PMID- 15553105
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 terfenadine in the treatment of seasonal allergic rhinitis.
PG  - 660-5
AB  - OBJECTIVE: Emedastine is a new H1-receptor antagonist endowed with potent and 
      selective antihistamine activity. The aim of this study was to evaluate the 
      therapeutic efficacy and tolerability of emedastine difumarate (CAS 87233-62-3) 
      in Caucasian patients in the treatment of seasonal allergic rhinitis as compared 
      to terfenadine (CAS 50679-08-8). METHODS: A total of 130 patients suffering from 
      grass pollen allergic rhinitis were randomly assigned to 14 days treatment with 
      either emedastine difumarate (2 mg b.i.d.) or terfenadine (60 mg b.i.d.) in a 
      double-blind, randomised, crossover design. Primary efficacy parameter was a 
      Total Severity Symptom Score, including among symptoms nasal congestion, 
      sneezing, rhinorrhea, nasal/throat/palate itching, eye itching and lacrimation. 
      Safety was assessed on routine laboratory tests and recording vital signs and 
      adverse events (AEs). RESULTS: Emedastine 2 mg b.i.d. was significantly more 
      effective than terfenadine 60 mg b.i.d. in reducing Total Symptom Severity Score 
      (p = 0.0258). This statistical significant difference was also obtained in 
      controlling sneezing and rhinorrhea (p = 0.003). Moreover, both the physician and 
      patients indicated emedastine as the preferred therapy (p < 0.01). Forty-seven 
      drug related AEs were reported for emedastine (= 51.07 %) and 53 for terfenadine 
      (64.15 %), most of them involving the CNS. CONCLUSION: The results of study show 
      that emedastine difumarate is more effective than terfenadine in the symptomatic 
      management of seasonal allergic rhinitis and is particularly active in 
      controlling the main nasal symptoms, such as sneezing and rhinorrhea; it is safe 
      and well tolerated in this therapeutic indication, while related AEs are less if 
      compared to those displayed by terfenadine.
FAU - Corrado, Mario E
AU  - Corrado ME
AD  - CROSS SA, Arzo, TI (Switzerland). croalliance@croalliance.com
FAU - Radicioni, Milko M
AU  - Radicioni MM
FAU - Hartwig, Jennifer
AU  - Hartwig J
FAU - Assandri, Alessandro
AU  - Assandri A
FAU - Oldeman, Hendrik G
AU  - Oldeman HG
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  - 7BA5G9Y06Q (Terfenadine)
RN  - 9J1H7Y9OJV (emedastine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Anti-Allergic Agents/adverse effects/*therapeutic use
MH  - Benzimidazoles/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
MH  - Terfenadine/adverse effects/*therapeutic use
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-0031-1297018 [doi]
PST - ppublish
SO  - Arzneimittelforschung. 2004;54(10):660-5. doi: 10.1055/s-0031-1297018.