The added value of H-2 antagonists in premedication regimens during paclitaxel treatment
Autor: | Patricia M. L. A. van den Bemt, Ingrid A. Boere, Roelof W F van Leeuwen, Esther Oomen-de Hoop, Juul M. Cox, Tessa M. Bosch, Ruben Malmberg, Leni van Doorn, Agnes Jager, Ron H.J. Mathijssen |
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Přispěvatelé: | Health Technology Assessment (HTA), Medical Oncology, Pharmacy, Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET) |
Jazyk: | angličtina |
Rok vydání: | 2021 |
Předmět: |
Cancer Research
Chemotherapy business.industry medicine.medical_treatment Confidence interval Ranitidine 03 medical and health sciences Regimen chemistry.chemical_compound 0302 clinical medicine SDG 3 - Good Health and Well-being Oncology chemistry 030220 oncology & carcinogenesis Anesthesia Clemastine medicine Premedication business Adverse effect Histamine medicine.drug |
Zdroj: | British Journal of Cancer, 124(10), 1647-1652. Nature Publishing Group |
ISSN: | 0007-0920 |
Popis: | Background: Ranitidine, a histamine 2 blocker, is the standard of care to prevent hypersensitivity reactions (HSRs) caused by paclitaxel infusion. However, the added value of ranitidine in this premedication regimen is controversial. Therefore, we compared the incidence of HSRs during paclitaxel treatment between a standard regimen including ranitidine and a regimen without ranitidine. Methods: This prospective, pre–post interventional, non-inferiority study compared the standard premedication regimen (N = 183) with dexamethasone, clemastine and ranitidine with a premedication regimen without ranitidine (N = 183). The primary outcome was the incidence of HSR grade ≥3. Non-inferiority was determined by checking whether the upper bound of the two-sided 90% confidence interval (CI) for the difference in HSR rates excluded the +6% non-inferiority margin. Results: In both the pre-intervention (with ranitidine) and post-intervention (without ranitidine) group 183 patients were included. The incidence of HSR grade ≥3 was 4.4% (N = 8) in the pre-intervention group and 1.6% (N = 3) in the post-intervention group: difference −2.7% (90% CI: −6.2 to 0.1). Conclusions: As the upper boundary of the 90% CI does not exceed the predefined non-inferiority margin of +6%, it can be concluded that a premedication regimen without ranitidine is non-inferior to a premedication regimen with ranitidine. Clinical Trial Registration: www.trialregister.nl; NL8173. |
Databáze: | OpenAIRE |
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