Trial reportLancet (London, England)2008

Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial.

Luigi Tavazzi, Aldo P Maggioni, Roberto Marchioli, Simona Barlera, Maria Grazia Franzosi, Roberto Latini, Donata Lucci, Gian Luigi Nicolosi, Maurizio Porcu, Gianni Tognoni and 1 more

3 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Lancet (London, England), 2008. The graph read 2 numbers from its abstract, feeding 1 cell of the map: it finds no clear difference in 1. It reports registered trial NCT00336336. Cited by 335 papers, 31 of them syntheses that pooled it.

2numbers the graph read from it
1cell of the map it votes in
335citing papers in PubMed, 31 pooled it
88.6field-weighted citation impact, top 1% 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 →
1 · no effect
Death or admission to hospital for cardiovascular reasonsrosuvastatin 10 mg daily vs placebono clear difference · heart_failure, dyslipidemiafeeds one cell of the map
HR 1.010.91 to 1.110.903
FINDINGS: We analysed all randomised patients. 657 (29%) patients died from any cause in the rosuvastatin group and 644 (28%) in the placebo group (adjusted hazard ratio [HR] 1.00 [95.5% CI 0.898-1.122], p=0.943). 1305 (57%) patients in the rosuvastatin group and 1283 (56%) in the placebo group died or were admitted to hospital for cardiovascular reasons (adjusted HR 1.01 [99% CI 0.908-1.112], p=0.903).
Death from any causerosuvastatin 10 mg daily vs placebono clear difference · heart_failure, dyslipidemiafeeds one cell of the map
HR 1.000.90 to 1.120.943
FINDINGS: We analysed all randomised patients. 657 (29%) patients died from any cause in the rosuvastatin group and 644 (28%) in the placebo group (adjusted hazard ratio [HR] 1.00 [95.5% CI 0.898-1.122], p=0.943). 1305 (57%) patients in the rosuvastatin group and 1283 (56%) in the placebo group died or were admitted to hospital for cardiovascular reasons (adjusted HR 1.01 [99% CI 0.908-1.112], p=0.903).

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×all-cause mortality

InconclusiveOpen on the map →What to test next →

14 readable studies in this cell: 3 favour the treatment, 9 find no difference, 2 favour the comparator.

Belief with this paper
0.50contested · 3 families support, 2 contradict · against placebo
Without it
0.50This paper does not move the number.
← favours the treatmentfavours the comparator →
1 · no effect
This paper6,975 enrolled · 2002
HR 1.000.90 to 1.12
NCT023442907,769 enrolled · 2015
HR 0.880.70 to 1.12
NCT03944512102 enrolled · 2019
RR 0.670.37 to 1.19
RR 0.990.89 to 1.11
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.

NCT00336336 phase3completed

A Large Scale Clinical Trial Testing the Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic Congestive Heart Failure

Ran2002Enrolled6,975Registered outcomes10Posted comparisons0ConditionsHeart FailureArmsn-3 PUFA, Placebo, Rosuvastatin
PMID 15302013PMID 18757090other papers from this trial
Open the trial in the graph
NCT06304896 phase1unknown statusnot on this mapstarted 2024, after this paper: background citation

Colchicine Versus Beta-blockers, Angiotensin-converting Enzyme Inhibitors, and Statins for Prevention of Chemotherapy-Induced Cardiomyopathy

TypeinterventionalSponsorArab Contractors Medical CentreRan2024 to 2025Enrolled150ConditionsChemotherapy Induced Systolic DysfunctionArmsCarvedilol, Ramipril, Rosuvastatin, Colchicine, Placebo
NCT07490054 phase1recruitingnot on this mapstarted 2025, after this paper: background citation

An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients With Chronic Heart Failure

TypeinterventionalSponsorMelana Yuzefpolskaya, MDRan2025 to 2027Enrolled40ConditionsChronic Heart FailureArmsMTP-101-C encapsulated Microbiota, Vancomycin, Neomycin
5 · Its place in the literature

Who cites it

335 citing papers in PubMed, 31 syntheses or guidelines pooled it, 1,100 citations in OpenAlex.

  1. Pooled it
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  3. Statins for the primary prevention of venous thromboembolism.The Cochrane database of systematic reviews · 2024
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  5. Benefits and Risks of Antihyperlipidemic Medication in Adults with Different Low-Density Lipoprotein Cholesterol Based on the Number Needed to Treat.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2024 · on this map
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  14. Prevalence of statin intolerance: a meta-analysis.European heart journal · 2022 · on this map
    Pooled it
  15. Pooled it
  16. Marine-derived n-3 fatty acids therapy for stroke.The Cochrane database of systematic reviews · 2022
    Pooled it
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  18. Residual inflammatory risk after contemporary lipid lowering therapy.European heart journal. Quality of care & clinical outcomes · 2020
    Pooled it
  19. Pooled it
  20. Omega-3 Polyunsaturated Fatty Acids and Stroke Burden.International journal of molecular sciences · 2019
    Pooled it

275 more citing papers are in PubMed but not listed here.

6 · The record

Corrections and comments

7 · Who and what money

Authors and funding

11 authors.

Luigi Tavazzi
Aldo P Maggioni
Roberto Marchioli
Simona Barlera
Maria Grazia Franzosi
Roberto Latini
Donata Lucci
Gian Luigi Nicolosi
Maurizio Porcu
Gianni Tognoni
Gissi-HF Investigators

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.

backgroundLarge observational studies, small prospective studies and post-hoc analyses of randomised clinical trials have suggested that statins could be beneficial in patients with chronic heart failure. However, previous studies have been methodologically weak. We investigated the efficacy and safety of the statin rosuvastatin in patients with heart failure.

methodsWe undertook a randomised, double-blind, placebo-controlled trial in 326 cardiology and 31 internal medicine centres in Italy. We enrolled patients aged 18 years or older with chronic heart failure of New York Heart Association class II-IV, irrespective of cause and left ventricular ejection fraction, and randomly assigned them to rosuvastatin 10 mg daily (n=2285) or placebo (n=2289) by a concealed, computerised telephone randomisation system. Patients were followed up for a median of 3.9 years (IQR 3.0-4.4). Primary endpoints were time to death, and time to death or admission to hospital for cardiovascular reasons. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00336336.

findingsWe analysed all randomised patients. 657 (29%) patients died from any cause in the rosuvastatin group and 644 (28%) in the placebo group (adjusted hazard ratio [HR] 1.00 [95.5% CI 0.898-1.122], p=0.943). 1305 (57%) patients in the rosuvastatin group and 1283 (56%) in the placebo group died or were admitted to hospital for cardiovascular reasons (adjusted HR 1.01 [99% CI 0.908-1.112], p=0.903). In both groups, gastrointestinal disorders were the most frequent adverse reaction (34 [1%] rosuvastatin group vs 44 [2%] placebo group).

interpretationRosuvastatin 10 mg daily did not affect clinical outcomes in patients with chronic heart failure of any cause, in whom the drug was safe.

Indexed as

AgedChronic DiseaseDouble-Blind MethodFemaleFluorobenzenesHeart FailureHospitalizationHumansHydroxymethylglutaryl-CoA Reductase InhibitorsItalyMaleProportional Hazards ModelsPyrimidinesRosuvastatin CalciumSulfonamidesFluorobenzenesHydroxymethylglutaryl-CoA Reductase InhibitorsPyrimidinesRosuvastatin CalciumSulfonamides

Identifiers

PMID18757089
OpenAlexW2116045728

What Socratic 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 Socratic graph.