Liraglutide, a glucose-lowering drug, has been shown to safely and effectively lower the overall risk of heart attack, stroke or cardiovascular death among people with type 2 diabetes at high risk for cardiovascular disease, according to results from the Liraglutide Effect and Action in Diabetes – Evaluation of Cardiovascular Outcome Results (LEADER) trial. Additionally, there was a reduction in all-cause mortality and kidney disease. The study is being published in the New England Journal of Medicine (NEJM) concurrent with its presentation at the American Diabetes Association’s 76th Scientific Sessions, Monday, June 13, 2016, in New Orleans.
In this randomized, double-blind study, 9,340 adults with type 2 diabetes at high risk for heart disease were assigned to either liraglutide (n=4,668) or placebo (n=4,672), and followed for an average of 3.8 years. Patients in the liraglutide arm received daily subcutaneous injections at an initial dose of 0.6 mg for the first week, 1.2 mg for the second week and up to 1.8 mg thereafter, based on tolerance. Participants, who were seen at 410 sites in 32 countries, had an average age of 64 years, were 64 percent male; and 73 percent (n=6,764) had prior cardiovascular disease.
Liraglutide is a long-acting, glucagon-like peptide-1 receptor agonist known to reduce blood glucose levels, blood pressure and weight. It is available to people with type 2 diabetes who have difficulty controlling blood glucose levels with a nutrition and exercise program alone. Participants in both arms of the trial took additional medications as needed to control their diabetes, high blood pressure, cholesterol levels and risk of complications.
Patients were assessed for clinical events, compliance with the study drug and other medication usage during visits at one, three and six months initially, then every six months for up to five years. (The average duration was 3.8 years, and the minimum duration was 3.5 years.) Blood tests, urine samples and electrocardiograms were taken at baseline and then annually for the duration of the patient&’s participation in the study. Blood (creatinine) and urine (protein) tests for diabetic kidney disease were obtained every six months.
Participants taking liraglutide experienced a 13 percent lower risk of time-to-first occurrence of cardiovascular death, non-fatal heart attack or non-fatal stroke, compared to those who were in the placebo group, which was the study’s primary outcome. In addition, the study results demonstrated a 22 percent lower risk of cardiovascular mortality, a 15 percent lower risk of all-cause mortality and a 22 percent lower risk of new evidence of advanced diabetic kidney disease for patients in the liraglutide arm, compared to the placebo arm. No significant indications of safety issues were found among the patients in the liraglutide group.
“Our results should give patients and providers comfort that liraglutide can safely improve outcomes beyond the core treatment of type 2 diabetes,” said lead investigator John B. Buse, MD, PhD, Verne S. Caviness Distinguished Professor, University of North Carolina School of Medicine, Chapel Hill. “In addition, liraglutide reduced the risk of the most serious complications associated with type 2 diabetes, including the risk of death. It is exciting to see such a broad-based benefit for patients who took liraglutide because most prior trials of diabetes medications have not shown such benefits.”
– See more at: http://www.nejm.org/doi/full/10.1056/NEJMoa1603827#t=article