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Titolo:
DOUBLE-BLIND, PARALLEL, RANDOMIZED PILOT-STUDY COMPARING THE EFFICACYAND TOLERANCE OF CETIRIZINE 10 MG, MEQUITAZINE 2X5 MG AND PLACEBO IN THE TREATMENT OF PATIENTS SUFFERING FROM CHRONIC URTICARIA - COMPARISON OF SUPPRESSIVE EFFECTS ON HISTAMINE-INDUCED WEALS AND FLARES
Autore:
ABUSHAREEAH AM; YOUSSUF M; DECKERS I; DEMAHIEU C;
Indirizzi:
UCB PHARMA,MED AFFAIRS,INT DIV,ALLEE RECH 60 B-1070 BRUSSELS BELGIUM MAFRAQ HOSP,DEPT DERMATOL ABU ZABY U ARAB EMIRATES MODERN PHARMACEUT CO DUBAI U ARAB EMIRATES
Titolo Testata:
Drug development research
fascicolo: 4, volume: 43, anno: 1998,
pagine: 185 - 192
SICI:
0272-4391(1998)43:4<185:DPRPCT>2.0.ZU;2-B
Fonte:
ISI
Lingua:
ENG
Soggetto:
CHRONIC IDIOPATHIC URTICARIA; ALLERGIC RHINITIS; TERFENADINE; LORATADINE; ANTIHISTAMINE; ASTEMIZOLE; RELEASE; INVIVO; SKIN; HCL;
Keywords:
CETIRIZINE; MEQUITAZINE; CHRONIC URTICARIA;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Science Citation Index Expanded
Citazioni:
24
Recensione:
Indirizzi per estratti:
Citazione:
A.M. Abushareeah et al., "DOUBLE-BLIND, PARALLEL, RANDOMIZED PILOT-STUDY COMPARING THE EFFICACYAND TOLERANCE OF CETIRIZINE 10 MG, MEQUITAZINE 2X5 MG AND PLACEBO IN THE TREATMENT OF PATIENTS SUFFERING FROM CHRONIC URTICARIA - COMPARISON OF SUPPRESSIVE EFFECTS ON HISTAMINE-INDUCED WEALS AND FLARES", Drug development research, 43(4), 1998, pp. 185-192

Abstract

In a double-blind, randomized, parallel-group study, 29 adult patients suffering from chronic urticaria were treated with either cetirizine10 mg od (n = 10), mequitazine 5 mg bid (n = 10), or placebo (n = 9) for 3 weeks. Three symptoms (weals, erythema, pruritus) were rated according to severity (none, mild, moderate, severe) by the investigator at each of the four visits (days 1, 3, 14, 21). At each visit the investigator and patients also assessed the patients' general condition using a 5-point scoring system (very bad, bad, moderate, good, very good). On day 21 the global evaluation of efficacy and tolerance was assessed by the investigator and patients on a 4-point scale (excellent, good, moderate, bad). Also, a histamine skin-prick test was performed ondays 3, 14, and 21. Evaluation of safety was based on the frequency of patients reporting adverse events as well as the clinical laboratoryresults. The cetirizine, mequitazine, and placebo groups of patients were comparable at inclusion. Overall compliance with the trial schedule was excellent for all groups. After 3 days of treatment a significant improvement in control of all urticaria symptoms was observed in the cetirizine group. Cetirizine elicited a statistically significant better control of pruritus (P = 0.006) and erythema (P = 0.018) than mequitazine on day 21. A trend in favor of cetirizine vs. mequitazine wasalso observed regarding control of weals (P = 0.114). Cetirizine clearly and rapidly improved the general condition of the patient as evaluated by both patients and investigator compared to the baseline results. The differences vs. mequitazine as well as vs. placebo were statistically significant on every visit, starting from day 3. After three weeks of treatment, the clinical efficacy results in the cetirizine group were rated by both patients and investigator as excellent or good, which was statistically significantly better than the results obtained in the mequitazine and placebo group (P < 0.05). The histamine skin-prick test results revealed a marked difference for the group treated with cetirizine compared to the two other groups in favor of CTZ. On day3, cetirizine produced a statistically significant suppression of theweals (98%) and flares (74%), compared to 24% and 3%, respectively, by mequitazine. With respect to the tolerance results, no statisticallysignificant differences were observed between the three groups. The safety profile was similar for all groups. No serious adverse event hasbeen reported during the present study, nor did the treatments induceany clinically significant abnormal changes in the laboratory tests. Ir can be concluded from the present study that the effect of cetirizine was statistically and clinically significantly superior to that of mequitazine. On the other hand, of all parameters studied there were no marked differences between the patients of the mequitazine group andthe patients of the placebo group. (C) 1998 Wiley-Liss, Inc.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 24/06/18 alle ore 17:04:18