H. Lundbeck A/S

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 of Escitalopram in  Premenstrual Dysphoric Disorder

    New data released today reinforces the superiority of escitalopram compared to duloxetine in the acute treatment of depression and provides a further insight into the impact of antidepressants on patient functioning and quality of life - an important consideration for physicians and patients.(1,2)

    The study, presented at the International Forum on Mood and Anxiety Disorders (IFMAD) in Budapest, Hungary, reports on a pooled analysis of two studies, both comparing the efficacy and tolerability of 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 greater improvement in depression symptoms (as measured by the MADRS scale) at weeks 1,2, 4 and 8 with the mean treatment difference at week 8 being 2.6 points (p<0.01) on the MADRS scale(1)

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

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

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

    "This study adds to the growing evidence for the superiority of escitalopram over SNRI antidepressants, but this is only part of the story," said Dr Alan Wade, study investigator and medical director of CPS Research, Glasgow, Scotland. "Looking at real-life measures such as improvement in disability and patient functioning allows us to better assess the impact of treatment on patients in the real-life setting."

    Impact of escitalopram on patient functioning and quality of life

    In a previously published study by Wade et al., patients treated with escitalopram showed significantly better functioning in their work, family and social life, compared to duloxetine.(3) Interim results of a separate health economic study conducted alongside this trial were presented today demonstrating the financial impact of treatment with escitalopram.(2)

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

    The analysis also assessed the total cost of treatment with escitalopram versus duloxetine, taking into account the cost of treatment, physician visits, hospitalisations, other healthcare professional costs and sick leave. The total cost of treatment with escitalopram after 24 weeks was GBP1,080 compared to GBP2,268 with duloxetine, 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 the indirect costs of depression, such as absence from work, are huge," said Dr Wade. "These data indicate that patients treated with escitalopram get back to work sooner than those taking duloxetine, which could prove to be an important differentiator when determining the most appropriate treatment for patients."

    Escitalopram in the treatment of premenstrual dysphoric disorder (PMDD)

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

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

    This single-centre, randomised, double-blind, placebo-controlled study was designed to assess the efficacy and tolerability of escitalopram in PMDD. 158 patients with PMDD were treated with either placebo, escitalopram 10mg or escitalopram 20mg on an intermittent basis within three menstrual cycles and efficacy was measured by assessing the change from baseline in the luteal VAS rating, one recognised rating scale for PMDD, which is used to measure the key symptoms of PMDD including irritability, tension, affective lability and depressed mood.

    Key PMDD study findings

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

    - 86 and 94 percent reduction in the key psychological symptom score for the escitalopram 10mg and 20mg groups respectively versus 69 percent for placebo

    - The reduction of the key symptom of PMDD, irritability, was 86 percent and 92 percent for the escitalopram 10mg and 20mg groups respectively, versus a reduction of 56 percent with placebo

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

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

    "Severe premenstrual syndrome is a serious, hormone-dependent condition that causes substantial impairment, yet is still under-diagnosed and undertreated, not least in Europe," said Dr Elias Eriksson, lead investigator, University of Goteborg, Sweden. "The results of this study reinforce the fact that few psychiatric conditions are as treatable as severe premenstrual dysphoria."

    Notes to Editors

    About depression

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

    The symptoms of depression can be chronic or recurrent, and impact patients both mentally and physically. Depression has a significant impact on patient quality of life and imposes a considerable burden on society, yet it is still underrecognised and undertreated with only 33 percent of those who suffer from clinical depression during their lives receiving effective treatment.(7)

    Symptoms include feelings of hopelessness, sadness, guilt, loss of interest in activities, decreased energy, poor concentration, persistent physical symptoms such as headache and digestive disorders, and in more severe cases, suicidal thoughts and suicide attempts.(8)

    About postmenopausal dysphoric disorder

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

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

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

    - Feeling of sadness of hopelessness, possible suicidal thoughts

    - 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 engaged in the research and development, production, marketing and sale of drugs for the treatment of psychiatric and neurological disorders. In 2006, the company's revenue was DKK 9.2 billion (approximately EUR 1.2 billion or USD 1.6 billion). The number of employees is approximately 5,300 globally. For further information, please visit http://www.lundbeck.com.

    References

    1) Lam, RW et al. Escitalopram and duloxetine in the treatment of major depressive disorder - A pooled analysis. Poster presented at the 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 of Mood Disorders. Presented at the Lundbeck sponsored satellite symposium, 7th International Forum on Mood and Anxiety Disorders Congress, 5-7 December 2007, Budapest, Hungary

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

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

    5) Depression. World Health Organisation. Last accessed on 20.11.07 from http://www.who.int/mental_health/management/depression/definition/en/

    6) Sclar, DA et al. Economic appraisal of citalopram in the management 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 care practice. Postgraduate Medicine. 1996; 100(1): 85-8, 93-6

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

    9) Premenstrual dysphoric disorder. Medline Plus: Medical Encyclopaedia. Last accessed on 20.11.07 from http://www.nlm.nih.gov/medlineplus/ency/article/007193.htm

ots Originaltext: H. Lundbeck A/S
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