Trulicity gains cardiovascular indication after REWIND trial cuts events in type 2 diabetes
A 9,901-patient trial found Trulicity lowered major cardiovascular events in type 2 diabetes, mostly by reducing nonfatal strokes, and the drug now carries a cardiovascular indication.
Trulicity (dulaglutide) now carries a cardiovascular indication, based on results from a 9,901-patient trial called REWIND published in The Lancet [1].
The trial tested dulaglutide 1.5 mg in adults with type 2 diabetes and followed them for a median of 5.4 years [1]. It was double-blind, randomized and placebo-controlled, meaning neither participants nor their doctors knew who received the drug and who received an inactive injection [1].
Major adverse cardiovascular events occurred in 12.0 percent of people taking dulaglutide and 13.4 percent of those taking placebo [1]. The hazard ratio was 0.88, which describes a lower rate of these events in the treatment group [1]. In absolute terms, the gap between the two groups was about 1.4 percentage points. The main measure was a composite of serious heart and blood vessel problems rather than a single outcome [1].
Most of the difference came from fewer nonfatal strokes: the trial reported a 24 percent reduction in nonfatal stroke [1]. Most people in the study did not have established cardiovascular disease when they enrolled, meaning they had not already had a heart attack or a stroke [1].
A hazard ratio and a percentage-point difference answer different questions. The hazard ratio compares event rates over time between the two groups [1]. The percentage-point gap describes how many people in each group had an event during the study [1].
Why it matters for patients
Many cardiovascular studies in diabetes enroll people who already have heart disease. REWIND's participants mostly did not have established cardiovascular disease at the start [1], so the results describe a group closer to the broader population of adults with type 2 diabetes.
The benefit was driven by nonfatal stroke rather than by heart attacks or cardiovascular deaths [1]. For patients whose main concern is stroke risk, that is the part of the result most directly supported by the trial.
REWIND tested dulaglutide, one molecule in a large class. Semaglutide (Ozempic, Wegovy and Rybelsus) and tirzepatide (Mounjaro and Zepbound) are different drugs with their own trials, and results for one GLP-1 do not automatically transfer to another [1]. Whether the stroke finding applies to a drug a patient is already taking is not answered by this trial [1].
A cardiovascular indication on a drug's label affects how a medication is prescribed and how insurers cover it. The trial report does not give the label wording or the date the indication took effect [1].
What happens next
The cardiovascular indication is on the Trulicity label. Longer follow-up on how the stroke benefit holds up over time, and whether other GLP-1 medications show the same pattern in people without established heart disease, has not been reported from this trial [1].
Sources
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