Double-blind multicentre comparative study of ebastine, terfenadine and placebo in the treatment of chronic idiopathic urticaria in adults. 1996

B Kalis
Service de Dermatologie, Hôpital Robert Debré, Reims, France.

Ebastine is a new second generation histamine H1 receptor antagonist that has shown clinical efficacy in the treatment of seasonal and perennial allergic rhinitis and chronic urticaria after once-daily administration. This double-blind multicentre randomised placebo-controlled study has investigated the long term efficacy of ebastine 10mg once daily in the treatment of chronic urticaria compared with that of terfenadine 60mg twice daily. At the end of a 3-month treatment period, ebastine was significantly superior to placebo in improving symptoms of chronic urticaria (including severity of itching, number of wheals per day), and its efficacy was similar to that of terfenadine. In a global assessment of efficacy, investigators considered chronic urticaria to have improved in 73% of ebastine recipients compared with 68% and 52% of patients treated with terfenadine or placebo, respectively. The patients' assessments of efficacy were similar to those of the investigators. Ebastine was well tolerated, the incidence and nature of adverse events with this agent being similar to those reported in patients treated with terfenadine or placebo. The most common adverse events were headache and dry mouth. Thus, these results, which show ebastine to be an effective and well tolerated agent, indicated that the drug should be considered for the first-line therapy of chronic urticaria.

UI MeSH Term Description Entries
D010880 Piperidines A family of hexahydropyridines.
D002090 Butyrophenones Compounds containing phenyl-1-butanone.
D002908 Chronic Disease Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care (Dictionary of Health Services Management, 2d ed). For epidemiological studies chronic disease often includes HEART DISEASES; STROKE; CANCER; and diabetes (DIABETES MELLITUS, TYPE 2). Chronic Condition,Chronic Illness,Chronically Ill,Chronic Conditions,Chronic Diseases,Chronic Illnesses,Condition, Chronic,Disease, Chronic,Illness, Chronic
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D006634 Histamine H1 Antagonists Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. Antihistamines, Classical,Antihistaminics, Classical,Antihistaminics, H1,Histamine H1 Antagonist,Histamine H1 Receptor Antagonist,Histamine H1 Receptor Antagonists,Histamine H1 Receptor Blockaders,Antagonists, Histamine H1,Antagonists, Histamine H1 Receptor,Antihistamines, Sedating,Blockaders, Histamine H1 Receptor,First Generation H1 Antagonists,H1 Receptor Blockaders,Histamine H1 Blockers,Receptor Blockaders, H1,Antagonist, Histamine H1,Classical Antihistamines,Classical Antihistaminics,H1 Antagonist, Histamine,H1 Antagonists, Histamine,H1 Antihistaminics,Sedating Antihistamines
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D014581 Urticaria A vascular reaction of the skin characterized by erythema and wheal formation due to localized increase of vascular permeability. The causative mechanism may be allergy, infection, or stress. Hives,Urticarial Wheals,Urticarial Wheal,Urticarias,Wheal, Urticarial,Wheals, Urticarial
D016593 Terfenadine A selective histamine H1-receptor antagonist devoid of central nervous system depressant activity. The drug was used for ALLERGY but withdrawn due to causing LONG QT SYNDROME. Balkis Saft Spezial,Cyater,Hisfedin,RMI-9918,Rapidal,Seldane,Teldane,Terfedura,Terfemundin,Terfenadin AL,Terfenadin Heumann,Terfenadin Stada,Terfenadin Von Ct,Terfenadin-Ratiopharm,Terfenidine,Ternadin,Triludan,alpha-(4-(1,1-Dimethylethyl)phenyl)-4-(hydroxydiphenylmethyl)-1-piperdinebutanol,RMI 9918,RMI9918,Terfenadin Ratiopharm
D018926 Anti-Allergic Agents Agents that are used to treat allergic reactions. Most of these drugs act by preventing the release of inflammatory mediators or inhibiting the actions of released mediators on their target cells. (From AMA Drug Evaluations Annual, 1994, p475) Anti-Allergic,Anti-Allergic Agent,Anti-Allergy Drug,Antiallergic,Antiallergic Agent,Antiallergic Drug,Anti-Allergics,Anti-Allergy Drugs,Antiallergic Agents,Antiallergic Drugs,Antiallergics,Antiallergy Agents,Agent, Anti-Allergic,Agent, Antiallergic,Agents, Anti-Allergic,Agents, Antiallergic,Agents, Antiallergy,Anti Allergic,Anti Allergic Agent,Anti Allergic Agents,Anti Allergics,Anti Allergy Drug,Anti Allergy Drugs,Drug, Anti-Allergy,Drug, Antiallergic,Drugs, Anti-Allergy,Drugs, Antiallergic

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