Efpeglenatide reduces MACE and kidney disease

      An innovative step from Hanmi in collaboration with Sanofi led to the identification of another potential drug Efpeglenatide for cardiovascular and kidney diseases. The Sanofi-led AMPLITUDE-O phase 3 clinical trial included 4,076 patients with type 2 diabetes or cardiovascular disease across 344 regions in 28 countries. Two different doses of efpeglenatide (4mg or 6mg) or a placebo was administered to patients on a weekly basis. According to the results, the risk of cardiovascular and kidney disease was significantly reduced in Type 2 diabetes patients who received the 4 mg and 6 mg doses of efpeglenatide. The investigators presented the results of the global, large-scale cardiovascular clinical trial (AMPLITUDE-O) at the "Independent Session on Efpeglenatide", which was held at the American Diabetes Association (ADA) Scientific Sessions.

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Dapagliflozin safe for reducing adverse kidney outcomes in CKD

      Mineralocorticoid receptor antagonists (MRAs) and sodium–glucose cotransporter-2 inhibitors (SGLT2i) are the established drugs that reduce the risk of kidney failure in chronic kidney disease (CKD). A recent study published in ‘Kidney International Reports’ revealed that patients with chronic kidney disease and type 2 diabetes who were or were not prescribed mineralocorticoid receptor antagonists saw reductions in major adverse kidney outcomes after taking dapagliflozin

Participants with CKD (estimated glomerular filtration rate [eGFR] 25–75 mL/min/1.73m2; urinary albumin-to-creatinine ratio 200–500 mg/g), with or without type 2 diabetes, were randomized 1:1 to dapagliflozin 10mg or placebo, once-daily. The primary outcome was a composite of sustained ≥50% eGFR decline, end-stage kidney disease, or kidney or cardiovascular death. Hyperkalaemia (serum potassium ≥6.0 mmol/L) was an exploratory endpoint Proportional Cox hazard regression was used to measure dapagliflozin vs. placebo in patient subgroups.

The key finding of the study was that 24-week EXE intervention significantly reduced UAC, which is significantly correlated with FGF 21. The levels of the anthropometric, glucose and lipid parameters (TG and HDL-c), and inflammation biomarkers (CRP and TNF-α) in the EXE group were improved at 12 weeks or 24 weeks, respectively compared with GLAR group. The results also showed that the patients in the EXE group presented more significant improvements in weight and glucose parameters (FBG, HbA1c). The study also unveiled a novel role of fibroblast growth factor 21 (FGF21) in the renoprotective effect of EXE.

The results showed that dapagliflozin did not have a significant impact on the primary outcome between groups. The effect of dapagliflozin on hyperkalemia was similar among those prescribed and those not prescribed MRAs at baseline. Adverse events were similar between treatment groups irrespective of MRA prescription. The researchers opined that dapagliflozin was similarly safe and efficacious in reducing major adverse kidney outcomes in participants with CKD who were, or were not, prescribed MRAs at baseline.

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