Evidence map›Paper›PMID 29270779›Full record

ReviewAdvances in therapy2018

Review of Post-Marketing Safety Data on Tapentadol, a Centrally Acting Analgesic.

Ariane Stollenwerk, Melanie Sohns, Fabian Heisig, Christian Elling, Detlef von Zabern

Abstract readReview
In one paragraph

Review in Advances in therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Tapentadol: an overview of the safety profile.Journal of pain research · 2019
    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

5 authors.

Ariane StollenwerkGrünenthal GmbH, Aachen, Germany. ariane.stollenwerk@grunenthal.com.
Melanie SohnsGrünenthal GmbH, Aachen, Germany.
Fabian HeisigGrünenthal GmbH, Aachen, Germany.
Christian EllingGrünenthal GmbH, Aachen, Germany.
Detlef von ZabernGrünenthal GmbH, Aachen, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTapentadol is a centrally acting analgesic that has been available for the management of acute and chronic pain in routine clinical practice since 2009.

methodsThis is the first integrated descriptive analysis of post-marketing safety data following the use of tapentadol in a broad range of pain conditions relating to the topics overall safety, dose administration above approved dosages, administration during pregnancy, serotonin syndrome, respiratory depression, and convulsion. The data analyzed pertain to spontaneous reports from healthcare and non-healthcare professionals and were put in the context of safety information known from interventional and non-interventional trials.

resultsThe first years of routine clinical practice experience with tapentadol have confirmed the tolerability profile that emerged from the clinical trials. Moreover, the reporting of expected side effects such as respiratory depression and convulsion was low and no major risks were identified. The evaluation of available post-marketing data did not confirm the theoretical risk of serotonin syndrome nor did it reveal unexpected side effects with administration of higher than recommended doses.

conclusionMore than 8 years after its first introduction, the favorable overall safety profile of tapentadol in the treatment of various pain conditions is maintained in the general population.

fundingGrünenthal GmbH.

Indexed as

Analgesics, OpioidChronic PainClinical Trials as TopicDose-Response Relationship, DrugFemaleHumansPainProduct Surveillance, PostmarketingRespiratory InsufficiencySeizuresSerotonin SyndromeTapentadolAnalgesics, OpioidTapentadolAcute painAnalgesiaChronic painPainRoutine clinical practiceSafety profileTapentadolTolerability

Identifiers

PMID29270779
PMCPMC5778188

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.