Salicylate (salsalate) in patients with type 2 diabetes: a randomized trial

AB Goldfine, V Fonseca, KA Jablonski… - Annals of internal …, 2013 - acpjournals.org
AB Goldfine, V Fonseca, KA Jablonski, YDI Chen, L Tipton, MA Staten, SE Shoelson
Annals of internal medicine, 2013acpjournals.org
Chinese translation 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 …
Chinese translation
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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