scholarly journals Early intensification of glucose-lowering therapy: VERIFY lessons and real clinical practice on the example of the Moscow region diabetes register data

2020 ◽  
Vol 66 (5) ◽  
pp. 86-95
Author(s):  
I. V. Misnikova ◽  
Yu. A. Kovaleva ◽  
V. A. Gubkina

BACKGROUND: The prevalence of T2DM is steadily increasing not only among the elderly, but also at a young age. T2DM is preceded by a long period of significant metabolic changes with the development of insulin resistance and в-cell dysfunction. To reduce the prevalence of complications, treatment is needed which affects several pathophysiological mechanisms underlying the disease. Monotherapy with metformin at the onset of T2DM is often insufficient. The VERIFY study demonstrated the advantage of early administration of a combination of vildagliptin and metformin in relation to the glycemic durability compared to the sequential intensification of metformin with vildagliptin in patients with type 2 diabetes.AIMS: To assess the current situation in terms of the incidence of T2DM complications and the structure of the prescribing glucose lowering drugs based on the data from the Diabetes Register (DR) of the Moscow Region. To demonstrate the advantages of early combination therapy in patients with newly diagnosed T2DM using clinical cases.MATERIALS AND METHODS: The data from the DR of the Moscow region, which is part of the National Diabetes Register of the Russian Federation, were used for the analysis. The data of 6,096 patients with T2DM who died in 2019 were evaluated for building the structure of the causes of death of patients with T2DM. The pattern of glucose-lowering therapy was analyzed based on data of 226,327 patients with T2DM (for 2020), as well as separately of 14,379 patients with newly diagnosed T2DM in 2019. Clinical cases are described based on the data of two patients with T2DM, available in the DR database and outpatient records.RESULTS: In patients with young onset T2DM (<40 years), the prevalence of severe complications is higher than in the general population of patients with T2DM: blindness is in 5.9 times, end-stage chronic renal failure in 2.9 times, lower limb amputations in 6.4 times more. When prescribing glucose lowering drugs, monotherapy is prevalent, mostly metformin. In double combination, metformin is used in 96.22% of cases. In the structure of glucose lowering drugs, with newly diagnosed T2DM, combination therapy is used less frequently than in patients with T2DM in general. Of the drugs of the IDP-4 group, vildagliptin is most often prescribed — 46.25% (including of a fixed combination with metformin — 12.22%). Clinical cases reflect a rapid clinical outcome: a decrease in HbA1c to the target in 6 months, the absence of hypoglycemia or other side effects, and positive weight dynamics.CONCLUSIONS: A fairly large propotion of patients with T2DM are on monotherapy with glucouse lowering drugs. Early prescription of the combination of metformin plus vildagliptin provides a longer maintenance of glycemic control without increasing the risk of hypoglycemia and weight gain for patients with newly diagnosed T2DM.

2020 ◽  
Vol 23 (2) ◽  
pp. 104-112
Author(s):  
Olga K. Vikulova ◽  
Anna V. Zheleznyakova ◽  
Mikhail А. Isakov ◽  
Alexey A. Serkov ◽  
Marina V. Shestakova ◽  
...  

BACKGROUND: Glikogemoglobin (HbA1c) is a key clinical marker for evaluating the effectiveness of glucose-lowering therapy for patients with diabetes mellitus (DM) and the quality of diabetic care. AIMS: to conduct dynamic monitoring of the quality of glycemic control in DM patients based on a comprehensive examination in mobile medical center (Diamodul) during repeated visits to the regions in 2019 compared with visits of Based Federal program Diabetes Mellitus (20052010) and data of the National diabetes register (NDR). MATERIALS AND METHODS: The object of the study: patients with T1DM and T2DM examined in Diamodul in 2019 in Voronezh region (Vr), Krasnodar region (Kr) (n = 600), there were dynamic group of re-examined (Vr n = 224; Kr n = 113), random group of new patients (Vr n = 72; Kr n = 191); group of adult patients from NDR with indicated HbA1c in 2019 (n = 2410067). RESULTS: According to Diamodul, the HbA1c levels are significantly worse than they were reported to NDR: the proportion of patients achieved HbA1c 7% for T1DM is 13.3% and 11.7%; T2DM 25.1% and 28.6%, in Kr and Vr, respectively; in NDR: T1DM 37.4%, T2DM 52.2%. The average HbA1c values in the Diamodul are higher than in NDR by 0.95% for T1DM, 1.41% for T2DM patients. The proportion of patients with HbA1c9% decrease in dynamic of examinations through years in T1: in Vr from 53.1% in 2005 and 55.8% in 2010 to 42.9% in 2019, in Kr from 53.2% in 2006 to 43.8% in 2019; also there were decreases in the average HbA1c values in Vr from 9.3% in 2005 and 9.4% in 2010 to 8.8% in 2019; in Kr from 9.1% in 2006 to 8.7% in 2019. In T2DM patients with the best parameters of DM control in a whole, the positive trends were less pronounced and are assessed as non-deterioration: the proportion of HbA1c9 % in Vr: 34.7%34.7%36.4%, in Kr 40.1%28.4%; average values of HbA1c: 8.2%8.4%8.5% and 8.6%8.4%, respectively. CONCLUSIONS: The data of the research clearly indicates the need for 100% inclusion of HbA1c in the examination standards in all DM patients at the primary level at least 1 time per year, in order to monitor the real clinical situation, the effectiveness of glucose-lowering therapy and its timely intensification to prevent development of complications.


2020 ◽  
Vol 23 (1) ◽  
pp. 106-110
Author(s):  
Marina V. Shestakova ◽  
Mikhail B. Antsiferov ◽  
Alexander S. Ametov ◽  
Gagik R. Galstyan ◽  
Tatiana Y. Demidova ◽  
...  

According to key diabetic studies, the early use of metformin glucose lowering therapy is associated with a reduced risk of developing micro- and, in the long term, 10-year follow-up, macrovascular complications and cardiovascular mortality. Short-term studies results on combined glucose lowering therapy with metformin suggests that combination therapy can have several advantages on the one side from the effectiveness of glycemic control and on another side from positive effect on the development of complications of type 2 diabetes. The question of the start time of combined hypoglycemic therapy remains open. According to the results of recent large-scale studies, real world evidence data, careful glycemic control during the first year from the moment of diagnosis of type 2 diabetes is crucial for further management of the disease and slow the progression of complications. However, due to the fact that the clinical benefits of early combination therapy were not demonstrated in randomized clinical trials, this approach, despite the theoretical background, was not recommended for widespread use in international guidelines for the treatment diabetes patients. Russian algorithms on the treatment diabetes patients recommend combined glucose lowering therapy at the start of treatment at a HbA1c level of 1% higher than the target. A 5-year VERIFY study results were demonstrated long-term sustained glycemic control in combination with vildagliptin + metformin prescribed for native diabetes patients with relatively low HbA1c values, as well as the advantages of this approach in comparison with the standard strategy for phased intensification of monotherapy. The results of the VERIFY study provided a wealth of information to discuss early treatment intensification, the clinical benefits of this approach and a possible review of the treatment strategy for native diabetes patients.


2019 ◽  
Vol 22 (3) ◽  
pp. 206-216
Author(s):  
Inna V. Misnikova ◽  
Yulia A. Kovaleva ◽  
Mikhail А. Isakov ◽  
Alexander V. Dreval

BACKGROUND: Data of real clinical practice in diabetes mellitus (DM) register allow to evaluate features and trends in structure of glucose-lowering therapy (GLT). AIM: Тo analyze of structure of GLT received by patients with type 2 diabetes mellitus (T2DM) in Moscow region for 2018 and to evaluate its dynamics over 15 years. METHODS: Analysis of GLT structure was carried out on basis of data from register of patients with DM in Moscow region, which is part of National register of diabetes mellitus in Russian Federation. In March 2018 it contained data on 211,792 T2DM patients of Moscow region. Structure of GLT administration was evaluated according T2DM duration, patients age and presence of cardiovascular diseases (CVD). Dynamics of GLT is analyzed from 2004 to 2018 yrs. RESULTS: In 2018 non-insulin glucose-lowering drugs (NIGD) prescription prevailed (78.3%), insulin therapy was prescribed in 18.5% of patients, 3.2% of patients did not receive drug therapy. Most commonly prescribed NIGD were metformin (69.3%) and sulfonylurea (51.3%). Older patients more often than younger did not use GLT at all and less frequently received insulin therapy and iDPP-4. Insulin therapy was prescribed twice as often in patients with CVD compared with patients without CVD (29.6% and 15.5%). NIGD monotherapy has been less commonly used in patients with CVD (67.3% and 81.2%). Glucagon-like peptide-1 receptor agonists (GLP-1 RA) were prescribed to patients with CVD GLP-1 RA in 0.1% of cases, without CVD in 0.3% of cases, and sodium-glucose cotransporter 2 (SGLT2) inhibitors in 1.1% and 0.6%. correspondently. CONCLUSION: Metformin was most commonly prescribed drug in GLT structure for T2DM patients in the Moscow region in 2018 yr. Percentage of new drugs in the structure of GLT increased mainly due to iDPP-4, and secondly due to SGLT2 inhibitors. New classes of GLT were more often prescribed to patients of younger age, with diabetes duration up to 10 years, overweight or obese. Administration of NIGD with proven cardiovascular protection in presence of CVD is almost two times less than for those without CVD.


2019 ◽  
Vol 10 (3) ◽  
pp. 83-90 ◽  
Author(s):  
P. B. Shorokhova ◽  
V. L. Baranov ◽  
N. V. Vorokhobina ◽  
I. Yu. Matezius ◽  
E. B. Bashnina ◽  
...  

Objective: to study a role of the rs5219 polymorphism in KCNJ11 in the formation of the response variability to vildagliptin therapy in patients with newly diagnosed type 2 diabetes mellitus (T2DM).Materials and methods: 48 patients with newly diagnosed T2DM were examined. For all patients vildagliptin in a dose of 50 mg/day was prescribed. If necessary, dose titration was carried out or other glucose-lowering therapy was prescribed for 6 months of observation. Dynamics of the main indicators of glycemic control and body mass index were studied, presence of the rs5219 polymorphism in KCNJ11 gene was also determined.Results: all patients-carriers the T allele had achieved the target values of glycated hemoglobin (HbA1c) in 3 months of vildagliptin monotherapy, compared to patients with wild-type gene who achieved target values of HbA1c in only 44,4% of cases. Increasing the dose to 100 mg/day required 35% of patients with wild-type gene and 17.9% of patients with rs5219 polymorphism. The appointment of a combination of glucose-lowering therapy was necessary in 40% of patients with the wild-type gene and no one with polymorphism.Conclusion: the presence of the polymorphic allele T rs5219 in KCNJ11 gene makes it possible to predict the high efficacy of vildagliptin monotherapy in patients with newly diagnosed T2DM.


BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e034613
Author(s):  
Kamlesh Khunti ◽  
Marilia B Gomes ◽  
Mikhail Kosiborod ◽  
Antonio Nicolucci ◽  
Stuart Pocock ◽  
...  

ObjectivesTo evaluate the extent to which patients with type 2 diabetes discontinue metformin therapy when initiating second-line treatment and factors associated with metformin discontinuation, using baseline data from the DISCOVER study programme.DesignDISCOVER is a 3-year, prospective, observational study programme including data from 38 countries across 6 continents from 2014 to 2019.SettingPrimary and secondary healthcare centres, hospitals and specialist diabetes centres in both urban and rural locations.ParticipantsA total of 15 992 patients with type 2 diabetes initiating second-line glucose-lowering therapy.Primary and secondary outcome measuresThe proportion of patients who discontinued metformin as a second-line therapy and the factors associated with this treatment change.ResultsOf the 14 668 patients (from 37 countries) with valid treatment data, 11 837 (80.7%) received metformin as first-line glucose-lowering therapy; 8488 (71.7%) received metformin monotherapy and 3349 (28.3%) received metformin as part of a combination therapy. Overall, treatment with metformin was discontinued in 15.1% (1782) of patients who received first-line metformin (14.1% (1194) and 17.6% (588) in those who received metformin as monotherapy and as part of a combination, respectively); this proportion varied across regions from 6.9% (54) in Africa to 20.6% (628) in South-East Asia. On metformin discontinuation, 73.6% (1311) of patients received a non-insulin monotherapy at second line. Factors associated with an increased odds of metformin discontinuation were older age (≥75 years) and having a history of chronic kidney disease. The probability of metformin monotherapy discontinuation was lower in patients from Africa than in those from Europe.ConclusionsA substantial number of patients discontinued taking metformin when beginning second-line therapy. Most of these patients subsequently received a non-insulin monotherapy at second line, in contradiction to international guidelines and potentially leaving them at an increased risk of hyperglycaemia and associated adverse outcomes.Trial registration numbersNCT02322762 and NCT02226822.


2018 ◽  
Vol 35 (7) ◽  
pp. 939-965 ◽  
Author(s):  
Lawrence Blonde ◽  
Susana Dipp ◽  
Daniel Cadena

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