2007-12-05

New Data Reinforces the Superiority of Escitalopram Over Duloxetine for Acute Treatment of Depression


Copenhagen (ots/PRNewswire) -

- Attention Medical Trade Press Only

- Further Study Demonstrates Efficacy and Tolerability ofEscitalopram in Premenstrual Dysphoric Disorder

New data released today reinforces the superiority of escitalopramcompared to duloxetine in the acute treatment of depression andprovides a further insight into the impact of antidepressants onpatient functioning and quality of life - an important considerationfor physicians and patients.(1,2)

The study, presented at the International Forum on Mood andAnxiety Disorders (IFMAD) in Budapest, Hungary, reports on a pooledanalysis of two studies, both comparing the efficacy and tolerabilityof escitalopram (an allosteric serotonin reuptake inhibitor - ASRI)and duloxetine (a serotonin and noradrenaline reuptake inhibitor -SNRI).(1)

Important findings from the study:

- Patients taking escitalopram demonstrated significantly greaterimprovement in depression symptoms (as measured by the MADRS scale)at weeks 1,2, 4 and 8 with the mean treatment difference at week 8being 2.6 points (p<0.01) on the MADRS scale(1)

- Escitalopram-treated patients with severe depressiondemonstrated an even more significant improvement in depressionsymptoms compared to duloxetine, with the mean treatment differenceat week 8 being 3.7 points (p<0.01) on the MADRS scale(1)

- 54.3 percent of escitalopram-treated patients achievedremission compared to 44.4 percent of duloxetine-treated patients(1)

- Withdrawal due to adverse events was significantly less in theescitalopram-treated group; 4.6 percent for escitalopram versus 12.7percent for duloxetine(1)

"This study adds to the growing evidence for the superiority ofescitalopram over SNRI antidepressants, but this is only part of thestory," said Dr Alan Wade, study investigator and medical director ofCPS Research, Glasgow, Scotland. "Looking at real-life measures suchas improvement in disability and patient functioning allows us tobetter assess the impact of treatment on patients in the real-lifesetting."

Impact of escitalopram on patient functioning and quality oflife

In a previously published study by Wade et al., patients treatedwith escitalopram showed significantly better functioning in theirwork, family and social life, compared to duloxetine.(3) Interimresults of a separate health economic study conducted alongside thistrial were presented today demonstrating the financial impact oftreatment with escitalopram.(2)

Patients in the escitalopram-treated group had a 58 percentshorter sick leave duration associated with their depression comparedto duloxetine (p<0.001).(2)

The analysis also assessed the total cost of treatment withescitalopram versus duloxetine, taking into account the cost oftreatment, physician visits, hospitalisations, other healthcareprofessional costs and sick leave. The total cost of treatment withescitalopram after 24 weeks was GBP1,080 compared to GBP2,268 withduloxetine, representing a significant cost benefit for escitalopram,the principal saving being related to reduced time lost from work.(2)

"Depression is the leading cause of disability worldwide and theindirect costs of depression, such as absence from work, are huge,"said Dr Wade. "These data indicate that patients treated withescitalopram get back to work sooner than those taking duloxetine,which could prove to be an important differentiator when determiningthe most appropriate treatment for patients."

Escitalopram in the treatment of premenstrual dysphoricdisorder (PMDD)

Another study presented today demonstrated the efficacy andtolerability of escitalopram in the under-recognised mood disorder,premenstrual dysphoric disorder (PMDD).

PMDD is a chronic disease occurring in 3-8 percent of women ofchildbearing age. It is characterised by depressed mood, irritabilityand tension before menstruation with the symptoms being more severeand debilitating than those seen in women with premenstrual syndrome(PMS).

This single-centre, randomised, double-blind, placebo-controlledstudy was designed to assess the efficacy and tolerability ofescitalopram in PMDD. 158 patients with PMDD were treated with eitherplacebo, escitalopram 10mg or escitalopram 20mg on an intermittentbasis within three menstrual cycles and efficacy was measured byassessing the change from baseline in the luteal VAS rating, onerecognised rating scale for PMDD, which is used to measure the keysymptoms of PMDD including irritability, tension, affective labilityand depressed mood.

Key PMDD study findings

Both of the escitalopram treatment groups demonstratedsuperior improvements in PMDD symptoms versus placebo:

- 86 and 94 percent reduction in the key psychological symptomscore for the escitalopram 10mg and 20mg groups respectively versus69 percent for placebo

- The reduction of the key symptom of PMDD, irritability, was86 percent and 92 percent for the escitalopram 10mg and 20mg groupsrespectively, versus a reduction of 56 percent with placebo

- The percentage of patients reaching remission, defined as atleast an 80 percent reduction in key symptoms, was 60 percent and 80percent with the escitalopram 10mg and 20mg groups respectivelycompared to only 30 percent with placebo

Withdrawal from the study due to adverse events was seen in 6percent of placebo patients, 13 percent with escitalopram 10mg and 6percent with escitalopram 20mg.

"Severe premenstrual syndrome is a serious, hormone-dependentcondition that causes substantial impairment, yet is stillunder-diagnosed and undertreated, not least in Europe," said Dr EliasEriksson, lead investigator, University of Goteborg, Sweden. "Theresults of this study reinforce the fact that few psychiatricconditions are as treatable as severe premenstrual dysphoria."

Notes to Editors

About depression

Depression is a serious illness that results in significantdisability and is associated with both increased morbidity and therisk of suicide.(4) Affecting around 121 million people globally,(5)the World Health Organization lists depression as the leading causeof disability worldwide, with a lifetime prevalence of 17 percent inthe western world.(6)

The symptoms of depression can be chronic or recurrent, and impactpatients both mentally and physically. Depression has a significantimpact on patient quality of life and imposes a considerable burdenon society, yet it is still underrecognised and undertreated withonly 33 percent of those who suffer from clinical depression duringtheir lives receiving effective treatment.(7)

Symptoms include feelings of hopelessness, sadness, guilt, loss ofinterest in activities, decreased energy, poor concentration,persistent physical symptoms such as headache and digestivedisorders, and in more severe cases, suicidal thoughts and suicideattempts.(8)

About postmenopausal dysphoric disorder

PMDD is a chronic disease occurring in 3-8 percent of women ofchildbearing age. It is characterised by severe depression,irritability and tension before menstruation with the symptoms beingmore severe and debilitating than those seen in women withpremenstrual syndrome (PMS).(9)

Symptoms occur during the last week of most menstrual cyclesand usually improve within a few days after the period starts.(9)

Five or more of the following symptoms must be present for adiagnosis of PMDD:9

- Feeling of sadness of hopelessness, possible suicidalthoughts

- Feelings of tension or anxiety

- Panic attacks

- Mood swings marked by periods of teariness

- Persistent irritability or anger that affects other people

- Disinterest in daily activities and relationships

- Trouble concentrating

- Fatigue or low energy

- Food cravings or binge eating

- Sleep disturbances

- Feeling out of control

- Physical symptoms such as bloating, breast tenderness,headaches and joint or muscle pain

About Lundbeck

H. Lundbeck A/S is an international pharmaceutical company engagedin the research and development, production, marketing and sale ofdrugs for the treatment of psychiatric and neurological disorders. In2006, the company's revenue was DKK 9.2 billion (approximately EUR1.2 billion or USD 1.6 billion). The number of employees isapproximately 5,300 globally. For further information, please visithttp://www.lundbeck.com.

References

1) Lam, RW et al. Escitalopram and duloxetine in the treatment ofmajor depressive disorder - A pooled analysis. Poster presented atthe 7th International Forum on Mood and Anxiety Disorders Congress,5-7 December 2007, Budapest, Hungary

2) Wade, A. What are the future challenges in the treatment ofMood Disorders. Presented at the Lundbeck sponsored satellitesymposium, 7th International Forum on Mood and Anxiety DisordersCongress, 5-7 December 2007, Budapest, Hungary

3) Wade, A et al. A comparative study of the efficacy of acute andcontinuation treatment with escitalopram versus duloxetine inpatients with major depressive disorder. Curr Med Res Opin. 2007; 23(7): 1605-1614

4) Bostwick, JM, Pakratz, VS. Affective disorders and suiciderisk: a reexamination. Am J Psychiatry. 2000; 157:1925-1932

5) Depression. World Health Organisation. Last accessed on20.11.07 fromhttp://www.who.int/mental_health/management/depression/definition/en/

6) Sclar, DA et al. Economic appraisal of citalopram in themanagement of single-episode depression. J Clin Psychopharmacol 1999;19 (5 Suppl.1): 47S-54S

7) El-Mallakh, RS et al. Clues to depression in primary carepractice. Postgraduate Medicine. 1996; 100(1): 85-8, 93-6

8) Depression. National Institute for Mental Health. Last accessedon 20.11.07 from http://www.nimh.nih.gov/health/publications/depression/complete-publication.s html

9) Premenstrual dysphoric disorder. Medline Plus: MedicalEncyclopaedia. Last accessed on 20.11.07 fromhttp://www.nlm.nih.gov/medlineplus/ency/article/007193.htm

ots Originaltext: H. Lundbeck A/SIm Internet recherchierbar: http://www.presseportal.de

$story.getcontactHeadline()Media contact: For more information, please contact: Paul Gittins, Red Health, Tel: +44-207-025-6571, Mobile: +44-7958-533462, Email: paul.gittins@redconsultancy.com

H. Lundbeck A/S

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New Data Reinforces the Superiority of Escitalopram Over Duloxetine for Acute Treatment of Depression

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