In an international, multi-center study, called SUSTAIN 6, a new diabetes drug by the name of “semaglutide” from Novo Nordisk has shown to reduce cardiovascular risk by 26%. These results were presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) 2016.
Including experts from the UK, Canada, Denmark, the UK, Germany and other countries, the study recruited 3,297 patients in 2013 and their follow-up continued till 2016, while the study results were published today in the New England Journal of Medicine on 16th September.
Semaglutide is a glucagon-like peptide-1 (GLP-1) injectable analogue which is administered once per week. Although it is still under clinical trials, the results look promising for the drug to be available for public use in near future.
Naturally occurring in a biological system, GLP-1 is a potent antihyperglycemic hormone that induces the beta-cells of the pancreas to release insulin in response to increased blood glucose level.
In this drug, a similar cascade of events is triggered by the injection to regulate blood sugar levels. Semaglutide helps stimulate insulin in the patients of diabetes type 2. It suppresses the glucagon secretion in a glucose-dependent manner, further lowering appetite and food intake.
Completing six phase 3a clinical trials, the drug is a strong contender to get the marketing approval. However, it is not the first anti-diabetic drug which is associated with secondary benefits of reducing cardiovascular and stroke risk.
Prior to this drug, Novo’s injectable drug Victoza and, Eli Lilly and Boehringer Ingelheim’s Jardiance pill have shown to improve heart health.
In this doubled blinded randomized study, the patients of diabetes type 2 were divided into groups who received 0.5 mg of semaglutide drug, 1.0 mg of semaglutide drug or placebo of similar volumes.
Continuing for 104 weeks, the outcome was measured as the first occurrence of cardiovascular death, non-fatal mycocardial infarction (heart attack) or non-fatal stroke. Upon analyzing the results, the researchers found out that primary outcome occurred in 6.6% patients in the experiment group while for the control group it was 8.9%.
Comparing results for non-fatal myocardial infarction was recorded in 2.9% patients in the experiment group and 3.95% in the control group. The rate for non-fatal stroke observed in the experiment group remained as low as 1.6%, while for the control group it was 2.7%
The researchers also recorded that the rate of deaths due to cardiovascular disease remained the same in both groups, while nephropathy (kidney problems induced by damaged capillaries in the kidney’s glomeruli) in the experiment group was lower than that in control group.
However, it is worth noting that the occurrence of diabetes retinopathy and associated complications were higher in the experiment group. In addition to this, a few adverse effects of the drug were recorded which majorly were gastrointestinal in nature.
These gastrointestinal problems were mild to moderate in nature and they took place during the first 30 weeks. Other side effects included acute pancreatitis, high lipase and amylase levels, gallbladder disorders and malignant neoplasm cases.
With the exception of a few complications, the researchers reckoned that the advantages of the drug outweighed the adverse effects. It was also believed that collectively reducing glycated hemoglobin levels, weight loss, and reduction in systolic blood pressure led to the improved health outcomes.
In addition to this, the study authors are of the opinion that the use of this drug will help contain whopping rates of cardiovascular disease burden by modifying the progression of atherosclerosis which is a prime contributor to the health condition.
Within a few hours after the press release, the shares of Novo Nordisk witnessed a rise. In a similar context, Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said, “The results of SUSTAIN 6 support the strong potential of once-weekly semaglutide in type 2 diabetes treatment and we look forward to regulatory submission later this year.
The SUSTAIN 6 results further strengthen the clinical evidence for the Novo Nordisk GLP-1 receptor agonist portfolio with the finding of additional benefits beyond glycemic control and weight loss in adults with type 2 diabetes at high cardiovascular risk.”
This drug is likely to change the landscape of diabetes management and make therapeutics convenient to be used by patients with improved health outcomes.