The Real DAPSI: A Real-World Retrospective Study on Assessing the Efficacy and Safety of a Fixed-Dose Combination of Dapagliflozin and Sitagliptin in the Indian Population

Abstract

IntroductionType 2 diabetes mellitus (T2DM) is a chronic metabolic disorder affecting millions of individuals worldwide. Effective management of T2DM is crucial to prevent complications. Dapagliflozin and sitagliptin are oral anti-diabetic agents that have been shown to provide synergistic effects in controlling blood glucose levels. However, there is limited data on the efficacy and safety of the dapagliflozin-sitagliptin fixed-dose combination (FDC) in the Indian population. This study aimed to evaluate the real-world effectiveness and safety of the dapagliflozin-sitagliptin FDC in the Indian population. MethodsThis was a retrospective study conducted at healthcare centers in India. The study included patients with T2DM who were prescribed a FDC of dapagliflozin and sitagliptin. Data were collected from the medical health records of patients, including demographics, baseline glycated hemoglobin (HbA1c), blood glucose levels, BMI, blood pressure, and adverse events. The primary outcome was the change in HbA1c, postprandial plasma glucose (PPG), and fasting plasma glucose (FPG) from baseline to 12 weeks after treatment initiation. ResultsA total of 358 patients were included in the study, with a mean age of 56.2 years. The majority of the patients were male (68.2%), and the mean baseline HbA1c was 8.9 ± 0.87%. After 12 weeks of treatment with dapagliflozin and sitagliptin, there was a significant reduction in HbA1c levels from 8.9 to 7.2 (p <0.0001). There was also a significant reduction in fasting blood glucose levels from 178.8 to 124.0 (p <0.0001) and postprandial blood glucose levels from 273.9 to 176.0 (p <0.0001). There were no serious adverse events reported during the study period. ConclusionThe FDC of dapagliflozin and sitagliptin is effective and safe in reducing blood glucose levels and BMI in the Indian population with T2DM. This real-world retrospective study provides valuable insights into the clinical effectiveness and safety of dapagliflozin-sitagliptin FDC in the Indian population. These findings highlight the potential benefits of this combination therapy in managing T2DM and pave the way for optimized treatment strategies and improved patient outcomes in the Indian healthcare landscape. Clinicians may consider dapagliflozin-sitagliptin FDC as a viable treatment option for T2DM patients.

Retrospective Observational Study on Assessing Sitagliptin and Dapagliflozin as a Fixed-Dose Combination in the Indian Population With Type 2 Diabetes Mellitus: The SIDAXA Study

“…Additionally, a 24-week study revealed that adding dapagliflozin to sitagliptin significantly reduced HbA1c levels compared to placebo, alongside weight reduction and fasting plasma glucose improvements. The clinical evidence supports the efficacy of the sitagliptin and dapagliflozin combination in enhancing key glycaemic parameters and overall patient outcomes [1,4,25].…”

“…Uncontrolled diabetes poses severe long-term complications such as cardiovascular disease, retinopathy, neuropathy, and nephropathy, emphasizing the importance of timely and comprehensive management to prevent adverse outcomes and enhance quality of life. As the prevalence of T2DM continues to rise globally, there is a growing emphasis on personalized treatment approaches that not only target glycaemic control but also address individual risk profiles and comorbidities to optimize patient outcomes [1][2][3][4].…”

Expert opinion on fixed-dose combinations of sitagliptin + dapagliflozin and the triple drug combination of dapagliflozin + sitagliptin + metformin in the management of type 2 diabetes mellitus in Indian settings

“…Most of the current survey clinicians recommended the FDC therapy with sitagliptin and dapagliflozin for patients initially diagnosed with an HbA1c level of 8%. A real-world retrospective study revealed that the dapagliflozin and sitagliptin FDC significantly contributed to a decrease in HbA1c levels from 8.9 to 7.2 in individuals with T2DM in the Indian population, thereby affirming the safety and efficacy of this combination [11] . According to Bhattacharyya et al, a real-world study conducted in India, a once-daily FDC of dapagliflozin and sitagliptin significantly improves glycemic parameters, such as average daily glucose, time in target, and time above the target, in Indian patients with T2DM at the end of 15 days [10] .…”

“…Furthermore, they have also been shown to improve both insulin resistance and beta cell function [16] . Bhattacharjee et al found that the combination of dapagliflozin and sitagliptin is effective and safe in reducing BMI among Indian patients with T2DM [11] . [17] .…”