Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Cardiovascular outcomes were evaluated in a safety study of RYBELSUS®

PIONEER 6: a cardiovascular outcomes trial (CVOT) for RYBELSUS®1,2
Objective:
Confirm treatment with RYBELSUS® does not result in an unacceptable increase in CV risk compared to placebo (rule out 80% excess risk) in subjects with type 2 diabetes at high risk of CV events.

event-driven

randomized

double-blind

placebo-controlled
Patients:
3183 with inadequately controlled type 2 diabetes and ASCVD.
Median observation time was 16 months.
Inclusion criteria:
Diagnosed with type 2 diabetes and ≥50 years of age and established CVD or CKD OR ≥60 years of age with at least 1 CV risk factora


Primary composite outcome
Time from randomization to first occurrence of MACE:

ASCVD=atherosclerotic cardiovascular disease; CKD=chronic kidney disease; CV=cardiovascular; CVD=cardiovascular disease; MACE=major adverse cardiovascular event; MI=myocardial infarction.
aCV risk factors included microalbuminuria or proteinuria, hypertension and left ventricular hypertrophy, left ventricular systolic or diastolic dysfunction, or ankle-brachial index of <0.9.2
bTreatment arms included patients taking either RYBELSUS® or placebo who were either treatment-naïve or taking oral antidiabetics (OADs) and/or insulin.2

RYBELSUS® demonstrated CV safety with no increased risk of MACE1
Noninferiority of RYBELSUS® vs placebo–both in addition to standard of care–was confirmed1,3,a

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with RYBELSUS®
Patients were at high CV risk and followed for a relatively short duration (16 months median observation time).1

21% fewer MACE events with RYBELSUS® vs placebo—both in addition to standard of care—
which helped establish no increased risk of MACE (P=0.17, NS)3
aTreatment arms included patients taking either RYBELSUS® or placebo who were either treatment-naïve or taking oral antidiabetics (OADs) and/or insulin.2

Dose escalation designed to help your patients adjust to therapy1
For your patients to experience the intended efficacy of RYBELSUS®, it’s important to understand proper dosing when you prescribe.
