Results from a trial study, have proven to reduce cardiovascular risks in vulnerable patients with Type 2 diabetes. Liraglutide, the drug under evaluation in the trial, is one of top diabetes two injectable medicines currently in the market, to treat the disease.
The Liraglutide Effect and Action In Diabetes- Evaluation of Cardiovascular Outcome Results (LEADER), has been highly expected by physicians, analysts and by the American Diabetes Association (ADA). LEADER and ADA have joined forces to understand the risks of the drug and if it’s safe for patients with cardiovascular risks.
Results of the LEADER trial have proven the Liraglutide drug reduces heart attack, stroke and cardiovascular deaths in patients with Type 2 diabetes. It has also shown a reduction in mortalities and kidney disease among patients.
The medicine is in the market under the name of Victoza, and it works as an injectable drug for patients suffering from diabetes type 2.
The medicine has also been sold in the United States and Europe by the name of Saxena, as a weight reduction drug for obese or overweight patients.
In 2009, the European Medicine Agency (EMA) approved the medication to treat diabetes type 2, and a year later the Food and Drug Administration (FDA). Both of the organizations have also approved its use as a weight reducing drug for obese adults.
The 4-year trial investigation
The study featured 9,350 adults suffering from Type 2 diabetes that also had high risks for heart diseases. 4,668 participants were assigned to take liraglutide, medicine while 4,672 were taking a placebo, both of the groups were evaluated for 3.8 years.
The group taking the medicine first received 0.6 mg injections of the drug. Then, it was upgraded to 1.2 mg in the second week and continued to 1.8 mg from there forward depending on the tolerance of the participants.
— NIDDK (@NIDDKgov) June 12, 2016
Both groups included in the trial were evaluated in 410 different sites, among 32 different countries and they were all surrounding their 60s, 73 percent of them had already cardiovascular diseases.
Since all of the participants were diabetes type 2 patients, a condition they all continued to take medications needed to control illness and other matters such as high blood pressure, cholesterol and other complications.
Researchers visited participants to measure the results and advance the medicine was having on their system. They started visiting every month, to three months and six months during the four years of the trial.
The investigation was held by taking blood tests, urine samples, and electrocardiograms at the beginning of the trial and annually on every patient. Researchers also searched for diabetic kidney disease.
Analyzing results of the LEADER trial
After four years, researchers concluded that participants receiving the injectable medicine had a 13 percent lower risk to suffering cardiovascular deaths, heart attacks, and strokes.
These data was based on the results comparing the group with the placebo takers, which showed a 14.9 percent of risks, also demonstrating a lower risk of 22 percent for cardiovascular mortality, 15 percent lower risk of all-cause mortality and a 22 percent lower risk of presenting diabetic kidney disease.
“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 the disease, 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 medication have not shown such benefits,” said lead investigator John B. Buse who is a professor at the North Carolina School of Medicine.
Cardiovascular diseases are the primary cause of death in patients suffering from diabetes. According to a study published in 2015, cardiovascular diseases were the leading cause of death in 28.7 percent of the diabetes cases.
The results of the trial give physicians the opportunity to focus on reducing overall risks on their patients, then just on reducing sugar levels on their systems.
The LEADER trial also has shown that the medicine doesn’t increase heart risks on patients, rather it reduces them.
The drug works by being injected into the patient on a once-a-day basis, and assembles the human metabolic hormone called Glucagon-like peptide-1 (GLP’1).
The medicine helps to improve the control of blood glucose and reduces hyperglycemia, thanks to the increment of insulin secretion in the body. It also increases glucose levels ( if needed), delays gastric emptying.
The medicine has to be proven to have more advantages than other therapies for type two diabetes, for example, it stimulates insulin secretion only when blood glucose levels are high this prevents overshooting the human body with insulin.
Risks of hyperglycemia decline when using the medicine, it decreases appetite and inhibits weight gain and lowers triglyceride levels.
The medicine has also been related and compared to other Type 2 Diabetes treatments, for having adverse effects that include higher rates on Thyroid cancer concerns and pancreatitis.
— alfonso bellia (@alfonsobellia) June 14, 2016
Liraglutide was evaluated for thyroid cancer concerns, showing that 1.3 out of 1000 patients showed thyroid tumors. Compared with a 1.0 out of 1000 patients with other medicines.
The FDA commented on the matter and said that serum calcitonin which is a biomarker that could result in thyroid cancer had increased in liraglutide patients but within normal rates and would be monitored.
A Josh Hopkins research group showed in 2013 statistical data that associated patients hospitalized with pancreatitis that had a previous history with Liraglutide. Both the FDA and the EMA studied statistics and concluded it was inconsistent.
Other studies on the medicine
A study held on mice in 2010 with a variant of the drug given orally, found that the medication reduced damages caused by dementia and helped with memory. According to the study, mice had dementia and had better performances.
This study has been continued by the Imperial College of London, who began a trial study in 2015 with 200 men and women surrounding their 50s, that had early stages of Alzheimer to prove this matter.
Source: PR Newswire