title: Salsalate improves glycaemia in overweight persons with diabetes risk factors of stable statin-treated cardiovascular disease: A 30-month randomized placebo-controlled trial.
abstract: To assess long-term efficacy and safety of salsalate to improve glycemia in persons with diabetes risk, who are overweight with statin-treated, stable coronary heart disease.
  
  
  
  Glycemic status was assessed in 192 persons without diabetes at baseline in a pre-specified secondary analysis from Targeting INflammation Using SALsalate in CardioVascular Disease (TINSAL-CVD), a multi-center, double-masked, randomized (1:1), placebo-controlled, parallel clinical trial.
  
  
  
  Participants were mostly Caucasian males, age 60±7 years, BMI 31.4±3.0 kg/m2, fasting glucose 92.8±11.0 mg/dL, and HbA1c 5.8±0.3%. Reductions in mean fasting glucose -5.70 mg/dL (95%CI: -7.44 to -3.97 mg/dL, P<0.001), HbA1c -0.11% (95%CI: -0.210 to -0.002%, P=0.046) and glycated serum protein -81.8 μg/mL (95%CI: -93.7 to -69.9 μg/mL, P<0.001) were demonstrated in salsalate compared to placebo-assigned groups over 30 months. Reductions in fasting glucose and glycated serum protein were greater with salsalate compared to placebo in participants with prediabetes compared to a normoglycemic sub-group (Pinteraction=0.018). Salsalate lowered total white blood cell counts (mean difference -0.7x103/μL, 95%CI: -1.0 to -0.4 x103/μL, P<0.001) and increased adiponectin (mean difference 1.8 μg/mL, 95%CI: 0.9 to 2.6 μg/mL, P<0.001) and albuminurea (16.7 μg/mg, 95%CI: 6.4 to 27.1 μg/mg, P<0.001) compared to placebo, consistent with previous results for patients with type 2 diabetes taking salsalate for shorter times.
  
  
  
  Salsalate improves glycemia in obese persons at increased risk for diabetes, and hence may decrease risk of incident type 2 diabetes. Salsalate may inform new therapeutic approaches for diabetes prevention, but renal safety may limit clinical utility.
authors.affiliation: Joslin Diabetes Center, Boston, Massachusetts.|Harvard Medical School, Boston, Massachusetts.
authors.forename: Ninad
authors.identifier: 0000-0002-3409-3706
authors.initials: N
authors.lastname: Salastekar
authors.affiliation: Joslin Diabetes Center, Boston, Massachusetts.|Harvard Medical School, Boston, Massachusetts.
authors.forename: Tanvi
authors.initials: T
authors.lastname: Desai
authors.affiliation: Harvard Medical School, Boston, Massachusetts.|Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Thomas
authors.initials: T
authors.lastname: Hauser
authors.affiliation: Tufts University School of Medicine, Boston, Massachusetts.|Boston Heart Diagnostics, Framingham, Massachusetts.
authors.forename: Ernst J
authors.initials: EJ
authors.lastname: Schaefer
authors.affiliation: Joslin Diabetes Center, Boston, Massachusetts.
authors.forename: Kristen
authors.initials: K
authors.lastname: Fowler
authors.affiliation: Joslin Diabetes Center, Boston, Massachusetts.
authors.forename: Stacey
authors.initials: S
authors.lastname: Joseph
authors.affiliation: Joslin Diabetes Center, Boston, Massachusetts.|Harvard Medical School, Boston, Massachusetts.
authors.forename: Steven E
authors.initials: SE
authors.lastname: Shoelson
authors.affiliation: Joslin Diabetes Center, Boston, Massachusetts.|Harvard Medical School, Boston, Massachusetts.|Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Allison B
authors.initials: AB
authors.lastname: Goldfine
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D002318:Cardiovascular Diseases / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D050177:Overweight / Q000097:blood* / Q000150:complications / Q000188:drug therapy*; D010919:Placebos; D011236:Prediabetic State / Q000097:blood* / Q000150:complications / Q000188:drug therapy*; D012307:Risk Factors; D012459:Salicylates / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D010919:Placebos; D012459:Salicylates; C014182:salicylsalicylic acid
keywords: clinical trial; glycaemic control; randomised trial; salsalate; type 2 diabetes