Dataset Information

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:BackgroundSalsalate, a nonacetylated prodrug of salicylate, has been shown to decrease blood glucose concentration in small studies.ObjectiveTo compare the efficacy and safety of salsalate at different doses in patients with type 2 diabetes.DesignParallel 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)Setting3 private practices and 14 universities in the United States.PatientsPersons 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.InterventionAfter 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.MeasurementsChange in HbA1c was the primary outcome. Adverse effects and changes in measures of coronary risk and renal function were secondary outcomes.ResultsHigher 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.LimitationThe number of patients studied and the trial duration were insufficient to warrant recommending the use of salsalate for type 2 diabetes at this time.ConclusionSalsalate 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.Primary funding sourceNational Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health.

Project description:ImportanceClinical pharmacists and health coaches using mobile health (mHealth) tools, such as telehealth and text messaging, may improve blood glucose levels in African American and Latinx populations with type 2 diabetes.ObjectiveTo determine whether clinical pharmacists and health coaches using mHealth tools can improve hemoglobin A1c (HbA1c) levels.Design, setting, and participantsThis randomized clinical trial included 221 African American or Latinx patients with type 2 diabetes and elevated HbA1c (≥8%) from an academic medical center in Chicago. Adult patients aged 21 to 75 years were enrolled and randomized from March 23, 2017, through January 8, 2020. Patients randomized to the intervention group received mHealth diabetes support for 1 year followed by monitored usual diabetes care during a second year (follow-up duration, 24 months). Those randomized to the waiting list control group received usual diabetes care for 1 year followed by the mHealth diabetes intervention during a second year.InterventionsThe mHealth diabetes intervention included remote support (eg, review of glucose levels and medication intensification) from clinical pharmacists via a video telehealth platform. Health coach activities (eg, addressing barriers to medication use and assisting pharmacists in medication reconciliation and telehealth) occurred in person at participant homes and via phone calls and text messaging. Usual diabetes care comprised routine health care from patients' primary care physicians, including medication reconciliation and adjustment.Main outcomes and measuresOutcomes included HbA1c (primary outcome), blood pressure, cholesterol, body mass index, health-related quality of life, diabetes distress, diabetes self-efficacy, depressive symptoms, social support, medication-taking behavior, and diabetes self-care measured every 6 months.ResultsAmong the 221 participants (mean [SD] age, 55.2 [9.5] years; 154 women [69.7%], 148 African American adults [67.0%], and 73 Latinx adults [33.0%]), the baseline mean (SD) HbA1c level was 9.23% (1.53%). Over the initial 12 months, HbA1c improved by a mean of -0.79 percentage points in the intervention group compared with -0.24 percentage points in the waiting list control group (treatment effect, -0.62; 95% CI, -1.04 to -0.19; P = .005). Over the subsequent 12 months, a significant change in HbA1c was observed in the waiting list control group after they received the same intervention (mean change, -0.57 percentage points; P = .002), while the intervention group maintained benefit (mean change, 0.17 percentage points; P = .35). No between-group differences were found in adjusted models for secondary outcomes.Conclusions and relevanceIn this randomized clinical trial, HbA1c levels improved among African American and Latinx adults with type 2 diabetes. These findings suggest that a clinical pharmacist and health coach-delivered mobile health intervention can improve blood glucose levels in African American and Latinx populations and may help reduce racial and ethnic disparities.Trial registrationClinicalTrials.gov Identifier: NCT02990299.

Dataset Information

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

Publications

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

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