Navigation Links
In New Study, Duloxetine Reduced Non-specific Pain and Emotional,Symptoms Associated with Depression

MADRID, Spain, 19 march 2007 - The antidepressant duloxetine, at a once-daily dose of 60 mg, significantly reduced non-specific pain and emotional symptoms associated with depression in a new, eight-week, placebo-controlled study of 327 adult patients with at least moderate pain and major depression. The results were presented today at the 15th European Congress of Psychiatry (AEP) in Madrid, Spain.

Duloxetine, a member of a class of drugs commonly referred to as serotonin and norepinephrine reuptake inhibitors (SNRIs), is approved in more than 70 countries for the treatment of major depression.

“Whereas traditionally, the focus has been on treating only emotional symptoms of depression, we now know that the presence of physical symptoms, specifically pain, can obscure the diagnosis and complicate the management of patients,” said Professor Koen Demyttenaere, Department of Psychiatry at University Hospital Gasthuisberg in Belgium and lead study investigator. “In this study of depressed patients with at least moderate pain, duloxetine helped by significantly reducing both painful and emotional symptoms of depression, and in decreasing the interference of pain with functioning.”

In the study:
Average pain scores, the primary outcome measured, decreased significantly among patients treated with duloxetine by 45 percent (on an 11-point Likert scale from 5.7 at baseline to 3.13 at the final visit in Week 8) compared with a decrease of 29 percent (from 5.7 to 4.06) among those taking placebo (p< 0.001).
Duloxetine significantly reduced core emotional symptoms, as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS), by 56 percent (from an average score of 29.6 at baseline to 12.91 at Week 8), compared with a 39-percent reduction (from 29.6 to 18.29) in patients taking placebo (p<0.0001).
53 percent of duloxetine-treated patients reached remis sion (MADRS <12) by the end of the study, compared with 29 percent of placebo-treated patients (p< 0.0001).
Compared with placebo, duloxetine-treated patients also experienced a significantly better outcome in response to pain (>30% reduction from baseline in average pain severity) and improved daily functioning not limited by pain (BPI interference subscale).
10.5 percent of study patients treated with duloxetine and 5.5 percent of patients treated with placebo discontinued treatment because of adverse events. The most commonly reported adverse events among those taking duloxetine were nausea (24.7 percent for duloxetine-treated patients, vs. 7.9 percent for those taking placebo), excessive sweating (11.7 percent vs. 2.4 percent), dry mouth (10.5 percent vs. 3.6 percent), headache (7.4 percent vs. 9.1 percent), fatigue (8.0 percent vs. 1.8 percent), dizziness (5.6 percent vs. 3.6 percent), and constipation (5.6 percent vs. 1.2 percent).
Notes to Editors:


This double-blind, eight week study included 327 patients randomized to placebo (n=165) or duloxetine 60mg (n=162) and was conducted in Belgium, Finland, France, Germany and Slovakia.
Trial participants were outpatients aged 18 or older presenting with:
Major depressive disorder (MDD), as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS, with a score of >20) and the Clinical Global Impression of Severity scale (CGI-S, with a score of >4).
At least moderate pain not attributable to a diagnosed pain syndrome, as assessed by the Brief Pain Inventory (BPI, with a score of >3), a validated scale used to assess the severity of pain and the impact of pain on daily functions.
The primary outcome measure was the brief pain inventory average pain score at endpoint, and the change from baseline, using the mixed-model-repeated-measures (MMRM) method.
Secondary measures included MADRS total score, CGI-S, SCL-90-R, response and remission, s afety and tolerability.
About Duloxetine
Duloxetine is believed to impact both serotonin and norepinephrine/noradrenaline mediated nerve signalling in the brain and the spinal cord. Based on pre-clinical studies, duloxetine is a balanced and potent reuptake inhibitor of serotonin and norepinephrine/noradrenaline. While the mechanism of action of duloxetine in humans is not fully known, scientists believe its effect on pain perception is due to increasing the activity of serotonin and noradrenaline in the central nervous system.

Duloxetine is approved for the treatment of depression and diabetic peripheral neuropathic pain in many countries and is approved in some countries for the treatment of stress urinary incontinence. Duloxetine also is approved in the United States and Mexico for the treatment of generalised anxiety disorder. Duloxetine is approved only for adults 18 and over. In children and teens, antidepressants can increase the risk of suicidal thoughts or actions. Patients should call their doctor right away if they experience worsening depression symptoms, unusual changes in behavior or thoughts of suicide, especially at the beginning of treatment or after a change in dose.

The most commonly reported adverse reactions in patients with depression treated with duloxetine in clinical trials were nausea, dry mouth, headache and diarrhea. However, the majority of common adverse reactions were mild to moderate, they usually started early in therapy and most tended to subside even as therapy was continued. The most commonly observed adverse reactions in patients with diabetic neuropathic pain treated with duloxetine were: nausea; somnolence; dizziness; and headache. The most common adverse reactions in patients with generalised anxiety disorder treated with duloxetine in clinical trials were nausea, fatigue, dry mouth, drowsiness, constipation, insomnia, decreased appetite, hyperhidrosis, decreased libido, vomiting, ejaculation delay an d erectile dysfunction.

Duloxetine is contraindicated in patients who are allergic to it, who have liver disease resulting in hepatic impairment, who are taking a monoamine oxidase inhibitor (MAOI), fluvoxamine, ciprofloxacin or enoxacine or who have severe kidney disease. The initiation of treatment with duloxetine also is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis.

About Depression
Major Depressive Disorder (MDD) affects approximately 121 million people worldwide.1 The World Health Organization estimates depression will be among the highest-ranking causes of disability in developed countries by 2020, second only to ischemic heart disease worldwide.2 It can happen to anyone of any age, race or ethnicity; however, women are nearly twice as likely to experience depression as men.3 Although it is one of the most frequently seen psychiatric disorders in the primary care setting, it often goes undiagnosed or is under-treated.4 This may be because depressed people often present physical symptoms rather than emotional complaints; pain is present in approximately 45 to 95 percent of patients with MDD, and can include headache, back, shoulder and abdominal pain.5

Complete elimination of symptoms, or remission, is the primary goal of depression treatment. Treating the full spectrum of emotional and physical symptoms to remission decreases a patient’s risk of relapse.6

Eli Lilly and Company and Boehringer Ingelheim
In November 2002, Eli Lilly and Company and Boehringer Ingelheim signed a long-term agreement to jointly develop and commercialize duloxetine hydrochloride. This partnership covers neuroscience indications in most countries outside of the United States and Japan, with few exceptions.

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world`s most urgent medical needs.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 143 affiliates in 47 countries and almost 37,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. In 2005, Boehringer Ingelheim posted net sales of 9.5 billion euro while spending almost one fifth of net sales in its largest business segment Prescription Medicines on research and development.

Duloxetine for major depressive episodes will be marketed by Lilly and Boehringer Ingelheim in all countries included in the partnership under the brand name Cymbalta®, except for Greece, Italy and Spain. In Greece, Italy and Spain Lilly will market the product as Cymbalta and Boehringer Ingelheim will market the product as Xeristar®. In the United States, Cymbalta is marketed by Lilly and Quintiles. In Japan, duloxetine will be co-developed and co-marketed by Lilly and Shionogi & Co., Ltd.

Duloxetine for stress urinary incontinence will be marketed by Lilly under the brand name Yentreve.®

Please be advised
This release is from the Corporate Headquarters of Boehringer Ingelheim and is intended for all international markets. This being the case, please be aware that there may be some differences between countries regarding specific medical information including licensed uses. Please take account of this when referring to the material.

Related links:
Eli Lilly and Company

Boehringer Ingelheim GmbH
Ute E. Schmidt
55216 Ingelheim
Phone: +49 (0)6132 7797296
Fax: +49 (0)6132 776601

Eli Lilly and Company
David Shaffer
Phone: +1, 317-651-3710

1 World Health Organization. Factsheet - Depression, 2005.
2 Murray CJL, Lopez AD, eds. The Global Burden of Disease; 1996.
3 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed., Text Revision. Washington DC: American Psychiatric Association; 2000:345-428.
4 Kroenke K, et al. Am J Med. 1997; 103(5):339-347.
5 Simon GE et al. New Engl J Med. 1999;341:1329-35.
6 Paykel ES, et al. Psychol Med. 1995;25(6):1171-1180.


Related medicine technology :

1. In New Study, Duloxetine Was Equally Effective, Regardless of Switch Method, in Reducing Painful Symptoms in Ssri Non- or Partial-responders with Depression
2. Newly Published Data Demonstrates Superiority of Cipralex Over Duloxetine for Acute Treatment of Depression
3. New Study Shows That Extending Prophylaxis With Clexane / Lovenox (enoxaparin Sodium Injection) to 5 Weeks is More Effective Than 10 Days for Reducing the Risk of Venous Thromboembolism (VTE) in Acutely ill Medical Patients With Reduced Mobility
4. Publication on Pixantrone Preclinical Studies Demonstrates Reduced Cardiotoxicity Compared to Equiactive Doses of Doxorubicin and Mitoxantrone
5. New Study Shows A1c Reduced Safely By Patients With Type 2 Diabetes Using Self-Adjusted Dosing Starting With Once-Daily Insulin Treatment Levemir
6. Lipitor Reduced the Risk of Coronary Events by Half and Stroke by Nearly One-Third in High-Risk Patients with Type 2 Diabetes Who Experienced a Recent Stroke
7. New Study Shows A1c Reduced Safely By Patients With Type 2 Diabetes Using Self-Adjusted Dosing Starting With Once-Daily Insulin Treatment Levemir
8. Arterial Plaque Significantly Reduced in Women Age 50-59 Taking Hormones, Says New Analysis of Womens Health Initiative Data
9. New Analysis of WHI Data Shows Reduced Levels of Coronary Artery Calcification, a Predictor of Cardiovascular Events, in Women aged 50-59 taking Estrogen Therapy
10. Pivotal Phase III Trial Showed Promacta (eltrombopag olamine) Raised Platelet Counts and Reduced Bleeding in Patients With Chronic ITP
11. Preclinical Study Finds Protease Inhibitor-Resistant HIV May Have Reduced Potential to Develop Resistance to Panacos Bevirimat
Post Your Comments:
(Date:2/17/2017)... Cryoablation, Electrical, Endometrial Hydrothermal, Laser/Light, Microwave, Radiofrequency, Ultrasound, Cardiovascular, Gynaecology, Musculoskeletal, ... to grow at a CAGR of 9.4% from 2017-2022 and CAGR ... a CAGR of 9.5% from 2017 to 2027. The market is ... ... you Read on to discover how you can exploit the ...
(Date:2/17/2017)... , Feb. 17, 2017 Theravance Biopharma, ... or the "Company") today announced the presentation of ... and orally administered pan-Janus kinase (JAK) inhibitor designed ... Congress of the European Crohn,s and Colitis ... reported further data from its completed Phase 1 ...
(Date:2/17/2017)...   Risperdal lawsuits involving gynecomastia (male breast growth) ... of the atypical antipsychotic medication continue to move forward ... Common Pleas, where the state,s Risperdal docket has been ... notice posted on the Court,s website , the ... 9, 2017 at 11:00 a.m. (In Re: Risperdal Litigation, ...
Breaking Medicine Technology:
(Date:2/19/2017)... ... February 19, 2017 , ... "At your fingertips" electronic access ... and the Delaware Health Information Network (DHIN) have partnered to improve connectivity of ... health information exchange, DHIN stores and shares real-time health data for more than ...
(Date:2/18/2017)... ... February 17, 2017 , ... Butler Mobility invited Ken Matthews ... and other Butler products. Ken was impressed with the safety and reliability of ... the product on his show. This endorsement by Ken Matthews can be heard ...
(Date:2/18/2017)... (PRWEB) , ... February 18, 2017 , ... ... today provides the latest information and contact points to easily connect elderly veterans ... care, assisted living, and elder-care funding. It also conveys material on this year's ...
(Date:2/17/2017)... ... 17, 2017 , ... Wells Pharmacy Network offers physicians WellsPx3, ... and non-controlled substances plus the ability to manage orders on their desktop or ... accept electronic prescriptions, according to the Office of the National Coordinator of Health ...
(Date:2/17/2017)... ... February 17, 2017 , ... Corrective Action ... Letter, **An FDAnews Webinar**, Feb. 23, 2017 — 1:30 p.m. – 3:00 p.m. ... action (CA) and preventive action (PA)? , The methods share techniques and tools ...
Breaking Medicine News(10 mins):