Cetirizine versus diphenhydramine in the prevention of chemotherapy-related hypersensitivity reactions

Durham, Charis; Thotakura, Deepthi; Sager, Lauren; Foster, Jennifer; Herrington, Jon D.

doi:10.1177/1078155218811505

Cited by 19 publications

(26 citation statements)

References 19 publications

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“…There are strengths and limitations to our design. Though oncology clinics may have already adopted different strategies to decrease side-effects from diphenhydramine based on experience or changes in practice, this prospective randomized trial design offers stronger internal validity compared with retrospective or observational designs [ 12 , 13 ]. The performance of recruitment for eligible patients was higher than previously reported (73 vs 60%, respectively) [ 26 ].…”

Section: Discussionmentioning

confidence: 99%

“…It is also the dosage that is recommended in the monograph [ 4 ]. Oral cetirizine 10 mg was selected as a comparator namely for the advantageous pharmacokinetics and pharmacodynamics properties found at this dose and the real-life experience described by Durham et al in more than 35 paclitaxel-naïve patients [ 13 , 15 , 16 ].…”

Section: Methodsmentioning

confidence: 99%

“…Although the study was underpowered, no IRR occurred in patients receiving loratadine. More recently, Durham et al compared oral cetirizine with intravenous or oral diphenhydramine as premedication for paclitaxel, rituximab, or cetuximab-based chemotherapy [ 13 ]. In patients receiving paclitaxel, IRR rates were comparable between cetirizine (used in 38 patients) and diphenhydramine (used in 62 patients) [ 13 ].…”

Section: Introductionmentioning

confidence: 99%

“…More recently, Durham et al compared oral cetirizine with intravenous or oral diphenhydramine as premedication for paclitaxel, rituximab, or cetuximab-based chemotherapy [ 13 ]. In patients receiving paclitaxel, IRR rates were comparable between cetirizine (used in 38 patients) and diphenhydramine (used in 62 patients) [ 13 ]. Although these results are promising, the retrospective design of these studies and the small sample sizes limit the generalizability of this practice.…”

Section: Introductionmentioning

confidence: 99%

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A randomized double-blind feasibility study comparing cetirizine and diphenhydramine in the prevention of paclitaxel-associated infusion-related reactions: the PREMED-F1 study

Beaucage-Charron

Gaudet

Lamothe

et al. 2022

Support Care Cancer

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Purpose Cetirizine is a less sedative alternative to diphenhydramine for the prevention of infusion-related reactions (IRR) to paclitaxel. However, its use remains controversial. In this study, we assessed feasibility for a future definitive non-inferiority trial comparing cetirizine to diphenhydramine as premedication to prevent paclitaxel-related IRR. Methods This was a single-center randomized prospective feasibility study. Participants were paclitaxel-naive cancer patients scheduled to start paclitaxel chemotherapy. They were randomly assigned to receive either intravenous diphenhydramine 50 mg + oral placebo (control) or intravenous placebo + oral cetirizine 10 mg (intervention) for their first two paclitaxel treatments. The percentage of eligible patients completing a first paclitaxel treatment and the recruitment rate were assessed (feasibility outcomes). Drowsiness was measured at baseline and at selected time points using the Stanford Sleepiness Scale (SSS) (safety outcome). IRR events were also documented (efficacy outcome). Results Among 37 eligible patients, 27 were recruited and randomized (control 13; intervention 14) and 25 completed the study. The recruitment rate was 4.8 participants/month, meeting the primary feasibility target. Drowsiness was the main adverse effect associated with the premedication. The increase in drowsiness compared to baseline (ΔSSS) was greater in the diphenhydramine group compared to the cetirizine group (median ΔSSS 2 (IQR 3.25) vs median ΔSSS 0 (IQR 1), p < 0.01) when measured one hour after the premedication administration. One participant had an IRR and no unexpected serious adverse event occurred. Conclusion The trial methods were feasible in terms of recruitment, retention, and safety. Cetirizine was significantly less sedating than diphenhydramine. IRR were infrequent and a larger trial is warranted to confirm non-inferiority for IRR prevention. Trial registration ClinicalTrials.gov, NCT04237090 (22.01.2020). Supplementary Information The online version contains supplementary material available at 10.1007/s00520-021-06734-4.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

A randomized double-blind feasibility study comparing cetirizine and diphenhydramine in the prevention of paclitaxel-associated infusion-related reactions: the PREMED-F1 study

Beaucage-Charron

Gaudet

Lamothe

et al. 2022

Support Care Cancer

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“…Perceived quicker onset of action of older AHs is often cited as a reason why patients and practitioners choose first-generation medications, however this perception has been proven inaccurate in clinical studies [33, 41]. Indeed, in a double-blind placebo controlled trial, both cetirizine and loratadine were found to have significantly faster onset of action, potency, and duration of action when compared to chlorpheniramine [42].…”

Section: Newer Generation H1-antihistaminesmentioning

confidence: 99%

CSACI position statement: Newer generation H1-antihistamines are safer than first-generation H1-antihistamines and should be the first-line antihistamines for the treatment of allergic rhinitis and urticaria

Fein

Fischer

O’Keefe

et al. 2019

Allergy Asthma Clin Immunol

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Oral H1-antihistamines (AHs) are the most commonly used therapy to treat allergic rhinitis and chronic urticaria. Older, first-generation AHs (e.g. diphenhydramine, hydroxyzine) have significant and common side effects including sedation, impairment with decreased cognitive function, poor sleep quality, dry mouth, dizziness, and orthostatic hypotension. These drugs have also been found to result in death from accidents, intentional or unintentional overdoses, and sudden cardiac death. The unfavourable risk–benefit profile of first-generation AHs led to the development of newer, less-sedating second- and third-generation AHs, which first became available in Canada in the 1980s. High-quality trials have proven that newer generation AHs are superior in safety compared to older first-generation AHs. On average, they have improved potency and efficacy. Second- and third-generation AHs are the recommended first-line treatment for mild allergic rhinitis and acute and chronic urticaria. Despite this evidence, older first-generation AHs continue to be over-utilized because of their over-the-counter (OTC) status and long history of use. The Canadian Society of Allergy Clinical Immunology (CSACI) recommends that newer generation AHs should be preferred over first-generation AHs for the treatment of allergic rhino-conjunctivitis and urticaria. To promote this recommendation, education of health professionals and the public is necessary. Further, given the dangers of older first-generation AHs, we believe they should be used only as a last resort with eventual consideration given to having them only available behind the counter in pharmacies.

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Repurposing of H1-receptor antagonists (levo)cetirizine, (des)loratadine, and fexofenadine as a case study for systematic analysis of trials on clinicaltrials.gov using semi-automated processes with custom-coded software

Specht,

Seifert

2023

Naunyn-Schmiedeberg's Arch Pharmacol

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To gain a comprehensive overview of the landscape of clinical trials for the H1-receptor antagonists (H1R antagonists) cetirizine, levocetirizine, loratadine, desloratadine, and fexofenadine and their potential use cases in drug repurposing (the use of well-known drugs outside the scope of the original medical indication), we analyzed trials from clincialtrials.gov using novel custom-coded software, which itself is also a key emphasis of this paper. To automate data acquisition from clincialtrials.gov via its API, data processing, and storage, we created custom software by leveraging a variety of open-source tools. Data were stored in a relational database and annotated facilitating a specially adapted web application. Through the data analysis, we identified use cases for repurposing and reviewed backgrounds and results in the scientific literature. Even though we found very few trials with published results for repurpose indications, extended literature research revealed some prominent use cases: Cetirizine seems promising in mitigating infusion-associated reactions and is also more effective than placebo in the treatment of androgenetic alopecia. Loratadine may be beneficial in the prophylaxis of G-CSF-related bone pain. In COVID-19, H1R antagonists may be helpful, but placebo-controlled scientific evidence is needed. For asthma, the effect of H1R antagonists only seems to be secondary by alleviating allergy symptoms. Our novel method to find potential use cases for repurposing of H1R antagonists allows for high automation, reduces human error, and was successful in revealing potential areas of interest. The software could be used for similar research questions and analyses in the future.

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Cetirizine versus diphenhydramine in the prevention of chemotherapy-related hypersensitivity reactions

Cited by 19 publications

References 19 publications

A randomized double-blind feasibility study comparing cetirizine and diphenhydramine in the prevention of paclitaxel-associated infusion-related reactions: the PREMED-F1 study

A randomized double-blind feasibility study comparing cetirizine and diphenhydramine in the prevention of paclitaxel-associated infusion-related reactions: the PREMED-F1 study

CSACI position statement: Newer generation H1-antihistamines are safer than first-generation H1-antihistamines and should be the first-line antihistamines for the treatment of allergic rhinitis and urticaria

Repurposing of H1-receptor antagonists (levo)cetirizine, (des)loratadine, and fexofenadine as a case study for systematic analysis of trials on clinicaltrials.gov using semi-automated processes with custom-coded software

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