Last Monday, the FDA approved Tradjenta (linagliptin) tablets, used with diet and exercise, to improve blood glucose control in adults for adults with Type 2 diabetes.
Type 2 diabetes is a chronic disease marked by high levels of sugar (glucose) in the blood, and is the most common form of diabetes.
Ramsey said Type 2 is the type of diabetes that nearly all of the patients in the CNMI have.
He said there are many types of medications that are currently used to lower blood sugar, and this latest addition would give more option for treatment.
“The most common categories of drugs used are the sulfonylureas and biguanides, but not everyone responds to these medications so it is useful to have other categories of drugs to try,” Ramsey said.
Tradjenta (linagliptin) belongs to a class of DPP-4 inhibitors or “gliptins.” There are two other “gliptins” that have been approved by the FDA — sitagliptin in 2006 and marketed as Januvia, and saxagliptin, approved in 2009, and marketed as Onglyza.
Ramsey said the problem with diabetes is that if it’s not controlled it can lead to “end organ” damage. That means damage to the eyes which can lead to blindness, damage to the kidneys which can lead to kidney failure leading to dialysis, and damage to the circulation which can lead to heart attacks, strokes and amputations.
“These are all common problems in the CNMI,” Ramsey said.
The key to treating diabetes and preventing these complications is to lower the blood sugar.
“This can be done by a combination of watching your diet, increasing your physical activity and, if necessary, taking medications,” he said.
But Ramsey said although it’s nice having more medications to choose from to treat this most prevalent disease in the island, prevention is still the most important thing.
“Don’t become overweight, eat more fruits and vegetables and get regular exercise, at least 30 minutes four or more times per week,” Ramsey said.
In a press statement issued on Monday, Dr. Mary Parks, director of the Division of Metabolism and Endocrinology Products of the FDA’s Center for Drug Evaluation and Research said the approval of Tradjenta provides another treatment option for the millions of Americans with Type 2 diabetes.
“It is effective when used alone or when added to existing treatment regimens,” Parks said.
The FDA said that “people with Type 2 diabetes do not produce or respond normally to insulin, a hormone that regulates the amount of glucose in the blood, increasing the risk of serious complications.”
“The newly approved Tradjenta will increase the level of hormones that stimulate the release of insulin after a meal by blocking the enzyme dipeptidyl peptidase-4 or DPP-4, which leads to better blood glucose control,” the FDA stated.
Between 90 and 95 percent of the 24 million diabetics people in the United States are suffering from Type 2 diabetes.
The FDA approved Tradjenta following improvements in blood glucose control of 3,800 patients with Type 2 diabetes during clinical studies. It has also been studied as a stand-alone therapy and in combination with other medications. It is not advised for people with Type 1 diabetes.
Tradjenta is marketed by Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Conn., and Indianapolis-based Eli Lilly Co.
