sanofi-aventis has issued the release of an Expert Statement by a multidisciplinary board of renowned international experts following an in-depth assessment of the recent publications of registry analyses with Lantus (insulin glargine [rDNA] injection) in Diabetologia.
The board of international specialists in the field of endocrinology, oncology and epidemiology have come to the conclusion, that all four published manuscripts have significant methodological limitations and shortcomings, and that they provide inconsistent and inconclusive results regarding a potential link between insulin glargine use and an increased risk of cancer.
According to Prof. Matthew Riddle, Professor of Medicine, Diabetes Section Head, Division of Endocrinology/Diabetes/Clinical Nutrition, Oregon Health Sciences University, Portland, OR, USA, the nature of these limitations and their potential magnitude are such that, individually or in aggregate, these studies provide inconsistent and inconclusive results which do not justify new clinical recommendations to patients".
This statement signed by 14 international experts following their independent, rigorous and thorough review of the published data, comes in the midst of a wave of recent releases from Health Authorities around the globe, such as the European Medicines Agency (EMEA), the US Food and Drug Administration (FDA), as well as patient and scientific association such as the American Diabetes Association (ADA), the American Association of Clinical Endocrinologists (AACE), the International Diabetes Federation (IDF) cautioning against over-interpretation of and over reaction to these data. The limitations of these studies were also highlighted by the authors of each publication and by EASD (European Association for the Study of Diabetes).
The recommendation of experts and regulatory bodies have proposed a set of actions to be implemented by the company and by independent experts or professional associations that they believe will lead to a clear and definite conclusion on this situation.
What we know about the safety of Lantus comes from a robust clinical program that includes prospective, randomized clinical trials, supported by solid post-marketing surveillance observations", said Dr. Jean-Pierre Lehner, chief medical officer, sanofi-aventis. "We are moving forward confidently with the external scientific and medical experts and health authorities toward next steps to resolve this controversy." Patient safety has always been the primary concern of the company.
sanofi-aventis has 80 years of experience in the development of insulins and stands behind the safety of Lantus. Extensive data involving over 70 000 patients in clinical studies, including randomized, controlled clinical trials that represent the gold standard of evidence and the results of post-marketing surveillance arising from 24 million patient-years of clinical experience do not indicate an association between insulin glargine and cancer.