Evidence map›Paper›PMID 22115874›Full record

Trial reportLancet (London, England)2011

Effects on 11-year mortality and morbidity of lowering LDL cholesterol with simvastatin for about 5 years in 20,536 high-risk individuals: a randomised controlled trial.

Heart Protection Study Collaborative Group

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lancet (London, England), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 215 papers, 24 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
215citing papers in PubMed, 24 pooled it
–field-weighted citation impact
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.

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

3 · Its place in the literature

Who cites it

215 citing papers in PubMed, 24 syntheses or guidelines pooled it.

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  3. Pravastatin for lowering lipids.The Cochrane database of systematic reviews · 2023 · on this map
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  8. Guideline
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  10. Clinical significance of 'cardiometabolic memory': a systematic review of randomized controlled trials.Hypertension research : official journal of the Japanese Society of Hypertension · 2017
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  14. Guideline
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  18. Dietary advice for reducing cardiovascular risk.The Cochrane database of systematic reviews · 2013
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  19. Statins for the primary prevention of cardiovascular disease.The Cochrane database of systematic reviews · 2013 · on this map
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  20. Pooled it

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

1 author.

Heart Protection Study Collaborative Group

Funding

British Heart FoundationMedical Research Council MC_EX_G0801669Medical Research Council MC_U137686853
6 · The paper itself

Abstract

backgroundFindings of large randomised trials have shown that lowering LDL cholesterol with statins reduces vascular morbidity and mortality rapidly, but limited evidence exists about the long-term efficacy and safety of statin treatment. The aim of the extended follow-up of the Heart Protection Study (HPS) is to assess long-term efficacy and safety of lowering LDL cholesterol with statins, and here we report cause-specific mortality and major morbidity in the in-trial and post-trial periods.

methods20,536 patients at high risk of vascular and non-vascular outcomes were allocated either 40 mg simvastatin daily or placebo, using minimised randomisation. Mean in-trial follow-up was 5·3 years (SD 1·2), and post-trial follow-up of surviving patients yielded a mean total duration of 11·0 years (SD 0·6). The primary outcome of the long-term follow-up of HPS was first post-randomisation major vascular event, and analysis was by intention to treat. This trial is registered with ISRCTN, number 48489393.

findingsDuring the in-trial period, allocation to simvastatin yielded an average reduction in LDL cholesterol of 1·0 mmol/L and a proportional decrease in major vascular events of 23% (95% CI 19-28; p<0·0001), with significant divergence each year after the first. During the post-trial period (when statin use and lipid concentrations were similar in both groups), no further significant reductions were noted in either major vascular events (risk ratio [RR] 0·95 [0·89-1·02]) or vascular mortality (0·98 [0·90-1·07]). During the combined in-trial and post-trial periods, no significant differences were recorded in cancer incidence at all sites (0·98 [0·92-1·05]) or any particular site, or in mortality attributed to cancer (1·01 [0·92-1·11]) or to non-vascular causes (0·96 [0·89-1·03]).

interpretationMore prolonged LDL-lowering statin treatment produces larger absolute reductions in vascular events. Moreover, even after study treatment stopped in HPS, benefits persisted for at least 5 years without any evidence of emerging hazards. These findings provide further support for the prompt initiation and long-term continuation of statin treatment.

fundingUK Medical Research Council, British Heart Foundation, Merck & Co, Roche Vitamins.

Indexed as

AdultAgedAged, 80 and overCholesterolCholesterol, LDLFemaleFollow-Up StudiesHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypercholesterolemiaMaleMiddle AgedMyocardial InfarctionMyocardial RevascularizationNeoplasmsSimvastatinCholesterolCholesterol, LDLHydroxymethylglutaryl-CoA Reductase InhibitorsSimvastatin

Identifiers

PMID22115874
PMCPMC3242163

What OpenQuestion holds

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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 OpenQuestion graph.