Ozempic® is not indicated for reduction in major adverse cardiovascular events (MACE).
Ozempic® was evaluated for CV safety in a 2‑year CVOT1,a
SUSTAIN 6—a 2‑year CVOT for Ozempic®1,2
To rule out excess CV risk associated with Ozempic® plus standard of care vs standard of care alone by excluding the preapproval noninferiority margin of 1.8.b
A 104-week, randomized, multinational, multicenter, double-blind, placebo-controlled, parallel-group, noninferiority, CV safety trial with 3297 adult patients with type 2 diabetes. Patients had a mean duration of diabetes of 13.9 years, a mean baseline A1C of 8.7%, and 58% were taking insulin.
Previously on 0 to 2 OADs ± basal or premixed insulin
≥50 years of age and established CVDc OR ≥60 years of age with at least 1 CV risk factord
aThe primary composite endpoint was the time from randomization to first occurrence of a MACE: CV death, nonfatal myocardial infarction, or nonfatal stroke.
bStandard of care included, but were not limited to, oral antidiabetic treatments, insulin, antihypertensives, diuretics, lipid-lowering therapies, antiplatelets, and antithrombotic medications.
cEstablished CV disease (previous CV, cerebrovascular, or peripheral vascular disease) or chronic heart failure (New York Heart Association class II or III) or chronic kidney stage 3 or higher.
dDefined as persistent microalbuminuria (30-299 mg/g) or proteinuria, hypertension and left ventricular hypertrophy by electrocardiogram or imaging, left ventricular systolic or diastolic dysfunction by imaging, or ankle/brachial index <0.9 of those in the trial.
eTrial consisted of 104 weeks of treatment (including a 4- to 8-week dose escalation period), with a subsequent 5-week follow up period.
In a 2-year CVOT comparing Ozempic® plus standard of care vs standard of care alone
Ozempic® demonstrated CV safety with no increased risk for MACE1,g
Noninferiority of Ozempic® vs standard of care was confirmed2
Patients were at high CV risk and followed for a relatively short duration (2.1 years). Whether these results would be equivalent in a general patient population is unknown.
gStandard of care included, but were not limited to, oral antidiabetic treatments, insulin, antihypertensives, diuretics, lipid-lowering therapies, antiplatelets, and antithrombotic medications.