Evidence map›Paper›PMID 28460629›Full record

Trial reportBMC nephrology2017

Effect on non-vascular outcomes of lowering LDL cholesterol in patients with chronic kidney disease: results from the Study of Heart and Renal Protection.

C Reith, N Staplin, W G Herrington, W Stevens, J Emberson, R Haynes, M Mafham, J Armitage, A Cass, J C Craig and 5 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC nephrology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00125593 (Study of Heart and Renal Protection), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 21% 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.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · 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.

NCT00125593 phase4completednot on this map

Study of Heart and Renal Protection (SHARP): The Effects of Lowering LDL-cholesterol With Simvastatin 20mg Plus Ezetimibe 10mg in Patients With Chronic Kidney Disease: a Randomized Placebo-controlled Trial

TypeinterventionalSponsorUniversity of OxfordRan2003 to 2010Enrolled9,438ConditionsKidney Disease, ChronicArmsSimvastatin 20 mg, Ezetimibe 10mg, Placebo
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

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

Corrections and comments

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

5 · Who and what money

Authors and funding

15 authors at 4 institutions in 4 countries.

C ReithNuffield Department of Population Health (NDPH), University of Oxford, Oxford, UK. christina.reith@ndph.ox.ac.uk.ORCID http://orcid.org/0000-0001-7448-9847
N StaplinNuffield Department of Population Health (NDPH), University of Oxford, Oxford, UK.
W G HerringtonNuffield Department of Population Health (NDPH), University of Oxford, Oxford, UK.
W StevensNuffield Department of Population Health (NDPH), University of Oxford, Oxford, UK.
J EmbersonNuffield Department of Population Health (NDPH), University of Oxford, Oxford, UK.
R HaynesNuffield Department of Population Health (NDPH), University of Oxford, Oxford, UK.
M MafhamNuffield Department of Population Health (NDPH), University of Oxford, Oxford, UK.
J ArmitageNuffield Department of Population Health (NDPH), University of Oxford, Oxford, UK.
A CassMenzies School of Health Research, Charles Darwin University, Darwin, Australia.
J C CraigSydney School of Public Health, University of Sydney, Sydney, Australia.
L JiangCardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.
T PedersenCentre of Preventive Medicine, Oslo University Hospital, Oslo, Norway.
C BaigentNuffield Department of Population Health (NDPH), University of Oxford, Oxford, UK.
M J LandrayNuffield Department of Population Health (NDPH), University of Oxford, Oxford, UK.
SHARP Collaborative Group
University of Oxford · GBOslo University Hospital · NOThe University of Sydney · AUCharles Darwin University · AU

Funding

British Heart Foundation CH/1996001/9454Medical Research Council MC_UU_12026/5
6 · The paper itself

Abstract

backgroundReducing LDL cholesterol (LDL-C) with statin-based therapy reduces the risk of major atherosclerotic events among patients with chronic kidney disease (CKD), with no evidence of an excess risk of cancer or death from any non-vascular cause. However, non-randomized data have suggested that statin therapy may have effects (both adverse and beneficial) on particular non-vascular conditions that do not cause death.

methodsThe Study of Heart and Renal Protection (SHARP) randomized patients with CKD to simvastatin 20 mg plus ezetimibe 10 mg (simvastatin/ezetimibe) daily versus matching placebo. Participants were followed up at least 6 monthly and all post-randomization serious adverse events (SAEs) were recorded. This supplementary analysis reports the effects of treatment on non-vascular SAEs, overall, by system of disease, by baseline characteristics, and by duration of follow-up.

resultsDuring a median of 4.9 years follow-up, similar numbers of participants in the two groups experienced at least one non-vascular SAE (3551 [76.4%] simvastatin/ezetimibe vs 3537 [76.6%] placebo; risk ratio [RR] 0.99, 95% confidence interval [CI] 0.95-1.04). There was no good evidence of any significant effect of simvastatin/ezetimibe on SAEs attributed to any particular nonvascular disease system (of 43 comparisons, only 3 yielded an uncorrected p value < 0.05, of which the smallest was p = 0.02). The relative risk of any nonvascular SAE did not vary significantly among particular prognostic subgroups or by duration of follow-up.

conclusionsIn the SHARP trial, allocation to simvastatin/ezetimibe combination therapy was not associated with any significant non-vascular hazard. TRIALS REGISTRATION: SHARP was retrospectively registered after the first participant was enrolled in 2003 at ISRCTN (ISRCTN54137607 on 31 January 2005: http://www.isrctn.com/ISRCTN54137607) and ClinicalTrials.gov (NCT00125593 on 29 July 2005: https://clinicaltrials.gov/ct2/show/NCT00125593).

Indexed as

AdultAgedAged, 80 and overAnticholesteremic AgentsCausalityCholesterol, LDLComorbidityDrug-Related Side Effects and Adverse ReactionsFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypercholesterolemiaIncidenceInternationalityMaleMiddle AgedAnticholesteremic AgentsCholesterol, LDLHydroxymethylglutaryl-CoA Reductase Inhibitors

Identifiers

PMID28460629
PMCPMC5412040
OpenAlexW2610717454

What OpenQuestion holds

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LicenceCC BY
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.