Dulaglutide, an injectable GLP-1 receptor agonist, can be considered for both primary and secondary cardiovascular (CV) prevention in middle-aged and older patients with type 2 diabetes and cardiovascular risk factors, according to results from the Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND) trial reported Sunday, June 9, at the 79th Scientific Sessions.
The REWIND trial is the first study to include a majority of participants (69 percent) with no history of cardiovascular disease at enrollment. The trial had a median follow-up of more than five years, the longest for a CV outcomes trial of a GLP-1 receptor agonist.
“We showed that dulaglutide therapy for a median of 5.4 years, where half of the people were followed for more than 5.4 years, didn’t just reduce, but continuously and durably reduced hemoglobin A1C by about 0.6 percent — with a fairly stable effect over that period of time — weight by 1.5 kg, and systolic blood pressure by 1.7 mmHg,” said principal investigator Hertzel C. Gerstein, MD, MSc, FRCPC, Population Health Institute Chair in Diabetes Research, Director of the Division of Endocrinology and Metabolism, Director of the Diabetes Care and Research Program, and Deputy Director of the Population Health Research Institute at McMaster University in Hamilton, Ontario, Canada.
REWIND is an international, double-blind, randomized controlled trial that enrolled 9,901 patients age 50 and older with type 2 diabetes from 24 countries at 371 care centers. The study evaluated whether weekly subcutaneous injections of 1.5 mg dulaglutide could reduce major adverse cardiovascular events compared to placebo. A wide spectrum of participants similar to those seen in community practices were studied, including many without previous cardiovascular disease and many with guideline-recommended glucose levels. Participants had a mean A1C of 7.3 percent (with half of participants below 7.2 percent) at the beginning of the study and 46 percent were women, which Dr. Gerstein said was notable because previous studies had lower percentages of female participants.
The researchers concluded that the compelling reduction in CV events observed in a wide range of diabetes patients regardless of sex, baseline cardiovascular disease, age, and A1C provides conclusive evidence for the safety and efficacy of dulaglutide.
“Health-care providers and patients who are looking for ways to reduce cardiovascular risks while also lowering glucose levels, blood pressure, and weight will welcome the findings of this trial,” said study investigator Matthew C. Riddle, MD, Professor of Medicine in the Division of Endocrinology, Diabetes, and Clinical Nutrition at Oregon Health and Science University and editor-in-chief of Diabetes Care.