Introduction:
Chronic kidney disease (CKD) has been revolutionized by the introduction of sodium glucose co-transporter (SGLT-2) inhibitor in recent times. However, there are scarce prospective studies of safety and efficacy of Dapagliflozin in Indian cohort.
Methods:
This was a prospective, single-arm, open-label, observational study, institutional ethically approved conducted at ILBS-Vasant Kunj, New Delhi between Aug 2021 and Jan 2023. All patients with eGFR ≥ 25 ml/min/1.73 m2 and urine protein creatinine ratio (UPCR) ≥ 2000 and < 5000 mg/g with CKD diagnosis were enrolled. Dapagliflozin 10 mg was started in patients as per the standard acceptable criteria in published literature. The primary outcome was adverse event (AE) reporting. The secondary outcome was UACR reduction. Analysis of variance was used to measure statistical significance.
Results:
A total of 216 cases were enrolled with a follow-up of 1 year. The median age of the cohort was 52.50(46 – 61.75) years with 61.1% male proportion. The major co-morbidities included hypertension (79.6%), diabetes (65.7%), and hypothyroidism (23.1%). At baseline, the systolic blood pressure, serum creatinine and UPCR was 140(28-146) mmHg, 1.8(1.5 – 2.11) mg/dl, and 1555(950-2600) mg/g. The common anti-glycemic agents in diabetic patients were DPP-4 inhibitors (42%), sulfonylurea (20.4%), and insulin (19%). The serious AE was reported in only one case (%), while non-serious AE was reported in 35 cases. One patient developed euglycemic diabetic ketoacidosis. Acute kidney injury (AKI) stage 1 was the most frequent AE reported which all had AKI recovery. Only in 11(5.1%) cases Dapagliflozin was withdrawn. The mean difference in UACR (mg/g) reduction at 6 months and 12 months from baseline was 495.855(403-588); p-value <0.001 and 807.640(658.535 -956.744); p-value < 0.01 respectively.
Conclusions:
In this report, the AE associated with Dapagliflozin was exclusively mild and manageable with very few instances of drug discontinuation/withdrawal. AKI was the most frequent, with was transient and AKI complete recovery was achieved. Also, the reduction in proteinuria was clinically significant.
I have no potential conflict of interest to disclose.
I did not use generative AI and AI-assisted technologies in the writing process.