Cited by 251Diabetes Treatment and ManagementDiabetes Management and ResearchDiabetes, Cardiovascular Risks, and Lipoproteins

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

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Goldfine, Allison B., Fonseca, Vivian, Jablonski, Kathleen A., Chen, Yii-Der Ida, Tipton, Laura, Staten, Myrlene A., Shoelson, Steven E.·2013·Annals of Internal Medicine

DOI 10.7326/0003-4819-159-1-201307020-00003PMC PMC4128629

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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.

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Authors: Goldfine, A. B., Fonseca, V., Jablonski, K. A., Chen, Y.-D. I., Tipton, L., Staten, M. A., & Shoelson, S. E.
Affiliations: Tulane University (US)
Corresponding author: Shoelson, Steven E.
ORCID: Goldfine, Allison B.
Fonseca, Vivian
Chen, Yii-Der Ida
Tipton, Laura
Venue: Annals of Internal Medicine
Publisher: American College of Physicians
Published: 2013-07-02
Volume: 159
Issue: 1
Pages: 1-12
ISSN: 0003-4819 (ISSN-L)
1539-3704
DOI: 10.7326/0003-4819-159-1-201307020-00003
PMC: PMC4128629
OpenAlex: W2031980199
Cited by: 251
References: 55
Citations by year: 2026: 6 · 2025: 11 · 2024: 12 · 2023: 14 · 2022: 10 · 2021: 16 · 2020: 19 · 2019: 19 · 2018: 12 · 2017: 20 · 2016: 38 · 2015: 31 · 2014: 28 · 2013: 15
FWCI: 29.20
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.acpjournals.org/journal/aim/text-and-data-mining (tdm)
Locations: Annals of Internal Medicine (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: National Institutes of Health (UL1TR000124, UL1TR000454, 5p50hl083813-05)
National Heart, Lung, and Blood Institute (P50 HL83813, P50-HL083813)
National Institute of General Medical Sciences (U54GM104940)
National Institute of Diabetes and Digestive and Kidney Diseases (RC4DK090792, U01DK074556, P30 DK03836, P30DK036836, P30DK063491)
National Center for Advancing Translational Sciences
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Keywords: salsalate, type 2 diabetes, glycemic control, HbA1c, nonsteroidal anti-inflammatory drugs, anti-inflammatory activity, white blood cell count, adiponectin, uric acid, triglycerides, urinary albumin, estimated glomerular filtration rate, drug safety, long-term efficacy, weight gain
MeSH terms: Adolescent, Adult, Aged, Anti-Inflammatory Agents, Non-Steroidal, Blood Glucose, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Humans, Kidney, Male, Middle Aged, Salicylates, Single-Blind Method, Young Adult

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

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