Non sedating antihistamines urticaria treatment
In addition, patients were excluded if they met any criteria from a typical list of exclusion criteria for pharmacological studies: presence of a permanent gastrointestinal condition that may influence oral therapy, history or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischaemia, history or presence of myocardial infarction or cardiac arrhythmia that requires drug therapy, evidence of severe renal dysfunction, evidence of significant hepatic disease, presence of active cancer that requires chemotherapy, presence of alcohol abuse or drug addiction, participation in any clinical trial within 4 weeks prior to enrolment, pregnancy or breast-feeding, and existing or planned placement in an institution after ruling according to § 40 AMG (Arzneimittelgesetz). This was considered sufficient to adequately investigate the objectives of this study, based upon the investigator’s experience and previous studies on urticaria.Formally, our study had a power of 80% to detect effects of size 1.085 (quotient difference of means and standard deviation). At visit 1, screening for eligibility was performed, and patients were requested to stop taking any antihistamines for the duration of the study, if possible.Study design This was a randomized, double-blind, parallel group, single-dose study. Rescue medication (cetirizine 10 mg, and additional clemastine 1 mg if required) was allowed for severe symptoms, but its use had to be documented by the patients and was reviewed.During the ensuing wash-out phase of 7–10 days, patients documented their symptoms with the 7 day Urticaria Activity Score (UAS7) and a visual analogue scale (VAS).Symptoms of 29 patients with chronic spontaneous urticaria were followed without treatment on one day and again on another day during the next 3 weeks after a single dose of either 5 mg or 20 mg desloratadine, using different objective measures.
The only study in CSU examining both treatment approaches was published by Grob and colleagues (11), who showed that daily treatment with desloratadine resulted in significantly better quality of life compared with on-demand therapy.Increasing the ns AH to up to 4 times the standard dose is recommended by the current guidelines in all patients who cannot achieve symptom control with standard doses (7).Desloratadine is a modern ns AH that has been shown to reduce pruritus and wheals and to improve quality of life in several studies at the standard 5 mg dose (12–17).Most clinical trials rely on patient assessments of symptoms and quality of life over a period of outpatient treatment time.Although this is entirely appropriate, we designed the current clinical study to examine the efficacy of standard dose desloratadine (5 mg) and up-dosed desloratadine (20 mg) on existing wheals, under carefully monitored conditions, using the most technically reliable, objective measures.