PMID- 15553106
OWN - NLM
STAT- MEDLINE
DCOM- 20050111
LR  - 20131121
IS  - 0004-4172 (Print)
IS  - 0004-4172 (Linking)
VI  - 54
IP  - 10
DP  - 2004
TI  - Clinical study of the therapeutic efficacy and safety of emedastine difumarate 
      versus cetirizine in the treatment of seasonal allergic rhinitis.
PG  - 666-72
AB  - OBJECTIVE: The therapeutic efficacy and tolerability of emedastine difumarate 
      (CAS 87233-62-3) in male and female Caucasian patients with seasonal allergic 
      rhinitis as compared to cetirizine (CAS 83881-51-0) was evaluated. METHODS: The 
      study was designed as a double-blind, randomised, parallel groups comparison of 
      two antihistamines administered by oral route (emedastine 4 mg o.d. versus 
      cetirizine 10 mg o.d.) in a population of 120 patients suffering from grass 
      pollen allergic rhinitis. The duration of the treatment period was 14 days. 
      Primary efficacy variable was a total symptoms score (including among symptoms 
      nasal congestion, sneezing, rhinorrhea, nasal/throat/palate itching, eye itching 
      and lacrimation) evaluated after 14 days of treatment vs. baseline value. Safety 
      was assessed on routine laboratory assays and recording vital signs and adverse 
      events (AEs). RESULTS: The between-group difference in primary efficacy variable 
      averaged over the 2-week treatment period was not statistically significant. 
      Results clearly showed that no significant difference exists between the two 
      treatments as far as total symptoms score evaluated after 14 days of treatment 
      vs. baseline values are concerned. Therefore, the efficacy profiles of the study 
      medications are overlapping. The pattern and incidence of AEs was similar in both 
      treatment groups. The most frequent AEs with both compounds were related to the 
      CNS, headache being the most reported one. In particular, this study seems to 
      disclose a slighter tendency to drowsiness with emedastine than with cetirizine. 
      CONCLUSIONS: Both drugs under investigation in this trial appear to be effective 
      for relieving the symptoms of seasonal allergic rhinitis in Caucasian adult 
      patients. The results demonstrate that emedastine 4 mg o.d. is comparable in 
      efficacy to cetirizine 10 mg once daily in the symptomatic management of seasonal 
      allergic rhinitis. Moreover, based on the results of this study, emedastine can 
      be considered a safe and well-tolerated drug and its safety profile seems to 
      resemble that of cetirizine.
FAU - Horak, Friedrich
AU  - Horak F
AD  - Ear-Nose-Throat University Clinic, Vienna (Austria). f.horak@vienna.at
FAU - Stubner, Petra
AU  - Stubner P
FAU - Zieglmayer, Rene
AU  - Zieglmayer R
FAU - Kavina, Alexander
AU  - Kavina A
FAU - Corrado, Mario E
AU  - Corrado ME
FAU - Assandri, Alessandro
AU  - Assandri A
FAU - Mion, Alberto
AU  - Mion A
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - Germany
TA  - Arzneimittelforschung
JT  - Arzneimittel-Forschung
JID - 0372660
RN  - 0 (Anti-Allergic Agents)
RN  - 0 (Benzimidazoles)
RN  - 9J1H7Y9OJV (emedastine)
RN  - YO7261ME24 (Cetirizine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Anti-Allergic Agents/adverse effects/*therapeutic use
MH  - Benzimidazoles/adverse effects/*therapeutic use
MH  - Cetirizine/adverse effects/*therapeutic use
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Rhinitis, Allergic, Seasonal/*drug therapy
EDAT- 2004/11/24 09:00
MHDA- 2005/01/12 09:00
CRDT- 2004/11/24 09:00
PHST- 2004/11/24 09:00 [pubmed]
PHST- 2005/01/12 09:00 [medline]
PHST- 2004/11/24 09:00 [entrez]
AID - 10.1055/s-0031-1297019 [doi]
PST - ppublish
SO  - Arzneimittelforschung. 2004;54(10):666-72. doi: 10.1055/s-0031-1297019.