(ChemotherapyAdvisor) – Use of basal insulin glargine (Lantus) to target normal fasting plasma glucose levels for more than six years had a neutral effect on cardiovascular outcomes and cancers, results of the ORIGIN study published in the New England Journal of Medicine online June 11 and presented at the American Diabetes Association (ADA) 72nd Scientific Sessions has found.
The ORIGIN study found that at a median follow-up of 6.2 years, insulin glargine “maintained near-normal glycemic control and slowed progression of dysglycemia, but it was associated with a modest increase in hypoglycemic episodes and in weight.” The trial randomly assigned 12,537 people with cardiovascular risk factors plus impaired fasting glucose, impaired glucose tolerance, or type 2 diabetes to insulin glargine (with a target fasting blood glucose level of ≤95mg/dL) or standard care and n–3 fatty acids or placebo. Mean age was 63.5 years.
No significant difference was observed in incidence of any cancer (HR 1.00; P=0.97), death from cancer (HR 0.94; P=0.52), or breast, lung, colon, prostate, melanoma, or other cancers.
Also presented at the ADA meeting were results from three retrospective epidemiology studies sponsored by Sanofi, the manufacturer of insulin glargine, providing further evidence of no increase in cancer risk in people with diabetes treated with insulin glargine vs. other insulins.
- The Northern European Database Study includes 447,821 users of insulin from Denmark, Finland, Norway, Sweden, and Scotland. Average follow-up time is 3.1 years for patients on glargine and 3.5 years for those on other insulins. No evidence of an increased risk of breast cancer in women (HR 1.12), prostate cancer in men (HR 1.11), or colorectal cancer in men and women (HR 0.86) in users of insulin glargine vs. other insulins was observed. In addition, no evidence of an increased risk in users of insulin glargine vs. other insulins was found for risk of all forms of cancer combined or risk of lung or pancreatic cancer.
- Results from the Kaiser-Permanente Collaboration of 115,000 patients with a median duration of 1.2 years for glargine use and 1.4 years for neutral protamine Hagedorn (NPH) among all insulin users found no association between insulin glargine use and increased risk of breast cancer (HR 1.0), prostate cancer (HR 0.7), or colorectal cancer (HR 1.0), or between insulin glargine use and increased risk of all cancers combined (HR 0.9).
- The MedAssurant Database, with 43,306 patients on glargine and 9,147 on NPH and a mean duration of treatment of 1.2 years for glargine and 1.1 years for NPH, found no evidence of an increased risk for cancer; specifically, breast cancer.
Additional results are expected from the International Study of Insulin and Cancer (ISICA), which is expected to be completed this year.