Tuesday, December 05, 2006

Glaxo Avandia Can Slow Diabetes Progression

Long-term treatment with GlaxoSmithKline PLC's (GSK) blockbuster drug Avandia is more effective in slowing the progression of early-stage diabetes than two older treatments, according to a study published Monday in the New England Journal of Medicine.

The trial, presented Monday at the World Diabetes Congress in Cape Town, South Africa, showed that initial treatment of type-2 diabetes with Avandia slowed disease progression more effectively than did metformin and glyburide, which are currently used as first-line treatments.

Avandia is GlaxoSmithKline's second best-selling drug, with sales of GBP1.3 billion last year. It is prescribed to patients who do not respond to treatment with older anti-diabetics.

Compared with metformin, Avandia showed a risk reduction of 32%. This increased to 63% when it was compared with glyburide. The minimum target required in the trial, which studied 4,360 newly diagnosed diabetes patients over the course of four years, was a risk reduction of 30%.

However an accompanying editorial in the journal said that given Avandia's modest benefits, higher cost and side-effects, metformin remains "the logical choice" in the initial treatment of diabetes.

With all three drugs there was a high rate of patients dropping out of the trials due to adverse events. Around 60% of patients completed the study, the researchers said.

Treatment with Avandia highlighted a number of side-effects that are usually linked to the use of the drug, such as weight gain, increased levels of bad cholesterol and fluid retention.

However, Lawson Macartney, head of GlaxoSmithKline's cardiovascular and metabolic medicine development center, told an agency that the data underscore the fact Avandia performs significantly better than older drugs.

"Metformin performed well, but Avandia performed better," he said, noting that the data also support the effectiveness of combination therapy with both drugs in earlier-stage diabetes.

The trial showed that Avandia had clearer beneficial effect on older people and on those with a larger waist circumference.

Type-2 diabetes, the most common form of diabetes, is a chronic disease marked by high levels of sugar in the blood, and is more prevalent among older, overweight people. In addition to Avandia, GlaxoSmithKline's diabetes portfolio includes Avandamet, which is a combination of Avandia and metformin, as well as Avandaryl, which combines Avandia with glimepiride, an older oral antidiabetic.

GlaxoSmithKline is planning to file the results of the trial with drug regulators worldwide in the first half of 2007, Macartney said.

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