The European Medicines Agency's Committee for Medicinal Products for Human Use ( CHMP ) issued a positive opinion recommending an update to the Trulicity ( Dulaglutide ) label and indication statement based on results from the REWIND cardiovascular outcomes trial, which achieved a significant 12% risk reduction in major adverse cardiovascular events ( MACE ).

The CHMP has recommended updating the Trulicity indication to reflect both glycemic control and the impact on cardiovascular events as fundamental considerations in a treatment for people with type 2 diabetes.

REWIND is the longest cardiovascular outcomes trial in the glucagon-like peptide-1 receptor agonist ( GLP-1 RA ) class ( median follow-up of 5.4 years ) and consisted primarily of people without established cardiovascular disease.
The study had a more balanced ratio of women ( 46.3% ) to men ( 53.7% ) and one of the lowest median baseline A1Cs of any diabetes cardiovascular outcome trial to date ( 7.2% ).

REWIND ( Researching cardiovascular Events with a Weekly INcretin in Diabetes ) was a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the effect of Dulaglutide 1.5 mg, a weekly GLP-1 RA, compared to placebo, both added to standard of care ( according to local standard of care guidelines ), on cardiovascular events in adults with type 2 diabetes.
The primary endpoint was the first occurrence of MACE ( the composite of cardiovascular death or non-fatal myocardial infarction or non-fatal stroke ).
Secondary endpoints included each component of the primary composite endpoint, a composite clinical microvascular endpoint comprising retinal or renal disease, hospitalization for unstable angina, heart failure requiring hospitalization or an urgent heart failure visit, and all-cause mortality.
The 9,901 participants from 24 countries had a mean duration of diabetes of 10.5 years and a median baseline HbA1c of 7.2%.
While all participants had cardiovascular risk factors, only 31% of the study participants had established cardiovascular disease. Prior ( or established ) cardiovascular disease in REWIND was defined as prior myocardial infarction, prior ischemic stroke, prior unstable angina, prior revascularization ( coronary, carotid, or peripheral ), prior hospitalization for ischemia-related events ( unstable angina or myocardial ischemia on imaging, or need for percutaneous coronary intervention ), or prior documented myocardial ischemia.

Trulicity is a once-weekly injectable prescription medicine to improve glucose in adults with type 2 diabetes mellitus. It should be used along with diet and exercise.
Trulicity is not recommended as the first medication to treat diabetes. It has not been studied in people who have had inflammation of the pancreas ( pancreatitis ).
Trulicity should not be used by people with type 1 diabetes, people with diabetic ketoacidosis, or people with a history of severe gastrointestinal disease.
It is not a substitute for Insulin.
It has not been studied in children under 18 years of age. ( Xagena_2019 )

Source: Lilly, 2019

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