The first results of an observational retrospective study assessing the effectiveness of the use dapagliflozin in patients with type 2 diabetes mellitus in real clinical practice in the Russian Federation (GLORIA study)
M.B. Antsiferov (1), B.B. Kvasnikov (2)
1) Endocrinological Dispensary of the Moscow Healthcare Department, Moscow, Russia;
2) OOO AstraZeneca Pharmaceuticals, Moscow, Russia
Background. The number of patients with type 2 diabetes mellitus (DM2) is growing steadily both in the whole world and in the Russian Federation. Dapagliflozin is a selective type 2 sodium-glucose cotransporter (SGLT2) inhibitor, which blocks glucose reabsorption in the proximal tubule of the kidney and thus promotes glucosuria.
Objective: to describe changes in key glucose metabolism parameters and other clinical and laboratory characteristics against the Background of the use of dapagliflozin in the Russian patient population.
Methods. The GLORIA study is an observational, retrospective, multicenter study that included 922 diabetic patients who started therapy with dapagliflozin. Dynamics of the glycated hemoglobin (HbA1c) level was assessed as the primary endpoint. Additionally, the clinical characteristics of patients treated with dapagliflozin were evaluated, as well as the proportion of patients with a decrease in HbA1c level by 0.5% or more, the proportion of patients who reached the target HbA1c value (<7.0%), and the dynamics of fasting blood glucose level, body weight and blood pressure (BP).
Results. A history of macrovascular complications was registered in 338 (36.7%) patients. When evaluating the clinical efficacy of dapagliflozin, a significant decrease in HbA1c level by 0.9% compared to the initial value was observed. The dynamics of fasting blood glucose level was -1.95 mmol/L. The target Hb1Ac value of <7.0% was reached in 357 (40.1%) patients. In patients taking dapagliflozin, a significant decrease in body weight was observed: the median difference of this indicator was 3.0 kg. Dapagliflozin administration was accompanied by a significant decrease in systolic and diastolic blood pressure: the median difference between the initial and final values was 6.5 and 4.5 mm Hg, respectively. 260 side effects occured in the study. Only 12 of them, however, were established to have a causal relationship with the fact of taking the drug. Mild hypoglycemic episodes occurred in 2 (0.2%) patients. When using regression equations to assess the associations between the clinical characteristics studied and taking dapagliflozin to achieve target HbA1c values, it was found that using the drug both as monotherapy and in combination with metformin increases the chances of achieving target HbA1c values.
Conclusion. The use of dapagliflozin in the Russian patient population is accompanied by a significant decrease in HbA1 level, fasting plasma glucose level and other indicators of the effectiveness of therapy, as well as a favorable safety profile.
Keywords: type 2 diabetes mellitus, glycated hemoglobin, fasting blood glucose, dapagliflozin
About the Autors
Corresponding author: Mikhail B. Antsiferov, MD, Professor, Chief Physician of the Endocrinological Dispensary of the Moscow Healthcare Department, Moscow, Russia; e-mail: firstname.lastname@example.org; ORCID: http://orcid.com/0000-0002-9944-2997; eLibrary SPIN: 1035-4773
Address: 37, Prechistenka Street, Moscow 119034, Russian Federation