Edinburgh Pharma

Abstract Introduction:  This study compared efficacy and safety of triple drug fixed-dose combination (FDC) of dapagliflozin (DAPA) + sitagliptin (SITA) + metformin (MET) extended release (ER) with SITA + MET sustained release (SR) and DAPA + MET ER in patients with type 2 diabetes poorly controlled with metformin. Methods:  This phase 3, randomized, open-label, active-controlled study included adult patients with glycated hemoglobin (HbA1c) ≥ 8% (64 mmol/mol) and ≤ 11% (97 mmol/mol), randomized in 1:1:1 ratio to receive either FDC of DAPA + SITA + MET ER (10 mg + 100 mg + 1000 mg) tablets once daily (n = 137) or co-administration of SITA + MET SR (100 mg + 1000 mg) tablets once daily (n = 139) or FDC of DAPA + MET ER (10 mg + 1000 mg) tablets once daily (n = 139). Primary endpoint was mean change in HbA1c from baseline to week 16. Results:  Mean baseline HbA1c was approximately 9% (75 mmol/mol) in each treatment group. At week 16, adjusted mean reduction in HbA1c from ba...

  Aims/Hypothesis -  There are limited data comparing dipeptidyl peptidase-4 (DPP-4) inhibitors directly. We compared the safety and efficacy of vildagliptin and sitagliptin in patients with type 2 diabetes and severe renal impairment (RI). Methods -  This study was a parallel-arm, randomized, multicenter, double-blind, 24 week study conducted in 87 centers across Brazil and the USA. Patients with type 2 diabetes, either drug naïve or treated with any glucose-lowering agents, who had inadequate glycaemic control (HbA 1c  6.5–10.0% [48–86 mmol/mol]) and an estimated GFR <30 ml min −1  [1.73 m] −2  were randomized (via interactive voice response technology) to vildagliptin 50 mg once daily or sitagliptin 25 mg once daily. These doses are recommended in this patient population and considered maximally effective. Participants, investigators and the sponsor were blinded to group assignment. Efficacy endpoints included change...

  The selective, oral sodium–glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin reduces the risk of cardiovascular (CV) death or worsening heart failure (HF) in patients with HF and mildly reduced or preserved ejection fraction (HFmrEF or HFpEF) in the phase III DELIVER* trial, touted as the largest and most inclusive thus far in this patient group. After a median follow-up of 2.3 years, there was an 18-percent reduction in the risk of the primary composite endpoint of CV death or worsening HF (hospitalization for HF [HHF] or urgent HF visit) with dapagliflozin vs placebo (16.4 percent vs 19.5 percent; hazard ratio [HR], 0.82; 95 percent confidence interval [CI], 0.73–0.92; p=0.0008). “Looking at each component of the primary endpoint, there was a 21-percent significant reduction in the risk of worsening HF (HR, 0.79, 95 percent CI, 0.69–0.91; p=0.001),  and a 12-percent nonsignificant reduction in the risk of CV death (HR, 0.88, 95 percent CI, 0.74–1.05; p=0.17),” report...