Efficacy of mizolastine, a new antihistamine, compared with placebo in the treatment of chronic idiopathic urticaria

Brostoff, Jonathan; Fitzharris, Penny; Dunmore, C.; Theron, M.; Blondin, Patrick

doi:10.1111/j.1398-9995.1996.tb04616.x

Cited by 35 publications

(31 citation statements)

References 23 publications

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“…Seven articles did not specify the final number of participants. The median percentage of drop-outs per study was 12%, with a maximum of 52% [16].…”

Section: Resultsmentioning

confidence: 99%

Study Design and Quality of Reporting of Randomized Controlled Trials of Chronic Idiopathic or Autoimmune Urticaria: Review

et al. 2013

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BackgroundThe recommended first-line therapy of chronic urticaria is second-generation antihistamines, but the modalities of treatment remains unclear. Numerous recommendations with heterogeneous conclusions have been published. We wondered whether such heterogeneous conclusions were linked to the quality of published studies and their reporting.ObjectiveTo review the study design and quality of reporting of randomized control trials investigating pharmacological treatment of autoimmune or idiopathic chronic urticaria.Methodology/Principal FindingsMEDLINE and EMBASE were searched for pharmacological randomized controlled trials involving patients with chronic autoimmune or idiopathic urticaria, with the main outcome being treatment efficacy. Data were collected on general characteristics of the studies, internal validity, studied treatments, design of the trial, outcome measures and “spin” strategy in interpreting results. Spin was defined as use of specific reporting strategies to highlight that the experimental treatment is beneficial, despite statistically nonsignificant results. We evaluated 52 articles that met our criteria. Patients were reported as blinded in 42 articles (81%) and the outcome assessor was blinded in 37 (71%). A placebo was the only comparator in 13 (25%) studies. The study duration was <8 weeks in 39 articles (75%), with no follow-up after discontinuation of treatment in 37 (71%). In 4 articles (8%), blinding was clear because they described blinding of the outcome assessor, the treatment was not recognizable (identical or double-dummy) or had no major secondary effects, and computed randomization was centralized. The primary outcome was specified in 33 articles (63%) and was a score in 31. In total, 15 different scores were used. A spin strategy was used for 10 of 12 studies with a nonsignificant primary outcome.ConclusionFor establishing guidelines in treatment of chronic urticaria, studies should focus on choosing clinically relevant and reproducible primary outcomes, long-term follow-up, limited use of placebo and avoiding spin strategies.

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“…Seven articles did not specify the final number of participants. The median percentage of drop-outs per study was 12%, with a maximum of 52% [16].…”

Section: Resultsmentioning

confidence: 99%

Study Design and Quality of Reporting of Randomized Controlled Trials of Chronic Idiopathic or Autoimmune Urticaria: Review

et al. 2013

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“…Several clinical studies demonstrated the efficacy of mizolastine in treating the symptoms of CIU [60,61,62,63]. In a 4-week multi-centre, double-blind, parallel-group study of 247 patients with CIU, mizolastine 10 mg/day was shown to be as effective as loratadine 10 mg/day with respect to reduction of pruritus and episodes of urticaria, compared with placebo (p < 0.009) [61].…”

Section: Chronic Idiopathic Urticariamentioning

confidence: 99%

Antihistamines in late-phase clinical development for allergic disease

Salmun

2002

Expert Opinion on Investigational Drugs

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Allergic rhinitis (AR) is a global health concern and shares a high comorbidity with asthma. Recent research suggests that different allergic diseases, such as AR, asthma, allergic conjunctivitis and chronic idiopathic urticaria (CIU), are evoked by common pathological mechanisms characterised by the release of histamine and other inflammatory mediators. Although H(1) receptor antagonists are the mainstay of therapy for allergic disease, the unacceptably high incidence of anticholinergic and CNS-related side effects of first-generation H(1) antagonists led to the search for improved second-generation H(1) antagonists. While many of these agents were largely devoid of CNS side effects, their tendency for drug-drug interactions (e.g., terfenadine and astemizole) resulted in an increased incidence of cardiotoxicity. Furthermore, second-generation H(1) antagonists exhibited weak anti-inflammatory properties and had no effect on nasal congestion. These observations emphasised the need for newer anti-allergic agents with a broader spectrum of activity and an improved safety profile. Among the newer H(1) antagonists currently in clinical development, desloratadine and mizolastine are the most widely studied. Both have a rapid onset of action, and desloratadine has demonstrated clinical efficacy in AR, CIU and seasonal asthma. Desloratadine has several advantages over other H(1) antagonists in that it has proven decongestant activity, a sparing effect on the use of bronchodilators (beta(2)-agonists) and a low potential for drug interactions. The broad anti-inflammatory properties of desloratadine and mizolastine, which distinguish these agents from other H(1) antagonists in clinical development (e.g., norastemizole and levocetirizine), suggest they may have a more profound impact on the underlying disease in patients suffering from different forms of allergy. The lack of clinical efficacy and safety data on rupatadine and HSR-609, both novel H(1) antagonists, precludes an accurate assessment of their potential for treating allergic disease. Epinastine and efletirizine are being developed exclusively for topical application and are unlikely to play a significant role in the management of allergic diseases as a whole.

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“…Mizolastine has been found to be safe and effective in the treatment of chronic urticaria [84,85] . It appears to be equally but not more effective than loratidine, cetirizine or fexofenadine.…”

Section: Mizolastinementioning

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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Efficacy of mizolastine, a new antihistamine, compared with placebo in the treatment of chronic idiopathic urticaria

Cited by 35 publications

References 23 publications

Study Design and Quality of Reporting of Randomized Controlled Trials of Chronic Idiopathic or Autoimmune Urticaria: Review

Study Design and Quality of Reporting of Randomized Controlled Trials of Chronic Idiopathic or Autoimmune Urticaria: Review

Antihistamines in late-phase clinical development for allergic disease

Antihistamines in Dermatology

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