The European Commission has authorized the marketing of weekly treatment with albiglutida, Glaxosmithline Biological drug (GSK) whose commercial name is 'Eperzan', indicated to improve glycemic control in patients with type 2 diabetes mellitus type 2 in adults.
Specifically, the drug has been authorized in monotherapy, when diet and exercise alone are not enough to achieve glycemic control in patients in which the use of metformin is considered inappropriate by intolerance or contraindication;And in combination with other medications to control glucose, including basal insulin, when they, together with diet and exercise, do not provide adequate glycemic control.
The drug is part of the family of the agonists of the GLP-1 receptors, an important incredine hormone that helps to normalize the organism's glucose level and whose production is reduced or disappears in people with type 2 diabetes, and administersOnce a week with a pen and a 5 millimeter needle in length.
The authorization has been based on the results of the extensive program 'Harmony', composed of eight phase III studies in which about 5,000 patients have participated.
In these studies its use was compared to the most common drugs in the treatment of type 2 diabetes, including insulin, in patients in different stages of the disease and several degrees of renal failure.
Although most diabetes registration studies have a duration of six months, in five of the 'Harmony' tests, patients have been followed up to three years.
In this period it has been seen that the most serious adverse reaction was pancreatitis, which has also been registered with other GLP-1 recipient agonists, something that patients must be informed since, if there is suspicion, it should be interruptedThe treatment.Also, in patients with pancreatitis history its use should be made "with caution."
Likewise, the risk of hypoglycemia is increased when albiglutide is used in combination with insulin secretagogues (such as sulfonylurea) or insulin, so in these patients they will need a readjustment of their dose of sulfonilurea or insulin to reduce the risk of hypoglycemia.
Other limitations to its use
It is also known that the use of a GLP-1 recipient agonist can be associated with gastrointestinal adverse reactions.Although since the use of albiglutida has not been studied in patients with severe gastrointestinal disease, including severe gastroparesia, it is not recommended in these patients.
In Europe, given the limited albigli experience in patients with severe renal failure or dialysis, use is not recommended.
Likewise, the most frequent adverse reactions during clinical trials, which affected 5 percent of the patients who received the drug, were diarrhea, nausea and reactions in the injection place, including eruption, erythema or redness in the place ofinjection1.
After this approval, GSK hopes to launch albiglutida in several European countries in the third and fourth quarter of 2014, with additional releases next year.Likewise, health authorities from other countries are currently reviewing Albiglutida as the American Medication Agency (FDA), which in a few weeks will announce a decision.
For the director of the Global Cardiovascular, Metabolism and Neurosciences franchise of GSK, Vlad Hogenhuis, this approval will allow health professionals and patients to have access to a new weekly therapeutic option that has demonstrated its effectiveness in the reduction of glucose "with a controldurable and, in general, good tolerance. "
