Study Suggests Cymbalta Significantly Reduces Core Anxiety Symptoms of Generalized Anxiety Disorder

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Study Suggests Cymbalta(R) Significantly Reduces Core Anxiety Symptoms of Generalized Anxiety Disorder

Patients Taking Cymbalta Also Reported Reduced Painful Physical Symptoms and Improved Functioning

(March 24, 2006) -- A new study of approximately 500 patients evaluated the safety and efficacy of the antidepressant Cymbalta (R) (duloxetine HCl) on the core anxiety symptoms in patients with generalized anxiety disorder. Cymbalta significantly reduced core anxiety symptoms and associated painful physical symptoms and improved functional impairment associated with the illness. Results will be announced on Saturday, March 25, in two separate presentations(i,ii) at the Anxiety Disorders Association of America (ADAA) Annual Conference.

In this nine-week study, Cymbalta significantly improved core anxiety symptoms such as anxious mood, fears and tension by 51 percent in patients taking 60mg/day and by 50 percent in patients taking 120mg/day compared to an improvement of 32 percent in patients taking sugar pill. Patients taking both 60mg/day and 120mg/day had significantly greater response and remission rates compared to patients taking sugar pill. In addition, Cymbalta significantly reduced overall pain by 41 percent and 37 percent respectively, compared to 16 percent in patients taking sugar pill. Cymbalta patients also reported greater improvement in quality of life as measured by the Sheehan Disability Scale, Quality of Life Enjoyment and Satisfaction Questionnaire and European Quality of Life 5 Dimensions, including improved ability to perform everyday activities at work, home, and in social situations compared to sugar pill.

"While it is important to evaluate anxiety symptoms such as excessive worry and irritability, it is also important to evaluate associated painful physical symptoms and functioning because many patients also report these symptoms," said Christer Allgulander, MD, associate professor, senior lecturer, Karolinska Institutet, and lead author on the study. "These data suggest that not only was Cymbalta able to significantly improve the core anxiety symptoms, but it also reduced painful physical symptoms associated with the disorder and improved functioning resulting in improved quality of life."

"We are encouraged by these results that suggest Cymbalta may address a broad range of core anxiety symptoms and the associated physical symptoms that are often reported in patients with generalized anxiety disorder," said James Russell, MD, medical advisor, Eli Lilly and Company.

Study Highlights

Compared to sugar pill, patients receiving Cymbalta 60mg/day and 120mg/day experienced significant improvement in symptom severity and disability associated with generalized anxiety disorder, including:
- Significantly greater improvement in the severity of anxiety symptoms, such as anxious mood, fears and tension, as measured by the Hamilton Anxiety Scale. (average improvement 60mg = 51%, 120mg = 50%, sugar pill = 32%)
- Greater response rates (58%, 56%, 31%, respectively) -
- Greater sustained improvement rates (64%, 67%, 43%, respectively)
Patients receiving Cymbalta 60mg/day and 120mg/day experienced greater remission rates compared to those receiving sugar pill (31%, 38% and 19%, respectively).
Compared to sugar pill, patients receiving Cymbalta 60mg/day and 120mg/day reported significant improvement in ratings on the Visual Analogue Scale for Pain for each of the following pain items:
- Overall pain (average improvement 60mg = 41%, 120mg = 37%, sugar pill = 16%)
- Headaches (34%, 38%, 13%, respectively)
- Back pain (44%, 46%, 14%, respectively)
- Shoulder pain (47%, 43%, 19%, respectively)
- Interference due to pain (39%, 41%, 10%, respectively)
- Pain during waking hours (42%, 43%, 12%, respectively)
In this study, the most common adverse events (occurred at a rate of greater than or equal to 5 percent and at least twice the rate of placebo) were nausea, dizziness, dry mouth, fatigue, hyperhidrosis, insomnia, constipation, diarrhea, decreased libido, anorexia, somnolence, vomiting and sedation.

Methods

In this study of patients with generalized anxiety disorder, 168 patients were randomly assigned to receive 60mg of Cymbalta a day, 170 patients received 120mg of Cymbalta a day and 175 patients received a sugar pill. Patients with a recent diagnosis (within six months) of major depression were excluded from this study. The primary endpoint of the study was effect on anxiety symptoms as measured by the Hamilton Anxiety Scale (HAMA). Changes from baseline to endpoint were analyzed using ANCOVA. Secondary measures included effects on associated pain and functioning. Pain was assessed using a Visual Analogue Scale. Functional outcomes, such as the ability to complete everyday activities at work, home, and in social situations, were measured using the Sheehan Disability Scale (SDS), the Quality of Life Enjoyment and Satisfaction Questionnaire short form (Q-LES-Q-SF) and the European Quality of Life 5 Dimensions (EQ-5D).

About Generalized Anxiety Disorder

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Approximately four million Americans are diagnosed with generalized anxiety disorder each year.(iii) Symptoms persist for at least six months and can include exaggerated worry or chronic anxiety and irritability, which can lead to poor concentration, and procrastination, as well as physical symptoms like muscle tension, fatigue and nausea.(iv) Episodes of generalized anxiety disorder may be brought on, or worsened by, stressful life events. The illness also tends to be chronic with periods of exacerbation and remission.(v)

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Last updated: 03/06

Study Suggests Cymbalta(R) Significantly Reduces Core Anxiety Symptoms of Generalized Anxiety Disorder

Study Highlights

Methods

About Generalized Anxiety Disorder

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