Evidence map›Paper›PMID 28697767›Full record

Trial reportTrials2017

The impact of the time of drug administration on the effectiveness of combined treatment of hypercholesterolemia with Rosuvastatin and Ezetimibe (RosEze): study protocol for a randomized controlled trial.

Karolina Obońska, Michał Kasprzak, Joanna Sikora, Ewa Obońska, Krzysztof Racki, Natalia Goździkiewicz, Magdalena Krintus, Jacek Kubica

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02772640 (The Impact of the Time of Drug Administration on the Effectiveness of Combined Treatment of Hypercholesterolemia With ROSuvastatin and EZEtimibe), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT02772640 phase4completednot on this map

The Impact of the Time of Drug Administration on the Effectiveness of Combined Treatment of Hypercholesterolemia With ROSuvastatin and EZEtimibe (ROSEZE) - A Single-center, Crossover, Open-label Study

TypeinterventionalSponsorCollegium Medicum w BydgoszczyRan2016 to 2020Enrolled83ConditionsHypercholesterolemiaArmsRosuvastatin and Ezetimibe morning or evening administration
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Review
  3. Observational
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

8 authors at 1 institution in 1 country.

Karolina ObońskaDepartment of Cardiology and Internal Medicine, Nicolaus Copernicus University, Collegium Medicum, 9 Skłodowskiej-Curie Street, 85-094, Bydgoszcz, Poland. kalaobonska@op.pl.ORCID 0000-0002-0440-2563
Michał KasprzakDepartment of Cardiology and Internal Medicine, Nicolaus Copernicus University, Collegium Medicum, 9 Skłodowskiej-Curie Street, 85-094, Bydgoszcz, Poland.
Joanna SikoraDepartment of Pharmacology and Therapy, Nicolaus Copernicus University, Collegium Medicum, 9 Skłodowskiej-Curie Street, 85-094, Bydgoszcz, Poland.
Ewa ObońskaDepartment of Pharmacology and Therapy, Nicolaus Copernicus University, Collegium Medicum, 9 Skłodowskiej-Curie Street, 85-094, Bydgoszcz, Poland.
Krzysztof RackiDepartment of Cardiology and Internal Medicine, Nicolaus Copernicus University, Collegium Medicum, 9 Skłodowskiej-Curie Street, 85-094, Bydgoszcz, Poland.
Natalia GoździkiewiczStudents Scientific Society, Department of Cardiology and Internal Medicine, Nicolaus Copernicus University, Collegium Medicum, 9 Skłodowskiej-Curie Street, 85-094, Bydgoszcz, Poland.
Magdalena KrintusDepartment of Laboratory Medicine, Nicolaus Copernicus University, Collegium Medicum, 9 Skłodowskiej-Curie Street, 85-094, Bydgoszcz, Poland.
Jacek KubicaDepartment of Cardiology and Internal Medicine, Nicolaus Copernicus University, Collegium Medicum, 9 Skłodowskiej-Curie Street, 85-094, Bydgoszcz, Poland.
Nicolaus Copernicus University · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHypercholesterolemia is one of the main risk factors for cardiovascular disease. The first line treatment for hypercholesterolemia is statin therapy. When the expected low-density lipoprotein cholesterol (LDL-C) concentration is not achieved, the pharmacotherapy may be extended by combining the statin with the cholesterol absorption inhibitor ezetimibe. METHODS/

designThe study is designed as a randomized, open-label, single-center, crossover study evaluating the effectiveness of combined therapy with rosuvastatin and ezetimibe for hypercholesterolemia. The study is planned to include 200 patients with hypercholesterolemia ineffectively treated with statins for at least 6 weeks. After enrollment participants are randomized into one of two arms receiving rosuvastatin and ezetimibe. In the first arm the study drug is administered in the morning (8:00 am) for 6 weeks and then in the evening for the next 6 weeks; in the second arm the study drug is administered at first in the evening (8:00 pm) for the first 6 weeks and then in the morning for the following 6 weeks. In order to minimize non-adherence to the treatment, all patients will receive the study drug free of charge. The primary outcome of the study is change in LDL-C at 6 and 12 weeks of the treatment, depending on the time of day of study drug administration. The secondary endpoints include change in total cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, apolipoproteins ApoB and Apo AI, non-HDL cholesterol, small, dense (sd)-LDL cholesterol, lipoprotein(a), glucose, glycated hemoglobin, high-sensitivity C-reactive protein, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, and creatine kinase at 6 and 12 weeks of the study drug treatment, as well as assessment of plasma fluorescence using stationary and time-resolved fluorescence spectroscopy at baseline and at 6 and 12 weeks of the therapy. DISCUSSION: The RosEze trial is expected to demonstrate whether there is a significant difference in the effectiveness of the lipid-lowering therapy in reducing the concentration of cholesterol when the medications are taken in the morning compared with the evening time of day.

trial registrationClinicalTrials.gov, NCT02772640 . Registered on 28 March 2016.

Indexed as

Anticholesteremic AgentsBiomarkersCholesterol, LDLClinical ProtocolsCross-Over StudiesDrug Administration ScheduleDrug CombinationsEzetimibeHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypercholesterolemiaPolandResearch DesignRosuvastatin CalciumTime FactorsTreatment OutcomeAnticholesteremic AgentsBiomarkersCholesterol, LDLDrug CombinationsEzetimibeHydroxymethylglutaryl-CoA Reductase InhibitorsRosuvastatin CalciumAdherenceCardiovascular riskCoronary artery diseaseDyslipidemiaEzetimibeHydroxymethylglutaryl-CoAHypercholesterolemiaLDL-CMorning/evening dosingRosuvastatin

Identifiers

PMID28697767
PMCPMC5504756
OpenAlexW2735604960

What OpenQuestion holds

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LicenceCC BY
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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.