Evidence map›Paper›PMID 33791829›Full record

Trial reportEuropean journal of clinical pharmacology2021

Pharmacokinetic interaction between atorvastatin and fixed-dose combination of sofosbuvir/ledipasvir in healthy male Egyptian volunteers.

H A Elmekawy, F Belal, A E Abdelaziz, K S Abdelkawy, A A Ali, F Elbarbry

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 43% 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

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Article
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

6 authors at 3 institutions in 2 countries.

H A ElmekawyDepartment of Clinical Pharmacy, Faculty of Pharmacy, Kafrelsheikh University, Kafr El-Sheikh, 33511, Egypt.
F BelalDepartment of Analytical Chemistry, Faculty of Pharmacy, University of Mansoura, Mansoura, 35516, Egypt.
A E AbdelazizDepartment of Pharmaceutical Technology, Faculty of Pharmacy, Kafrelsheikh University, Kafr El-Sheikh, Egypt.
K S AbdelkawyDepartment of Clinical Pharmacy, Faculty of Pharmacy, Kafrelsheikh University, Kafr El-Sheikh, 33511, Egypt.
A A AliDepartment of Clinical Pharmacy, Faculty of Pharmacy, Kafrelsheikh University, Kafr El-Sheikh, 33511, Egypt.
F ElbarbryPacific University Oregon School of Pharmacy, Hillsboro, OR, 97123, USA. Fawzy.elbarbry@pacificu.edu.ORCID http://orcid.org/0000-0002-5238-2712
Kafrelsheikh University · EGMansoura University · EGPacific University Oregon · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeComorbid conditions of heart and liver disorders added to HCV-induced hepatic steatosis make co-administration of statins, and direct-acting antivirals is common in clinical practice. This study aimed to evaluate the pharmacokinetic interaction of atorvastatin and fixed-dose combination of sofosbuvir/ledipasvir "FDCSL" with rationalization to the underlying mechanism.

methodsA randomized, three-phase crossover study that involves 12 healthy volunteers was performed. Participants received a single-dose of atorvastatin 80 mg alone, atorvastatin 80-mg plus tablets containing 400/90 mg FDCSL, or tablets containing 400/90 mg FDCSL alone. Plasma samples were analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) for atorvastatin, sofosbuvir, ledipasvir, and sofosbuvir metabolite "GS-331007," and their pharmacokinetics parameters were determined.

resultsCompared to atorvastatin alone, the administration of FDCSL caused a significant increase in both areas under the concentration-time curve from time zero to infinity (AUC

conclusionAfter concurrent administration of FDCSL with atorvastatin, the AUC

Indexed as

AdultAnticholesteremic AgentsAntiviral AgentsArea Under CurveAtorvastatinBenzimidazolesCross-Over StudiesEgyptFluorenesHealthy VolunteersHumansMaleMetabolic Clearance RateSingle-Blind MethodSofosbuvirAnticholesteremic AgentsAntiviral AgentsAtorvastatinBenzimidazolesFluorenesledipasvir, sofosbuvir drug combinationSofosbuvirAtorvastatinGS-331007LedipasvirP-glycoproteinPharmacokinetic interactionSofosbuvir

Identifiers

PMID33791829
OpenAlexW3147054939

What Socratic 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 Socratic graph.