PMID- 15031611 OWN - NLM STAT- MEDLINE DCOM- 20040510 LR - 20131121 IS - 1018-2438 (Print) IS - 1018-2438 (Linking) VI - 133 IP - 4 DP - 2004 Apr TI - Efficacy and safety of ebastine 20 mg compared to loratadine 10 mg once daily in the treatment of seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled study. PG - 371-9 AB - BACKGROUND: Few randomized studies have compared loratadine to ebastine in the symptomatic treatment of seasonal allergic rhinitis (SAR) patients. METHODS: This double-blind, placebo-controlled, randomized, parallel-group, comparative trial compared the efficacy and safety of ebastine 20 mg (E20), loratadine 10 mg (L10) and placebo (P), administered once daily, in the control of SAR symptoms over a 2-week period. An additional 2-week treatment period was included in order to check sustained efficacy and tolerability. RESULTS: A total of 703 patients were enrolled: 282 patients in the E20 group, 279 in the L10 group and 142 in the P group. E20 showed a greater decrease from baseline in the main efficacy variable (mean daily reflective total symptom score) than L10 (p = 0.0018) or P (p = 0.0024), whereas the difference between L10 and P was not significant. Moreover, reductions from baseline in all composite/individual daily reflective rhinitis symptom scores were significantly larger in patients receiving E20 than in patients receiving L10 or P. Most significant differences between E20 and L10 or P were maintained after 4 weeks of treatment. Overall, all treatments were safe and well tolerated. There was no significant difference in the percentage of patients who reported one or more adverse events (AEs) between the groups, and most AEs were mild to moderate (89.9%). CONCLUSIONS: E20 given once daily for 2 weeks was more effective in the treatment of SAR symptoms than L10 or P. E20 also showed a sustained efficacy after 4 weeks of treatment, and overall was well tolerated and proved safe. CI - Copyright 2004 S. Karger AG, Basel FAU - Ratner, P AU - Ratner P AD - Sylvana Research, San Antonio, TX 78229, USA. phratner@swbell.net FAU - Hampel, F Jr AU - Hampel F Jr FAU - Van Bavel, J AU - Van Bavel J FAU - Howland, W 3rd AU - Howland W 3rd LA - eng PT - Clinical Trial PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20040317 PL - Switzerland TA - Int Arch Allergy Immunol JT - International archives of allergy and immunology JID - 9211652 RN - 0 (Butyrophenones) RN - 0 (Histamine H1 Antagonists) RN - 0 (Piperidines) RN - 7AJO3BO7QN (Loratadine) RN - TQD7Q784P1 (ebastine) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Butyrophenones/adverse effects/*therapeutic use MH - Child MH - Double-Blind Method MH - Female MH - Histamine H1 Antagonists/adverse effects/*therapeutic use MH - Humans MH - Least-Squares Analysis MH - Loratadine/adverse effects/*therapeutic use MH - Male MH - Middle Aged MH - Piperidines/adverse effects/*therapeutic use MH - Rhinitis, Allergic, Seasonal/*drug therapy EDAT- 2004/03/20 05:00 MHDA- 2004/05/11 05:00 CRDT- 2004/03/20 05:00 PHST- 2003/05/15 00:00 [received] PHST- 2003/12/03 00:00 [accepted] PHST- 2004/03/20 05:00 [pubmed] PHST- 2004/05/11 05:00 [medline] PHST- 2004/03/20 05:00 [entrez] AID - 77357 [pii] AID - 10.1159/000077357 [doi] PST - ppublish SO - Int Arch Allergy Immunol. 2004 Apr;133(4):371-9. doi: 10.1159/000077357. Epub 2004 Mar 17.