A new combination drug used to treat type 2 diabetes and lower cholesterol has been approved by the US Food and Drug Administration (FDA).
JANUVIA, manufactured by Merck, combines the glucose-lowering medication sitagliptin, with the cholesterol-lowering medication ZOCOR (simvastatin).
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About 20 million people in the US have type 2 diabetes, and they often have high cholesterol levels as well. These conditions can lead to increased risk of heart disease, stroke, kidney disease and blindness.
Mary Parks, the FDA’s director of the division of metabolism and endocrinology products, said, "This is the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet. However, to ensure safe and effective use of this product, tablets containing different doses of sitagliptin and simvastatin in fixed-dose combination have been developed to meet the different needs of individual patients."
Merck vice-president of diabetes and endocrinology Barry Goldstein added, "Although clinical guidelines put people with type 2 diabetes who need glycaemic and lipid therapy at the same risk level as those with coronary heart disease, nearly 40% of eligible patients do not receive statin treatment. We are proud to bring forward a treatment option that can help these patients who need both glycaemic and lipid therapy."
The FDA believes that the potential risk of statins increasing blood sugar levels in type 2 diabetes patients is outweighed by the benefits of the combination pill in reducing heart disease.
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By GlobalData
