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DGDispatch
Fast Onset of Action Using Rupatadine 10 and 20 mg for Pruritis Relief in Patients With Chronic Urticaria: Presented at EADV
By Chris Berrie
VIENNA, AUSTRIA -- May 24, 2007 -- The potent new nonsedative antihistamine rupatadine provides rapid and long-lasting relief from pruritis in patients with moderate to severe chronic urticaria or chronic idiopathic urticaria (CIU), according to a combined analysis of pooled data from 2 multicentre, randomised, double-blind, placebo-controlled studies.
Principal Investigator Ana Giménez-Arnau, MD, professor in dermatology, department of dermatology, Hospital del Mar, Barcelona, Spain, presented the results here on May 19th at the 16th European Academy of Dermatology and Venereology Congress (EADV).
The structure of rupatadine fumarate conveys dual antagonistic properties upon this novel agent: as a potent selective antagonist towards the histamine H1 receptor, and as an antagonist towards platelet-activating factor receptors.
As such, it has been shown to rapidly attenuate the symptoms of moderate to severe allergic rhinitis. Two randomised clinical trials in patients with CIU also demonstrated significant rapid and potent reduction in the severity of pruritis, in the number of wheals, and in the total symptom scores.
Dr. Giménez-Arnau presented this pooled analysis that was aimed at determining the onset of pruritis relief following first daily oral dosing with the standard regimen of 10 mg or 20 mg rupatadine, for patients with moderate to severe chronic urticaria due to CIU or with no identifiable aetiology.
The primary outcome efficacy determinations were mean variation of mean pruritis severity (MPS) scores from baseline over the 4 weeks of treatment with rupatadine. The researchers also monitored the mean variation in the number of wheals (MNW) and in total symptom score (MTSS).
In the phase 2 trial, 283 patients were randomised to placebo or rupatadine at 5 mg, 10 mg, or 20 mg. In the phase 3 trial, 334 patients were randomised to placebo or to rupatadine at 10 mg or 20 mg.
The demographics of the full pooled dataset were similar across these 4 patient-dosing groups of placebo (n = 182) and 5 mg (n = 70), 10 mg (n = 186), and 20 mg (n = 179) rupatadine dosing. The pooled analysis specifically considered placebo dosing versus both 10 mg and 20 mg rupatadine, Dr. Giménez-Arnau indicated.
During each trial, patients were assessed following the first morning dosing at both 12 hours (first evening scoring) and 24 hours (first morning scoring).
For the MPS scores, there were significantly greater reductions seen over placebo for rupatadine both at 10 mg (P <.01 for both) and 20 mg (P <.001 for both). Thus, at both doses, rupatadine effectively relieved the pruritis symptoms after the first 12-hour dosing.
Similar significance and rapidity of onset was seen at both 12 and 24 hours from initial dosing for the MNW reductions (respectively) for placebo (11.0%, 21.5%) and for rupatadine at 10 mg (26.0%, 32.5%) and 20 mg (31.3%, 37.6%).
Mean total symptoms scores at 12 and 24 hours according to MTSS reductions for the 3 dosing arms were 17.7%, 24.7% versus 31.9%, 36.8% versus 36.6%, 42.7%, respectively.
Further analysis of the combined data for the MPS over the first full week of treatment demonstrated the continuing significant improvements in MPS scores over baseline relative to placebo for both rupatadine doses studied. After the initial rapid onset of pruritis relief, there was a further slow increase until day 7, when the maximal activity was seen at with the rupatadine 20-mg dose (P <.001 vs placebo). This was paralleled by the MNW and MTSS scores.
"In conclusion, we can say that this new molecule is another new and effective antihistaminic, and just 10 or 20 mg are needed to provide rapid and long-lasting relief from pruritis, which is probably the most bothersome and troublesome symptom of chronic idiopathic urticaria," Dr. Giménez-Arnau said.
This study was supported by Uriach Pharma.
[Presentation title: Fast Onset of Action Using Rupatadine 10 and 20 mg for Pruritis Relief in Patients With Chronic Urticaria. Abstract FC10.7]
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