Salicylate (salsalate) in patients with type 2 diabetes: a randomized trial.
Ann Intern Med
; 159(1): 1-12, 2013 Jul 02.
Article
em En
| MEDLINE
| ID: mdl-23817699
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Salicilatos
/
Anti-Inflamatórios não Esteroides
/
Diabetes Mellitus Tipo 2
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
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Adult
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Aged
/
Female
/
Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2013
Tipo de documento:
Article