Evidence map›Paper›PMID 16872244›Full record

Trial reportDrug safety2006

Effect of ezetimibe and/or simvastatin on coenzyme Q10 levels in plasma: a randomised trial.

Heiner K Berthold, Ali Naini, Salvatore Di Mauro, Maarit Hallikainen, Helena Gylling, Wilhelm Krone, Ioanna Gouni-Berthold

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Drug safety, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 4 pooled it
3.7field-weighted citation impact, top 7% 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.

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

30 citing papers in PubMed, 4 syntheses or guidelines pooled it, 84 citations in OpenAlex.

  1. Coenzyme Q10 for heart failure.The Cochrane database of systematic reviews · 2021
    Pooled it
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  9. Article
  10. Association of Coenzyme Q10 with Premature Ovarian Insufficiency.Reproductive sciences (Thousand Oaks, Calif.) · 2023
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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

7 authors at 5 institutions in 3 countries.

Heiner K BertholdDrug Commission of the German Medical Association, Berlin, Germany. berthold@uni-bonn.de
Ali Naini
Salvatore Di Mauro
Maarit Hallikainen
Helena Gylling
Wilhelm Krone
Ioanna Gouni-Berthold
Columbia University Irving Medical Center · USUniversity of Cologne · DEArzneimittelkommission der deutschen ÄrzteschaftKuopio University Hospital · FIUniversity of Eastern Finland · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHMG-CoA reductase inhibitors ('statins') have been associated with a decrease in ubidecarenone (ubiquinone) levels, a lipophilic enzyme also known as coenzyme Q10 (CoQ10), due to inhibition of mevalonate synthesis. There is speculation that a decrease in CoQ10 levels may be associated with statin-induced myopathy. The cholesterol absorption inhibitor ezetimibe increases endogenous cholesterol synthesis. The purpose of this study was to examine (i) the effects of ezetimibe and simvastatin on plasma CoQ10 levels and (ii) whether ezetimibe coadministered with simvastatin abrogates the suggested statin-induced decrease in the CoQ10 plasma levels.

methodsSeventy-two healthy male subjects were enrolled in a single-centre, randomised, parallel-group study with three arms. Subjects received ezetimibe 10 mg/day, simvastatin 40 mg/day or the combination of ezetimibe 10 mg/day plus simvastatin 40 mg/day for 14 days.

resultsBaseline CoQ10 (0.99 +/- 0.30 mg/L) levels for the combined groups remained unchanged in the ezetimibe group (0.95 +/- 0.24 mg/L), and significantly decreased in the simvastatin and combination groups (0.82 +/- 0.18 mg/L, p = 0.0002 and 0.7 +/- 0.22 mg/L, p < 0.0001, respectively). There was a correlation between the percentage change in the levels of low-density lipoprotein-cholesterol (LDL-C) and the percentage change in CoQ10 levels in all treatment groups (correlation coefficient [R] = 0.67, p < 0.0001). The ratios of CoQ10 levels to LDL-C levels were significantly increased in all treatment groups (p < 0.0001). CoQ10 level was independent of cholesterol synthesis or absorption markers.

conclusionsSimvastatin and the combination of simvastatin and ezetimibe significantly decrease plasma CoQ10 levels whereas ezetimibe monotherapy does not. There is a significant correlation between the CoQ10 level decrease and the decrease in total and LDL-C levels in all three treatment groups, suggesting that the CoQ10 decrease may reflect the decrease in the levels of its lipoprotein carriers and might not be statin-specific. The statin-associated CoQ10 reduction is not abrogated through ezetimibe coadministration. Changes of CoQ10 levels are independent of cholesterol synthesis and absorption.

Indexed as

AdultAnticholesteremic AgentsAzetidinesCholestanolCholesterolCholesterol, LDLCoenzymesDrug CombinationsEzetimibe, Simvastatin Drug CombinationHumansLipid MetabolismLogistic ModelsMaleMiddle AgedReference ValuesSimvastatinAnticholesteremic AgentsAzetidinesCholestanolCholesterolCholesterol, LDLcoenzyme Q10CoenzymesDrug CombinationsEzetimibe, Simvastatin Drug CombinationlathosterolSimvastatinUbiquinone

Identifiers

PMID16872244
OpenAlexW1969057629

What OpenQuestion holds

Textmetadata
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.