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Research raises questions over safety of diabetes medication

4 May 2017
Widely used diabetes drug linked to hypoglycemia and cardiac death

Diabetes drugs based off a commonly used compound have been linked to an increased risk of hypoglycemia and cardiac death

University of Sydney research published in has revealed a link between the Type 2 diabetes medication gliclazide and an elevated risk of and cardiac distress.

Type 2 diabetes develops when the body becomes resistant to insulin or when the pancreas stops producing enough insulin, resulting in high blood glucose levels, known as .

Gliclazide is in the聽聽family of medications and works mostly by increasing the release of聽, which lowers blood glucose. Left untreated, diabetes and hyperglycaemia pose major risks to key organs, including the heart, blood vessels, nerves, eyes and kidneys.

Medications belonging to the sulfonylurea class have long been linked to higher rates of hypoglycemic episodes in Type 2 diabetic patients and until now, gliclazide was thought to pose a low risk for hypoglycaemia.聽

The study鈥檚 lead author Dr Tim Middleton of the University of Sydney says the new finding shows that even with gliclazide, a significant number of hypoglycemic events may still occur in clinical practice.

鈥淭hirty percent of our gliclazide-treated participants experienced clinically significant over 48 hour-period of continuous blood glucose monitoring,鈥 says Dr Middleton.

鈥淢ore than 60 per cent of these hypoglycemic episodes occurred at night but nocturnal hypoglycaemia is often asymptomatic, hard to detect outside a clinical or research setting, and may therefore go untreated.鈥

鈥湼咔甯@ also adds weight to a body of accumulating evidence that hypoglycaemia predisposes patients to cardiac arrhythmia and therefore raises the risk of adverse cardiac outcomes, including sudden cardiac death.鈥

The research also found similar results in a small cohort of patients treated with insulin.

Sulfonylurea-based diabetes drugs have been in clinical use for over 50 years; gliclazide has been on the Australian Register of Therapeutic Goods since 1999 and is the most commonly prescribed sulfonylurea in Australia today.

Dr Middleton says over the past few decades multiple new drugs to treat type two diabetes have been developed and he believes a re-evaluation of the drugs used in treatment would be appropriate.

鈥淭here has been much debate regarding the safety of sulfonylurea therapy over the years. Unlike the newer anti-diabetic pharmaceuticals, sulfonylureas have never undergone rigorous cardiovascular safety trials,鈥 he says.

鈥淭hat being said, sulfonylureas have been used effectively in the treatment of type two diabetes for many years across thousands of patients. However, in light of the development of new agents which have been shown to be safe from a cardiovascular perspective, clinicians should re-evaluate how sulfonylurea therapy is utilised in the treatment of type two diabetes.鈥

Sulfonylurea and Diabetes:

- Sulfonylurea is an organic compound that has been used as a basis for diabetes medications for over 50 years.

- Sulfonylurea-based drugs are used to lower blood glucose levels.

- Hypoglycemia occurs when a person鈥檚 blood glucose levels drop below a safe level and there isn鈥檛 enough glucose for energy production.

- Symptoms of hypoglycemia include blurred vision, headache, nausea, loss of concentration, shaking, excess sweating, fatigue and fainting.

- There is a link between hypoglycaemia and cardiac arrhythmia which can result in sudden cardiac death.

Elliott Richardson

Assistant Media Advisor (Medicine, Dentistry, Nursing and Pharmacy)

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