Cipralex demonstrates superiority to duloxetine for acute treatment of depression in new study
COPENHAGEN, June 4, 2007-A new study published today in the journal Current Medical Research and Opinion showed that Cipralex® (escitalopram) was superior to Cymbalta® (duloxetine) in the acute treatment of patients with major depressive disorder (MDD) and was at least as efficacious in long-term treatment. The study directly compared Cipralex® (an allosteric serotonin reuptake inhibitor - ASRI) to duloxetine (a serotonin and noradrenaline reuptake inhibitor - SNRI) and also demonstrated that Cipralex® was better tolerated, with fewer patients discontinuing treatment with Cipralex® due to adverse events compared to duloxetine.
Depression is a serious illness that results in significant disability and is associated with both increased morbidity and the risk of suicide. Affecting around 121 million people globally, the World Health Organization lists depression as the leading cause of disability worldwide.
"Cipralex® is an effective and well-tolerated drug for the treatment of depression and a wide range of anxiety disorders," said Senior Vice President Anders Gersel Pedersen, Head of Development at Lundbeck. "These new data provide further evidence of the strong efficacy and tolerability profile of Cipralex® compared to other antidepressants in the treatment of depression."
About the clinical study The study was designed to look at the efficacy and tolerability of Cipralex® compared to duloxetine in patients with moderate to severe MDD over 24 weeks, with a secondary endpoint at eight weeks (acute treatment).
The double-blind, fixed-dose, comparative study included 294 patients with MDD from 35 centres in nine countries. Patients were randomised to either Cipralex® (n=143) or duloxetine (n=151), at dosing regimens currently recommended in the package inserts in participating countries (Cipralex® 20mg, duloxetine 60mg).
Patients were evaluated using the MADRS rating scale from baseline to week 24. Efficacy and tolerability were assessed at baseline and after 1, 2, 4, 8, 12, 16, 20 and 24 weeks; a safety follow-up visit was performed at 28 weeks. The 24-week study found that:
* Patients taking Cipralex® demonstrated significantly greater improvement in depression symptoms at week eight (acute treatment) than patients taking duloxetine. This superiority was evident after the first week of treatment and was maintained at all time points until week 16 (p<0.05)
* Cipralex® was at least as effective as duloxetine at 24 weeks of treatment, the primary endpoint of the study (p=0.055, Cipralex® being numerically better than duloxetine)
* Patients treated with Cipralex® showed significantly better functioning in their work, family and social life at week eight and week 24, compared to duloxetine
* Cipralex® was better tolerated than duloxetine. Significantly more duloxetine patients withdrew from the study due to adverse events than those treated with Cipralex® (17 percent versus nine percent respectively)
* A post-hoc analysis of the study revealed that 68.8 percent of patients had an early onset of response with Cipralex® compared to only 54.8 percent of duloxetine-treated patients
About depression Depression is a very common, debilitating illness affecting around 121 million people worldwide. 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 less than 25 percent of those affected having access to effective treatment.
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.
The content of this release will have no influence on the Lundbeck Group's financial result for 2007.
Investors: Media: Jacob Tolstrup Caroline Broge Investor Relations Manager, Media Relations Manager North America +45 36 43 26 38 +1 201 350 0187
Release no. 276 - 4 June 2007
About Lundbeck H. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production, marketing and sale of pharmaceuticals 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 approx. 5300 globally. For more information, please visit www.lundbeck.com.
Posted: June 2007