Læknablaðið : fylgirit - 01.08.2003, Side 65

POSTERS / 27TH NORDIC PSYCHIATRIC CONGRESS I
antidepressant effect. The side-effect profile differed between the
groups. The fairly high number of early dropouts in the reboxetine
group is considered as a result of the non-titration starting dose of 8
mg reboxetine per day and this fact, however, weakens the validity
of the study.
P - 21 Thursday 14/8,14:00-15:00
Escitalopram versus citalopram: Well tolerated and more
efficacious in long-term treatment of moderately
depressed patients
EH Reines1, Section Head, H. Lundbeck A/S, Ottiliav ej 9, DK-2500 Copenhagen-
Valby, Denmark. HF Andersen1, L Colonna2.
!H. Lundbeck A/S, International Clinical Research, Copenhagen, Denmark, and
2University Hospital, Rouen Cedex, France
ER@lundbeck.com
Patients with Major Depressive Disorder were randomised into a
24-week, double-blind period, where they received lOmg/day
escitalopram or 20mg/day citalopram. The effect of treatment with
fixed doses of escitalopram versus citalopram is examined in the
sub-population of moderately depressed patients.
The mean change from baseline in MADRS total score showed
that escitalopram (n=85) was better at all time points compared to
citalopram (n=85) and demonstrated a statistically significantly supe-
rior therapeutic effect at many visits, including Week 8 (p=0.02) and
Week 24 (p=0.04). At Week 8, compared with citalopram, escita-
lopram showed a significantly higher response rate (>50% reduction
in MADRS) (75% with escitalopram versus 58% with citalopram,
p=0.002) as well as a significantly better remission rate (MADRS
S12) (75% with escitalopram versus 53% with citalopram, p<0.001).
Both escitalopram and citalopram were safe and well tolerated.
Statistically significantly more patients in the citalopram group than
in the escitalopram group withdrew from the study (31% with cita-
lopram and 12% with escitalopram, p<0.01). The overall adverse
event profile for escitalopram was similar to that for citalopram.
However, the higher withdrawal rate in the citalopram group was
especially pronounced from Week 8 to Week 24 (19% with citalo-
pram and 4% with escitalopram p=0.004), suggesling belter long-
term tolerability for escitalopram.
This study demonstrates that 10 mg/day escitalopram shows
significant clinical superiority to 20 mg/day citalopram in the treat-
ment of moderately depressed patients.
P - 22 Thursday 14/8,14:00-15:00
Escitalopram: Effective and better tolerated than
venlafaxine XR in the treatment of depression
•I Bothmcri, PhD, Lundbeck GmbH & Co, Karnapp 25, D-21079 Hamburg.
Germany. SA Montgomery2, AKT HuusomS, EH ReinesL
'Lundbeck GmbH & Co. Germany; 2Imperial College School of Medicine, London,
United Kingdom; ’H. Lundbeck A/S, International Clinical Research, Copenhagen,
Oenmark.
PLJB@lundbeck .com
The efficacy of escitalopram relative to venlafaxine (an SNRI) in
the treatment of Major Depressive Disorder (MDD) was assessed
in a randomised, double-blind, non-inferiority study of standard
dosages of venlafaxine XR and escitalopram. Patients in primary
care with a MADRS total score >18 at baseline were included.
Patients were randomised to 8 weeks of double-blind treatment
with either escitalopram (n=148) or venlafaxine (n=145). Patients
started with lOmg/day escitalopram or 75mg/day venlafaxine; if
needed, the dose could be doubled after 2 or 4 weeks of treatment.
Patients completing treatment entered a single-blind washout
period to evaluate discontinuation symptoms.
The primary efficacy variable showed that escitalopram was at
least as effective as venlafaxine. Patients in both treatment groups
had mean baseline MADRS total scores of a29, which decreased to
<9 by Week 8. The response rate (>50% reduction in MADRS) for
escitalopram versus venlafaxine was numerically superior at all
time points after Week 1. In the survival analysis of sustained re-
sponse and sustained remission, there was a significant superiority
of escitalopram relative to venlafaxine (p<0.05).
More patients treated with venlafaxine withdrew due to adverse
events (11%) than did those treated with escitalopram (8%).
Nausea was the most common adverse event, with a statistically
significantly higher incidence for venlafaxine-treated patients (27%
for venlafaxine and 17% for escitalopram, p=0.02). At the end of
the washout period, significantly more venlafaxine-treated patients
had an increase >4 in discontinuation-emergent signs and symp-
toms score (p<0.01).
In conclusion, escitalopram is a highly efficacious treatment for
MDD, with superiority on sustained remission and sustained re-
sponse rates when compared with venlafaxine XR, and with signifi-
cantly better tolerability.
P - 23 Thursday 14/8,14:00-15:00
Escitalopram is efficacious and well tolerated in the
treatment of depression in primary care
U Lepola1. PhD, Kuopion Psykiatripalvelu OY, Psychiatric Research, Clinic of
Kuopio, Kuopio, Finland. H Loft2, EH Reines2.
iPsychiatric Research Clinic of Kuopio, Helsinki, and Oulu University, Department
of Psychiatry, Finland; 2H. Lundbeck A/S, Copenhagen, Denmark.
Ulla. lepola@iwn.fi
This multinational, parallel-group study compared the efficacy and
safety of escitalopram and citalopram, the active reference, to
placebo in patients with Major Depressive Disorder. The mean
MADRS total score at baseline was 29, indicating that the patients
were moderately to severely depressed. After a 1-week, single-
blind placebo period, patients were randomised into an 8-week,
double-blind period where they received lOmg/day escitalopram
(n=155), 20mg/day citalopram (n=160), or placebo (n=154), with
the option of doubling the dosage after 4 or 6 weeks of treatment.
The efficacy analysis of mean change in MADRS total score from
baseline showed a statistically significantly superior therapeutic
effect for escitalopram versus placebo with a treatment difference
of 2.9 points (p=0.002) at Week 8 (LOCF). Further by-visit analysis
of the change in MADRS total score at each week showed escitalo-
pram to be statistically significantly superior to placebo from Week
1 onwards (OC). The proportion of escitalopram responders
(>50% reduction in MADRS) and remitters (MADRS <12) at
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