Australian Diabetes Society Publishes New Guidance On Insulin

By Adriana Rehbein
Wednesday, 06 March, 2013



Australian Diabetes Society (ADS) Publishes New Guidance On Insulin Glargine (Lantus®), Amy Sanders reports.
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On a position statement published on the ADS website on 17 October 2012, the ADS reported in light of new data 123. “ADS believes that the current data do not support a relationship between the use of insulin glargine and malignancy. Patients with diabetes taking insulin glargine (Lantus®) do not need to change their insulin therapy. Patients with diabetes can be initiated on glargine therapy without concern that insulin glargine will increase the risk of developing a malignancy.”
Commenting on this updated position, Associate Professor Michael d’Emden, Vice President of the ADS, said “The recent data reiterates to prescribers that insulin glargine does not increase the incidence of cancer, and specifically there is no increase in breast cancer rates.”
Dr Tal Rapke, Sanofi Acting Medical Director, said “Sanofi welcomes this updated statement which helps bring clarity to patients and doctors on the appropriateness of insulin glargine as a treatment for patients with diabetes.”
The announcement from the ADS comes on the back of the results of a large-scale epidemiological program, conducted by independent researchers in the northern European countries, at Kaiser Permanente in Northern and Southern California, and at the University of North Carolina in the United States, providing further evidence3 that there was no increased risk of cancer in people withdiabetes treated with Lantus compared to those treated with other insulins.
In June 2009, online publications in the diabetes journal Diabetologia suggested an association between insulin glargine (Lantus ®) and increased risk of cancer. The articles were published in the September 2009 issue.
These population studies collectively suggested there may be a link between glargine (Lantus ®) and cancer risk. Specifically, there was an association between glargine (Lantus ®) when used alone and breast cancer. However, these articles were widely criticized and the statistical methods used were unorthodox.
An online publication summarising controlled trials in >10,000 patients with type 1 or type 2 diabetes reported no significant difference in the incidence of malignancies, including breast cancer (1).
In a 5-year open-label randomised clinical trial in 1017 patients with type 2 diabetes, the overall rate of malignancies was similar in the insulin glargine and NPH groups (insulin glargine 23 (4.5%); NPH 32 (6.4%)) (2). The number of patients with breast cancer was also similar (insulin glargine 3 (0.6%), NPH 4 (0.8%)).
Recently, the results of the ORIGIN (Outcome Reduction with Initial Glargine Intervention) study were published (3). ORIGIN was a randomised, controlled study of >12,500 people assigned to treatment with insulin glargine or placebo.
Cancer was a pre-specified secondary outcome measure. There was no increase in risk of any cancer (Hazard ratio 1.00 (0.88-1.13)), death from cancer (HR 0.94 (0.77-1.15)) or death from any cause (HR 0.98 (0.90-1.08)). The results of the ORIGIN study suggested there is no increase in risk of cancer in that population, and specifically, there was no increase in the risk of breast cancer.
References:
1. Home PD and Lagarenne P. (2009) Combined randomised controlled trial experience of malignancies in studies using insulin glargine. Diabetologia. http://www.springerlink.com/content/r644844411g51752/fulltext.html
2. Rosenstock J et al. (2009) Similar risk of malignancy with insulin glargine and neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes: findings from a 5 year randomised, open-label study. Diabetologia. http://www.springerlink.com/content/131t04q531710g21/fulltext.html
3. ORIGIN Trial Investigators. (2012) Basal Insulin and Cardiovascular and Other Outcomes in Dysglycemia. New England Journal of Medicine, Michael d’Emden, DOI 10.1056/NEJMoa1203858

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