New Analysis Shows Cymbalta Reduced Anxiety Symptoms in Elderly Patients with Depression Significant Reduction in Anxiety Symptoms Seen as Early as One Week ATLANTA, Ga., May 24 /PRNewswire-FirstCall/ -- Cymbalta(TM) (duloxetine HCL) significantly reduced anxiety symptoms in elderly patients with depression, compared with those treated with a sugar pill, according to new research presented today at the annual meeting of the American Psychiatric Association. In the eight-week study of people over age 65 with depression, 60 mg of Cymbalta, taken once daily, significantly reduced psychic anxiety symptoms in depressed patients, such as worry, ability to concentrate, tension and irritability, compared to placebo (mean change 6.2 vs. 0.18), as measured by the psychic anxiety question on the Hamilton Depression Scale (HAMD17). Cymbalta also significantly reduced somatic anxiety -- or physical symptoms often associated with anxiety -- compared with placebo (mean change of 1.88 vs. 0.99), according to the anxiety/somatization subscale of the HAMD17. "When anxiety symptoms appear in elderly patients with depression it often makes treatment more complicated than when these symptoms emerge alone. This comorbidity is associated with an increased severity of symptoms, including a greater risk for suicide, and often less successful treatment outcomes," explained Olga Brawman-Mintzer, MD, associate professor of psychiatry, and the director of Anxiety Disorders Program at the Medical University of South Carolina. While depression alone affects two million Americans aged 65 and older(i), there is considerable overlap between depression and anxiety. Half of those with major depressive disorder actually meet the criteria for an anxiety disorder. Furthermore, one-quarter of those with anxiety disorders meet the criteria for major depressive disorder(ii). "Since treating this population is so challenging, the fact that patients responded to medication within one week while on Cymbalta is promising," stated Joel Raskin, MD, FRCPC, medical advisor Eli Lilly and Company. "Further research into the benefit of Cymbalta in anxiety is needed." Additional Study Highlights * When elderly patients were analyzed by age: - Patients under 75 treated with Cymbalta experienced significant improvements in both psychic anxiety symptoms, such as worry and tension, and physical anxiety symptoms, as measured by the anxiety/somatization subscale, compared with those treated with a sugar pill. - Patients 75 and older treated with Cymbalta showed significant improvements in psychic anxiety, as well. They also showed a numerical advantage on the anxiety/somatization subscale that was not statistically significant, as compared with those treated with a sugar pill. * A statistically significant improvement in the somatic anxiety item of the HAMD17 was not seen in patients treated with Cymbalta. * In this study, Cymbalta was safe and well tolerated, with discontinuations due to adverse events occurring in less than 10 percent of those treated, with no difference between Cymbalta and placebo. * The most common (>/= 5 percent) adverse events experienced by patients treated with Cymbalta in this study included dry mouth (14.5 percent), nausea (12.6 percent), constipation (10.1 percent), headache (7.2 percent), dizziness (8.2 percent), diarrhea (8.2 percent), fatigue (6.3 percent) and somnolence (5.3 percent). Methods Data were gathered from 311 patients with major depression aged 65 and older who participated in a multicenter, parallel, double-blind, placebo- controlled study. After one week, patients were randomly chosen to receive either Cymbalta 60 mg once daily (n=207) or placebo (n=104) for eight weeks. At the end of the study, patients entered a one-week, double-blind discontinuation phase where the dose of the study medication was tapered. A secondary analysis was conducted to measure anxiety using anxiety items 10 (psychic) and 11 (somatic,) and the anxiety/somatization subscale of the HAMD17. About Cymbalta Serotonin and norepinephrine are two chemicals in the brain and spinal cord called neurotransmitters. Serotonin and norepinephrine are believed to both mediate core depression symptoms and help regulate the perception of pain. Disturbances of serotonin and/or norepinephrine may explain the presence of both the emotional and physical symptoms of depression. Based on pre-clinical studies, Cymbalta is a balanced and potent reuptake inhibitor of serotonin and norepinephrine. While the mechanism of action of Cymbalta is not fully known, scientists believe its effect on both emotional symptoms and pain perception is caused by increasing the activity of serotonin and norepinephrine in the central nervous system. Cymbalta is approved in the United States for the treatment of major depressive disorder and the management of diabetic peripheral neuropathic pain, both in adults. Cymbalta is not specifically indicated for geriatric depression. As Cymbalta has not been studied in children, Lilly discourages its use in those under the age of 18. Important Safety Information In clinical studies, antidepressants increased the risk of suicidal thinking and behavior in children and adolescents with depression and other psychiatric disorders. Anyone considering the use of Cymbalta or any other antidepressant in a child or adolescent must balance the risk with the clinical need. Patients who are starting therapy should be observed closely. Families and caregivers should discuss with the doctor any observations of worsening depression symptoms, suicidal thinking and behavior, or unusual changes in behavior. Cymbalta is not approved for use in patients under the age of 18. Patients on antidepressants and their families or caregivers should watch for worsening depression symptoms, unusual changes in behavior and thoughts of suicide, as well as for anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme hyperactivity. Call the doctor if you have thoughts of suicide, or if any of these symptoms are severe or occur suddenly. Be especially observant at the beginning of treatment or whenever there is a change in dose. Prescription Cymbalta is not for everyone. People who are allergic to Cymbalta or the other ingredients in Cymbalta should not take it. If you have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI), are taking thioridazine or have uncontrolled narrow-angle glaucoma, you should not take Cymbalta. Talk with your doctor before taking Cymbalta if you have liver or kidney problems, glaucoma or consume large quantities of alcohol. Women who are pregnant should talk with their doctor before taking Cymbalta. Nursing while taking Cymbalta is not recommended. In clinical studies of Cymbalta for depression, the most common side effects were nausea, dry mouth, constipation, decreased appetite, fatigue, sleepiness, and increased sweating. Cymbalta is also approved for the management of neuropathic pain associated with diabetic peripheral neuropathy. In clinical studies of Cymbalta in these patients, the most common side effects were nausea, sleepiness, dizziness, constipation, dry mouth, increased sweating, decreased appetite, and loss of strength or energy. In all clinical trials, most people were not bothered enough by side effects to stop taking Cymbalta. Your doctor may periodically check your blood pressure. Don't stop taking Cymbalta without talking to your doctor. For full Patient Information, visit http://www.cymbalta.com/ . For full Prescribing Information, including Boxed Warning, visit http://www.cymbalta.com/. About Lilly Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and 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. Additional information about Lilly is available at http://www.lilly.com/ . P-LLY This press release contains forward-looking statements about the potential of Cymbalta hydrochloride for the treatment of anxiety, in addition to major depressive disorder, and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that the product will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements. (i) Kim, Crystal. "Major Depression in the Elderly," Johns Hopkins University, Spring 2003. Available at http://www.jhu.edu/hurj/issue2/07C%20MajorDepress.pdf . Accessed 1/5/05. (ii) Anxiety Disorders Association of America. Brief Overview of Anxiety Disorders. Available at: http://www.adaa.org/AnxietyDisorderInfor/AnxietyElderly.cfm . Accessed March 21, 2005. (Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO ) http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE: Eli Lilly and Company CONTACT: David Shaffer (US), +1-317-651-3710, cell: +1-317-332-9303, or Jennifer Yoder (OUS), +1-317-433-3445, cell: +1-317-332-3145, both of Eli Lilly and Company

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