Safety and efficacy of dapagliflozin in patients with type 2 diabetes mellitus during fasting in the month of Ramadan: an experience from tertiary care hospital

Objective

The data regarding the safety and efficacy of dapagliflozin during fasting is lacking especially in Pakistan. So, the current study aimed to explore the safety and efficacy of dapagliflozin in minimizing the episodes of hypoglycemia during fasting and reducing the HbA1c.

Methods

A single-center, prospective observational cohort study was conducted at the National Institute of Diabetes and Endocrinology Department (NIDE), Dow International Medical College (DIMC), from March to June 2022. Diabetic patients who were being treated with stable doses of metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors were included, and then, different doses of dapagliflozin (DAPA) were added in their standard regimen after dividing them into two groups (Group A and B receiving 5 mg and 10 mg of DAPA, respectively).

Results

Most of the study participants were females (63.9%) of which 37.7% had ages ranging from 41 to 50 years, were obese, and had diabetes ≤ 3 years with 24.6% participants having hypertension as comorbidity. Post-intervention analysis of the participants showed a significant decrease in HbA1c and blood pressure levels with the DAPA regimen (p-value = 0.000). Additionally, the efficacy of different doses was also significant (p-value = 0.008); however, the negative odds ratio of 0.929 indicated that increasing the dose would decrease the HbA1c.

Conclusions

It was found that DAPA was safe and effective for the patients as it improves the HbA1c levels, and there were no significant hypoglycemic events. Further, urinary tract infections and diabetic ketoacidosis were also not reported by the patients.