Liraglutide, a glucose-lowering drug, safely and effectively lowers the overall risk of heart attack, stroke or cardiovascular death among people with type 2 diabetes at high risk for cardiovascular disease, according to new research which involved Swansea University experts. Additionally, there was a reduction in all-cause mortality and kidney disease.
The research is based on the results of the LEADER trial (Liraglutide Effect and Action in Diabetes – Evaluation of Cardiovascular Outcome Results).
Professor Steve Bain of Swansea University is the UK chief investigator for the LEADER trial and co-chair of the LEADER global expert panel which guided the study.
The Joint Clinical Research Facility (JCRF) in Swansea recruited over 30 participants into the trial which was run over five years.
Professor Bain is the Director of the Diabetes Research Unit Cymru, based at Swansea University, and Assistant Medical Director for Research & Development for ABM University Health Board
Picture: Researchers working on diabetes research at Swansea University labs: Gareth Dunseath (standing), Dominic Bright, Danielle Jones.
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 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 patients’ 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.
Professor Steve Bain of Swansea University Medical School said:
"The LEADER trial is a landmark study, in that it has shown for the first time that an injection treatment to reduce blood sugar levels in people with type 2 diabetes also reduces the risk of death due to complications. The study also confirmed the safety of liraglutide and showed a lower risk of low blood glucose levels (hypoglycaemia).
Patients in South-West Wales made an important contribution to these findings which will influence the way that we manage type 2 diabetes in our clinics and in general practice."
Picture: Dr Richard Bracken from Swansea University, (standing, left), an expert in diabetes and exercise, who works as part of the Diabetes Research Unit, Cymru.
Lead investigator John B. Buse, MD, PhD, Verne S. Caviness Distinguished Professor, University of North Carolina School of Medicine, Chapel Hill.
“Our results should give patients and providers comfort that liraglutide can safely improve outcomes beyond the core treatment of type 2 diabetes.
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."
The American Diabetes Association's 76th Scientific Sessions, held June 10-14, 2016, at the Ernest N. Morial Convention Center in New Orleans, is the world's largest scientific meeting focused on diabetes. It attracts more than 16,000 attendees and offers researchers and health care professionals from around the world the opportunity to share ideas and learn about the significant advances in diabetes research, treatment and care.
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