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

ABSTRACT: Short-duration studies show that salsalate improves glycemia in type 2 diabetes mellitus (T2DM).To assess 1-year efficacy and safety of salsalate in T2DM.Placebo-controlled, parallel trial; computerized randomization and centralized allocation, with patients, providers, and researchers blinded to assignment. (ClinicalTrials.gov: NCT00799643).3 private practices and 18 academic centers in the United States.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.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).Change in hemoglobin A1c level (primary outcome) and safety and efficacy measures.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.Trial duration and number of patients studied were insufficient to determine long-term risk-benefit of salsalate in T2DM.Salsalate improves glycemia in patients with T2DM and decreases inflammatory mediators. Continued evaluation of mixed cardiorenal signals is warranted.

SUBMITTER: Goldfine AB

PROVIDER: S-EPMC4128629 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature

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

Goldfine Allison B AB Fonseca Vivian V Jablonski Kathleen A KA Chen Yii-Der Ida YD Tipton Laura L Staten Myrlene A MA Shoelson Steven E SE

Annals of internal medicine 20130701 1

<h4>Background</h4>Short-duration studies show that salsalate improves glycemia in type 2 diabetes mellitus (T2DM).<h4>Objective</h4>To assess 1-year efficacy and safety of salsalate in T2DM.<h4>Design</h4>Placebo-controlled, parallel trial; computerized randomization and centralized allocation, with patients, providers, and researchers blinded to assignment. (ClinicalTrials.gov: NCT00799643).<h4>Setting</h4>3 private practices and 18 academic centers in the United States.<h4>Patients</h4>Person ...[more]

PMID: 23817699

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Project description:Salsalate, a nonacetylated prodrug of salicylate, has been shown to decrease blood glucose concentration in small studies.To compare the efficacy and safety of salsalate at different doses in patients with type 2 diabetes.Parallel randomized trial with computer-generated randomization and centralized allocation. Patients and investigators, including those assessing outcomes and performing analyses, were masked to group assignment. (ClinicalTrials.gov registration number: NCT00392678)3 private practices and 14 universities in the United States.Persons aged 18 to 75 years with fasting plasma glucose concentrations of 12.5 mmol/L or less (< or = 225 mg/dL) and hemoglobin A1c (HbA1c) levels of 7.0% to 9.5% treated by diet, exercise, and oral medication at stable doses for at least 8 weeks.After a 4-week, single-masked run-in period, patients were randomly assigned to receive placebo or salsalate in dosages of 3.0, 3.5, or 4.0 g/d for 14 weeks (27 patients each) in addition to their current therapy.Change in HbA1c was the primary outcome. Adverse effects and changes in measures of coronary risk and renal function were secondary outcomes.Higher proportions of patients in the 3 salsalate treatment groups experienced decreases in HbA1c levels of 0.5% or more from baseline (P = 0.009). Mean HbA1c changes were -0.36% (P = 0.02) at 3.0 g/d, -0.34% (P = 0.02) at 3.5 g/d, and -0.49% (P = 0.001) at 4.0 g/d compared with placebo. Other markers of glycemic control also improved in the 3 salsalate groups, as did circulating triglyceride and adiponectin concentrations. Mild hypoglycemia was more common with salsalate; documented events occurred only in patients taking sulfonylureas. Urine albumin concentrations increased in all salsalate groups compared with placebo. The drug was otherwise well tolerated.The number of patients studied and the trial duration were insufficient to warrant recommending the use of salsalate for type 2 diabetes at this time.Salsalate lowers HbA1c levels and improves other markers of glycemic control in patients with type 2 diabetes and may therefore provide a new avenue for treatment. Renal and cardiac safety of the drug require further evaluation.National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health.

Project description:BackgroundNational guidelines for managing diabetes set standards for care. We sought to determine whether a 1-year intensive multitherapy program resulted in greater goal attainment than usual care among patients with poorly controlled type 2 diabetes mellitus.MethodsWe identified patients with poorly controlled type 2 diabetes receiving outpatient care in the community or at our hospital. Patients 30-70 years of age with a hemoglobin A1c concentration of 8% or greater were randomly assigned to receive intensive multitherapy (n = 36) or usual care (n = 36).ResultsThe average hemoglobin A1c concentration at entry was 9.1% (standard deviation [SD] 1%) in the intensive therapy group and 9.3% (SD 1%) in the usual therapy group. By 12 months, a higher proportion of patients in the intensive therapy group than in the control group had achieved Canadian Diabetes Association (CDA) goals for hemoglobin A(1c) concentrations (goal < or = 7.0%: 35% v. 8%), diastolic blood pressure (goal < 80 mm Hg: 64% v. 37%), low-density lipoprotein cholesterol (LDL-C) levels (goal < 2.5 mmol/L: 53% v. 20%) and triglyceride levels (goal < 1.5 mmol/L: 44% v. 14%). There were no significant differences between the 2 groups in attaining the targets for fasting plasma glucose levels, systolic blood pressure or total cholesterol:high-density lipoprotein cholesterol ratio. None of the patients reached all CDA treatment goals. By 18 months, differences in goal attainment were no longer evident between the 2 groups, except for LDL-C levels. Quality of life, as measured by a specific questionnaire, increased in both groups, with a greater increase in the intensive therapy group (13% [SD 10%] v. 6% [SD 13%], p < 0.003).InterpretationIntensive multitherapy for patients with poorly controlled type 2 diabetes is successful in helping patients meet most of the goals set by a national diabetes association. However, 6 months after intensive therapy stopped and patients returned to usual care, the benefits had vanished.

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

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

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