Evidence-Based Consensus on Positioning of SGLT2i in Type 2 Diabetes Mellitus in Indians

Abstract

The current diabetes management strategies not only aim at controlling glycaemic parameters but also necessitate continuous medical care along with multifactorial risk reduction through a comprehensive management concept. The sodium-glucose cotransporter 2 inhibitors (SGLT2i) are a group of evolving antidiabetic agents that have the potential to play a pivotal role in the comprehensive management of patients with diabetes due to their diverse beneficial effects. SGLT2i provide moderate glycaemic control, considerable body weight and blood pressure reduction, and thus have the ability to lower the risk of macrovascular and microvascular complications. Some of the unique characteristics associated with SGLT2i, such as reduction in body weight (more visceral fat mass loss than subcutaneous fat loss), reduction in insulin resistance and improvement in β-cell function, as measured by homeostatic model assessment-β (HOMA-β) could be potentially beneficial and help in overcoming some of the challenges faced by Indian patients with diabetes. In addition, a patient-centric approach with individualised treatment during SGLT2i therapy is inevitable in order to reduce diabetic complications and improve quality of life. Despite their broad benefits profile, the risk of genital tract infections, volume depletion, amputations and diabetic ketoacidosis associated with SGLT2i should be carefully monitored. In this compendium, we systematically reviewed the literature from Medline, Cochrane Library, and other relevant databases and attempted to provide evidence-based recommendations for the positioning of SGLT2i in the management of diabetes in the Indian population. Funding : AstraZeneca Pharma India Limited.

A real-world clinical experience on the effectiveness of remogliflozin etabonate in management of Indian patients with type II diabetes mellitus

“…2 In a recent evidencebased consensus report on the positioning of SGLT2i amongst T2DM patients in India, its use is recommended due to multiple clinical benefits. 17 Remogliflozin etabonate is a potent and selective SGLT2i recently approved in India for the treatment of patients with T2DM. 18,19 It has a short elimination half-life and is dosed twice-daily (BID) to obtain 24-hour glucoselowering effects compared with other approved SGLT2i.…”

RSSDI-ESI clinical practice recommendations for the management of type 2 diabetes mellitus 2020

“…[ 202 ] Dapagliflozin, canagliflozin, empagliflozin, and remogliflozin are the 4 Drug Controller General of India (DCGI) approved agents used in patients with T2DM. [ 203 204 ] The EMPA-REG OUTCOME trial evaluated the non-inferior cardiovascular safety of empagliflozin in high-CV-risk T2D patients with an estimated glomerular filtration ate (eGFR) of at least 30 mL/min/1.73 m 2 . Empagliflozin reduced the rate of new onset or worsening nephropathy, which were defined as new-onset microalbuminuria, doubling of creatinine, and eGFR ≤45 mL/min/1.73 m 2 , initiation of renal replacement therapy, and death due to renal disease (hazard ratio [HR]: 0.61, 95% CI: 0.53, 0.70; p<0.0001).…”

Sodium-glucose co-transporter-2 inhibitors in patients with type 2 diabetes mellitus without established cardiovascular disease: Do they have a role in primary prevention?

“…The minimal risk of hypoglycemia with significant reduction in CV complications like HF and the ease of use have contributed to endocrinologists and cardiologists adopting SGLT2i very early into their clinical practice, thus benefiting their patients [ 72 ]. Like all the other GLDs, SGLT2i are associated with class-specific adverse events such as – increased risk of genital tract infections, bone fractures, amputations, and volume depletion-related adverse events [ 73 ]. However, bone fractures were observed majorly in individuals with osteoporosis or those with high bone fracture risk and attributed to disordered calcium and phosphate homeostasis affecting bone metabolism with increased parathyroid hormone and decreased 1,25-dihydroxy vitamin D levels [ 74 ].…”