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FDA approves new drug for treatment of type 2 diabetes

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نوشته شده توسط دکتر افشین عشقی

The US Food and Drug and Administration has announced the approval of a drug called Farxiga (dapaglifozin) to help treat adults with type 2 diabetes. The tablets, in combination with diet and exercise, are said to improve control of blood sugar levels.

Farxiga, a sodium-glucose co-transporter 2 inhibitor (SGLT2), works by preventing the kidney from reabsorbing glucose. This increases the excretion of glucose and reduces blood sugar levels.

According to the US Food and Drug Administration (FDA), 16 clinical trials involving more than 9,400 patients with type 2 diabetes assessed the safety and effectiveness of the drug.

These trials demonstrated that Farxiga was able to improve HbA1c (hemoglobin A1c or glycosylated hemoglobin) levels – a measure of blood glucose control – in type 2 diabetic patients.

Commenting on the drug approval, Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II at the FDA’s Center for Drug Evaluation and Research, says:

“Controlling blood sugar levels is very important in the overall treatment and care of diabetes, and Farxiga provides an additional treatment option for millions of Americans with type 2 diabetes.”

The FDA says as well as being assessed as a stand-alone therapy, the drug has also been tested in combination with other treatments for type 2 diabetes, including insulin, pioglitazone, metformin, glimepiride, and sitagliptin.

Not suitable for patients with with bladder cancer or type 1 diabetes

A drug called Farxiga has been FDA-approved for the treatment of type 2 diabetes. The drug, in combination with diet and exercise, can help patients control blood glucose levels.

Furthermore, clinical trials revealed that among users of Farxiga, there were an increased number of bladder cancers diagnosed.

Therefore, the FDA recommends that patients with bladder cancer do not use the drug, and that patients with a history of the disease should consult their physician prior to using it.

Dehydration was found to be a side effect of the drug. The FDA notes that elderly patients with impaired kidney function and patients using diuretics seemed to be more susceptible to this.

The most common side effects from Farxiga in clinical trials were fungal infections and urinary tract infections.

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