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2015 ; 5
(4
): 217-230
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gab.com Text
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English Wikipedia
Rupatadine in Established Treatment Schemes Improves Chronic Spontaneous
Urticaria Symptoms and Patients Quality of Life: a Prospective,
Non-interventional Trial
#MMPMID26591001
Metz M
; Weller K
; Neumeister C
; Izquierdo I
; Bödeker RH
; Schwantes U
; Maurer M
Dermatol Ther (Heidelb)
2015[Dec]; 5
(4
): 217-230
PMID26591001
show ga
INTRODUCTION: Chronic spontaneous urticaria (CSU) is a common and hard to treat
condition associated with a substantial negative impact on patients' quality of
life (QoL). Clinical studies have shown that rupatadine is effective and safe in
the treatment of CSU, but data from routine clinical care are scarce. Therefore,
we assessed the effectiveness and tolerability of rupatadine in established
dosages on CSU activity and patients' QoL in a routine daily practice setting.
METHODS: This was an open, prospective, non-interventional study performed in 146
dermatological practices in Germany. CSU patients for whom treatment with
rupatadine was indicated were eligible to participate. Key symptoms of urticaria
activity and their impact on patients' QoL were assessed at the beginning and the
end of treatment. Adverse events (AEs) and withdrawals, as well as the dosage
regimens chosen, were documented. Patients and physicians were requested to rate
effectiveness and tolerability of therapy at the final visit. All statistical
analyses were descriptive. RESULTS: The majority of the 660 patients screened to
be treated (median age 44 years, IQR = 31-59 years, n = 654) received rupatadine
10 mg tablets once (477 patients) or twice (105 patients) daily for a median time
of 28 days. After treatment, 93.2% of the patients (606/650) reported a clear
overall improvement of symptoms. Rupatadine significantly reduced the urticaria
activity score (UAS7) as well as the frequency and severity of existing
angioedema episodes. Similarly all domains of the urticaria-specific QoL
questionnaire (CU-Q(2)oL) were markedly improved. The majority of physicians and
patients rated rupatadine treatment as effective and well tolerated. There were
39 (5.9%) early treatment withdrawals, and 21 patients (3.2%) experienced AEs.
CONCLUSION: Rupatadine when given according to the routine treating schemes
improves symptoms and CU-Q(2)oL of CSU patients; the drug is also safe and well
tolerated. FUNDING: Dr. R. Pfleger GmbH.