Aspirin-Like Treatment May Be Safe, Effective for Type 2 Diabetes

Jane Salodof MacNeil

May 03, 2004

May 3, 2004 (Boston) — Salsalate, an aspirin-like anti-inflammatory agent, has shown promise as a type 2 diabetes treatment in a small pilot study at the Joslin Clinic.

Robert J. Silver, MD, a fellow in endocrinology and diabetes at the Boston-based diabetes center, reported that 3.0 g taken orally for two weeks was enough to reduce blood fasting glucose by 9% in nine patients. Other benefits included reductions of 12% in triglyceride and 15% in free fatty acid levels.

"Salsalate may be a safe and effective treatment for type 2 diabetes," Dr. Silver concluded here at the American Association of Clinical Endocrinologists 13th annual meeting and clinical congress, where he presented data in an oral presentation and a poster.

The investigators were inspired by studies in rats that show high doses of aspirin can inhibit IIKKβ, a serine kinase that mediates insulin resistance and activates inflammation. Aspirin also has been shown to improve glucose metabolism in human type 2 diabetes patients, but it is not used because it can cause bleeding.

A commercially available, nonsteroidal anti-inflammatory drug (NSAID), salsalate is approved for the treatment of rheumatoid arthritis. Although similar to aspirin, it is not known to cause bleeding.

"Let's get higher levels of salicylates without the toxicity of aspirin," is how Dr. Silver described the thinking behind the investigation. The protocol also included 200 µg of misoprostol (Cytotec) as an added protection against ulcers.

An earlier experiment with 4.5 g daily of salsalate produced greater benefits for nine diabetes patients, but Dr. Silver said they all experienced mild to moderate tinnitus. Therefore, the investigators decided to try a lower dose.

The new experiment enrolled six women and three men with a mean age of 50 years. The subjects had an average HbA 1c of 8.2 and body mass index of 33 kg/m 2.

The patients' fasting glucose levels decreased from 201 mg/dL to 183 mg/dL, and their triglyceride levels declined from 150 mg/dL to 133 mg/dL. Free fatty acids levels decreased from .73 mEq/L to .62 mEq/L, but this was not statistically significant. No changes were reported in weight or cholesterol levels, and none of the patients developed tinnitus.

Dr. Silver said the investigators plan to continue exploring whether salsalate or other similar drugs could be safe alternatives for treating type 2 diabetes. "A great deal of research needs to be done, and we don't know necessarily that this dose is the most effective," he said.

AACE 13th Annual Meeting and Clinical Congress: Abstract 85. Presented April 30 and May 1, 2004.

Reviewed by Gary D. Vogin, MD

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