Evidence map›Paper›PMID 19783896›Full record

Trial reportJournal of endocrinological investigation2009

A multi-center, open label, crossover designed prospective study evaluating the effects of lipid lowering treatment on steroid synthesis in patients with Type 2 diabetes (MODEST Study).

M Kanat, E Serin, A Tunckale, O Yildiz, S Sahin, M Bolayirli, H Arinc, A Dirican, Y Karagoz, Y Altuntas and 2 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of endocrinological investigation, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 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

4 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Lipid-lowering efficacy of atorvastatin.The Cochrane database of systematic reviews · 2015 · on this map
    Pooled it
  2. Do statins decrease testosterone in men? Systematic review and meta-analysis.International braz j urol : official journal of the Brazilian Society of Urology
    Pooled it
  3. Acute Statin Administration Reduces Levels of Steroid Hormone Precursors.Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme · 2020
    Article
  4. Hypogonadism and metabolic syndrome.Journal of endocrinological investigation
    Review
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

12 authors.

M KanatDepartment of Internal Medicine, Izzet Baysal Medical School, Abant Izzet Baysal University, TR14280-Golkoy, Bolu, Turkey. mustafa.kanat@gmail.com
E Serin
A Tunckale
O Yildiz
S Sahin
M Bolayirli
H Arinc
A Dirican
Y Karagoz
Y Altuntas
H Celebi
A Oguz

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveIt has been suggested that lipid-lowering treatment with the use of statins adversely affects the steroid hormones. However, the safety of lipid lowering treatment targeting very low levels of LDL with respect to the steroid hormones has not been established. RESEARCH DESIGN AND

methodsA prospective, randomized, multicenter trial was conducted involving 98 patients. The patients were randomized into 2 groups: group-I received 10 mg of atorvastatin plus 10 mg of ezetimibe and group-II 80 mg of atorvastatin for the first 3 months. After crossover, the first group received 80 mg of atorvastatin and the second group 10 mg of atorvastatin plus 10 mg of ezetimibe for the following 3 months. Cortisol, DHEAS, testosterone, and estradiol levels were measured at the enrollment and at the end of the 1st, 2nd, 3rd, and 6th months.

resultsAlong with a decrease in LDL level, the levels of DHEAS, testosterone, and estradiol decreased in both groups (p<0.001). While cortisol levels were maintained in the group given 10 mg of atorvastatin plus 10 mg of ezetimibe, it decreased significantly after the crossover to 80 mg of atorvastatin (p<0.001). The group initially given 80 mg of atorvastatin measured a lower level of cortisol for the first 3 months and it returned to normal levels after switching to 10 mg of atorvastatin plus 10 mg of ezetimibe.

conclusionEighty milligrams of atorvastatin decreased all adrenal and gonadal steroids, whereas 10 mg of ezetimibe combined with 10 mg of atorvastatin had at least no impact on cortisol levels.

Indexed as

AdultAnalysis of VarianceAnticholesteremic AgentsAtorvastatinAzetidinesCholesterol, LDLCross-Over StudiesDehydroepiandrosteroneDiabetes Mellitus, Type 2Drug Administration ScheduleEstradiolEzetimibeFemaleHeptanoic AcidsHumansHydrocortisoneAnticholesteremic AgentsAtorvastatinAzetidinesCholesterol, LDLDehydroepiandrosteroneEstradiolEzetimibeHeptanoic AcidsHydrocortisonePyrrolesTestosterone

Identifiers

PMID19783896

What OpenQuestion holds

Texttitle and abstract
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.