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- W2507399503 abstract "www.thelancet.com/diabetes-endocrinology Vol 4 May 2016 379 New glucose-lowering agents for type 2 diabetes are expensive compared with older drugs, so it is important for patients, those treating them, and payers that information used to guide treatment decisions is based on a clear analysis of the benefi ts and risks of each drug. Although the benefi t of glucose lowering to reduce microvascular complications was established in the UKPDS trial, uncertainty remains in relation to the risk of cardiovascular disease, as highlighted by the controversy about thiazolidinediones, particularly rosiglitazone, and the adverse eff ects on cardiovascular death seen in the ACCORD trial of intensive glucose lowering in patients with longstanding diabetes. As a result, regulators such as the US Food and Drug Administration now require evidence (based on adjudicated outcomes from phase 3 trials) that the risk of cardiovascular harm is low for all new glucose-lowering therapies before a drug is made available and usually also require a post-marketing cardiovascular safety trial. The results of published cardiovascular outcome trials with the dipeptidyl peptidase 4 inhibitor class of drugs and of one trial with a glucagon-like peptide 1 receptor agonist have largely substantiated the safety of these treatments— with the exception of a signal for increased admission to hospital for heart failure with saxagliptin—but have not shown cardiovascular benefi t, although a press release from the LEADER (NCT01179048) trial with liraglutide suggests that this GLP-1 analogue does reduce major cardiovascular events. The latest class of glucose-lowering therapies, sodium-glucose cotran sporter-2 (SGLT2) inhibitors, inhibit glucose reabsorption from the proximal renal tubules, resulting in glycosuria. These drugs cause lowering of blood glucose, weight loss, and (partly as a result of a transient natriuresis) blood pressure reduction; they do, however, slightly increase LDL cholesterol and increase the risk of genital fungal infections. Several other safety concerns have also been raised, particularly the risk of bacterial urinary tract infections, bone fractures, hypotension, ketoacidosis, and bladder and breast cancers. Regulatory assessment of benefi ts and risks of these drugs, including cardiovascular safety meta-analyses based on phase 3 data, allowed them to be marketed, but the results of the fi rst of the cardiovascular outcome trials, EMPA-REG OUTCOME, in which 7020 patients with type 2 Published Online March 18, 2016 http://dx.doi.org/10.1016/ S2213-8587(16)00084-X" @default.
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- W2507399503 date "2016-01-01" @default.
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- W2507399503 title "SGLT2 inhibitors: providing cardiovascular protection in type 2 diabetes?" @default.
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