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Type II diabetes

Diabetes drug Liraglutide reduces cardiovascular events and mortality

11 Jul, 16 | by flee

Type II diabetes, an epidemic fuelled by an unrelenting rise in obesity and sedentary behaviors, is a major risk factor for both micro- and macrovascular disease. An array of new treatments have recently come to trial with the aim of improving glycemic control and reducing disease complications. But lingering doubts remain regarding the cardiovascular implications of several of these agents, with FDA mandated studies now taking place to establish their safety.  Injectable liraglutide, a glucagon-like peptide 1 analogue,  improves HbA1c levels and also leads to weight loss but its cardiovascular effects are unknown.  In this post-approval double-blind study, 9340 patients with type 2 diabetes and at least one other major cardiovascular risk factor, were randomly allocated 1:1 to liraglutide or matching placebo, as well as usual care.  Patients were followed up for a median of 3.8 years with a primary composite study end-point of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.  Designed as a non-inferiority study, liraglutide demonstrated statistically significant and clinically meaningful reductions in the primary end-point (13.0% vs. 14.9%, HR, 0.87; 95% CI, 0.78 to 0.97; P<0.001 for noninferiority; P=0.01 for superiority) with reductions in both cardiovascular death (P=0.007) and all cause mortality (P=0.02).  Liraglutide also demonstrated a good safety profile with numerically lower rates of heart failure hospitalisations and no increase in rates of pancreatitis, a previous concern.  At 36 months HbA1c was 0.4 lower in the liraglutide group. Of note, significant differences in blood pressure (1.2 mmHg lower) and weight reduction (2.3 kg better) were observed in the trial group.  The NNT to prevent one primary end-point event was 66 and the NNT for all cause mortality 98.

 

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Empagliflozin reduces cardiovascular mortality in Type 2 Diabetics

22 Oct, 15 | by flee

The prevalence of type 2 diabetes is increasing rapidly and represents a major risk factor for cardiovascular disease.  Although glycemic control has been shown to reduce microvascular complications, the effect of glycemic control on macrovascular disease is more limited.  Furthermore, some glucose lowering drugs have been associated with worse cardiovascular outcomes.  Accordingly, ensuring the cardiovascular safety of new diabetic therapies is important. Empaglifozin is one of the first in a new class of drugs that lowers serum glucose levels by decreasing renal glucose reabsorption.  In this study of 7020 patients at high risk of cardiovascular events, patients were randomized to one of two doses of empagliflozin (10 mg or 25 mg) or placebo, as well as standard guideline based diabetic therapy.  The primary outcome was a composite of major adverse cardiovascular events or cardiovascular death.  Although powered as a non-inferiority study, empaglifozin demonstrated statistical superiority as add-on diabetic therapy, significantly reducing the incidence of the primary end-point (10.5% vs. 12.1%, HR 0.86; 95% CI, 0.74 to 0.99; P=0.04 for superiority), including a significant reduction in the risk of death (5.7% and 8.3%, respectively; 32% relative risk reduction).  Use of empaglifozin increased the rates of genital infection (although UTI rates were similar), presumably secondary to the increased amount of glucose present in urine.  No other adverse events were increased with use of empaglifozin. more…

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