Other aspects
Clinical laboratory parameters
No clinically significant changes in laboratory tests have been reported in clinical studies. Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion, has been reported as a rare adverse reaction to the use of SSRIs, especially in elderly female patients (ref.1).
Cardiovascular parameters
Escitalopram does not affect blood pressure (ref.2). In line with other SSRIs, escitalopram causes a slight, but clinically unimportant, decrease in heart rate of two to three beats per minute (ref.3). The frequency and magnitude of this decrease did not differ from that of citalopram (ref.4). Apart from this, escitalopram has no effect on the ECG (ref.5). In studies in elderly patients and in medium- to long-term studies, specific evaluation was made of adverse events associated with the cardiac system. None of the events were attributable to escitalopram. In addition, when comparing these adverse events with those potentially associated with the cardiac system reported in the pooled analysis, there is no suggestion that long-term treatment has a different adverse-event profile to that seen in short-term studies.
Body weight
Escitalopram is weight neutral. Short-term data (8 weeks) from the fixed- and flexible dose studies do not indicate any effect of escitalopram on weight (Figure 63) (ref.6). In a 6-month study (ref.7) there was a negligible increase in mean body weight from 73.2 Kg to 73.6 Kg. No patients withdrew because of weight change.
Seizures
Reports of seizures are extremely rare both in the clinical trials programme and in postmarketing surveillance. Like other antidepressants, escitalopram should be discontinued in any patient who develops seizures. As a general recommendation, SSRIs should be avoided in patients with unstable epilepsy, and patients with controlled epilepsy should be carefully monitored. In an open study assessing the efficacy and safety of citalopram in depressed epileptic patients (ref.8), there were no reports of seizures worsening. In addition, no de novo generalised tonic-clonic seizures were observed.
Mean DESS score (ref.10) # Significantly different from Paroxetine, p<0.05
### Significantly different from Paroxetine, p<0.001 |
Manic reactions
Reports of mania are extremely rare both in the clinical trials programme and in postmarketing surveillance. Manic reactions are expected as part of MDD and have been reported at low rates with escitalopram treatment. These rates are comparable with Paroxetine and fluvoxamine, and are lower than the rates observed with TCA treatment. The SSRIs should be used with caution in patients with a history of mania/hypomania, and discontinued in any patient entering a manic phase.
Haemorrhage
There have been reports of cutaneous bleeding abnormalities such as ecchymoses and purpura with SSRIs (ref.9). Caution is advised in patients taking SSRIs, particularly if they also use drugs known to affect platelet function or they have a history of bleeding disorders.
Enhancement of 5-HT associated effects
Escitalopram is contraindicated in combination with non-selective monoamine oxidase inhibitors (MAOIs).
References:
1. Lane., 1997
2. Burke et al., 2002; Wade et al., 2002a; Lepola et al., 2003; Bielski et al., 2004a
3. Montgomery et al., 2004
4. Rasmussen et al., 1999
5. Burke et al., 2002; Wade et al., 2002a; Lepola et al., 2003
6. Wade et al., 2002a; Lepola et al., 2003
7. Colonna et al., 2005
8. Hovorka et al., 2000
9. Nelva et al., 2000
10. Lader et al., 2003