Evidence map›Paper›PMID 26888096›Full record

Trial reportEuropean journal of clinical pharmacology2016

Bioavailability of paracetamol with/without caffeine in Egyptian patients with hepatitis C virus.

Naglaa M El-Lakkany, Ahmed S Hendawy, Sayed H Seif El-Din, Ahmed A Ashour, Raafat Atta, Abdel-Aziz H Abdel-Aziz, Ahmed M Mansour, Sanaa S Botros

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 28% 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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. 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

8 authors at 2 institutions in 1 country.

Naglaa M El-LakkanyDepartment of Pharmacology, Theodor Bilharz Research Institute, Warak El-Hadar, Imbaba, P.O. Box 30, Giza, 12411, Egypt. n.ellakkany@tbri.gov.eg.ORCID http://orcid.org/0000-0002-5783-9945
Ahmed S HendawyDepartment of Pharmacology, Theodor Bilharz Research Institute, Warak El-Hadar, Imbaba, P.O. Box 30, Giza, 12411, Egypt.
Sayed H Seif El-DinDepartment of Pharmacology, Theodor Bilharz Research Institute, Warak El-Hadar, Imbaba, P.O. Box 30, Giza, 12411, Egypt.
Ahmed A AshourDepartment of Pharmacology and Toxicology, Faculty of Pharmacy, Al-Azhar University, Nasr city, Cairo, Egypt.
Raafat AttaDepartment of Hepatogastroenterology, Theodor Bilharz Research Institute, Warak El-Hadar, Imbaba, P.O. Box 30, Giza, 12411, Egypt.
Abdel-Aziz H Abdel-AzizDepartment of Pharmacology and Toxicology, Faculty of Pharmacy, Al-Azhar University, Nasr city, Cairo, Egypt.
Ahmed M MansourDepartment of Pharmacology and Toxicology, Faculty of Pharmacy, Al-Azhar University, Nasr city, Cairo, Egypt.
Sanaa S BotrosDepartment of Pharmacology, Theodor Bilharz Research Institute, Warak El-Hadar, Imbaba, P.O. Box 30, Giza, 12411, Egypt.
Theodor Bilharz Research Institute · EGAl-Azhar University · EG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study investigates the involvement of liver dysfunction in the modulation of paracetamol pharmacokinetic profile in genotype-4 HCV patients treated with either paracetamol alone (Para) or in combination with caffeine (Para-Caf).

methodsTwenty healthy volunteers and 20 Child-Pugh B HCV patients, each divided into two equal subgroups, were examined, whose liver/kidney functions were correlated with their main clinical manifestation. After an overnight fasting, healthy and hepatic subjects received either a single dose of Para (1000 mg paracetamol) or Para-Caf (1000 mg paracetamol/130 mg caffeine). Two milliliters of saliva samples were collected prior to and at different time-intervals after drug administration and analyzed using HPLC.

resultsThere was a noticeable increase in the mean concentration time profile of salivary paracetamol concentrations in hepatic patients, with concomitant decrease in paracetamol clearance (CLT), along with induction in the primary pharmacokinetic (PK) parameters, C max, AUC(0-8 h) and AUC(0-∞) (by about 95, 82, and 64 %, respectively, after treatment with Para, and 98, 96, and 101 %, respectively, after treatment with Para-Caf), when compared with the corresponding parameters in healthy subjects. Additionally, the healthy subjects treated with Para-Caf exhibited bioinequivalent increase in C max, K a, and t 1/2 with decrease in T max when compared with the healthy individuals treated with Para alone. A similar pattern was recorded in hepatic patients after addition of caffeine to paracetamol, with even augmented significant increase in K a and t 1/2 (by 100 and 32 %, respectively).

conclusionsLiver dysfunction modified the PK of paracetamol expressed as earlier effective paracetamol concentration, with obvious decrease in its clearance. Caffeine induced faster absorption (evidenced by shorter T max and higher K a) and prolonged t 1/2 of paracetamol, the effects that were more profound in hepatic patients. Further studies are needed to evaluate the influence of liver damage on paracetamol pharmacokinetics whenever repeated dosing is applied, to avoid possible drug accumulation.

Indexed as

AcetaminophenAdultAgedAnalgesicsArabsBiological AvailabilityCaffeineFemaleHepatitis CHumansLiver DiseasesMaleMiddle AgedSalivaAcetaminophenAnalgesicsCaffeineAbsorption rate constantBioavailabilityCaffeineChild-Pugh B HCV patientsHPLCParacetamol

Identifiers

PMID26888096
OpenAlexW2285648548

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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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.