FDA Approves Glyxambi (empagliflozin and linagliptin) for Type 2 Diabetes (粮食与药物管理局批准Glyxambi (empagliflozin和linagliptin) 治疗第二类型糖尿病)
The U.S. Food and Drug Administration (FDA) has approved Glyxambi (empagliflozin / linagliptin) tablets as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) when both empagliflozin and linagliptin are appropriate treatments.
The FDA approval was based on a phase III study that assessed the efficacy and safety of GLYXAMBI (10/5 mg and 25/5 mg) compared with the individual components of empagliflozin (10 mg or 25 mg) or linagliptin (5 mg) in adults with T2D who were also taking high-dose metformin (mean dose 1889 mg daily)
GLYXAMBI is not recommended in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. GLYXAMBI has not been studied in patients with a history of pancreatitis, and it is unknown if using GLYXAMBI increases the risk of developing pancreatitis in these patients.
GLYXAMBI is not suitable for patients with severe renal impairment, end-stage renal disease, or dialysis, a history of hypersensitivity reaction to linagliptin, such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity, or a history of serious hypersensitivity reaction to empagliflozin.
It is the first in the United States to combine a sodium glucose cotransporter 2 (SGLT2) inhibitor (empagliflozin) with a dipeptidyl peptidase-4 (DPP-4) inhibitor (linagliptin). The tablets contain 10 or 25 mg of empagliflozin and 5 mg of linagliptin to be once daily.
In accordance to Eli Lilly and Company, “Use as an add-on to metformin, GLYXAMBI was superior in reducing A1C when compared with either empagliflozin or linagliptin alone.”
GLYXAMBI may cause serious side effects, including:
· Low blood sugar (hypoglycemia), if you take GLYXAMBI with another medicine that can cause low blood sugar such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, confusion, irritability, hunger, fast heartbeat, sweating, or feeling jittery.
· Urinary tract infections are a common side effect of GLYXAMBI but can sometimes be serious. Symptoms may include burning feeling when passing urine, urine that looks cloudy, and/or pain in the pelvis or back.
· Allergic (hypersensitivity) reactions can happen after your first dose or up to 3 months after starting GLYXAMBI. Symptoms may include swelling of your face, lips, throat, and other areas on your skin; difficulty with swallowing or breathing; raised, red areas on your skin (hives); and/or skin rash, itching, flaking, or peeling. If you have any of these symptoms, stop taking GLYXAMBI and call your doctor or go to the emergency room right away.
· Kidney problems, especially in people 75 years and older and people who already have kidney problems
· Increased fats in your blood (cholesterol).
The drug was developed by Eli Lilly in collaboration with Boehringer Ingelheim. Mike Mason, Vice president for the US Diabetes division for Lilly, said, "The approval of GLYXAMBI gives US physicians and patients a first-in-class prescription medicine to help manage this condition".
Reports have shown that around 29 million people in the US and 387 million people around the world suffer from type I or type II diabetes, and among them type II diabetes is most common.
Here is the link to its medication guide – Medication Guide – GLYXAMBI
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Disclaimer: I am not a Medical Doctor. All my blog postings are based on my personal experience that I've went thru and what I've read up from the internet. If you've any symptoms of diabetes OR want to better manage your health, I strongly urge you to have regular medical-ups to avoid future complications. In addition, control your diet portions and have regular exercise.