Dapagliflozin effectiveness in improvement of clinical outcomes in diabetic patients (extention of CARDIA-MOS study, Moscow)

OBJECTIVES. Dapagliflozin is a glucose-lowering drug of the class of type 2 sodium-glucose cotransporter inhibitors (iSGLT-2) that also has cardio- and nephroprotective properties. Its efficacy in improving cardiovascular and renal outcomes in patients with type 2 diabetes mellitus (T2D) is well studied in international randomized clinical trials, but there are no data on the effectiveness of the drug in real clinical practice in Russian patients. The CARDIA-MOS observational study was conducted to investigate this issue using data from the Moscow segment of the diabetes registry and UMIAS electronic outpatient records. In addition to the previously published results, updated data for the 6-year follow-up period are presented.

OBJECTIVE. To study the impact of dapagliflozin on clinical outcomes and mortality rates of patients with T2D in real clinical practice in Moscow.

MATERIALS AND METHODS. To assess outcomes, we retrospectively collected data from the main and control groups, each consisting of 499 patients with T2D who met the selection criteria. Patients in the main group initiated dapagliflozin therapy in 2017; the control group comprised patients matched for baseline characteristics but who did not receive iSGLT-2 before inclusion in the study and during the follow-up period.

RESULTS. The majority of patients in the main and control groups were women (58.9%), the mean age was about 63 years, and the duration of T2D history was about 9 years. Administration of dapagliflozin as an add-on therapy of patients in the main group was associated with relative risk (RR) reduction of death from any cause by 42% (RR=0.58; 95% CI 0.43–0.78; p<0.001), risk of death from heart failure (HF) by 66% (OR=0.34; 95% CI 0.16–0.72; p<0.001), risk of death from cardiovascular disease (CVD) by 72% (OR=0.28; 95% CI 0.17–0.47; p<0.001), and risk of major adverse cardiovascular events (MACE) by 49% (OR=0.51; 95% CI 0.40–0.67; p<0.001) after 6 years of follow-up. Also, the dapagliflozin group showed a decrease in HbA1с from 8.53% to 7.92%, a decrease in body weight, and a slower decrease in glomerular filtration rate (GFR) compared to the control group.

CONCLUSIONS. Long-term treatment with dapagliflozin significantly improves clinical outcomes in patients with T2D, including a reduction in the risk of death from any cause, the risk of death from HF and CVD, and the risk of developing MACE compared with standard therapy without iSGLT-2. Along with high effectiveness profile of the drug in terms of improvement in glycemic control parameters, the use of dapagliflozin in routine practice also led to a decrease in body weight and the rate of progression of chronic kidney disease (CKD).

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