8. Drug Updates

Linagliptin does not affect the risk for heart failure

In a secondary analyses of Heart Failure(HF) and related outcomes with the dipeptidyl peptidase-4 inhibitor linagliptin versus placebo in CARMELINA (The Cardiovascular and Renal Microvascular Outcome Study With Linagliptin) trial- a cardiovascular outcomes trial that enrolled participants with type 2 diabetes mellitus and atherosclerotic cardiovascular disease and/or kidney disease, linagliptin did not affect the risk for hospitalisation for heart failure (hHF) or related HF outcomes.

In CARMELINA trial, 6979 patients with type 2 diabetes and concomitant CVD and/or kidney disease, including 1873 (26.8%) with HF history were randomly assigned to receive oral linagliptin (5 mg/day; n=3494) or placebo (n=3485). Median follow-up was 2.2 years. There was no significant difference in (hHF) between linagliptin and placebo (6.0% vs 6.5%; HR, 0.90; 95% CI, 0.74-1.08). No difference was seen in composite hHF or cardiovascular death (HR, 0.94; 95% CI, 0.82-1.08) or hHF or all-cause death (HR, 0.95; 95% CI, 0.84-1.07). There were no significant differences by treatment group within subgroups by baseline estimated glomerular filtration rate, urinary albumin:creatinine ratio status or pretrial left ventricular ejection fraction.

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Long-term efficacy and safety of ertugliflozin in T2DM demonstrated in VERTIS MET trial

VERTIS MET trial, a Phase III, randomized, double-blind study evaluating long-term efficacy and safety of ertugliflozin in adults with type 2 diabetes mellitus inadequately controlled on metformin has demonstrated that adding ertugliflozin to metformin monotherapy provide effective clinical improvements in glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), body weight and systolic blood pressure (SBP) over 104-week. This double-blind study had a 26-week placebo-controlled period (Phase A) and a 78-week period (Phase B) where blinded glimepiride was added to non-rescued placebo participants with fasting fingerstick glucose ≥6.1 mmol/L. The incidence of female genital mycotic infections (GMIs) was higher with ertugliflozin, and symptomatic hypoglycaemia was lower for ertugliflozin vs placebo/glimepiride. Reduction in FBG, body weight, SBP with ertugliflozin from baseline was noted through Week 104.

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