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Few randomized
studies have
compared the
H1-receptor
antagonists
loratadine and
ebastine in seasonal
allergic rhinitis
(SAR) patients.
The objective of
this study was to
compare the efficacy
and safety of
ebastine 20 mg
(E20), ebastine 10
mg (E10), loratadine
10 mg (L10), and
placebo (P), once
daily, in
controlling symptoms
of SAR over a 4-week
period. This was a
double-blind,
placebo-controlled,
randomized, parallel-group
study. Efficacy was
assessed in 749
patients (12 to 70
years old) by SAR
symptom scores
(nasal discharge,
congestion, itching,
sneezing, and total
eye symptoms)
entered on diary
cards every morning
and every evening
over the previous 12
hours (reflective
score) and at the
time of recording (snapshot
score). The E20
group showed greater
reductions from
baseline compared
with the L10 group
in 2 daily
reflective composite
scores (nasal index
[with or without
congestion]) and in
all
4 daily snapshot
composite scores.
E10 and L10 groups
showed no
significant
differences in
either the daily
reflective or
snapshot scores
overall although E10
showed a greater
improvement of nasal
discharge snapshot
score than L10. The
efficacy of E20 at
controlling the
symptoms of SAR was
well sustained
during the fourth
week of treatment,
with significant
differences over
placebo in 22/36
total rhinitis
symptom scores,
followed by E10
(6/36), whereas L10
showed no
differences (0/36).
Patient and
physician global
evaluations at the
final visit were not
statistically
significant for any
treatment group
compared with
placebo. There was
no significant
difference
among all groups in
the number of
patients who
reported adverse
events. In
conclusion, ebastine
20 mg given once
daily for 4 weeks in
the treatment of SAR
showed larger mean
reductions from
baseline in most
rhinitis symptoms
scores than
loratadine 10 mg.
Sustained efficacy
was most frequently
observed with
ebastine 20 mg over
placebo, whereas
loratadine 10 mg did
not provide a
statistically
significant
improvement in any
individual or
composite symptom
score at the end of
the fourth week.
Both ebastine 20 and
10 mg were well
tolerated and proved
safe in the
treatment of SAR.
Key words:
Antihistamines -
Clinical trial -
Ebastine -
Loratadine -
Seasonal allergic
rhinitis |
