Cymbalta(R) Helped Patients with Depression Stay Better Longer, New Data Show
04 May 2004 - 2:00AM
PR Newswire (US)
Cymbalta(R) Helped Patients with Depression Stay Better Longer, New
Data Show Rescue dosing strategy was safe and effective in relapse
prevention study NEW YORK, May 3 /PRNewswire-FirstCall/ -- Patients
treated successfully with 60 mg per day of the investigational
antidepressant Cymbalta(R) (duloxetine hydrochloride), were less
likely to have their emotional and physical symptoms of depression
return than those who stopped taking medication after beginning to
feel better, according to results of a 38-week study presented
today at the American Psychiatric Association meeting. At the
conclusion of the trial, roughly 80 percent of Cymbalta-treated
patients remained free of the emotional and physical symptoms of
depression. Increasing the dose of Cymbalta from 60 mg once a day
to 120 mg (60 mg twice daily) was a benefit for the majority of the
smaller group of patients whose symptoms did return (n=29), and did
not produce additional side effects. Increasing daily doses of
medication is a common clinical practice when patients experience a
re-emergence of symptoms. In clinical practice for the treatment of
major depressive disorder, the prevention of relapse and the
ability to "rescue" relapsed patients with a previously
well-tolerated and efficacious antidepressant is a significant
advantage. In this study, the time to relapse was longer in
Cymbalta-treated patients than in those who received sugar pills.
"Patients have the best chance of sustaining symptom control when
they continue treatment for at least six months after their
symptoms resolve," said Michael Detke, M.D., Ph.D., Cymbalta
medical director, Eli Lilly and Company. "This study demonstrates
that in these patients Cymbalta was effective at keeping depression
at bay. These data can also give healthcare practitioners insight
into a compound's safety when increasing the dose in instances when
relapse does occur." 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. The U.S. Food and
Drug Administration is reviewing it as a potential treatment for
Major Depressive Disorder. Additional Study Highlights * By 12
weeks, 68 percent of patients treated with 60 mg of Cymbalta once
daily responded to treatment, defined as 50 percent reduction in
symptoms, and 53 percent were virtually symptom free, which is the
definition of achieving remission. * By 38 weeks, patients treated
with Cymbalta had overall greater symptom control (HAMD17) compared
with patients taking sugar pills. * Cymbalta-treated patients had
greater relief of physical symptoms, including headaches, back
pain, shoulder pain, and pain while awake and reported increased
quality of life (QLDS), by the end of the study. Among patients who
relapsed while taking 60 mg of Cymbalta once a day, 62 percent
responded to an increased dose, with 38 percent becoming virtually
symptom free. * Among patients whose symptoms returned while taking
a sugar pill, 77 percent responded once they resumed taking 60 mg
Cymbalta once a day with 57 percent becoming virtually symptom
free. * Cymbalta 60 mg, at both once and twice daily, was well
tolerated. Methods Data were gathered from 533 adult outpatients
who participated in a randomized, double-blind, multi-site,
placebo-controlled study in Europe and the United States.
Participants met the criteria for major depressive disorder and had
Hamilton Depression Rating Scale (HAMD17) scores of >/= 18 at
the first and second visits and a Clinical Global
Impression-Severity (CGI- Severity) score of >/= 4 at the first
and second visits. During the first 12 weeks of the study, all
patients (n=533) received 60 mg of Cymbalta in an open-label
setting. At the beginning of the continuation phase (weeks 13-38),
patients who no longer met the criteria for major depressive
disorder were randomized to either continue on 60 mg of Cymbalta
(n=136) or receive placebo (n=142). Patients who relapsed during
this period had the option of entering the rescue phase for up to
12 weeks. During this phase, placebo-treated patients received 60
mg of Cymbalta (n=56) and Cymbalta-treated patients had their dose
doubled to 120 mg/day (n=29). All patients (n=200) entered a
one-week follow-up phase after either completing the study or
following early discontinuation during either the continuation or
rescue phases. At that time, Cymbalta-treated patients had their
dose reduced by 50 percent for three days and safety and efficacy
data was collected. The primary efficacy measure was analysis of
time to relapse. Secondary efficacy measures analyzed were HAMD17
subscores, the CGI Severity scale, the Patient Global Impression of
Improvement (PGI-I) scale, the Symptom Questionnaire-Somatic
subscale (SQ-SS), Visual analog scales (VAS), the Quality of Life
in Depression Scale (QLDS) and the Sheehan Disability Scale (SDS).
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 based upon
eight- and nine-week trials. Duloxetine hydrochloride also is being
studied by Lilly for the treatment of stress urinary incontinence
and diabetic neuropathic pain, conditions 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; Jennifer Yoder (OUS), +1-317-433-3445, cell:
+1-317-652-0912, both of Eli Lilly and Company
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