Fexofenadine hydrochloride in the treatment of chronic idiopathic urticaria: A placebo-controlled, parallel-group, dose-ranging study

Paul, Eberhard; Berth‐Jones, J.; Jp, Ortonne; Stern, Martin

doi:10.3109/09546639809160545

Cited by 42 publications

(48 citation statements)

References 15 publications

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“…It has previously been shown that cetirizine may produce more drowsiness and impairment than other newergeneration antihistamines (6). In addition, 23.7% (23/116) of patients enrolled in this study (1) had constitutional symptoms including fever, arthralgia and abdominal pain, which is in contrast to other published studies (2)(3)(4)(5), suggesting that this may have influenced the study outcome measure.…”

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confidence: 56%

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Assessing the therapeutic benefits of antihistamines for the treatment of chronic idiopathic urticaria – a requirement for well‐designed comparative clinical studies

Dhar

Varghese²,

Georges³

2005

Journal of Dermatological Treatment

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Key words:Handa and colleagues (1) recently assessed the comparative efficacy of fexofenadine HCI 180 mg and cetirizine 10 mg once daily (q.d.) in 97 patients with chronic idiopathic urticaria (CIU), and generated somewhat surprising results. The study highlighted that cetirizine had a therapeutic advantage over fexofenadine in the treatment of CIU. As this is the first published comparative clinical trial of cetirizine and fexofenadine in this disorder, the results should be interpreted with caution before implementing the authors' conclusion in the daily management of CIU.At the end of the 28-day study period, 51.9% (27/ 52) and 4.5% (2/45) of cetirizine-and fexofenadinetreated patients, respectively, were symptom-free (p50.00001). However, the authors failed to provide baseline symptom severity data scores for either treatment group or discuss how patients' symptoms were assessed. More importantly, the variability of this outcome measure appears to be wide. In another CIU study, 30% and 11% of cetirizine-(10 mg q.d.) and placebo-treated patients were reported as being symptom-free (2). If we consider a ratio of 1.73 between these two studies (1,2) for the cetirizine arm, a hypothetical placebo arm in the Handa study (1) would have reported approximately 19% of symptom-free patients. This would suggest that the percentage of symptom-free patients receiving fexofenadine would hypothetically be lower than that estimated for placebo. We, therefore, doubt the reliability and robustness of this outcome measure and challenge the authors' conclusions.In most published trials in CIU, mean daily changes from baseline in pruritus severity and number of wheals are normally assessed as study endpoints (2-5). Fexofenadine HCl 180 mg q.d. has shown significant improvements in the pruritus score and reductions in the number of wheals compared with placebo (pv0.05) over a 6-week study period in adults with CIU (5). Similarly, in additional studies, fexofenadine HCI 60, 120 and 240 mg twice daily doses effectively relieved pruritus severity and decreased the number of wheals in CIU patients (3,4). Importantly, in the absence of well-designed comparative clinical trials, the published placebo-controlled data provide reassurance that fexofenadine and cetirizine are both effective for the treatment of CIU (2-5), but they do not allow the physician to differentiate clearly between them.When considering antihistamines as a potential treatment option for CIU, the appropriate agent should achieve optimal effectiveness with the most acceptable side effect profile. Interestingly, in this study (1) adverse effects occurred more frequently with cetirizine than fexofenadine: 7.7% (4/52) and 4.5% (2/45) of cetirizine-and fexofenadine-treated patients, respectively, experienced drowsiness. It has previously been shown that cetirizine may produce more drowsiness and impairment than other newergeneration antihistamines (6). In addition, 23.7% (23/116) of patients enrolled in this study (1) had constitutional symptoms including fever, arthralg...

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“…In most published trials in CIU, mean daily changes from baseline in pruritus severity and number of wheals are normally assessed as study endpoints (2)(3)(4)(5). Fexofenadine HCl 180 mg q.d.…”

mentioning

confidence: 99%

Assessing the therapeutic benefits of antihistamines for the treatment of chronic idiopathic urticaria – a requirement for well‐designed comparative clinical studies

Dhar

Varghese²,

Georges³

2005

Journal of Dermatological Treatment

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“…First‐line therapy for CIU is the administration of H 1 ‐antihistamines. A number of H 1 ‐antihistamines are currently available for the treatment of CIU, including cetirizine 19 and fexofenadine 20–24 . In patients whose symptoms are inadequately controlled by H 1 ‐antihistamines alone, H 2 ‐antihistamines, such as cimetidine, may also be added, as histamine mediates its effects through both H 1 ‐ and H 2 ‐receptors.…”

Section: Management Of Ciumentioning

confidence: 99%

Review of fexofenadine in the treatment of chronic idiopathic urticaria

2002

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Chronic idiopathic urticaria (CIU), characterized by the appearance of itchy wheals of unknown etiology, can be extremely debilitating and can significantly reduce a patient's quality of life (QOL). Fexofenadine, a non-sedating, H1-receptor selective, long-acting antihistamine, is licensed worldwide for the treatment of CIU. A number of dose-ranging studies have evaluated the efficacy and safety of fexofenadine for the the treatment of CIU. In two similar North American studies, patients received either fexofenadine HCI (20, 60, 120, or 240 mg bid) or placebo. All four doses of fexofendine were statistically superior to placebo at reducing pruritus and reducing the number of wheals (P < or = 0.0238). A dose-finding study undertaken in Japanese patients confirmed that fexofenadine HCI (60 mg and 120 mg bid) is an effective treatment for CIU. A similar dose response was shown in all three studies when the results were compared. Furthermore, health outcome analyses of the North American studies indicated that fexofenadine HCI 60 mg bid significantly improved patient's QOL. In these studies, fexofenadine had a consistently comparable safety profile to placebo, with no dose-related trends in the incidence of adverse events. In conclusion, fexofenadine is an effective and well-tolerated treatment for CIU, with a wide therapeutic window. Importantly, the lack of ethnic differences between the studies from North America and Asia indicate that the efficacy and safety of fexofenadine demonstrated in these studies are cross-culturally applicable.

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“…However, fexofenadine is devoid of cardiac toxicity [49] with little or no sedation or anti-cholinergic activity. Administered in a dosage of 180 mg daily (120 mg daily in the USA) it is effective in the treatment of chronic urticaria, relieving both wheal numbers and size, and pruritus [80,81] . It also improves quality of life in patients with chronic urticaria [82] .…”

Section: Fexofenadinementioning

confidence: 99%

Antihistamines in Dermatology

Greaves¹

2005

Skin Pharmacol Physiol

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Along with antibiotics, antihistamines are the most widely used systemic drugs in dermatology. This is attributable to the major role played by histamine in common diseases such as urticaria and atopic eczema. Of the currently recognised four subtypes of G protein-coupled histamine receptors, only the H₁ and H₂ subtypes have been positively identified in human skin. Traditionally believed to be competitive antagonists of histamine, H₁ and H₂ antihistamines are now considered to behave as inverse agonists. By consensus, H₁ antihistamines are classified as ‘first generation’ (associated with troublesome side-effects including somnolence, anti-adrenergic and atropine-like actions) and ‘second-generation’ compounds (in which these side-effects are reduced or absent). The main indications for H₁ antihistamines in skin are suppression of pruritus in urticaria and atopic eczema, both of which are associated with increased mast cell numbers and tissue histamine levels. However the evidence basis for use in atopic eczema is ambiguous and controversial, even though these drugs are widely used in practice. Currently, significant side-effects are mainly confined to the first-generation compounds and are especially troublesome in the elderly. Psychomotor impairment may persist throughout the day following administration. Anti-cholinergic and anti-α-adrenergic blockade and cardiotoxicity (torsade de pointes) may also occur with first-generation antihistamines. Two early low-sedation second-generation antihistamines caused arrhythmias in a small number of patients but these compounds have now been withdrawn. Generally, the second-generation H₁ antihistamines are well tolerated.

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Fexofenadine hydrochloride in the treatment of chronic idiopathic urticaria: A placebo-controlled, parallel-group, dose-ranging study

Cited by 42 publications

References 15 publications

Assessing the therapeutic benefits of antihistamines for the treatment of chronic idiopathic urticaria – a requirement for well‐designed comparative clinical studies

Assessing the therapeutic benefits of antihistamines for the treatment of chronic idiopathic urticaria – a requirement for well‐designed comparative clinical studies

Review of fexofenadine in the treatment of chronic idiopathic urticaria

Antihistamines in Dermatology

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