Trial reportJAMA cardiology2016

Effect of Targeting Inflammation With Salsalate: The TINSAL-CVD Randomized Clinical Trial on Progression of Coronary Plaque in Overweight and Obese Patients Using Statins.

Thomas H Hauser, Ninad Salastekar, Ernst J Schaefer, Tanvi Desai, Harvey L Goldfine, Kristen M Fowler, Griffin M Weber, Francine Welty, Melvin Clouse, Steven E Shoelson and 2 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in JAMA cardiology, 2016. The graph read 2 numbers from its abstract, feeding 1 cell of the map: it finds no clear difference in 1. It is linked to trial NCT00624923 (Targeting Inflammation Using Salsalate in CardioVascular Disease), which is not on this map. Cited by 29 papers, 2 of them syntheses that pooled it.

2numbers the graph read from it
1cell of the map it votes in
29citing papers in PubMed, 2 pooled it
6.9field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

← favours the treatmentfavours the comparator →
-11.09.000 · no effect
Cardiac & vascular functionno clear difference · against placebo · obesity, ascvdfeeds one cell of the map
Δ 3.00-11.0 to 9.00P = .87
Compared with baseline, there was no increase in noncalcified plaque volume in the placebo-treated patients and no difference in change between the salsalate and placebo groups (mean difference, -1 mm3; 95% CI, -11 to 9 mm3; P = .87).
Change in noncalcified plaque volumesalsalate vs placebono clear difference · obesity, ascvdfeeds one cell of the map
Δ -1.00-11.0 to 9.00.87
Compared with baseline, there was no increase in noncalcified plaque volume in the placebo-treated patients and no difference in change between the salsalate and placebo groups (mean difference, -1 mm3; 95% CI, -11 to 9 mm3; P = .87).

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Statins×cardiac & vascular function

InconclusiveOpen on the map →What to test next →

11 readable studies in this cell: 4 favour the treatment, 6 find no difference, 1 favour the comparator.

Belief with this paper
0.50contested · 3 families support, 3 contradict · against placebo
Without it
0.50This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2016
Δ 3.00-11.0 to 9.00
NCT023442907,769 enrolled · 2015
Δ -4.30-8.60 to -0.10
NCT02546323543 enrolled · 2015
Δ -0.01-0.02 to -0.00
NCT00728988499 enrolled · 2008
Δ 4.90-6.20 to 15.9
NCT0181335784 enrolled · 2013
Δ 0.00
4 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00624923 phase2 / phase3completednot on this map

Targeting Inflammation Using Salsalate in CardioVascular Disease (TINSAL-CVD)

TypeinterventionalSponsorJoslin Diabetes CenterRan2008 to 2016Enrolled340ConditionsCoronary Artery Disease, OverweightArmsSalsalate, Placebo
5 · Its place in the literature

Who cites it

29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Review
  9. Article
  10. Review
  11. Review
  12. MicroRNA-regulated B cells in obesity.Immunometabolism (Cobham, Surrey) · 2022
    Review
  13. Review
  14. Review
  15. Review
  16. Regression of human coronary artery plaque is associated with a high ratio of (18-hydroxy-eicosapentaenoic acid + resolvin E1) to leukotriene BFASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2021
    Article
  17. Article
  18. Article
  19. Article
  20. Review
6 · The record

Corrections and comments

7 · Who and what money

Authors and funding

12 authors at 5 institutions in 1 country.

Thomas H HauserDivision of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts2Harvard Medical School, Boston, Massachusetts.
Ninad SalastekarHarvard Medical School, Boston, Massachusetts3Department of Radiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts4Clinical Behavioral and Outcomes Research, Joslin Diabetes Center, Boston, Massachusetts.
Ernst J SchaeferCardiovascular Nutrition Laboratory, Human Nutrition Research Center on Aging at Tufts University, Boston, Massachusetts.
Tanvi DesaiHarvard Medical School, Boston, Massachusetts4Clinical Behavioral and Outcomes Research, Joslin Diabetes Center, Boston, Massachusetts.
Harvey L GoldfineThe Heart Center of MetroWest, Framingham, Massachusetts.
Kristen M FowlerClinical Behavioral and Outcomes Research, Joslin Diabetes Center, Boston, Massachusetts.
Griffin M WeberHarvard Medical School, Boston, Massachusetts7Division of Interdisciplinary Medicine and Biotechnology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Francine WeltyDivision of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts2Harvard Medical School, Boston, Massachusetts.
Melvin ClouseHarvard Medical School, Boston, Massachusetts3Department of Radiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Steven E ShoelsonHarvard Medical School, Boston, Massachusetts4Clinical Behavioral and Outcomes Research, Joslin Diabetes Center, Boston, Massachusetts.
Allison B GoldfineHarvard Medical School, Boston, Massachusetts4Clinical Behavioral and Outcomes Research, Joslin Diabetes Center, Boston, Massachusetts8Division of Endocrinology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Targeting Inflammation Using Salsalate in Cardiovascular Disease (TINSAL-CVD) Study Team
Beth Israel Deaconess Medical Center · USHarvard University · USJoslin Diabetes Center · USMetroWest Medical Center · USTufts University · US

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

importanceInflammation may contribute to pathological associations among obesity, diabetes mellitus, and cardiovascular disease.

objectiveTo determine whether targeting inflammation using salsalate compared with placebo reduces progression of noncalcified coronary artery plaque. DESIGN, SETTING, AND

participantsIn the Targeting Inflammation Using Salsalate in Cardiovascular Disease (TINSAL-CVD) trial participants were randomly assigned between September 23, 2008, and July 5, 2012, to 30 months of salsalate or placebo in addition to standard, guideline-based therapies. Randomization was computerized and centrally allocated, with patients, health care professionals, and researchers masked to treatment assignment. Participants were overweight and obese statin-using patients with established, stable coronary heart disease.

interventionsSalsalate (3.5 g/d) or placebo orally over 30 months. MAIN OUTCOMES AND MEASURES: The primary outcome was progression of noncalcified coronary artery plaque assessed by multidetector computed tomographic angiography. Secondary outcomes were other measures of safety and efficacy.

resultsTwo hundred fifty-seven participants were randomized to salsalate (n = 129) or placebo (n = 128). Their mean (SD) age was 60.8 (7.0) years, and 94.0% (236 of 251) were male. One hundred ninety participants (89 in the salsalate group and 101 in the placebo group) completed the study. Compared with baseline, there was no increase in noncalcified plaque volume in the placebo-treated patients and no difference in change between the salsalate and placebo groups (mean difference, -1 mm3; 95% CI, -11 to 9 mm3; P = .87). Salsalate treatment decreased total white blood cell, lymphocyte, monocyte, and neutrophil counts and increased adiponectin levels without change in C-reactive protein levels. Fasting glucose, triglycerides, uric acid, and bilirubin levels were decreased in the salsalate group compared with the placebo group, while hemoglobin levels were increased. Urinary albumin levels increased, with tinnitus and atrial arrhythmias more common, in the salsalate group compared with the placebo group. CONCLUSIONS AND RELEVANCE: Salsalate when added to current therapies that include a statin does not reduce progression of noncalcified coronary plaque volume assessed by multidetector computed tomographic angiography in statin-using patients with established, stable coronary heart disease. The absence of progression of noncalcified plaque volume in the placebo group may limit interpretation of the trial results.

trial registrationclinicaltrials.gov Identifier: NCT00624923.

Indexed as

ObesityOverweightAgedAnti-Inflammatory Agents, Non-SteroidalDouble-Blind MethodFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsInflammationMaleMiddle AgedPlaque, AtheroscleroticSalicylatesAnti-Inflammatory Agents, Non-SteroidalHydroxymethylglutaryl-CoA Reductase InhibitorsSalicylatessalicylsalicylic acid

Identifiers

PMID27438317
OpenAlexW2399826353

What OpenQuestion holds

Texttitle and abstract
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.