June 11, 2012
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In a modern-day clinical trial of a medicine belonging to one of the world’s oldest classes of drugs, researchers have found that a drug related to aspirin and salicylate, which was first used by ancient Egyptians and Greeks to ease pain caused by inflammation, also has glucose-lowering properties and may be a potential treatment for people with type 2 diabetes, according to results presented at the American Diabetes Association’s 72nd Scientific Sessions®.
Salsalate, a pain medication used for decades as a treatment for rheumatoid arthritis, is notable for lacking many of the side effects of aspirin and is available as an inexpensive, generic prescription drug. Small, preliminary trials of salsalate indicated that it may be effective as a treatment for type 2 diabetes.
“The exciting thing here is that this drug is relatively inexpensive and has a long safety record for other uses, such as treating joint pain,” said Steven Shoelson, MD, PhD, Associate Director of Research at the Joslin Diabetes Center and Principal Investigator for the study. “We now have to determine whether the degree to which this drug lowers blood glucose levels is large enough to warrant using it as an addition to the diabetes drug armamentarium.”
In a year-long trial sponsored by the National Institutes of Health, researchers compared use of salsalate to placebo in 286 patients with type 2 diabetes and found that it reduced A1C levels (a measure of average blood glucose levels over time) by 0.24 percent and fasting blood glucose levels by 11 mg/dl over 48 weeks. Although these improvements may seem modest, the group taking salsalate achieved them while requiring lower doses of other diabetes medications compared to the control group.
Researchers also found evidence of the drug’s anti-inflammatory effects. White blood cell, neutrophil and lymphocyte counts decreased in those who took the drug, from high levels to lower levels within the normal range. While anti-inflammatory effects of salsalate have long been known, these particular effects have not been documented previously in clinical trials. In addition, those who took the drug saw an increase in adiponectin of 21 percent and a decrease in uric acid of 11 percent, suggesting some cardiovascular protective qualities and a potential reduction in risk for gout, which is often associated with diabetes.
Side effects included minimal weight gain of 2.2 pounds (1 kg) over the study’s duration and slightly elevated cholesterol (a rise of 8 mg/dl over a year). However, triglyceride levels dropped in those who took the drug, compared to those who took placebo. Finally, there was a small change in urinary albumin (1.8 micrograms per mg of creatinine), which reversed upon discontinuation of the drug, suggesting there may be some impact on kidney function. However, there was no change in glomerular filtration rate (GFR), which is considered the major indicator of kidney function.
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