΡΠΎΠ² ΠΊΡΠΈΠΏΡΠΎΡΠΈΡΡΠ΅ΠΌΡ ΠΈ Π΄Π°Π½Ρ ΡΠ΅ΠΊΠΎΠΌΠ΅Π½Π΄Π°ΡΠΈΠΈ, ΠΊΠΎΡΠΎΡΡΠ΅ ΠΌΠΎΠ³ΡΡ ΠΏΠΎΠΌΠΎΡΡ ΡΠ»ΡΡΡΠΈΡΡ ΠΊΡΠΈΠΏΡΠΎΡΡΠΎΠΉΠΊΠΎΡΡΡ.
ΠΡΠΎΠ³ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½Π½ΠΎΠ³ΠΎ Π°Π½Π°Π»ΠΈΠ·Π° Π·Π°ΠΊΠ»ΡΡΠ°Π΅ΡΡΡ Π² ΡΠΎΠΌ, ΡΡΠΎ ΠΎΠ±Π΅ ΠΊΡΠΈΠΏΡΠΎΡΠΈΡΡΠ΅ΠΌΡ ΡΠ²Π»ΡΡΡΡΡ ΡΡΠ·Π²ΠΈΠΌΡΠΌΠΈ ΠΊ Π°ΡΠ°ΠΊΠ΅ Ρ ΠΈΠ·Π²Π΅ΡΡΠ½ΡΠΌΠΈ ΠΎΡΠΊΡΡΡΡΠΌΠΈ ΡΠ΅ΠΊΡΡΠ°ΠΌΠΈ. ΠΠΎΡΡΠΎΠΌΡ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°ΡΡ ΠΈΡ
Π΄Π»Ρ ΡΠΈΡΡΠΎΠ²Π°Π½ΠΈΡ ΠΊΠΎΠ½ΡΠΈΠ΄Π΅Π½ΡΠΈΠ°Π»ΡΠ½ΡΡ
Π΄Π°Π½Π½ΡΡ
ΠΌΠΎΠΆΠ΅Ρ Π±ΡΡΡ Π½Π΅Π±Π΅Π·ΠΎΠΏΠ°ΡΠ½ΠΎ.
ΠΡΠ½ΠΎΠ²Π½ΡΠΌ Π°Π»Π³ΠΎΡΠΈΡΠΌΠΎΠΌ, ΠΈΡΠΏΠΎΠ»ΡΠ·ΡΠ΅ΠΌΡΠΌ Π² ΠΏΡΠ΅Π΄Π»ΠΎΠΆΠ΅Π½Π½ΡΡ
Π°ΡΠ°ΠΊΠ°Ρ
Π½Π° ΠΊΡΠΈΠΏΡΠΎΡΠΈΡΡΠ΅ΠΌΡ, ΡΠ²Π»ΡΠ΅ΡΡΡ Π°Π»Π³ΠΎΡΠΈΡΠΌ ΠΏΠΎΠΈΡΠΊΠ° Π½Π°ΠΈΠ±ΠΎΠ»ΡΡΠ΅Π³ΠΎ ΠΎΠ±ΡΠ΅Π³ΠΎ Π΄Π΅Π»ΠΈΡΠ΅Π»Ρ. ΠΠ°ΠΊ ΡΠ»Π΅Π΄ΡΡΠ²ΠΈΠ΅, Π²ΡΠ΅ΠΌΡ, Π½Π΅ΠΎΠ±Ρ
ΠΎΠ΄ΠΈΠΌΠΎΠ΅ Π΄Π»Ρ ΡΠ΅Π°Π»ΠΈΠ·Π°ΡΠΈΠΈ Π°ΡΠ°ΠΊ, ΡΠ²Π»ΡΠ΅ΡΡΡ ΠΏΠΎΠ»ΠΈΠ½ΠΎΠΌΠΈΠ°Π»ΡΠ½ΡΠΌ ΠΎΡ ΡΠ°Π·ΠΌΠ΅ΡΠ° Π²Ρ
ΠΎΠ΄Π½ΡΡ
Π΄Π°Π½Π½ΡΡ
Predictors of effectiveness of glucagon-like peptide-1 receptor agonist therapy in patients with type 2 diabetes and obesity
Background: Type 2 diabetes mellitus (DM2), which mainly develops from visceral obesity, is a socially significant disease. Reduction of losses from DM2 is a priority in modern medicine development. Glucagon-like peptide-1 receptor agonists (aGLP-1) present one of few groups of antidiabetic drugs that allows to reduce not only glycemia, but also weight in DM2. Taking into account predictors of response to the therapy will allow to reach trearment targets with the highest probability, maintaining a safety of treatment, to optimize recommendations for administration of aGPP-1 as much as possible. Aims: To assess dynamics of metabolic parameters, to identify predictors of reduction in blood glucose, body weight and other metabolic parameters on aGLP-1 therapy in patients with DM2 with body mass index (BMI) ≥35 kg/m2. Materials and methods: The study involved 33 patients (10 men, 23 women), who had been treated with aGLP-1, the observation period for 24 weeks was planned. 3 patients terminated the participation before the appointed time (1 – due to pancreatitis development 2 – due to the lack of financial opportunity to purchase the drug). So, 30 patients (10 men, 20 women) were included in the final analysis. Examination consisted of the survey, physical examination with measurement of anthropometric, clinical parameters, filling questionnaires. Data were evaluated at baseline and after 24 weeks of treatment. Results: The study found that patients who achieved weight loss ≥ 5% initially had higher BMI (p = 0.028), lower GLP-1 (p = 0.036), had lower level of ghrelin after standard breakfast test (p = 0.022). There was trend (p = 0.071) to greater decrease in BMI in patients with restrictive type of eating behavior compared to patients who had a mixed type. More pronounced decrease in glycemia was noted in patients who had higher fasting plasma glucose level at inclusion (p = 0.001). Dynamics of HbA1c was better in patients with initially higher GLP-1 (p = 0.016) and higher levels of glycemia (p = 0.001). Also, we revealed the statistically significant decrease in triglycerides level, blood pressure by end of the treatment period. Conclusions: Results indicate the different predictors for reduction in weight, glycemia and blood pressure on aGLP-1 therapy. In addition to the metabolic parameters, level of orexigenic and anorexigenic hormones and psycho-social characteristics of patients help to estimate an expected effect of aGLP-1 therapy. When being identifying, the predictors of weight loss and the predictors of carbohydrate metabolism compensation should be studied separately. Identification of response predictors is necessary to optimize indications for this group of drugs administration in DM2
Thr92Ala Polymorphism of Human Type 2 Deiodinase Gene (hD2) Affects the Development of Graves' Disease, Treatment Efficiency, and Rate of Remission
Clinical symptoms vary in thyrotoxicosis, and severity of these depends on many factors. Over the last years, impact of genetic factors upon the development and clinical significance of thyrotoxic symptoms became evident. It is known that a production of T3 in various tissues is limited by deiodinase 2 (D2). Recent studies revealed that certain single nucleotide polymorphisms (including threonine (Thr) to alanine (Ala) replacement in D2 gene codon 92, D2 Thr92Ala) affect T3 levels in tissues and in serum. Individuals with Ala92Ala genotype have lower D2 activity in tissues, compared with that in individuals with other genotypes. In our study, we have assessed an association of D2 Thr92Ala polymorphism with (1) frequency of disease development, (2) severity of clinical symptoms of thyrotoxicosis, and (3) rate of remissions, in Graves' disease patients
Thr92Ala Polymorphism of Human Type 2 Deiodinase Gene (hD2) Affects the Development of Graves' Disease, Treatment Efficiency, and Rate of Remission
Clinical symptoms vary in thyrotoxicosis, and severity of these depends on many factors. Over the last years, impact of genetic factors upon the development and clinical significance of thyrotoxic symptoms became evident. It is known that a production of T3 in various tissues is limited by deiodinase 2 (D2). Recent studies revealed that certain single nucleotide polymorphisms (including threonine (Thr) to alanine (Ala) replacement in D2 gene codon 92, D2 Thr92Ala) affect T3 levels in tissues and in serum. Individuals with Ala92Ala genotype have lower D2 activity in tissues, compared with that in individuals with other genotypes. In our study, we have assessed an association of D2 Thr92Ala polymorphism with (1) frequency of disease development, (2) severity of clinical symptoms of thyrotoxicosis, and (3) rate of remissions, in Graves' disease patients
Effectiveness prediction of Evogliptin treatment in type 2 diabetes mellitus in russian-korean population
Background: Individualized treatment has already become a part of a routine clinical care. Many data on the effectiveness prediction of commercially available DPP-4 inhibitors had been published, but not on the effectiveness prediction of evogliptin.
Aim: To reveal the clinical characteristics and metabolic predictors of better hypoglycemic response to evogliptin. Matherials and methods: We have conducted a retrospective study, based on the data of a randomized clinical trial comparing effectiveness and safety of evogliptin and sitagliptin in Russian and Korean subpopulations. We provide univariate linear regression models for separate subpopulations and a multivariate stepwise regression model for the combined subpopulation. HbA1c change after 24 weeks of evogliptin treatment was a primary endpoint and a dependent variable in the analysis.
Results: The decrease of HbA1c after 24 weeks of treatment with evogliptin in Russian subpopulation negatively correlates with triglycerides/HDL level (p = 0,046). In South Korean subpopulation it correlates positively with HbA1c level at baseline (p 0,0001). In order to increase the statistical power of the analysis the data of both populations were combined. According to the combined data, the decrease of HbA1c after 24 weeks of treatment with evogliptin positively correlates with HbA1c level at baseline (p0.0001) and log(HOMA-B) (p=0.0042), and it negatively correlates with log(triglycerides/HDL) (p=0.0057), blood phosphorous concentration (p=0.014) and statin treatment (p=0.044). No correlation of HbA1c change at week 24 was observed with body mass index, diabetes duration and blood C-peptide concentration. Patients able to achieve HbA1c7,0 % had higher HOMA-B (53.22 36.95 ΠΈ 39.67 24.74, respectively, Ρ=0.033) and were tend to have higher HDL concentration (1.36 0.28 ΠΈ 1.26 0.26 mmol/l, respectively, Ρ=0.076) and lower triglycerides to HDL ratio (0.87 0.70 ΠΈ 1.48 0.95, respectively, Ρ=0.079).
Conclusion: A patient, who benefits more when treated with evogliptin, has higher HOMA-B, lower triglycerides to HDL ratio and phosphorous concentration in the 1-2 quartiles of the normal range. Triglycerides to HDL ratio is, probably, a specific effectiveness predictor for Russian, but not for Korean subpopulation. These data prove the difference in effectiveness prediction for different drugs of DPP-4 inhibitors group and reveal the need of further investigation
Efficacy and safety of evogliptin versus sitagliptin as add on to metformin alone in a combined russian-korean population. Evo-combi trial
Background: Dipeptidyl-peptidase-4 inhibitors (iDPP-4) are pathogenically targeted drugs for diabetes mellitus type 2 (T2DM). Evogliptin is a new member of iDPP-4 class. The drug has the longest half-elimination period among the class, and its efficacy and safety as monotherapy have been already studied in placebo-controlled randomized clinical trials.
Aims: To study efficacy and safety of evogliptin as compared to sitagliptin in T2DM patients with unsatisfying glycemic control with metformin monotherapy via a multinational double blind randomized controlled trial. To compare the study results in Russian and Korean subpopulations.
Materials and methods: We used a combined Russian-Korean database (1:4) of EVO-COMBI trial. 281 adult T2DM patients administered metformin alone (at least 1000 mg/day) were randomized 1:1 to add on evogliptin (142 patients) or sitagliptin (139 patients) for 24 weeks once daily. The primary endpoint was change in glycated hemoglobin (HbA1c) level at Week 24 as compared to baseline. Non-inferiority was concluded if the upper limit of the 2-sided 95% confidence interval for the HbA1c difference between treatments was 0.35 %. Subgroup analysis for between-subpopulation difference in treatment effect was also conducted.
Results: The mean between-group difference was 0.03 % [95 % CI: -0.14; 0.19 %], that confirms non-inferiority of evogliptin (mean HbA1c decrease -0.58 0.70 %, p0.001) to sitagliptin (mean HbA1c decrease -0.61 0.66 %, p0.001). Evogliptin and sitagliptin both tend to be more effective in South Korean subpopulation in terms of fasting plasma glucose lowering (p=0.030), however HbA1c decrease in subpopulations was comparable (p=0.657). Both drugs were well tolerated in both subpopulations. Adverse effects were associated mostly with gastrointestinal disorders, and the frequency was comparable between treatment groups (p0.05). Gastrointestinal adverse effects were registered more often in Korean patients (p=0.014). There were no severe hypoglycemia. Frequency of mild hypoglycemia was comparable between evogliptin and sitagliptin (0.7 % and 5.2 %, respectively, p=0.365).
Conclusions: Evogliptin 5 mg/day is non-inferior to sitagliptin 100 mg/day in T2DM patients with unsatisfying glycemic control with metformin monotherapy. Safety profile is also comparable. Efficacy-safety profile of evogliptin is comparable in Russian and South Korean subpopulations