Intravenous Cetirizine Versus Intravenous Diphenhydramine for the Treatment of Acute Urticaria: A Phase III Randomized Controlled Noninferiority Trial

Abella, Benjamin S.; Berger, William; Blaiss, Michael S.; Stiell, Ian G.; Herres, Joseph; Moellman, Joseph J.; Suner, Selim; Kessler, Adam; Klausner, Howard; Caterino, Jeffrey M.; Du, Jie

doi:10.1016/j.annemergmed.2020.05.025

Cited by 8 publications

(28 citation statements)

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“…Patients receiving cetirizine had a shorter amount of time at the treatment center compared with those receiving diphenhydramine (1.7 h vs 2.3 h, respectively) and fewer returned to the treatment center within 24 h ( n = 0 and n = 2, respectively; Table 2 ). A similar, phase 3 trial evaluated the non-inferiority of IV cetirizine 10 mg versus IV diphenhydramine 50 mg in 262 adults who presented with acute urticaria (with or without angioedema) that required H 1 antihistamines in EDs or UC centers [ 20 ]. For the primary efficacy endpoint of change in patient-rated pruritus score at baseline to 2 h after treatment administration, the mean change with IV cetirizine was − 1.6 and with IV diphenhydramine it was − 1.5, with the treatment difference of 0.1 (95% CI − 0.1, 0.3) between the two groups meeting the non-inferiority criteria (Table 2 ).…”

Section: Treatment Of Acute Urticariamentioning

confidence: 99%

“…There are no phase 3 trials of IV diphenhydramine specifically for the treatment of angioedema. In the phase 3 non-inferiority trial of IV cetirizine versus IV diphenhydramine, 12% of the patients in each treatment group had urticaria and angioedema [ 20 ]. In a post hoc subgroup analysis of patients with urticaria and angioedema, for the primary endpoint of the change in patient-rated pruritus score from baseline to 2 h after treatment administration, the mean (SD) change with IV cetirizine was − 1.5 (1.1) and with IV diphenhydramine was − 1.4 (0.9) [ 28 ].…”

Section: Treatment Of Angioedemamentioning

confidence: 99%

“…The most common AEs with IV diphenhydramine are sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, and thickening of bronchial secretions [ 11 ]. In the phase 3 RCT of IV cetirizine versus IV diphenhydramine for acute urticaria, 1 (0.8%) patient receiving IV cetirizine experienced treatment-related AEs (dysgeusia, paresthesia, and sensation of warmth) and 9 (6.7%) patients receiving IV diphenhydramine experienced treatment-related AEs, the most common of which were dizziness ( n = 5) and nausea ( n = 3) (Table 2 ) [ 20 ].…”

Section: Safetymentioning

confidence: 99%

“…In the phase 3 RCT of IV cetirizine versus IV diphenhydramine for acute urticaria, the change in mean patient-rated sedation scores from baseline were significantly less with IV cetirizine than with IV diphenhydramine at the 1-h, 2-h, and discharge assessments (Fig. 1 ; p ≤ 0.04 for all time points) [ 20 ].

Fig.…”

Section: Safetymentioning

confidence: 99%

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The Role of Cetirizine in the Changing Landscape of IV Antihistamines: A Narrative Review

et al. 2021

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Since 1955, the only available H 1 antihistamines for intravenous administration have been first-generation formulations and, of those, only intravenously administered (IV) diphenhydramine is still approved in the USA. Orally administered cetirizine hydrochloride, a second-generation H 1 antihistamine, has been safely used over-the-counter for many years. In 2019, IV cetirizine was approved for the treatment of acute urticaria. In light of this approval, this narrative review discusses the changing landscape of IV antihistamines for the treatment of histamine-mediated conditions. Specifically, IV antihistamines will be discussed as a treatment option for acute urticaria and angioedema, as premedication to prevent infusion reactions related to anticancer agents and other biologics, and as an adjunct treatment for anaphylaxis and other allergic reactions. Before the development of IV cetirizine, randomized controlled trials of IV antihistamines for these indications were lacking. Three randomized controlled trials have been conducted with IV cetirizine versus IV diphenhydramine in the ambulatory care setting. A phase 3 trial of IV cetirizine 10 mg versus IV diphenhydramine 50 mg was conducted in 262 adults who presented to the urgent care/emergency department with acute urticaria requiring antihistamines. For the primary efficacy endpoint, defined as change from baseline in a 2-h patient-rated pruritus score, non-inferiority of IV cetirizine to IV diphenhydramine was demonstrated (score − 1.6 vs − 1.5, respectively; 95% CI − 0.1, 0.3). Compared with IV diphenhydramine, IV cetirizine demonstrated fewer adverse effects including less sedation, a significantly shorter length of stay in the treatment center, and fewer returns to the treatment center at 24 and 48 h. Similar findings were demonstrated in another phase 2 acute urticaria trial and in a phase 2 trial assessing IV cetirizine for pretreatment for infusion reactions in the oncology/immunology setting. IV cetirizine is associated with similar patient outcomes, fewer adverse effects, and increased treatment center efficiency than IV diphenhydramine.

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Section: Treatment Of Acute Urticariamentioning

confidence: 99%

Section: Treatment Of Angioedemamentioning

confidence: 99%

Section: Safetymentioning

confidence: 99%

Fig.…”

Section: Safetymentioning

confidence: 99%

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The Role of Cetirizine in the Changing Landscape of IV Antihistamines: A Narrative Review

et al. 2021

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“…The first-generation H 1 antihistamines can cause hypotension at rapid intravenous administration and sedation which are counterproductive in anaphylaxis. Intravenous cetirizine, the only second-generation parenteral H 1 antihistamine, available in some countries, may be recommended in the treatment of acute urticaria [ 145 ], but as any other H 1 antihistamine should never replace intramuscular epinephrine as first-line therapy in anaphylaxis. An injectable H 2 antihistamine, also not life-saving in anaphylaxis, is sometimes used.…”

Section: Management Of Anaphylaxismentioning

confidence: 99%

State-of-the-Art on Biomarkers for Anaphylaxis in Obstetrics

Simionescu

Stănescu

Popescu

2021

Life

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Anaphylaxis is an unpredictable systemic hypersensitivity reaction and constitutes a high risk of maternal and fetal morbidity and mortality when occurring during pregnancy. Currently, the acute management of anaphylaxis is based on clinical parameters. A total serum tryptase is only used to support an accurate diagnosis. There is a need to detect other biomarkers to further assess high-risk patients in obstetrics. Our objective is to present biomarkers in this complex interdisciplinary approach beyond obstetrician and anaesthetic management. Candidate biomarkers derive either from mediators involved in immunopathogenesis or upcoming molecules from systems biology and proteomics. Serum tryptase is determined by singleplex immunoassay method and is important in the evaluation of anaphylactic mast cell degranulation but also in the assessment of other risk factors for anaphylaxis such as systemic mastocytosis. Another category of biomarkers investigates the IgE-mediated sensitization to triggers potentially involved in the etiology of anaphylaxis in pregnant women, using singleplex or multiplex immunoassays. These in vitro tests with natural extracts from foods, venoms, latex or drugs, as well as with molecular allergen components, are useful because in vivo allergy tests cannot be performed on pregnant women in such a major medical emergency due to their additional potential risk of anaphylaxis.

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Antihistamines (H1 receptor antagonists)

Horlen¹,

Cuevas²

2021

Side Effects of Drugs Annual

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Intravenous Cetirizine Versus Intravenous Diphenhydramine for the Treatment of Acute Urticaria: A Phase III Randomized Controlled Noninferiority Trial

Cited by 8 publications

References 15 publications

The Role of Cetirizine in the Changing Landscape of IV Antihistamines: A Narrative Review

The Role of Cetirizine in the Changing Landscape of IV Antihistamines: A Narrative Review

State-of-the-Art on Biomarkers for Anaphylaxis in Obstetrics

Antihistamines (H1 receptor antagonists)

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