Roche's Xenical improves diabetic glycaemic control


LONDON (Reuters Health) – Treating overweight diabetes patients with Roche's obesity drug Xenical (orlistat) cuts weight, improves glycaemic control and reduces the need for anti-diabetic medication, according to study findings presented at the European Association for the Study of Diabetes meeting in Glasgow on Monday.

The company, which is seeking a licence extension for diabetes, said that people with type 2 diabetes who were overweight or obese were put on a reduced calorie diet and randomised to Xenical (189 patients) or a placebo (180 patients).

After one year, those on Xenical had significantly improved glycaemic control, as shown by significant reductions in HbAlc, fasting glucose and post prandial glucose, leading to a reduction in the mean daily dose of anti-diabetic medication required.

The reduction in HbA1c was 0.9% versus 0.4%, the reduction in fasting glucose was 1.63 versus 0.71 mmol/litre, and the reduction in post prandial glucose was 1.81 versus 0.53 mmol/litre. The Xenical group achieved a greater reduction in mean daily sulfonylureas dose than patients treated with placebo (-1.2% versus +0.5%)

Xenical was also effective in promoting weight loss among diabetics. After one year, those on the drug had lost 5.3 kg, whereas those on diet alone had lost only 3.4 kg.

Study investigator Professor Markolf Hanefeld, from the University of Dresden, Germany, said in a company news release: "Achieving sufficient weight loss is a vital first step in the treatment of people with type 2 diabetes, although less than 10% of people with type 2 diabetes manage to achieve sufficient weight loss through diet alone.

"Any medication, therefore, which helps people to lose weight, improves blood sugar control, whilst also reducing their need for anti-diabetic medication, is of real value for people who need to control their weight and their type 2 diabetes."

Regulatory authorities are currently reviewing an application for an additional type 2 diabetes indication in Xenical's licence in the US and Canada, and a variation to include type 2 diabetes in the licence in the EU. According to Roche, more than 90% of the 120-140 million people with type 2 diabetes worldwide are overweight.

Sales of Xenical reached roughly 950 million Swiss francs (US$564 million) in 2000, only a small increase on the 940 billion achieved in 1999. However, analysts at Schroder Salomon Smith Barney said that the diabetes indication would be a "key driver of market expansion."

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