PMID- 23817699
OWN - NLM
STAT- MEDLINE
DCOM- 20130918
LR  - 20240321
IS  - 1539-3704 (Electronic)
IS  - 0003-4819 (Print)
IS  - 0003-4819 (Linking)
VI  - 159
IP  - 1
DP  - 2013 Jul 2
TI  - Salicylate (salsalate) in patients with type 2 diabetes: a randomized trial.
PG  - 1-12
LID - 10.7326/0003-4819-159-1-201307020-00003 [doi]
AB  - 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.
FAU - Goldfine, Allison B
AU  - Goldfine AB
AD  - Joslin Diabetes Center and Harvard Medical School, Boston, Massachusetts 02215, 
      USA. allison.goldfine@joslin.harvard.edu
FAU - Fonseca, Vivian
AU  - Fonseca V
FAU - Jablonski, Kathleen A
AU  - Jablonski KA
FAU - Chen, Yii-Der Ida
AU  - Chen YD
FAU - Tipton, Laura
AU  - Tipton L
FAU - Staten, Myrlene A
AU  - Staten MA
FAU - Shoelson, Steven E
AU  - Shoelson SE
CN  - Targeting Inflammation Using Salsalate in Type 2 Diabetes Study Team
LA  - eng
SI  - ClinicalTrials.gov/NCT00799643
GR  - P30 DK03836/DK/NIDDK NIH HHS/United States
GR  - P50 HL83813/HL/NHLBI NIH HHS/United States
GR  - U54 GM104940/GM/NIGMS NIH HHS/United States
GR  - P30 DK036836/DK/NIDDK NIH HHS/United States
GR  - P30 DK063491/DK/NIDDK NIH HHS/United States
GR  - UL1 TR000454/TR/NCATS NIH HHS/United States
GR  - U01 DK74556/DK/NIDDK NIH HHS/United States
GR  - P50 HL083813/HL/NHLBI NIH HHS/United States
GR  - RC4 DK090792/DK/NIDDK NIH HHS/United States
GR  - U01 DK074556/DK/NIDDK NIH HHS/United States
GR  - UL1 TR000124/TR/NCATS NIH HHS/United States
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PL  - United States
TA  - Ann Intern Med
JT  - Annals of internal medicine
JID - 0372351
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Salicylates)
RN  - V9MO595C9I (salicylsalicylic acid)
SB  - IM
SPIN- Ann Intern Med. 2013 Jul 2;159(1):I-32. PMID: 23817718
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Inflammatory Agents, Non-Steroidal/*administration & dosage/adverse effects
MH  - Blood Glucose/metabolism
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy/physiopathology
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Kidney/drug effects/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Salicylates/*administration & dosage/adverse effects
MH  - Single-Blind Method
MH  - Young Adult
PMC - PMC4128629
MID - NIHMS600363
COIS- Potential Conflicts of Interest: Disclosures can be viewed at 
      www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-2782.
FIR - Shoelson, Steven E
IR  - Shoelson SE
FIR - Goldfine, Allison B
IR  - Goldfine AB
FIR - Fonseca, Vivian
IR  - Fonseca V
FIR - Jablonski, Kathleen
IR  - Jablonski K
FIR - Staten, Myrlene
IR  - Staten M
FIR - Jablonski, Kathleen
IR  - Jablonski K
FIR - Pyle, Laura
IR  - Pyle L
FIR - Aroda, Vanita
IR  - Aroda V
FIR - Barzilay, Joshua
IR  - Barzilay J
FIR - Buse, John
IR  - Buse J
FIR - Crandall, Jill
IR  - Crandall J
FIR - Desouza, Cyrus
IR  - Desouza C
FIR - Donovan, Daniel
IR  - Donovan D
FIR - Dulin, Michael
IR  - Dulin M
FIR - Fonseca, Vivian
IR  - Fonseca V
FIR - Goldfine, Allison B
IR  - Goldfine AB
FIR - Henry, Robert
IR  - Henry R
FIR - Hershon, Kenneth
IR  - Hershon K
FIR - Lorber, Dan
IR  - Lorber D
FIR - Mather, Kieren
IR  - Mather K
FIR - Ovalle, Fernando
IR  - Ovalle F
FIR - Piziak, Veronica
IR  - Piziak V
FIR - Pop-Busui, Rodica
IR  - Pop-Busui R
FIR - Raskin, Philip
IR  - Raskin P
FIR - Rudo, Arthur
IR  - Rudo A
FIR - Umpierrez, Guillermo
IR  - Umpierrez G
FIR - Warren, Wayne
IR  - Warren W
EDAT- 2013/07/03 06:00
MHDA- 2013/09/21 06:00
PMCR- 2014/08/11
CRDT- 2013/07/03 06:00
PHST- 2013/07/03 06:00 [entrez]
PHST- 2013/07/03 06:00 [pubmed]
PHST- 2013/09/21 06:00 [medline]
PHST- 2014/08/11 00:00 [pmc-release]
AID - 1700640 [pii]
AID - 10.7326/0003-4819-159-1-201307020-00003 [doi]
PST - ppublish
SO  - Ann Intern Med. 2013 Jul 2;159(1):1-12. doi: 
      10.7326/0003-4819-159-1-201307020-00003.