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Study finds no increased progression of retinopathy with sanofi-aventis' Lantus
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by Matthew Dennis firstword.com
July 06, 2009
Sanofi-aventis announced Monday that a 5-year study of Lantus (insulin glargine) found no increased progression of retinopathy in patients with type 2 diabetes compared to human NPH insulin. The results, published in the journal Diabetologia, indicated that "Lantus does not have mitogenic effects different from the human NPH insulin within the eye," the company said.
The trial involved 1024 patients with type 2 diabetes who were randomised to receive either once-daily Lantus or twice-daily NPH insulin. Results showed similar effects on retinopathy progression in both groups at the end of the study, with 14.2 percent of patients who were treated with Lantus experiencing an increased progression of retinopathy from baseline that was greater than or equal to a pre-specified severity measure, compared with 15.7 percent of patients treated with NPH insulin. Sanofi-aventis also noted that there was "no observable trend for a difference in the incidence of serious adverse events, including cancer," between the treatments.
Data from four studies published last month in Diabetologia suggested that there may be a link between the use of Lantus and an increased risk of cancer. Sanofi-aventis CEO Chris Viehbacher said the studies had significant limitations and reiterated that the company has not found "any evidence of increased risk" associated with the insulin analogue.
Reference Articles
Sanofi's Lantus didn't raise blindness risk in study - (Bloomberg)
Sanofi says diabetes drug not riskier than insulin - (CNBC)
Similar progression of diabetic retinopathy with insulin glargine and neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes: a long-term, randomised, open-label study - (Diabetologia)
Sanofi-aventis: study shows long-term safety of Lantus - (Easybourse)
Sanofi-Aventis study shows Lantus safety on eyes - (Yahoo!Finance)
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