Market Wire - Data Suggest Cymbalta(R) Improved Functioning in Patients With Generalized Anxiety Disorder
Data suggest that patients with
generalized anxiety disorder (GAD) treated with Cymbalta (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, eight 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 greater 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.
