Cymbalta and Lexapro(R) Compared in New Study, Presented at Major
Medical Meeting INDIANAPOLIS, May 22 /PRNewswire-FirstCall/ -- Data
suggests that male patients with major depressive disorder (MDD)
treated with Cymbalta(R) (duloxetine HCl) had significantly better
sexual functioning when compared to those taking Lexapro(R)
(escitalopram) within the first eight weeks of treatment, according
to a head-to-head study of more than 680 patients. These results
were presented today at a major medical meeting of psychiatrists.
The sexual functioning assessment was part of a larger trial, the
primary end point of which was to compare the onset of efficacy
between Cymbalta, an SNRI, and Lexapro, an SSRI. In this study, 42
percent of Cymbalta-treated patients met the definition of onset of
efficacy compared to 35 percent of Lexapro-treated patients. Onset
of efficacy was defined as at least a 20 percent decrease in Maier
Subscale of the Hamilton Depression Rating Scale (HAM-D17) at week
two and sustained throughout eight weeks of acute treatment. While
not indicative of faster onset of efficacy than Lexapro in patients
with MDD, this study showed the onset of Cymbalta to be at least as
fast as that of Lexapro. (i) At the end of the acute period of the
sexual functioning assessment (eight weeks), 37 percent of male
patients treated with Cymbalta reported a worsening in sexual
functioning, 59 percent treated with Lexapro reported worsening and
49 percent taking a sugar pill experienced worsening, as measured
by the Changes in Sexual Functioning Questionnaire (CSFQ). Whereas,
36 percent of female patients treated with Cymbalta reported a
worsening of sexual functioning, 38 percent taking Lexapro reported
worsening and 26 percent taking a sugar pill experienced worsening,
as measured by the CSFQ. "Sexual dysfunction is common among
patients with depression, affecting up to 64 percent of people with
the illness (ii)," said Dr. Madelaine Wohlreich, a study co-author
and medical advisor at Eli Lilly and Company. "Antidepressant
treatment can also impact sexual functioning, so differences in the
likelihood of sexual side effects are an important consideration
for patients taking antidepressants." Sexual dysfunction can be
marked by a loss of sexual drive, interest, and/or performance.
Loss of sexual functioning is a common side effect of
antidepressant treatments, causing up to 70 percent of those who
experience it to stop taking medication. (iii) "When sexual
dysfunction due to medication occurs, a person may be inclined to
stop treatment, which can have a devastating impact on his or her
illness," said Dr. Wohlreich. "In the case of depression,
noncompliance with antidepressants can lead to a relapse." Among
the up to 19 million Americans who suffer from depressive
disorders, including major depression, annually, an estimated 50
percent will suffer a relapse within two years. (iv) Additional
Study Highlights * At four weeks and eight weeks, there was
statistically significant worsening of sexual functioning for
Lexapro compared to patients treated with a sugar pill, while
Cymbalta was not statistically different from sugar pill at any
time. * At eight weeks, categorical changes in sexual functioning
on the CSFQ differed significantly for men treated with Cymbalta
compared to men treated with Lexapro. There were no significant
differences between Cymbalta and Lexapro in women. * Anorgasmia was
the only treatment-emergent sexual adverse event reported
statistically more frequently for Cymbalta or Lexapro compared to
sugar pill during the course of the study. * At the end of the
study, there were no significant differences in discontinuation
rates due to sexual side effects for those treated with Cymbalta
(n=2) compared to those treated with Lexapro (n=7). - Adverse
events causing discontinuation included erectile dysfunction,
decreased libido, and orgasmic dysfunction including anorgasmia and
ejaculation delay. Methods In this double-blind, placebo-controlled
study of adult patients with MDD, 273 patients treated with
Cymbalta 60 mg once-daily, 274 patients treated with Lexapro 10 mg
once per day and 137 treated with a sugar pill, participated in an
eight-week acute phase, fixed-dose comparison. Following the acute
phase, patients participated in a six-month, flexible dose
extension phase where they received Cymbalta 60, 90, or 120 mg
once-daily; Lexapro 10 or 20 mg once per day or sugar pill. Dose
escalations and switching from sugar pill to active drug were based
on predefined blinded criteria, but the number of patients taking
sugar pill decreased significantly after eight weeks. Onset of
action, the primary endpoint of this study, was defined as at least
a 20 percent decrease in the Maier Subscale of the HAM-D17 Rating
Scale at week two, maintained at each visit throughout eight weeks
of acute treatment. Sexual dysfunction was measured in this study
by the 14-item, self-reported CSFQ and the Quality of Life
Enjoyment and Satisfaction Questionnaire-short form (Q-LES-Q-SF),
as well as spontaneously reported sexual side effects and
discontinuation due to sexual side effects. This study compared
Cymbalta at its highest approved dose of 60 mg per day to the
lowest approved dose of Lexapro, 10 mg per day. However, those
doses represent the recommended therapeutic doses of each
medication and are widely used. After eight weeks, the power to
detect a difference between the active treatments and sugar pill
was significantly decreased due to attrition and switching to
placebo, and by the study endpoint very few patients (n=15)
remained on sugar pill compared with Cymbalta (n=105) or Lexapro
(n=124). In four pooled studies of Cymbalta 40 to 120 mg/day for
registration, sexual functioning was proactively measured by the
Arizona Sexual Experience Scale (ASEX). Sexual dysfunction occurred
more often in patients treated with Cymbalta compared to those
receiving sugar pill. For males, only the ease of orgasm individual
ASEX score was significantly different compared to sugar pill. For
females, no ASEX scores were significantly different versus sugar
pill. About Depression Up to 19 million Americans suffer from
depressive disorders, including major depression. (v) It can happen
to anyone of any age, race or ethnic group, however women are
nearly twice as likely to experience depression as men. (vi)
Although it is one of the most frequently seen psychiatric
disorders in the primary care setting, it often goes undiagnosed or
is under- treated. (vii) This may be because depressed patients
often present physical symptoms rather than emotional complaints.
In fact, in one study about seven out of 10 patients diagnosed with
MDD presented with only physical symptoms as their chief complaint.
Pain is present in approximately 45 to 75 percent of patients with
MDD, (viii, ix, x) and can include headache, back, shoulder and
abdominal pain. (xi, xii, xiii) The goal of treatment is to help
people with depression feel more like themselves, so they can move
forward with their lives. Depression symptoms that don't go away
completely can prevent people with depression from getting fully
well, and may increase the risk of symptoms coming back. (xiv)
Nobody should settle for feeling only slightly better. With the
right treatment and support, recovering from depression is
possible. About Cymbalta Cymbalta is believed to modulate both
serotonin and norepinephrine in the brain and the spinal cord.
Based on pre-clinical studies, Cymbalta is a balanced and potent
reuptake inhibitor of serotonin and norepinephrine. While the
mechanism of action of Cymbalta in humans is not fully known,
scientists believe its effect on mood and pain perception is 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 MDD and the management of diabetic peripheral
neuropathic pain, both in adults. Cymbalta is not approved for use
in pediatric patients. Important Safety Information In clinical
studies, antidepressants increased the risk of suicidal thinking
and behavior in children and adolescents with depression and other
psychiatric disorders. Anyone considering the use of Cymbalta or
any other antidepressant in a child or adolescent must balance the
risk with the clinical need. Patients who are starting therapy
should be observed closely for worsening depression symptoms,
suicidal thoughts or behavior, or unusual changes in behavior.
Cymbalta is not approved for use in patients under the age of 18.
Patients on antidepressants and their families or caregivers should
watch for worsening depression symptoms, unusual changes in
behavior and thoughts of suicide, as well as for anxiety,
agitation, panic attacks, difficulty sleeping, irritability,
hostility, aggressiveness, impulsivity, restlessness, or extreme
hyperactivity. Call the doctor if you have thoughts of suicide or
if any of these symptoms are severe or occur suddenly. Be
especially observant at the beginning of antidepressive treatment
or whenever there is a change in dose. Prescription Cymbalta is not
for everyone. People who are allergic to Cymbalta or the other
ingredients in Cymbalta should not take it. If you have recently
taken a type of antidepressant called a monoamine oxidase inhibitor
(MAOI), are taking Mellaril(R) (thioridazine) or have uncontrolled
narrow- angle glaucoma, you should not take Cymbalta. Talk with
your doctor before taking Cymbalta if you have liver or kidney
problems, glaucoma or consume large quantities of alcohol. Women
who are pregnant should talk with their doctor before taking
Cymbalta. Nursing while taking Cymbalta is not recommended. Tell
your doctor if you are taking other prescription or nonprescription
medications. In clinical studies of Cymbalta for depression, the
most common side effects were nausea, dry mouth, constipation,
decreased appetite, fatigue, sleepiness, and increased sweating.
Nausea was the most common side effect. For most people, the nausea
was mild to moderate, and usually subsided within one-to-two weeks.
Cymbalta is also approved for the management of neuropathic pain
associated with diabetic peripheral neuropathy. In clinical studies
of Cymbalta in these patients, the most common side effects were
nausea, sleepiness, dizziness, constipation, dry mouth, increased
sweating, decreased appetite, and loss of strength or energy. In
all clinical trials, most people were not bothered enough by side
effects to stop taking Cymbalta. Your doctor may periodically check
your blood pressure. Don't stop taking Cymbalta without talking to
your doctor. For full Patient Information, visit
http://www.cymbalta.com/. For full Prescribing Information,
including Boxed Warning, visit http://www.cymbalta.com/. Lexapro is
a registered trademark of Forest Pharmaceuticals, Inc. 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 major depressive 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. (i)
Study presented as a poster at the annual meeting of the American
College of Neuropsychopharmacology, December 13, 2005. (ii)
Montejo-Gonzalez, et al, J Sex & Mar Th. 1997;23:176-188 (iii)
Clayton, Prevalence of Sexual Dysfunction Among Newer
Antidepressants. J Clin Psych; 2002 Apr;63(4):357-66. (iv)
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 (v)
National Institute of Mental Health. Depression Research at the
National Institute of Mental Health: Fact Sheet. Available at
http://www.nimh.nih.gov/publicat/depresfact.cfm. Accessed May 12,
2004. (vi) American Psychiatric Association. Diagnostic and
Statistical Manual of Mental Disorders. 4th ed., Text Revision.
Washington DC: American Psychiatric Association; 2000:345-428.
(vii) Kroenke K, et al. Am J Med. 1997; 103(5):339-347. (viii)
Ohayan M. J Clin Psych 2004;65:5-9 (ix) Corruble E, et al.
Psychopathology 2000;33:307-309 (x) Bair MJ, et al, Arch Intern
Med. 2003;163:2433-2445 (xi) Simon GE, et al. N Engl J Med. 1999;
341(18):1329-1335. (xii) Corruble E, et al. Psychopathology
2000;33:307-309 (xiii) Miranda H, et al., Am J Epidemiol.
2005;161:847-855 (xiv) Paykel ES et al., Psychological Med
1995;25:1171-1180 (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: Tammy Hull (US), +1-317-651-9116,
mobile: +1-317-614-3152, David Shaffer (OUS), +1-317-651-3710, both
of Eli Lilly and Company
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