[Pharmacotherapy of urticaria--an analysis of the discrepancies between guidelines of expert bodies, registration documents and evidence for the effectiveness of drugs].
The year 2012 has seen relevant changes in Polish pharmaceutical legislation and drug reimbursement, among others limiting the reimbursement solely to indications stated in the Summaries of Product Characteristics (SPCs). A discrepancy with expert recommendations became apparent. The aim of this study was to analyze discordances between up-to-date expert recommendations, the SPCs in force, and the evidence for the effectiveness of recommended drugs in urticaria. Guidelines for the treatment of urticaria issued by Polish and international expert bodies were analyzed, along with the SPCs. A systematic review of clinical trials of recommended drugs was carried out. Of drugs recommended by the experts, 203 were authorized in Poland for urticaria treatment, including 167 oral preparations of second-generation antihistamines (SGAH, 8 active substances), 29 oral preparations of first-generation antihistamines (6 substances), 4 preparations of systemic glucocorticosteroids (2), 2 topical glucocorticosteroid preparations (2) and one combined preparation of human immunoglobulin with histamine. Among products both recommended by experts and licensed for the treatment of urticaria in Poland, high or moderate-level of evidence of effectiveness was available for 7 active substances (bilastine, cetirizine, desloratadine, fexofenadine, loratadine, levocetirizine, rupatadine). Nevertheless, 39% of SGAH available in Poland (66 preparations of cetirizine, emedastine, levocetirizine, loratadine or fexofenadine) were registered exclusively for "chronic idiopathic urticaria" - a diagnosis inconsistent with the current state of medical knowledge. We conclude that there exist considerable discrepancies between expert recommendations for the pharmacotherapy of urticaria, the licensed use of drugs as defined in Summaries of Product Characteristics and scientific evidence for their effectiveness.
Danuta
D
Plichta
Radosław
R
Spiewak
D000284:Administration, Oral; D000287:Administration, Topical; D018926:Anti-Allergic Agents / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000627:therapeutic use; D017332:Cetirizine / Q000627:therapeutic use; D005938:Glucocorticoids / Q000627:therapeutic use*; D006633:Histamine Antagonists / Q000627:therapeutic use*; D039563:Histamine H1 Antagonists, Non-Sedating / Q000627:therapeutic use; D006801:Humans; D017336:Loratadine / Q000627:therapeutic use; D010880:Piperidines / Q000627:therapeutic use; D011044:Poland; D017410:Practice Guidelines as Topic; D016593:Terfenadine / Q000031:analogs & derivatives / Q000627:therapeutic use; D016896:Treatment Outcome; D014581:Urticaria / Q000175:diagnosis / Q000188:drug therapy*
D018926:Anti-Allergic Agents; D001562:Benzimidazoles; D005938:Glucocorticoids; D006633:Histamine Antagonists; D039563:Histamine H1 Antagonists, Non-Sedating; D010880:Piperidines; C472067:levocetirizine; D017336:Loratadine; D016593:Terfenadine; C043345:emedastine; C093230:fexofenadine; C445659:bilastine; D017332:Cetirizine