Generic Drug Salsalate Continues to Show Promise
We continue to monitor the progress of studies to determine the effectiveness of salsalate, a generic aspirin-like drug, to reduce inflammation and lower blood glucose in people with type 2 diabetes. As previously reported here in October 2008 and January 2009, researchers from the Joslin Diabetes Center at Harvard University are conducting clinical trials to determine if this well known and proven drug for joint pain can be added to the list of diabetes drugs. Recently, results from a three-month trial were announced online in the Annals of Internal Medicine, showing that those who took salsalate demonstrated significantly improved blood glucose levels.
This small trial, involving 108 patients, revealed that hemoglobin A1c levels dropped by 0.5% among those taking salsalate, a result that is on par with some recently released diabetes drugs. Other measures related to glucose were also improved. "These results are exciting," says Allison Goldfine, MD, Joslin's Director of Clinical Research, an Associate Professor at Harvard Medical School, and the first author of the article. "They indicate that salsalate may provide an effective, safe, and inexpensive new avenue for diabetes treatment. However, these findings are preliminary, and we do not recommend patients use this medication for their diabetes treatment until further studies are completed."
Research on the use of salsalate for diabetes was triggered by the investigations of Steven Shoelson, MD, PhD, head of the Joslin Diabetes Center's Section on Pathophysiology and Molecular Pharmacology as well as Professor at Harvard Medical School. In the 1990s, he discovered a report by a 19th century German doctor, which suggested that the anti-inflammatory agent sodium salicylate could be a diabetes treatment. Sodium salicylate, similar to aspirin, is a stomach irritant at high doses. The less irritating salsalate was considered as a treatment at that time, but it never caught on, "probably because people didn't know the difference between type 1 and type 2 diabetes," says Shoelson. Salsalate has no impact on type 1 diabetes. However, "modern-day thinking about inflammation being a mediator in [type 2] diabetes," he says, prompted his animal model research that found promising results from salsalate.
"It may turn out that this is an inexpensive and somewhat effective treatment for diabetes, but there are a lot of 'if's' that have to be answered along the way," says Robert Vigersky, president of the Endocrine Society and director of the Diabetes Institute at Walter Reed Army Medical Center. "It clearly is not as potent as Avandia and Actos," he says, "but it does add another drug that we can use in various combinations" for treatment. Dr. Vigersky is not involved in the current trial.
Pharmaceutical companies are interested in anti-inflammatories for diabetes treatments, but are not pursuing salsalate because of its generic status and lack of profit potential. "So we went for funding to the federal government, which has been interested in a safe, effective and inexpensive new drug for diabetes," states Dr. Shoelson. Salsalate studies, which are funded by the National Institute of Diabetes and Digestive and Kidney Diseases along with Joslin Center, are moving forward in a larger Phase 3 clinical trial. It is possible that salsalate could be used as an add-on treatment with other drugs, especially to reduce microvascular and macrovascular complications related to diabetes.
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