Observational studyCardiovascular diabetology2016

Moderate-intensity statin therapy seems ineffective in primary cardiovascular prevention in patients with type 2 diabetes complicated by nephropathy. A multicenter prospective 8 years follow up study.

Ferdinando Carlo Sasso, Nadia Lascar, Antonella Ascione, Ornella Carbonara, Luca De Nicola, Roberto Minutolo, Teresa Salvatore, Maria Rosaria Rizzo, Plinio Cirillo, Giuseppe Paolisso and 2 more

Registry-linked trialOpen access · goldFull text readMulticenter StudyObservational Study
In one paragraph

Observational study in Cardiovascular diabetology, 2016. The graph read 1 number from its abstract, feeding 1 cell of the map, but it casts no vote: the report of the main result of NCT00535925 is not on the map. It also reports an association that does not count as treatment evidence, such as HR 1.20 (1.04 to 1.39) for MACE. It reports registered trial NCT00535925. Cited by 10 papers, 1 of them a synthesis that pooled it.

1number the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 26% 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

MACEHbA1can association or prognostic statement, not a treatment comparison · ascvd, t2dfeeds one cell of the map
HR 1.201.04 to 1.39
HbA1c only showed a significant difference in the incidence of MACE between the two groups (HR 1.201, CI 1.041-1.387, p 0.012).

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×cardiovascular events

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

29 readable studies in this cell: 19 favour the treatment, 9 find no difference, 1 favour the comparator.

Belief with this paper
0.86replicated · 12 families support, 2 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the treatmentfavours the comparator →
1 · no effect
HR 0.750.64 to 0.88
NCT023442907,769 enrolled · 2015
HR 0.640.48 to 0.84
HR 0.880.69 to 1.11
NCT03944512102 enrolled · 2019
RR 0.670.37 to 1.19

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.

NCT00535925 phase4completed

Nephropathy in Type 2 Diabetes: Effects of an Intensive Multifactorial Intervention Trial on Cardio-renal Events.

Ran2005Enrolled850Registered outcomes2Posted comparisons1ConditionsDiabetic NephropathyArmsamlodipine, Aspirin, atenolol, Clonidine, doxazosin
PMID 16505495PMID 16877970other papers from this trial
Open the trial in the graph
5 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
6 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

7 · Who and what money

Authors and funding

12 authors at 2 institutions in 2 countries.

Ferdinando Carlo SassoDepartment of Internal and Experimental Medicine ''Magrassi-Lanzara'', Second University of Naples, Naples, Italy. ferdinando.sasso@unina2.it.ORCID 0000-0002-9142-7848
Nadia LascarSchool of Life and Health Sciences, Aston University, Birmingham, UK.
Antonella AscioneDepartment of Internal and Experimental Medicine ''Magrassi-Lanzara'', Second University of Naples, Naples, Italy.
Ornella CarbonaraDepartment of Internal and Experimental Medicine ''Magrassi-Lanzara'', Second University of Naples, Naples, Italy.
Luca De NicolaUnit of Nephrology, Second University of Naples, Naples, Italy.
Roberto MinutoloUnit of Nephrology, Second University of Naples, Naples, Italy.
Teresa SalvatoreDepartment of Internal and Experimental Medicine ''Magrassi-Lanzara'', Second University of Naples, Naples, Italy.
Maria Rosaria RizzoDepartment of Geriatrics and Metabolic Diseases, Second University of Naples, Naples, Italy.
Plinio CirilloDepartment of Advanced Biomedical Science, University of Naples Federico II, Naples, Italy.
Giuseppe PaolissoDepartment of Geriatrics and Metabolic Diseases, Second University of Naples, Naples, Italy.
Raffaele MarfellaDepartment of Geriatrics and Metabolic Diseases, Second University of Naples, Naples, Italy.
NID-2 study group
University of Campania "Luigi Vanvitelli" · ITAston University · GB

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.

backgroundAlthough numerous studies and metanalysis have shown the beneficial effect of statin therapy in CVD secondary prevention, there is still controversy such the use of statins for primary CVD prevention in patients with DM. The purpose of this study was to evaluate the occurrence of total major adverse cardio-vascular events (MACE) in a cohort of patients with type 2 diabetes complicated by nephropathy treated with statins, in order to verify real life effect of statin on CVD primary prevention.

methodsWe conducted an observational prospective multicenter study on 564 patients with type 2 diabetic nephropathy free of cardiovascular disease attending 21 national outpatient diabetes clinics and followed them up for 8 years. 169 of them were treated with statins (group A) while 395 were not on statins (group B).

resultsNotably, none of the patients was treated with a high-intensity statin therapy according to last ADA position statement. Total MACE occurred in 32 patients from group A and in 68 patients from group B. Fatal MACE occurred in 13 patients from group A and in 30 from group B; nonfatal MACE occurred in 19 patients from group A and in 38 patients from group B. The analysis of the Kaplan-Meier survival curves showed a not statistically significant difference in the incidence of total (p 0.758), fatal (p 0.474) and nonfatal (p 0.812) MACE between the two groups. HbA1c only showed a significant difference in the incidence of MACE between the two groups (HR 1.201, CI 1.041-1.387, p 0.012).

conclusionsThese findings suggest that, in a real clinical setting, moderate-intensity statin treatment is ineffective in cardiovascular primary prevention for patients with diabetic nephropathy. Trial registration ClinicalTrials.gov Identifier NCT00535925. Date of registration: September 24, 2007, retrospectively registered.

Indexed as

AgedAmbulatory CareBiomarkersCardiovascular DiseasesDiabetes Mellitus, Type 2Diabetic NephropathiesDrug Administration ScheduleFemaleFollow-Up StudiesGlycated HemoglobinHumansHydroxymethylglutaryl-CoA Reductase InhibitorsItalyKaplan-Meier EstimateMaleMiddle AgedBiomarkersGlycated Hemoglobinhemoglobin A1c protein, humanHydroxymethylglutaryl-CoA Reductase InhibitorsCVDDiabetesNephropathyPrimary preventionStatin

Identifiers

PMID27733159
PMCPMC5062846
OpenAlexW2531621030

What Socratic holds

Textfull text, public
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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 Socratic graph.