A four-year study on diabetes medication liraglutide has finally concluded and results are quite impressive. The drug showed evidence that it can safely lower cardiovascular risk by 13 percent in patients with type 2 diabetes.
Liraglutide is one of the top two injectable medicines in the market for the treatment of type 2 diabetes. It acts as an agonist of the human glucagon peptide 1 (GLP-1), which is associated with weight loss and low blood pressure.
The American Diabetes Association (ADA) initiated the Liraglutide Effect and Action In Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial in 2010 to gain insight on the drug's efficacy and safety for diabetic patients with concurrent cardiovascular risks.
Although liraglutide has been approved for use in patients with type 2 diabetes, its safety and efficacy for the patients with concurrent cardiovascular diseases are not known.
Additionally, regulatory bodies require evidence of safety for new therapies for diabetic patients, hence the need for the assessment.
LEADER Clinical Trials
The liraglutide clinical trial took three years and 8 months, involving 9,350 type 2 diabetes patients with 73 percent of them having concurrent cardiovascular diseases. About 4,600 patients were given liraglutide while the remaining participants were given placebo. The study participants were from more than 400 varied sites from 32 countries. Patients qualified are aged at least 50 years old and must have at least one diagnosed case of cardiovascular risk.
The patients were also asked to continue medications for other illnesses such as hypertension and elevated cholesterol levels.
The liraglutide group received incremental increases in the dosage from 0.6 milligrams to 1.2 milligrams after two weeks before it was continually increased to 1.8 milligrams. Patients were regularly followed up to assess the effects of the drug.
Baseline blood tests, electrocardiograms and urine samples were also established prior to drug initiation. Diabetic kidney disease was also noted by the researchers.
Efficacy and Safety Of Liraglutide
At the conclusion of the study, the researchers found that diabetic patients who received liraglutide have a 13 percent reduced risk of heart attacks, cardiovascular mortality and strokes.
When the results were compared with placebo, those who took liraglutide had reduced risk for diabetic kidney disease, all-cause mortality and cardiovascular-related death by 22 percent, 15 percent and 22 percent respectively.
"Our results should give patients and providers comfort that liraglutide can safely improve outcomes beyond the core treatment of type 2 diabetes," said lead researcher Dr. John Buse of the North Carolina School of Medicine. "Liraglutide reduced the risk of the most serious complications associated with the disease, including the risk of death."
Adverse Effects Of Liraglutide
One of the main concerns of health providers is the risk for thyroid cancer and pancreatitis in patients taking the injectable drug. About 1.3 in 1,000 patients manifested presence of thyroid tumors and increase in serum calcitonin levels. However, the U.S. Food and Drug Administration said that the level of biomarker, while increased, is still within the normal rates and can be easily monitored.
The findings of the clinical trial are published in the New England Journal of Medicine and presented at the ADA's 76th Scientific Sessions on June 13.
Photo: Mike Mozart | Flickr
