Jan. 28, 2008 -- A chemical cousin of aspirin that is more than a century old could prove to be the next big thing for type 2 diabetes treatment and even prevention if early studies are confirmed, researchers say.
The nonsteroidal anti-inflammatory drug salsalate is similar to aspirin but has a much lower risk for stomach bleeding at higher doses. It has been approved for decades for the treatment of arthritis pain.
In a newly published study, researchers from Harvard Medical School's Joslin Diabetes Center found that salsalate had a positive impact on blood sugar levels and inflammation in obese young adults at risk for developing type 2 diabetes.
The study was small, involving just 20 people who took salsalate or a placebo for only a month.
But Joslin researcher Allison B. Goldfine, MD, characterized the early findings as "very exciting," in part because salsalate has been proven to be a very safe drug over decades of use.
"This drug has been marketed for more than 40 years and the safety profile looks quite good," she tells WebMD.
Salsalate Targets Inflammation
The hope of the Joslin researchers was that salsalate would do the same thing with much less bleeding risk.
Their latest study included obese people in their 20s treated with either 4 grams of salsalate or placebo daily. Glucose levels were assessed at study entry and after a month of treatment, as was a key marker of inflammation.
Compared with placebo, salsalate was associated with a 13% reduction in fasting glucose levels and a 20% reduction in blood sugar response to an oral glucose tolerance test. The test measures the body's ability to control glucose after a patient consumes a specific amount of glucose. It can be used to diagnose diabetes.
Treatment with the anti-inflammatory drug was also associated with a 34% reduction in circulating levels of the inflammation marker C-reactive protein.
"This study is limited by the relatively small sample size and short-term duration," the researchers write in the February issue of the journal Diabetes Care. "However, the excellent efficacy ... in this proof of principle trial does support potential use of anti-inflammatory modulators for prevention of insulin resistance and diabetes."
More Studies Under Way
The preliminary findings prompted the National Institutes of Health to fund a much larger trial designed to examine the safety and effectiveness of salsalate as a treatment for diabetes.
The three-year trial is now under way at 16 diabetes centers across the U.S.
A three-month study evaluating salsalate for the prevention of diabetes in patients at high risk for developing the disease has also been funded, as has a study examining the drug's impact on cardiovascular disease in high-risk patients.
Joslin researcher Steven Shoelson, MD, PhD, tells WebMD that if early findings are confirmed, salsalate could prove to be even more beneficial than the widely prescribed diabetes drug metformin.
The generically available drug would also be much cheaper for patients than most other drugs used in the treatment of diabetes.
"If we establish that this drug works, it could be the second metformin, with the added benefit of possibly lowering the risk of cardiovascular disease" he says.