On January 25, The United States Food and Drug Administration announced the approval of three new drugs to treat Type 2 diabetes. All produced by Takeda Pharmaceutical Company, Alogliptin will be used as a standalone medication and sold under the brand name Nesina. The other two will be used in combination with other, currently used diabetes medications.
Alogliptin will also be used in combination with Metformin; one of the most common and widely prescribed oral treatments of the disease. The brand name for this combination will be Kazano. Additionally, Alogliptin will be used in combination with Pioglitazone, the scientific name for Takeda's Actos brand of diabetes medication. The new combination will be sold under the brand name Oseni. There will warnings on the labels of these newly approved drugs.
Kazano will have a boxed warning for lactic acidosis. Associated with the use of Metformin, lactic acidosis is a build-up of lactic acid in the bloodstream. Oseni will have a boxed warning for heart failure. Heart failure has been associated with the use of Pioglitazone, which is in the same class of diabetes medication as Avandia.
In light of the risk factors, The FDA is requiring five post-marketing studies for Nesina, including one that involves a cardiovascular clinical trial to make sure that the newly approved drug does not present increased risk factors for heart attack and stroke. Another study will assess Nesina for any liver or pancreatic disease associated with the drug's use. The standalone drug, Alogliptin, has been studied in 14 clinical trials which involved approximately 8,500 patients with type 2 diabetes. It is considered safe.
Type 2 diabetes, also known as adult onset diabetes, is growing to close to epidemic proportion. The FDA has stated that type 2 diabetes affects more that 24 million people in the United States, with more and more children and adolescents being diagnosed each year. Type 2 diabetes is an extremely serious health issue. Uncontrolled, Type 2 diabetes can lead to serious heart and cardiovascular disease. Type 2 diabetes is also the leading cause of new blindness. Properly prescribed medication, taken in combination with a controlled diet and regular exercise, can greatly lower the risk of serious complications.
Symptoms of Type 2 diabetes can be subtle or significant, including unusual fatigue, excessive thirst and unusually frequent urination. An annual physical examination, with appropriate blood screenings, can detect the possibility of risk or onset. However, experiencing any or all of the symptoms requires immediate attention. This writer was diagnosed some years ago. It continues to be well under control.
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