Cymbalta(R) Helped Patients with Depression Feel Better Fast, According to Pooled Data from Two 9-week Trials
May 05 2004 - 9:00AM
PR Newswire (US)
Cymbalta(R) Helped Patients with Depression Feel Better Fast,
According to Pooled Data from Two 9-week Trials NEW YORK, May 5
/PRNewswire-FirstCall/ -- Patients treated with 60 mg per day of
the investigational antidepressant Cymbalta(R) (duloxetine
hydrochloride), experienced significant improvements in both mood
and painful physical symptoms after one week, according to pooled
data from two 9-week studies presented at the American Psychiatric
Association meeting. The data show that response to Cymbalta was
fastest for the core emotional and painful physical symptoms of
depression. After the first week of treatment, significant
improvements were observed in depressed mood, feelings of guilt,
suicidal ideation, work and activities, anxiety, back pain and
shoulder pain. "Patients are more likely to stay on a medication if
they feel symptom relief early on in the course of treatment," said
Robert Hirschfeld, M.D., Titus Harris Chair and Professor and Chair
of Psychiatry and Behavioral Sciences at the University of Texas
Medical Branch in Galveston. "These data demonstrate that in these
patients duloxetine was effective at providing improvements in
several symptoms of depression as early as one week." Complete
elimination of symptoms, or remission, is the primary goal of
depression treatment. Treating the full spectrum of emotional and
physical symptoms to remission puts patients at a decreased risk of
relapse.(1, 2) Among the 19 million Americans with depression
annually, an estimated 50 percent will suffer a relapse within two
years.(3) Cymbalta, is a potent serotonin and norepinephrine
reuptake inhibitor. It is being reviewed by the U.S. Food and Drug
Administration as a potential treatment for Major Depressive
Disorder. Additional Study Highlights * At week one, patients
treated with Cymbalta experienced greater improvement in core
emotional (depressed mood, guilt, suicidal ideation,
work/activities, psychic anxiety) and physical symptoms (back and
shoulder pain) of depression compared with patients treated with
sugar pills. * In patients treated with Cymbalta, greater
improvements in sleep, genital and non-painful somatic symptoms
were achieved between five and nine weeks. * At weeks one and two,
patients treated with sugar pills experienced greater improvement
in somatic gastrointestinal (GI) symptoms and weight loss than
patients taking Cymbalta; by week nine, however, Cymbalta-treated
patients experienced significant improvements in somatic GI
symptoms in comparison with patients taking sugar pills. Methods
Data were pooled from two identical, randomized, double-blind,
parallel- group, placebo-controlled studies. Participants were
males and females, 18 years of age and older, who met DSM-IV
criteria for major depressive disorder, had Hamilton Depression
Rating Scale (HAMD17) scores of >/= 15 and Clinical Global
Impression-Severity (CGI-S) scores of >/= 4 at baseline.
Patients were not pre-screened for pain. Patients were randomized
to receive 60 mg once daily of Cymbalta (n=244) or placebo (n=251)
for up to 9 weeks. Mean changes in individual HAMD17 items and a
visual analog scale (VAS) for pain (overall, shoulder and back)
were analyzed. About Cymbalta In placebo-controlled clinical trials
for Major Depressive Disorder, the most commonly observed adverse
events (>/= 5 percent and at least twice placebo) for Cymbalta
vs. placebo (n = 1,139 vs. 777) were: nausea (20 percent vs. 7
percent), dry mouth (15 percent vs. 6 percent), constipation (11
percent vs. 4 percent), decreased appetite (8 percent vs. 2
percent), fatigue (8 percent vs. 4 percent), sleepiness (7 percent
vs. 3 percent), and increased sweating (6 percent vs. 2 percent).
The overall discontinuation rate due to adverse events for Cymbalta
vs. placebo was 10 percent vs. 4 percent. Nausea was the only
common adverse event reported as a reason for discontinuation and
considered to be drug related (1.4 percent vs. 0.1 percent). The US
Food and Drug Administration issued an approvable letter for
Cymbalta (duloxetine for depression) in September 2003. Duloxetine
hydrochloride also is being studied by Lilly for the treatment of
stress urinary incontinence and diabetic neuropathic pain. All
three conditions are believed to be mediated by serotonin and
norepinephrine. 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/ . This press release contains forward-looking
statements about the potential of an investigational compound,
duloxetine, for the treatment of depression and reflects Lilly's
current beliefs. However, as with any pharmaceutical product under
development, there are substantial risks and uncertainties in the
process of development and regulatory review. There is no guarantee
that the product will receive regulatory approvals, or that the
regulatory approval will be for the indications(s) anticipated by
the company. There is also no guarantee that the product will prove
to be commercially successful. For further discussion of these and
other risks and uncertainties, see Lilly's filing with the United
States Securities and Exchange Commission. Lilly undertakes no
update to forward-looking statements. 1. Nierenberg, A. Long-Term
Management of Chronic Depression. J Clin Psychiatry 2001; 62 (Suppl
6): 17-20 2. Delgado, P. Approaches to the Enhancement of Patient
Adherence to Antidepressant Medication Treatment. J Clin Psychiatry
2000; 61 (Suppl 6): 6-9 3. Hirschfeld RMA, Keller MB, Panico S, et.
al. The National Depressive and Manic Depressive Association
Consensus Statement on the Undertreatment of Depression. JAMA,
1997; 277; 333-340 (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: +1-317-997-0632, or Jennifer Yoder (OUS), +1-317-433-3445,
cell: +1-317-652-0912, both of Eli Lilly and Company
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