Tirzepatide vs insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): A randomized, open-label, parallel-group, multicentre, phase 3 trial
The Lancet Oct 24, 2021
Del Prato S, Kahn SE, Pa I, et al. - Treatment of type 2 diabetes cases with high cardiovascular risk using tirzepatide (dual GIP and GLP-1 receptor agonist) provided a greater and clinically meaningful glycated hemoglobin (HbA 1c ) reduction with a lower incidence of hypoglycemia at week 52, relative to glargine. No excess cardiovascular risk was noted in relation to tirzepatide use.
An open-label, parallel-group, phase 3 study of 2002 adults with type 2 diabetes and high cardiovascular risk inadequately controlled on oral glucose-lowering medications.
Patients were randomly assigned to tirzepatide or glargine.
Mean HbA 1c changes at 52 weeks were −2·43% and −2·58% with 10 mg and 15 mg doses of tirzepatide, respectively, vs −1·44% with glargine; the non-inferiority margin of 0·3% was met for both doses of tirzepatide.
Mostly mild to moderate adverse effects were more frequent with tirzepatide than glargine.
With tirzepatide, no increase occurred in adjudicated major adverse cardiovascular events (MACE)-4 events (cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina), vs glargine (hazard ratio 0·74).
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