Evidence map›Paper›PMID 30804681›Full record

ArticleJournal of pain research2019

An integrated safety analysis of combined acetaminophen and ibuprofen (Maxigesic

Phillip Aitken, Ioana Stanescu, Rebecca Playne, Jennifer Zhang, Christopher M A Frampton, Hartley C Atkinson

Open access · goldAbstract read
In one paragraph

Article in Journal of pain research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 24% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Review
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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 2 institutions in 1 country.

Phillip AitkenDrug Development, AFT Pharmaceuticals Ltd, Auckland, New Zealand, phillip.aitken@aftpharm.com.
Ioana StanescuDrug Development, AFT Pharmaceuticals Ltd, Auckland, New Zealand, phillip.aitken@aftpharm.com.
Rebecca PlayneDrug Development, AFT Pharmaceuticals Ltd, Auckland, New Zealand, phillip.aitken@aftpharm.com.
Jennifer ZhangDrug Development, AFT Pharmaceuticals Ltd, Auckland, New Zealand, phillip.aitken@aftpharm.com.
Christopher M A FramptonDepartment of Medicine, University of Otago, Christchurch, New Zealand.
Hartley C AtkinsonDrug Development, AFT Pharmaceuticals Ltd, Auckland, New Zealand, phillip.aitken@aftpharm.com.
AFT Pharmaceuticals (New Zealand) · NZUniversity of Otago · NZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAcetaminophen (APAP) and ibuprofen (IBP) are two analgesic compounds with a long history of use. Both are considered safe at recommended over-the-counter daily doses. Chronic use, high doses, or concomitant medication can produce safety risks for both drugs. APAP is associated with increased risk of hepatic injury, while IBP can produce gastric bleeding and thromboembolic events. Using a combination of APAP and IBP provides superior analgesia without transgressing daily dose limits of each individual drug.

methodsThe present study aimed to determine if treatment with a fixed-dose combination (FDC) containing APAP and IBP results in any unexpected adverse events (AEs) and/or changes in the safety profiles of its two ingredients compared to monotherapy. The analysis will examine clinical safety data obtained from either single dose trials, multiple dose trials, a long-term exposure trial, and post-marketing surveillance data of APAP/IBP FDC tablets (Maxigesic

resultsA safety population of 922 patients who received full doses of either FDC, APAP alone, IBP alone, or placebo was compiled from the four studies. A total of 521 AEs were experienced with the incidence of FDC AEs similar to or below either monotherapy group or placebo. The FDC did not alter the incidence and percentage of the most common AEs, including gastrointestinal events and postoperative bleeding.

conclusionOverall, the FDC is well tolerated and has a strong safety profile at single and multiple doses with improved efficacy over monotherapy.

Indexed as

multimodal pain managementnonsteroidal anti-inflammatory drugsparacetamolpostoperative analgesiasurgical pain

Identifiers

PMID30804681
PMCPMC6371943
OpenAlexW2914404264

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.