Data Suggest Cymbalta(R) Improved Functioning in Patients with Generalized Anxiety Disorder
May 21 2007 - 3:11PM
PR Newswire (US)
Relationship Between Ability to Function and Treatment of Anxious
and Painful Physical Symptoms Studied INDIANAPOLIS, May 21
/PRNewswire-FirstCall/ -- Data suggest that patients with
generalized anxiety disorder (GAD) treated with Cymbalta(R)
(duloxetine HCl) experienced improved ability to perform everyday
activities at home, work and in social situations compared to sugar
pill. These improvements in global functioning were the result of
improvements in anxious symptoms, as well as through an improvement
in the painful physical symptoms that can be associated with the
condition. The results of these data from two GAD registration
studies of more than 840 patients were presented today at a major
medical meeting of psychiatrists. These analyses focused on the
relationship between global functional impairment and the treatment
of anxious and painful physical symptoms in patients with GAD.
Improvement in global functioning was measured by the Sheehan
Disability Scale (SDS), which assesses the extent emotional
symptoms disrupt ability to perform everyday activities at work,
home and in social situations. In one of the two studies, patients
treated with 60 mg and 120 mg once daily of Cymbalta experienced
statistically significant improvements compared to those treated
with a sugar pill (defined by mean change on SDS, 7.76 and 7.04 vs.
3.83). In the second study, patients treated with 60-120 mg once
daily of Cymbalta experienced statistically significant
improvements compared to those treated with a sugar pill (defined
by mean change on SDS 5.78 vs. 3.11). In the pooled analysis, among
Cymbalta-treated patients, 48 percent of improvement in global
functioning was from improvements in psychic anxiety, while 9
percent was from improvements in painful physical symptoms and 7
percent was from improvements in somatic anxiety associated with
GAD. Since GAD presents with a variety of symptoms, it can be
difficult to diagnose(1) and may have a negative impact on a
person's ability to function properly in work, family and social
situations.(2) "This study underscores the importance of treating
all of the many symptoms of GAD and reducing the global functional
impairment associated with the disorder," says Dr. David Sheehan,
lead study author and professor of psychiatry at the University of
South Florida College of Medicine in Tampa. "This information may
be important for physicians to consider when choosing a treatment
for their patients with GAD since different medications may affect
symptoms differently." Additional Study Highlights -- Thirty-six
percent of the improvement in global functioning was due to an
undefined effect of Cymbalta, which was not measured on any of the
three scales used in the study. -- In improvement in work
functioning, 36 percent was due to treatment of psychic anxiety, 8
percent was due to treatment of painful physical symptoms and 4
percent was due to treatment of somatic anxiety, while 51 percent
was due to an undefined effect of Cymbalta. -- In improvement in
social functioning, 46 percent of the improvement was due to
treatment of psychic anxiety, 9 percent was due to treatment of
painful physical symptoms and 6 percent was due to treatment of
somatic anxiety, while 39 percent was due to an unexplained effect
of Cymbalta. -- In improvement in family life functioning, 51
percent of the improvement was due to treatment of psychic anxiety,
10 percent was due to treatment of painful physical symptoms and 10
percent was due to treatment of somatic anxiety, while 30 percent
was due to an undefined effect of Cymbalta. -- In the pooled
analyses of all the GAD registration studies, the most commonly
observed adverse events (incidence of 5 percent or greater and at
least twice the incidence of sugar pill) were: nausea; fatigue; dry
mouth; somnolence; constipation; insomnia; appetite decreased;
hyperhidrosis; libido decreased; vomiting; ejaculation delayed; and
erectile dysfunction. Approximately 16 percent of patients taking
Cymbalta discontinued treatment due to an adverse event compared to
4 percent of patients receiving sugar pill. The most common adverse
events reported as reasons for discontinuation (occurring at a rate
of less than or equal to 1.2 percent and at a significantly higher
rate compared to sugar pill) were nausea, vomiting and
dizziness.(3) Methods Data from two double-blind,
placebo-controlled trials in adults with generalized anxiety
disorder were pooled. In the first trial, patients received 60 mg
of Cymbalta once daily, 120 mg once daily or sugar pill for nine
weeks. In the second trial, patients were started at a dose of 60
mg of Cymbalta but dose could be increased to 120 mg once daily, or
they were given sugar pill for 10 weeks. In both trials, the
Hamilton Anxiety Scale (HAMA) was used to measure anxious symptoms,
the SDS was used to assess global functional impairment and the
Visual Analog Scale for Overall Pain (VAS) was used to measure
severity of painful physical symptoms. Pearson partial correlations
were used to assess the magnitude and significance of the
associations between global functional impairment and psychic
anxiety or painful physical symptoms. Path analysis was used to
assess the relative contributions of changes in psychic and somatic
anxiety and painful physical symptoms on improved functional
outcomes. The large unexplained effect of Cymbalta implies that
Cymbalta improves global functioning through the treatment of
additional symptoms that the scales in our clinical trials do not
measure. These symptoms could be related to other anxious symptoms,
painful physical symptoms, or entirely separate symptom domains not
mentioned in this analysis. About Generalized Anxiety Disorder
Approximately 6.5 million Americans are diagnosed with generalized
anxiety disorder each year.(4) Symptoms persist for at least six
months and can include exaggerated worry or chronic anxiety,
irritability, poor concentration, sleep disturbance and
fatigue.(5,6) 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.(7) About
Cymbalta Serotonin and norepinephrine in the brain and spinal cord
are believed to both mediate core mood symptoms and help regulate
the perception of pain. Based on pre-clinical studies, duloxetine
is a balanced and potent reuptake inhibitor of serotonin and
norepinephrine that is believed to potentiate the activity of these
chemicals in the central nervous system (brain and spinal cord).
While the mechanism of action of duloxetine is not fully known,
scientists believe its effects on depression and anxiety symptoms,
as well as its effect on pain perception, may be due to 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, the management of diabetic peripheral
neuropathic pain and the treatment of generalized anxiety disorder,
all in adults. Cymbalta is not approved for use in pediatric
patients. Important Safety Information Cymbalta is approved to
treat major depressive disorder, diabetic peripheral neuropathic
pain and generalized anxiety disorder. 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. Cymbalta is approved only for
adults 18 and over. Cymbalta is not for everyone. Patients should
not take Cymbalta if they have recently taken a type of
antidepressant called a monoamine oxidase inhibitor (MAOI), are
taking Mellaril(R) (thioridazine) or have uncontrolled glaucoma.
Patients should speak with their doctor about all medicines they
are taking, including those for migraine to avoid a potentially
life- threatening condition. Patients should tell their doctor
about their alcohol consumption, if they have liver disease, and
about all of their medical conditions. Patients taking Cymbalta may
experience dizziness or fainting upon standing. The most common
side effects of Cymbalta include: -- For MDD: nausea, dry mouth and
constipation -- For DPNP: nausea, sleepiness and dizziness -- For
GAD: nausea, fatigue and dry mouth This is not a complete list of
side effects. For full Patient Information, visit
http://www.cymbalta.com/. For full Prescribing Information,
including Boxed Warning, visit http://www.cymbalta.com/. About Eli
Lilly and Company 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 for the
treatment of generalized anxiety 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 continue 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. (1)
Gliatto, Michael, F. "Generalized Anxiety Disorder." American
Family Physicians, Vol. 62/No. 7, October 1, 2000. (2) Leon, Andrew
et al. "Assessing Psychiatric Impairment in Primary Care with the
Sheehan Disability Scale." Int'l J. Psychiatry in Medicine. Vol. 27
(2), 1997, pp. 93-105 (3) Cymbalta Prescribing Information,
http://www.cymbalta.com/ (4) Mental Health America. "Generalized
Anxiety Disorder." Available at:
http://www1.nmha.org/camh/anxiety/gad.cfm. Accessed on January 17,
2007. (5) National Institute of Mental Health (NIMH). "Anxiety
Disorders." Available at:
http://www.nimh.nih.gov/publicat/anxiety.cfm#anx7. December 2006.
(6) APA. "Diagnostic and Statistical Manual of Mental Disorders -
Fourth Edition." 1994, pp 472-476. (7) APA. "Diagnostic and
Statistical Manual of Mental Disorders - Fourth Edition." 1994, pp
472-476. (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: Tamara Hull (US), +1-317-651-9116,
mobile: +1-317-614-5132, or David Shaffer (OUS), +1-317-651-3710,
mobile: +1-317-614-5106, both of Eli Lilly and Company
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