Salicylate (Salsalate) in Patients With Type 2 Diabetes: A Randomized Trial

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Abstract

Background:

Short-duration studies show that salsalate improves glycemia in type 2 diabetes mellitus (T2DM).

Objective:

To assess 1-year efficacy and safety of salsalate in T2DM.

Design:

Placebo-controlled, parallel trial; computerized randomization and centralized allocation, with patients, providers, and researchers blinded to assignment. (ClinicalTrials.gov: NCT00799643)

Setting:

3 private practices and 18 academic centers in the United States.

Patients:

Persons aged 18 to 75 years with fasting glucose levels of 12.5 mmol/L or less (≤225 mg/dL) and hemoglobin A1c (HbA1c) levels of 7.0% to 9.5% who were treated for diabetes.

Intervention:

286 participants were randomly assigned (between January 2009 and July 2011) to 48 weeks of placebo (n = 140) or salsalate, 3.5 g/d (n = 146), in addition to current therapies, and 283 participants were analyzed (placebo, n = 137; salsalate, n = 146).

Measurements:

Change in hemoglobin A1c level (primary outcome) and safety and efficacy measures.

Results:

The mean HbA1c level over 48 weeks was 0.37% lower in the salsalate group than in the placebo group (95% CI, −0.53% to −0.21%; P < 0.001). Glycemia improved despite more reductions in concomitant diabetes medications in salsalate recipients than in placebo recipients. Lower circulating leukocyte, neutrophil, and lymphocyte counts show the anti-inflammatory effects of salsalate. Adiponectin and hematocrit levels increased more and fasting glucose, uric acid, and triglyceride levels decreased with salsalate, but weight and low-density lipoprotein cholesterol levels also increased. Urinary albumin levels increased but reversed on discontinuation; estimated glomerular filtration rates were unchanged.

Limitation:

Trial duration and number of patients studied were insufficient to determine long-term risk-benefit of salsalate in T2DM.

Conclusion:

Salsalate improves glycemia in patients with T2DM and decreases inflammatory mediators. Continued evaluation of mixed cardiorenal signals is warranted.

Primary Funding Source:

National Institutes of Health.

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