No cancer link with Lantus, says Sanofi
pharmafile | December 7, 2011 | News story | Sales and Marketing | Cancer, Lantus, Sanofi, diabetes, insulin, safety
Sanofi has presented a new meta-analysis which suggests its insulin blockbuster Lantus does not raise the risk of cancer.
A link between Lantus – the world’s most widely used insulin product – and increased cancer risk was first suggested by four meta-analyses published by academics in 2009. A subsequent FDA review concluded the evidence was inconclusive because of limitations in the design and execution of the studies, but the controversy has refused to go away.
Further meta-analysis studies have found a raised risk of breast cancer in women using Lantus compared to human insulin users.
Now Sanofi has released its own meta-analysis, covering many more patients than previous reviews, which it says shows there is no link.
Its analysis draws on data from 80,000 patients enrolled in clinical trials and 38 million patient years of treatment exposure to Lantus (insulin glargine), and showed no increased risk in people using Lantus.
The meta-analysis on observational studies derived from databases as well as from randomised controlled clinical trials, and from a case-control study in numerous countries (such as Sweden, Germany, Scotland, England and Taiwan) assessed the risk for cancer in individuals with diabetes using different insulins.
“This important milestone highlights the need to go beyond single study reports and utilise all available data about a topic and place the findings from any single study in the context of all available information,” stated Dr. Peter Boyle, the study Principal Investigator and President of the International Prevention Research Institute (IPRI), Lyon, France.
“In the context of all available information, the current evidence supports that insulin glargine is associated with no increased risk of cancer as compared to other insulin therapies. These findings are reassuring for patients and their physicians.”
“These new data further reinforce the growing clinical evidence supporting the safety profile of Lantus,” said Dr. Jean-Pierre Lehner, Chief Medical Officer, Sanofi. “As an ethical company dedicated to patient safety, we welcome the coherence of these new data, which reinforce the clinical profile of Lantus, one of the most studied treatments in the management of diabetes.”
Large-scale epidemiology programme
Sanofi is committed to generating more data on the question, and in particular if there is a difference in risk between insulin glargine and other insulins.
The company is sponsoring a large-scale, methodologically robust epidemiology programme. Three large studies including two retrospective cohort studies and one case-control study are currently being conducted by independent investigators.
Final results of the first study based on Nordic databases will be communicated to regulatory agencies by the end of 2011, and scientific presentations are expected to follow in 2012.
Lantus is not the only diabetes treatment being examined for increased cancer risk. GLP-1 analogue products, Lilly’s Byetta and Novo Nordisk’s Victoza have been linked with increased risk of pancreatitis, which in turn raises the risk of tumours.
Both companies deny there is any convincing evidence to prove any such link. Meta-analyses have also linked Merck’s oral treatment for diabetes, Januvia (sitagliptin) with an increased risk of pancreatitis, but this has also rejected by its manufacturer.
Andrew McConaghie
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