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Escitalopram Safe and Effective for Patients Switched from Citalopram to Escitalopram: Presented at WCP

By Bruce Sylvester
Special to DG News

YOKOHAMA, JAPAN -- August 29, 2002 -- Patients with depression show no increase in adverse events if treatment is switched from citalopram to escitalopram, the single-isomer version of citalopram, researchers report.

Presenting at the 12^th World Congress of Psychiatry in Yokohama, lead author E. H. Raines, M.D. and clinical investigator at H. Lundbeck A/S in Copenhagen, Denmark, said that this is a safe and well-tolerated treatment.

"As it may be expected that some patients being treated with citalopram will, at their physician's discretion, be switched to escitalopram, the efficacy and safety consequences of this switch should be determined," the study authors wrote.

This multi-national, open-label, long-term safety, follow-up study was conducted in primary care centers in eight countries (Belgium, Canada, Finland, France, Norway, Sweden, Switzerland, and the United Kingdom).

Subjects entered this study after completing a lead-in study in which they received escitalopram 10-20 mg/day, 20-40 mg/day citalopram, or placebo for eight weeks. The dose could be doubled once after four to six weeks.

All subjects in the extension study began at escitalopram 10mg/day. After two weeks, the dose could be raised to a maximum of 20mg/day.

Subject eligibility criteria included: outpatient status, 18-65 years of age, fulfillment of DSM-IV criteria for a current episode of Major Depressive Disorder, a total Montgomery-Asberg Depression Rating Scale (MADRAS) score of >/= 22 and </= 40.

The investigators determined new treatment-emergent adverse events after the first week of the extension study, based on patient treatment and dosage levels at the end of the lead-in study.

A total of 471 subjects were randomized to enter the lead-in study, and 437 finished; 313 continued in the extension study. The 104 subjects included in this analysis did not stop medication between lead-in and extension studies and did not increase the dosage of citalopram or escitalopram in the lead-in study.

In the week following the switch from 20 mg/day citalopram to 10 mg/day escitalopram, there were no clinically relevant differences in the incidence of treatment-emergent adverse events as compared to subjects treated previously with 10 mg/day escitalopram.

Three subjects withdrew from the 20 mg/day citalopram group and two patients from the group continuing on 10 mg/day escitalopram.

The investigators observed continued improvement in subjects with further reductions in the MADRS and CGI-S scores. The incidence of adverse events declined during escitalopram treatment versus short-term treatment. There were no clinically significant mean changes in vital signs, electrocardiogram (ECG), or laboratory values observed during continued escitalopram treatment, regardless of previous treatment. Researchers observed no new clinically significant adverse events in patients switching from citalopram to escitalopram treatment.

"In patients switched from citalopram to escitalopram, there are no safety concerns, and depressive symptoms continue to improve." the researchers concluded.

The study was sponsored by H. Lundbeck A/S, Valby, Denmark

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