Special populations

Pregnancy and breast-feeding
Analysing the small subset of clinical study data on escitalopram exposure during pregnancy (60 pregnancies), Baldwin et al. (2007a) did not identify any obvious risk of either spontaneous abortion or malformation. In a cumulative analysis of all pregnancies (117) spontaneously reported to H. Lundbeck A/S, no signal for congenital malformation was seen. Neonatal behavioural symptoms have been reported; this symptom complex is part of the class labelling for SSRIs. Treatment should be avoided during pregnancy unless clearly necessary (Escitalopram SPC, 2007). As with any type of psychotropic medication, a careful risk–benefit evaluation should be carried out when considering the treatment of pregnant women. Breast-feeding is not recommended during treatment (Escitalopram SPC, 2007).

Paediatric and adolescent population
Escitalopram has received FDA approval for use in the acute and maintenance treatment of MDD in adolescents (aged 12–17 years) (see Section 5.5). However, this indication relates only to the USA, and the European Summary of Product Characteristics does not recommend the use of escitalopram in patients younger than 18 years (Escitalopram SPC, 2007). Data in children under 12 years is limited (see Section 5.5) and escitalopram is not indicated for use in this population (Escitalopram SPC, 2007).

The elderly population
Because of a prolonged escitalopram half-life and reduced clearance in patients >65 years, it is recommended to initiate treatment with half the usual recommended dose and to consider
a lower maximal dose than in younger patients (Escitalopram SPC, 2007). Escitalopram 10–20 mg/day has been demonstrated to be an effective and well tolerated treatment in elderly patients. The analysis by Baldwin et al. (2007a) found the tolerability profile of escitalopram in the elderly to be similar to that in younger (²65 years) patients. Nausea was the only event that occurred significantly more frequently with escitalopram than with placebo (6.9% versus 1.7%).

Patients with hepatic dysfunction
In patients with mild or moderate hepatic impairment, the half-life of escitalopram was found to be twice as long, and exposure approximately 60% higher, than in patients with normal liver function. An initial dose of 5 mg daily for the first 2 weeks of treatment is recommended. Depending on the patient response, the dose may be increased to 10 mg/day (Escitalopram SPC, 2007). Caution and extra careful dose titration is advised in patients with severely reduced hepatic function.

Patients with renal dysfunction
Dosage adjustment is not necessary in patients with mild or moderate renal impairment (Escitalopram SPC, 2007). Caution is advised in patients with severely reduced (creatinine clearance <30 ml/min) renal function.

Concurrent diabetes
In patients with diabetes, treatment with escitalopram may alter glycaemic control (Escitalopram SPC, 2007). A warning of this possibility is included as a class labelling for SSRIs.

References:

Escitalopram SPC 2007

Rampono et al. Br J Clin Pharmacol 2006; 62(3): 316-22

Baldwin et al. Ann Pharmacother 2007; 41: 1583-1592