Trial reportJournal of vascular surgery2013

Statin use and lower extremity amputation risk in nonelderly diabetic patients.

Min-Woong Sohn, Judith L Meadows, Elissa H Oh, Elly Budiman-Mak, Todd A Lee, Neil J Stone, William B Pearce

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of vascular surgery, 2013. The graph read 2 numbers from its abstract, feeding 1 cell of the map, but none could be read as for or against, so it casts no vote. Cited by 16 papers.

2numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
3.2field-weighted citation impact, top 9% 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.

Read, but not usablea number the graph found but could not read as for or against

Lipidscomparator not stated · t1d, t2dfeeds one cell of the map
HR 0.650.42 to 0.99
Compared with patients who did not use cholesterol-lowering agents, statin users were 35% to 43% less likely to experience an LEA (HR, 0.65; 95% confidence interval [CI], 0.42-0.99) and a treatment failure (HR, 0.57; 95% CI, 0.54-0.60).
Lipidscomparator not stated · t1d, t2dfeeds one cell of the map
HR 0.570.54 to 0.60
Compared with patients who did not use cholesterol-lowering agents, statin users were 35% to 43% less likely to experience an LEA (HR, 0.65; 95% confidence interval [CI], 0.42-0.99) and a treatment failure (HR, 0.57; 95% CI, 0.54-0.60).

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×lipids

No readable resultOpen on the map →What to test next →

38 readable studies in this cell: 27 favour the treatment, 5 find no difference, 6 favour the comparator.

Belief with this paper
0.50contested · 21 families support, 7 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the treatmentfavours the comparator →
0 · no effect
NCT002899002,340 enrolled · 2006
Δ -13.2-16.8 to -9.60
reduced -66.0-73.0 to -58.0
NCT02546323543 enrolled · 2015
Δ -35.5-40.2 to -30.7
NCT01678820299 enrolled · 2012
Δ 0.50-4.80 to 5.80
NCT01218204287 enrolled · 2010
Δ 5.47-15.7 to 26.7
NCT0093525931 enrolled · 2009
Δ -51.7
reductions -33.6-38.8 to -28.4

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

5 · Its place in the literature

Who cites it

16 citing papers in PubMed, 50 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Peripheral vascular remodeling during ischemia.Frontiers in pharmacology · 2022
    Review
  6. Article
  7. Article
  8. Statins and Peripheral Arterial Disease: A Narrative Review.Frontiers in cardiovascular medicine · 2021
    Review
  9. Article
  10. Diagnosing and managing diabetic somatic and autonomic neuropathy.Therapeutic advances in endocrinology and metabolism · 2019
    Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
6 · The record

Corrections and comments

7 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Min-Woong SohnCenter for Management of Complex Chronic Care, Hines VA Hospital, Hines, Ill; Center for Healthcare Studies, Feinberg School of Medicine, Northwestern University, Chicago, Ill. Electronic address: min-woong.sohn@va.gov.
Judith L Meadows
Elissa H Oh
Elly Budiman-Mak
Todd A Lee
Neil J Stone
William B Pearce
Northwestern University · USEdward Hines, Jr. VA Hospital · USLoyola University Chicago · US

Funding

AHRQ HHS 1R01HS018542-01A2AHRQ HHS R01 HS018542NHLBI NIH HHS 5T32HL094293NHLBI NIH HHS T32 HL094293
8 · The paper itself

Abstract

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

objectiveTo examine the association between use of statin and nonstatin cholesterol-lowering medications and risk of nontraumatic major lower extremity amputations (LEAs) and treatment failure (LEA or death).

methodsA retrospective cohort of patients with Type I and Type 2 diabetes mellitus (diabetes) was followed for 5 years between 2004 and 2008. The follow-up exposure duration was divided into 90-day periods. Use of cholesterol-lowering agents, diabetic medications, hemoglobin A1c, body mass index, and systolic and diastolic blood pressures were observed in each period. Demographic factors were observed at baseline. Major risk factors of LEA including peripheral neuropathy, peripheral artery disease, and foot ulcers were observed at baseline and were updated for each period. LEA and deaths were assessed in each period and their hazard ratios (HRs) were estimated. The study took place in the U.S. Department of Veterans Affairs Healthcare system, and the subjects consisted of cholesterol drug-naïve patients with Type I or II diabetes who were treated in the U.S. Department of Veterans Affairs Healthcare system in 2003 and were <65 years old at the end of follow-up.

resultsOf 83,953 patients in the study cohort, 217 (0.3%) patients experienced a major LEA and 11,716 (14.0%) patients experienced an LEA or death (treatment failure) after a mean follow-up of 4.6 years. Compared with patients who did not use cholesterol-lowering agents, statin users were 35% to 43% less likely to experience an LEA (HR, 0.65; 95% confidence interval [CI], 0.42-0.99) and a treatment failure (HR, 0.57; 95% CI, 0.54-0.60). Users of other cholesterol-lowering medications were not significantly different in LEA risk (HR, 0.95; 95% CI, 0.35-2.60) but had a 41% lower risk of treatment failure (HR, 0.59; 95% CI, 0.51-0.68).

conclusionsThis is the first study to report a significant association between statin use and diminished amputation risk among patients with diabetes. In this nonrandomized cohort, beneficial effects of statin therapy were similar to that seen in large-scale clinical trial experience. For LEA risk, those given nonstatins did not have a statistically significant benefit and its effect on LEA risk was much smaller compared with statins. Unanswered questions to be explored in future studies include a comparison of statins of moderate vs high potency in those with high risk of coronary heart disease and an exploration of whether the effects seen in this study are simply effects of cholesterol-lowering or possibly pleiotropic effects.

Indexed as

Amputation, SurgicalDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetic FootDisease ProgressionFemaleFollow-Up StudiesHumansHydroxymethylglutaryl-CoA Reductase InhibitorsIllinoisLegMaleMiddle AgedRetrospective StudiesRisk AssessmentRisk FactorsHydroxymethylglutaryl-CoA Reductase Inhibitors

Identifiers

PMID23932803
PMCPMC3844128
OpenAlexW2076790234

What Socratic holds

Texttitle and abstract
LicenceTDM
Read underepoch 390

Registered trials

None linked

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 Socratic graph.