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Safety and efficacy of desloratadine in chronic idiopathic urticaria in clinical practice: an observational study of 9246 patients.
J Eur Acad Dermatol Venereol. 2009 Mar; 23(3):292-9.JE

Abstract

BACKGROUND

Post-marketing surveillance studies (PMSS) of medications are often mandated by authorities, provide crucial insights for health services and are useful to define the clinical profiles of therapies. Desloratadine, a non-sedating, second-generation H(1)-receptor antagonist, is an effective and well-tolerated treatment for chronic idiopathic urticaria (CIU).

METHODS

A PMSS in CIU patients evaluated the tolerability and efficacy of desloratadine in clinical practice. At Visit 1 (baseline), demographic and CIU history were recorded and patients/physicians rated the severity of CIU symptoms, interference with sleep/daily activities and the general state of urticaria. Patients also noted the use and effectiveness of previous antihistamine therapy. At the end of treatment (Visit 2), CIU symptom severity and other disease criteria were re-assessed. Adverse events reported during or < or = 30 days after treatment were collected.

RESULTS

A total of 9246 patients with CIU participated (63% female). Itching, number of wheals and the size of the largest wheal decreased significantly from baseline with desloratadine therapy (P < 0.0001). Improvements in CIU-impaired sleep and daily activities were reported by 67% and 71% of patients, respectively (P < 0.0001). In patients that received previous therapy with cetirizine, loratadine or fexofenadine alone, patients rated the onset of efficacy of desloratadine as faster in 55.5%, 54.7% and 57.6% of cases, respectively. The incidence of adverse events was low (0.5% of patients) and no serious adverse events were reported.

CONCLUSIONS

This large PMSS confirms evidence from multiple placebo-controlled trials that desloratadine is effective and well tolerated in the treatment of CIU.

Links

Publisher Full Text (DOI)

Authors+Show Affiliations

Augustin M
Clinic for Dermatology and Venerology, University Hospital Eppendorf, Hamburg, Germany. m.augustin@derma.de
Ehrle S
No affiliation info available

MeSH

Activities of Daily LivingAdolescentAdultAgedAged, 80 and overChildChild, PreschoolChronic DiseaseFemaleHistamine H1 Antagonists, Non-SedatingHumansLoratadineMaleMiddle AgedSleepUrticariaYoung Adult

Pub Type(s)

Journal Article

Language

eng

PubMed ID

19438819

Citation

Augustin, M, and S Ehrle. "Safety and Efficacy of Desloratadine in Chronic Idiopathic Urticaria in Clinical Practice: an Observational Study of 9246 Patients." Journal of the European Academy of Dermatology and Venereology : JEADV, vol. 23, no. 3, 2009, pp. 292-9.
Augustin M, Ehrle S. Safety and efficacy of desloratadine in chronic idiopathic urticaria in clinical practice: an observational study of 9246 patients. J Eur Acad Dermatol Venereol. 2009;23(3):292-9.
Augustin, M., & Ehrle, S. (2009). Safety and efficacy of desloratadine in chronic idiopathic urticaria in clinical practice: an observational study of 9246 patients. Journal of the European Academy of Dermatology and Venereology : JEADV, 23(3), 292-9. https://doi.org/10.1111/j.1468-3083.2008.03034.x
Augustin M, Ehrle S. Safety and Efficacy of Desloratadine in Chronic Idiopathic Urticaria in Clinical Practice: an Observational Study of 9246 Patients. J Eur Acad Dermatol Venereol. 2009;23(3):292-9. PubMed PMID: 19438819.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of desloratadine in chronic idiopathic urticaria in clinical practice: an observational study of 9246 patients. AU - Augustin,M, AU - Ehrle,S, PY - 2009/5/15/entrez PY - 2009/5/15/pubmed PY - 2009/8/14/medline SP - 292 EP - 9 JF - Journal of the European Academy of Dermatology and Venereology : JEADV JO - J Eur Acad Dermatol Venereol VL - 23 IS - 3 N2 - BACKGROUND: Post-marketing surveillance studies (PMSS) of medications are often mandated by authorities, provide crucial insights for health services and are useful to define the clinical profiles of therapies. Desloratadine, a non-sedating, second-generation H(1)-receptor antagonist, is an effective and well-tolerated treatment for chronic idiopathic urticaria (CIU). METHODS: A PMSS in CIU patients evaluated the tolerability and efficacy of desloratadine in clinical practice. At Visit 1 (baseline), demographic and CIU history were recorded and patients/physicians rated the severity of CIU symptoms, interference with sleep/daily activities and the general state of urticaria. Patients also noted the use and effectiveness of previous antihistamine therapy. At the end of treatment (Visit 2), CIU symptom severity and other disease criteria were re-assessed. Adverse events reported during or < or = 30 days after treatment were collected. RESULTS: A total of 9246 patients with CIU participated (63% female). Itching, number of wheals and the size of the largest wheal decreased significantly from baseline with desloratadine therapy (P < 0.0001). Improvements in CIU-impaired sleep and daily activities were reported by 67% and 71% of patients, respectively (P < 0.0001). In patients that received previous therapy with cetirizine, loratadine or fexofenadine alone, patients rated the onset of efficacy of desloratadine as faster in 55.5%, 54.7% and 57.6% of cases, respectively. The incidence of adverse events was low (0.5% of patients) and no serious adverse events were reported. CONCLUSIONS: This large PMSS confirms evidence from multiple placebo-controlled trials that desloratadine is effective and well tolerated in the treatment of CIU. SN - 1468-3083 UR - https://www.unboundmedicine.com/medline/citation/19438819/Safety_and_efficacy_of_desloratadine_in_chronic_idiopathic_urticaria_in_clinical_practice:_an_observational_study_of_9246_patients_ DB - PRIME DP - Unbound Medicine ER -