Evidence map›Paper›PMID 32664962›Full record

ArticleBMC endocrine disorders2020

A clinical trial to evaluate the effect of statin use on lowering aldosterone levels.

Ezra S Hornik, Anne E Altman-Merino, Andrew W Koefoed, Kayla M Meyer, Isabella B Stone, Jessica A Green, Gordon H Williams, Gail K Adler, Jonathan S Williams

Registry-linked trialOpen access · goldFull text readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC endocrine disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02871687 (Effect of Statin Use on Aldosterone Secretion), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 23% 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.

NCT02871687 phase1completednot on this map

Effect of Statin Use on Aldosterone Secretion

TypeinterventionalSponsorBrigham and Women's HospitalRan2016 to 2021Enrolled103ConditionsHealthy SubjectsArmsSimvastatin, Pravastatin, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Effects of Statins on Renin-Angiotensin System.Journal of cardiovascular development and disease · 2021
    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

9 authors at 2 institutions in 1 country.

Ezra S HornikDivision of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital and Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.
Anne E Altman-MerinoDivision of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital and Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.
Andrew W KoefoedDivision of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital and Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.
Kayla M MeyerDivision of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital and Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.
Isabella B StoneDivision of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital and Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.
Jessica A GreenDivision of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital and Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.
Gordon H WilliamsDivision of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital and Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.
Gail K AdlerDivision of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital and Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA.
Jonathan S WilliamsDivision of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital and Harvard Medical School, 221 Longwood Ave, Boston, MA, 02115, USA. jwilliams5@bwh.harvard.edu.
Harvard University · USBrigham and Women's Hospital · US

Funding

The Harvard Clinical and Translational Science CenterUL1TR002541 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2018 to 2022
$93.0M
Regulation of Aldosterone: The Effect of StatinsR01HL136567 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI ADLER, GAIL KURR · 2017 to 2020
$3.4M
Aldosterone and Diabetic Cardiovascular Disease: Research and Mentoring ProgamK24HL103845 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI ADLER, GAIL KURR · 2011 to 2021
$1.6M
NCATS NIH HHS UL1 TR002541NCATS NIH HHS UL1TR002541NHLBI NIH HHS K24 HL103845NHLBI NIH HHS R01 HL136567NHLBI NIH HHS R01HL136567
6 · The paper itself

Abstract

backgroundStatins are the first-line pharmaceutical agent in the management of hypercholesterolemia and cardiovascular (CV) risk reduction, and the most commonly prescribed class of drugs worldwide. Studies describing CV risk reduction independent of LDL-cholesterol lowering have evoked an interest in the pleiotropic mechanisms of statins' benefits. We recently demonstrated that administration of statins in animal models lowers aldosterone levels and observed an association between statin use and reduced aldosterone levels in two human cohorts, with lipophilic statins displaying a greater effect than hydrophilic statins. Therefore, we designed a randomized, placebo-controlled, double-blinded intervention study to assess whether statin treatment lowers aldosterone in a type-dependent manner in humans, with simvastatin (lipophilic) showing a greater effect than pravastatin (hydrophilic). METHODS/

designOne hundred five healthy participants will be recruited from the general population to enroll in a 12-week, randomized, placebo-controlled, double-blinded, 3-arm clinical trial. Ninety participants are anticipated to complete the protocol. After baseline assessment of aldosterone levels, participants will be randomized to daily simvastatin, pravastatin, or placebo. Aldosterone levels will be assessed after 2 days on study drug and again after 6 weeks and 12 weeks on study drug. Prior to each aldosterone assessment, participants will consume an isocaloric sodium and potassium-controlled run-in diet for 5 days. Assessments will occur on an inpatient research unit to control for diurnal, fasting, and posture conditions. The primary outcome will compare 12-week angiotensin II-stimulated serum aldosterone by study drug. Secondary outcomes will compare baseline and 12-week 24-h urine aldosterone by study drug. DISCUSSION: Results from this rigorous study design should provide strong support that statins lower aldosterone levels in humans. These results may explain some of the beneficial effects of statins that are not attributed to the LDL-lowering effect of this important class of medications. Results would demonstrate that statin lipophilicity is an important attribute in lowering aldosterone levels. The outcomes of this program will have implications for the design of studies involving statin medications, as well as for the differential use of classes of statins.

trial registrationClinicalTrials.gov; NCT02871687 ; First Posted August 18, 2016.

Indexed as

AdolescentAdultAgedAldosteroneCholesterol, LDLDouble-Blind MethodFemaleFollow-Up StudiesHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHyperlipidemiasMaleMiddle AgedPrognosisProspective StudiesRandomized Controlled Trials as TopicAldosteroneCholesterol, LDLHydroxymethylglutaryl-CoA Reductase InhibitorsAldosteroneCardiovascular healthHyperlipidemiaHypertensionMetabolic healthMineralocorticoidPravastatinSimvastatinStatins

Identifiers

PMID32664962
PMCPMC7362429
OpenAlexW3042292187

What OpenQuestion holds

Textfull text, public
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.