Evidence map›Paper›PMID 21768544›Full record

Trial reportCirculation2011

Combined effects of ezetimibe and phytosterols on cholesterol metabolism: a randomized, controlled feeding study in humans.

Xiaobo Lin, Susan B Racette, Michael Lefevre, Lina Ma, Catherine Anderson Spearie, Karen Steger-May, Richard E Ostlund

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Circulation, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00863265. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
7.1field-weighted citation impact, top 3% 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.

NCT00863265 early_phase1completed

Regulation of Cholesterol Absorption: LDL Cholesterol Response to a Combination of Phytosterols and Ezetimibe (Phyto-3)

Ran2009Enrolled22Registered outcomes3Posted comparisons9ConditionsCoronary Heart Disease, HypercholesterolemiaArmsEzetimibe, Phytosterols + ezetimibe, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 63 citations in OpenAlex.

  1. Ezetimibe Increases Endogenous Cholesterol Excretion in Humans.Arteriosclerosis, thrombosis, and vascular biology · 2017
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Xiaobo LinDivision of Endocrinology, Metabolism, and Lipid Research, Department of Medicine, Washington University School of Medicine, St. Louis, MO 63110, USA.
Susan B Racette
Michael Lefevre
Lina Ma
Catherine Anderson Spearie
Karen Steger-May
Richard E Ostlund
Washington University in St. Louis · US

Funding

Washington University Center for Cellular ImagingP30CA091842 · NCI · WASHINGTON UNIVERSITY · PI TIMOTHY J. EBERLEIN · 2001 to 2026
$128.0M
Washington University Nutrition Obesity Research CenterP30DK056341 · NIDDK · WASHINGTON UNIVERSITY · PI Brian N Finck · 1999 to 2026
$30.2M
YOGA FOR THE MANAGEMENT OF HIV-METABOLIC SYNDROMESM01RR000036 · NCRR · WASHINGTON UNIVERSITY · PI NEWCOMER, JOHN W. · 1985 to 2007
$25.4M
TRANSGENICS COREP60DK020579 · NIDDK · WASHINGTON UNIVERSITY · PI SCHAFFER, JEAN E. · 1986 to 2012
$25.2M
YOGA LIFESTYLE INTERVENTION REDUCES BLOOD PRESSURE IN HIV-INFECTED ADULTSP41RR000954 · NCRR · WASHINGTON UNIVERSITY · PI GROSS, MICHAEL L · 1985 to 2011
$16.0M
REGULATION OF INTESTINAL CHOLESTEROL ABSORPTIONR01HL050420 · NHLBI · WASHINGTON UNIVERSITY · PI OSTLUND, RICHARD E. · 1994 to 2008
$4.0M
NCI NIH HHS P30 CA091842NCI NIH HHS P30 CA 91842NCRR NIH HHS M01 RR000036NCRR NIH HHS MO1 RR-00036NCRR NIH HHS P41 RR000954NCRR NIH HHS RR-00954NHLBI NIH HHS R01 HL050420NIDDK NIH HHS P30 DK056341NIDDK NIH HHS P60 DK020579NIDDK NIH HHS P60-DK020579-30
6 · The paper itself

Abstract

backgroundBoth ezetimibe and phytosterols inhibit cholesterol absorption. We tested the hypothesis that the combination of ezetimibe and phytosterols is more effective than ezetimibe alone in altering cholesterol metabolism. METHODS AND

resultsTwenty-one mildly hypercholesterolemic subjects completed a randomized, double-blind, placebo-controlled, triple-crossover study. Each subject received a phytosterol-controlled diet plus (1) ezetimibe placebo+phytosterol placebo, (2) 10 mg/d ezetimibe+phytosterol placebo, and (3) 10 mg/d ezetimibe+2.5 g phytosterols for 3 weeks each. All meals were prepared in a metabolic kitchen. Primary outcomes were intestinal cholesterol absorption, fecal cholesterol excretion, and low-density lipoprotein cholesterol levels. The combined treatment resulted in significantly lower intestinal cholesterol absorption (598 mg/d; 95% confidence interval [CI], 368 to 828) relative to control (2161 mg/d; 95% CI, 1112 to 3209) and ezetimibe alone (1054 mg/d; 95% CI, 546 to 1561; both P<0.0001). Fecal cholesterol excretion was significantly greater (P<0.0001) with combined treatment (962 mg/d; 95% CI, 757 to 1168) relative to control (505 mg/d; 95% CI, 386 to 625) and ezetimibe alone (794 mg/d; 95% CI, 615 to 973). Plasma low-density lipoprotein cholesterol values during treatment with control, ezetimibe alone, and ezetimibe+phytosterols averaged 129 mg/dL (95% CI, 116 to 142), 108 mg/dL (95% CI, 97 to 119), and 101 mg/dL (95% CI, 90 to 112; (P<0.0001 relative to control).

conclusionThe addition of phytosterols to ezetimibe significantly enhanced the effects of ezetimibe on whole-body cholesterol metabolism and plasma low-density lipoprotein cholesterol. The large cumulative action of combined dietary and pharmacological treatment on cholesterol metabolism emphasizes the potential importance of dietary phytosterols as adjunctive therapy for the treatment of hypercholesterolemia. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT00863265.

Indexed as

AdultAgedAnticholesteremic AgentsAzetidinesCholesterol, DietaryCholesterol, LDLCombined Modality TherapyDrug SynergismEzetimibeFemaleHumansHypercholesterolemiaLipid MetabolismMaleMiddle AgedPhytosterolsAnticholesteremic AgentsAzetidinesCholesterol, DietaryCholesterol, LDLEzetimibePhytosterols

Identifiers

PMID21768544
PMCPMC3304455
OpenAlexW1978732012

What OpenQuestion holds

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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 OpenQuestion graph.