“Despite this theoretical superiority of short-acting insulin analogues over regular human insulin, the risk to benefit ratio of short-acting insulin analogues in the treatment of patients with diabetes is still unclear.”
That statement was the basis for researchers to assess the effects of treatment with short-acting insulin analogues as opposed to treatment with Regular human insulin.
Referring to the Cochrane Library (2003, issue 4), Medline and Embase.com, Michael Schooff, MD, and Krista Ehlers, MD, of the Clarkson Family Medicine Residency Program in Omaha, Nebraska, conducted a search for randomized controlled trials of short-acting insulin analogues versus Regular human insulin.
Schooff and Ehlers found only a minor benefit of short-acting insulin analogues in the majority of patients with diabetes who are treated with insulin.
They write, “Until long-term efficacy and safety data are available, the authors suggest a cautious response to the vigorous promotion of insulin analogues. Because of fears of potentially carcinogenic and proliferative effects, most studies to date have excluded patients with advanced diabetic complications. For safety purposes, we need a long-term follow up of large numbers of patients who use short-acting insulin analogues.”
In response to this opinion, Eli Lilly told Diabetes Health, “It is important to know that Humalog has been FDA-approved and marketed by Lilly for nearly 10 years in the United States and has a proven safety profile. During that 10 year period, Humalog has been used by millions of U.S. patients. In addition, Lilly reports all adverse events that it receives—from patients, physicians, through employees, and through any other source—to the FDA. Consequently, there is a large number of patients who have been using Humalog on a long-term basis, and follow up is provided through the FDA’s adverse event reporting system.”
—American Family Physician, September 1, 2005