Lack of Evidence for Blood Pressure Effects of Caffeine Added to Ibuprofen.


Journal

Current drug safety
ISSN: 2212-3911
Titre abrégé: Curr Drug Saf
Pays: United Arab Emirates
ID NLM: 101270895

Informations de publication

Date de publication:
2023
Historique:
received: 27 09 2021
revised: 07 02 2022
accepted: 17 02 2022
pubmed: 19 4 2022
medline: 9 2 2023
entrez: 18 4 2022
Statut: ppublish

Résumé

Caffeine enhances the efficacy of non-opioid analgesics. Data on the cardiovascular health effects of caffeine intake are controversial, and studies on the cardiovascular effects of medical caffeine use are lacking. The study aims to explore the cardiovascular effects of an ibuprofen/caffeine combination in comparison to ibuprofen alone. Secondary analysis of a previously reported bioequivalence study of a single dose of a fixed dose ibuprofen/caffeine combination (400/100 mg) vs. ibuprofen alone in a randomized, cross-over design in 36 healthy volunteers. Plasma catecholamines were analyzed to enhance mechanistic interpretation of the data. After exclusion of 10 protocol violators (pre-dosing intake of caffeine), vital signs were comparable over a 24-h period in the absence and presence of caffeine. Plasma catecholamine levels were also comparable. These data do not support the hypothesis that occasional intake of a small dose of caffeine as part of pain medication imposes a health risk due to vital sign changes. Based on the proven increase in efficacy, the addition of caffeine to non-opioid analgesics such as IBU has a favorable risk/benefit profile for occasional use.

Sections du résumé

BACKGROUND BACKGROUND
Caffeine enhances the efficacy of non-opioid analgesics. Data on the cardiovascular health effects of caffeine intake are controversial, and studies on the cardiovascular effects of medical caffeine use are lacking.
OBJECTIVE OBJECTIVE
The study aims to explore the cardiovascular effects of an ibuprofen/caffeine combination in comparison to ibuprofen alone.
METHODS METHODS
Secondary analysis of a previously reported bioequivalence study of a single dose of a fixed dose ibuprofen/caffeine combination (400/100 mg) vs. ibuprofen alone in a randomized, cross-over design in 36 healthy volunteers. Plasma catecholamines were analyzed to enhance mechanistic interpretation of the data.
RESULTS RESULTS
After exclusion of 10 protocol violators (pre-dosing intake of caffeine), vital signs were comparable over a 24-h period in the absence and presence of caffeine. Plasma catecholamine levels were also comparable.
CONCLUSION CONCLUSIONS
These data do not support the hypothesis that occasional intake of a small dose of caffeine as part of pain medication imposes a health risk due to vital sign changes. Based on the proven increase in efficacy, the addition of caffeine to non-opioid analgesics such as IBU has a favorable risk/benefit profile for occasional use.

Identifiants

pubmed: 35430997
pii: CDS-EPUB-122576
doi: 10.2174/1574886317666220414125027
pmc: PMC10173466
doi:

Substances chimiques

Analgesics, Non-Narcotic 0
Caffeine 3G6A5W338E
Ibuprofen WK2XYI10QM

Types de publication

Clinical Trial Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

97-102

Informations de copyright

Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.

Références

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Auteurs

Anette Lampert (A)

CHC Medical Affairs, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.

Robert Lange (R)

CHC Medical Affairs, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.

Thomas Weiser (T)

CHC Medical Affairs, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.

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Classifications MeSH