Dose-Finding Clinical Trial of Loratadine on Chronic Urticaria. Double Blind Controlled Study.
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Accession number;02A0685001
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| Title;Dose-Finding Clinical Trial of Loratadine on Chronic Urticaria. Double Blind Controlled Study. |
| Author;
HARADA SHOTARO
(Higashi-Nihon Denshin Denwa, Kanto Byoin)
KUKITA ATSUSHI
(Univ. of Tokyo)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.18;NO.7;PAGE.907-923(2002)
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| Figure&Table&Reference;FIG.3, TBL.16, REF.8 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;To determine the optimal dosing regimen of loratadine for the treatment of chronic urticaria, efficacy, safety and usefulness were assessed in a double-blind study comparing 5mg once a day (5mg OD group), 5mg twice a day (5mg BID group), and 10mg once a day (10mg OD group), and the following results were obtained: 1. Of a total of 216 patients, 215 were evaluated for safety of the drug and 212 were evaluated for efficacy variables. 2. Efficacy rates were 66.7% with 5mg OD, 66.2% with 5mg BID, and 71.0% with 10mg OD. There was no significant difference between groups. 3. Additional analysis indicated effect of presence/absence of previous treatment on efficacy variables. An imbalance between groups in presence/absence of previous treatment was also observed. In patients who had received previous treatment, the 5mg OD group was significantly inferior to the other two groups in marked efficacy rate. In efficacy adjusted by presence/absence of previous treatment, the 5mg OD group was also significantly inferior to the other groups in marked efficacy rate. 4. Side effects were noted in 7.2% of the patients in the 5mg OD group, 10.7% in the 5mg BID group, and 16.9% in the 10mg OD group, but no significant difference was noted in incidence among the 3 groups. 5. The frequency of abnormal clinical laboratory findings was 6.3%, 1.4%, and 4.8% in the 5mg OD, 5mg BID, and 10mg OD groups, respectively, with no significant difference observed among the 3 groups. 6. The "useful" and "markedly useful" rate was 63.8%, 64.9%, and 68.1% with the 5mg OD, 5mg BID, and 10mg OD groups, respectively, with no significant difference observed among the 3 groups. Based on the above, the optimal dose of loratadine for the treatment of chronic urticaria was determined to be 10mg/day. No difference in either efficacy or safety was observed between 10mg administered as a single dose or in two divided doses. (author abst.) |
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