Page 1 of 5
PRN 08:58 New Study Data Show Improved Cognitive Function in Elderly
Patients Treated with Cymbalta for Depression
Significant Improvements in Depressive Symptoms Seen as Early as One Week
SAN DIEGO, March 7 /PRNewswire-FirstCall/ -- Elderly patients with
depression treated with Cymbalta(R) (duloxetine hydrochloride, pronounced sim-
BAWL'-tuh), 60 mg once daily, had twice as much improvement in verbal learning
and recalling information than those given a sugar pill, according to new
research presented Saturday at the annual meeting of the American Association
for Geriatric Psychiatry.
By the end of the eight-week study, Cymbalta-treated patients demonstrated
significantly greater improvement in cognition when compared to patients
treated with a sugar pill (mean change 1.95 vs. .76). Additionally, 27.4
percent of Cymbalta-treated patients were virtually free of their depressive
symptoms, a rate nearly double that seen with a sugar pill (14.7 percent).
Significant improvements in depressive symptoms in Cymbalta-treated patients
were also seen as early as one week.
Impairment of cognitive functioning is a bigger issue among the elderly
with depression than younger adults, one analysis suggests.(i) It is not
uncommon for these patients to have short-term memory issues, like forgetting
where they placed their keys, or to experience a delay in recalling
information.(ii)
"Treating and diagnosing depression in elderly patients can be complicated
-- their condition presents differently from younger patients, making it more
difficult to diagnose, and their response to medication is less predictable,"
stated Alan Siegal, MD, associate clinical professor of psychiatry, Yale
University. "Depression-related cognitive impairment, along with a greater
sensitivity to medication side effects, often make it more difficult for older
patients to comply with treatment recommendations."
Depression is a common illness among the aging, affecting two million
Americans aged 65 and older.(iii) Often minimized by the patient and their
doctor,(iv,v) undiagnosed and untreated elderly depression leads to
unnecessary pain and suffering(vi) and increased healthcare costs.(vii) The
elderly are predisposed to this condition for many reasons, including failing
health, loss of loved ones and frustration with memory loss.(viii)
"Previous clinical trials using other antidepressants in this patient
population showed cognitive dysfunction persisted even after the depression
had responded to treatment,"(ix) explained Joel Raskin, MD, FRCPC, medical
advisor, Eli Lilly and Company. "In this study, significant improvements in
both cognition and depression were seen."
-----------------------------====================------------------------------
Page 2 of 5
Additional study highlights
* By 8 weeks, significantly more patients experienced a response in
depressive symptoms to treatment with Cymbalta than to a sugar pill (37.3 vs.
18.6 percent, respectively).
* In comparison with those treated with a sugar pill, significantly fewer
Cymbalta-treated patients stopped treatment due to lack of efficacy (9.6 vs.
2.9 percent, respectively).
* Discontinuation rates due to adverse events were similar for both
treatment groups (9.7 percent Cymbalta; 8.7 percent placebo).
* The most common adverse events experienced by patients treated with
Cymbalta in this study included dry mouth (14.5 percent), nausea (12.6
percent), constipation (10.1 percent), dizziness (8.2 percent), diarrhea (8.2
percent), fatigue (6.3 percent), and somnolence (5.3 percent).
Methods
Data were gathered from 311 patients aged 65 and older who participated in
a multicenter, double-blind, placebo-controlled study. After a one-week
screening and a one-week, double-blind placebo phase, patients were randomly
chosen to receive either Cymbalta 60 mg once daily (n=207) or a sugar pill
(n=104) for eight weeks.
Patients then entered a one-week, double-blind discontinuation phase where
the dose of the study medication was tapered.
The primary outcome measure was a composite cognitive score based on four
tests that measured verbal learning and memory, selective attention and
executive functioning. Secondary measures included the Geriatric Depression
Scale and the Hamilton Depression Scale (HAMD17). Response in depression
symptoms at endpoint was defined as a greater than 50 percent decrease in the
HAMD17 Total Score from baseline. Remission of depression symptoms at
endpoint was defined as a HAMD17 Total Score of less than 7.
About Cymbalta
Serotonin and norepinephrine are two neurotransmitters, or chemical
messengers, believed to help regulate a person's emotions and sensitivity to
pain. Research suggests that increasing levels of serotonin and
norepinephrine in the brain and spinal cord can reduce the body's sensation of
pain from the nerve damage caused by diabetes.
Based on preclinical data, Cymbalta (pronounced sim-BAWL'-tuh) is a
balanced and potent reuptake inhibitor of serotonin and norepinephrine.(x) It
is indicated in the United States for the treatment of major depression and
-----------------------------====================------------------------------
Page 3 of 5
the management of diabetic peripheral neuropathic pain. The European
Commission has also approved duloxetine for the treatment of major depression
and moderate-to-severe stress urinary incontinence in adults. As duloxetine
has not been studied in children, Lilly discourages its use in those under 18.
Cymbalta should not be confused with Symbyax(TM) (pronounced SIMM-bee-ax),
a medicine for bipolar depression also marketed by Lilly. Symbyax is a
combination of olanzapine, the active ingredient in Zyprexa(R), and
fluoxetine, the active ingredient in Prozac(R). Symbyax is available in
capsules of 6 mg/25 mg (olanzapine/fluoxetine), 12 mg/25 mg, 6 mg/50 mg and 12
mg/50 mg. Cymbalta is available in 20 mg, 30 mg and 60 mg capsules.
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.
Families and caregivers should discuss with the doctor any observations of
worsening depression symptoms, suicidal thinking and 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 are severe or occur suddenly. Be especially observant at the
beginning of treatment or whenever there is a change in dose.
Prescription Cymbalta is not for everyone. People who are allergic to
duloxetine hydrochloride 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 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. Breast-feeding while taking Cymbalta is not
recommended.
In clinical studies of Cymbalta for depression, the most common side
effects were nausea, dry mouth, constipation, decreased appetite, fatigue,
sleepiness, and increased sweating. Cymbalta also is 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
-----------------------------====================------------------------------
Page 4 of 5
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 prescribing information, including Boxed Warning, visit
http://www.Cymbalta.com/ .
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 www.lilly.com .
P-LLY
This press release contains forward-looking statements about the potential
of Cymbalta for the treatment of cognition, in addition to 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 prove 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) Serby, Michael, et al. "Overview: Depression in the Elderly." The
Mount Sinai Journal Of Medicine, Vol. 70 No. 1 January 2003.
(ii) Maynard, Carolyn K. "Differentiate Depression From Dementia," The
Nurse Practitioner: The American Journal of Primary Health Care Vol. 28 No. 2
March 2003.
(iii) Kim, Crystal. "Major Depression in the Elderly," Johns Hopkins
University, Spring 2003. Available at
http://www.jhu.edu/hurj/issue2/07C MajorDepress.pdf. Accessed 1/5/05.
(iv) Kim, Crystal. "Major Depression in the Elderly," Johns Hopkins
University, Spring 2003. Available at
http://www.jhu.edu/hurj/issue2/07C MajorDepress.pdf. Accessed 1/5/05.
(v) Birrer, Richard B, et al. "Depression in Later Life: A Diagnostic
-----------------------------====================------------------------------
Page 5 of 5
and Therapeutic Challenge." Am Fam
Physician 2004;69:2375-82. http://www.aafp.org/afp/20040515/2375.pdf
(vi) Serby, Michael, et al. "Overview: Depression in the Elderly." The
Mount Sinai Journal Of Medicine, Vol. 70 No. 1 January 2003.
(http://www.mssm.edu/msjournal/70/v70_1_page_39_44.pdf)
(vii) Serby, Michael, et al. "Overview: Depression in the Elderly."
The Mount Sinai Journal Of Medicine, Vol. 70 No. 1 January 2003.
(http://www.mssm.edu/msjournal/70/v70_1_page_39_44.pdf)
(viii) "Depression - Elderly." National Institutes of Health. Available
at http://www.nlm.nih.gov/medlineplus/ency/article/001521.htm. Accessed
1/14/04.
(ix) Nebes RD, Pollock BG, Houck PR, Butters MA, Mulsant BH, Zmuda MD,
Reynolds CF 3rd. J Psychiatr Res. 2003 Mar-Apr;37(2):99-108
(x) Bymaster F, Dreshfield-Ahmad L, Threlkeld P, Shaw J, Thompson B,
Nelson D, et al. Comparative affinity of duloxetine and venlafaxine for
serotonin and norepinephrine transporters in vitro and in vivo, human
serotonin receptor subtypes, and other neuronal receptors.
Neuropsychopharmacology. 2001;25(6):871-880.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
SOURCE Eli Lilly and Company
CONTACT:
Carole Witsken Puls (US), +1-317-277-1421, pager: +1-888-431-8355, or Jennifer
Yoder (OUS), +1-317-433-3445, pager: +1-888-274-0289, both of Eli Lilly and
Company
-0- (PRN) Mar/07/2005 13:58 GMT
-----------------------------====================------------------------------
############################ END OF STORY 1 ##############################
PRN 08:58 New Study Data Show Improved Cognitive Function in Elderly
Patients Treated with Cymbalta for Depression
Significant Improvements in Depressive Symptoms Seen as Early as One Week
SAN DIEGO, March 7 /PRNewswire-FirstCall/ -- Elderly patients with
depression treated with Cymbalta(R) (duloxetine hydrochloride, pronounced sim-
BAWL'-tuh), 60 mg once daily, had twice as much improvement in verbal learning
and recalling information than those given a sugar pill, according to new
research presented Saturday at the annual meeting of the American Association
for Geriatric Psychiatry.
By the end of the eight-week study, Cymbalta-treated patients demonstrated
significantly greater improvement in cognition when compared to patients
treated with a sugar pill (mean change 1.95 vs. .76). Additionally, 27.4
percent of Cymbalta-treated patients were virtually free of their depressive
symptoms, a rate nearly double that seen with a sugar pill (14.7 percent).
Significant improvements in depressive symptoms in Cymbalta-treated patients
were also seen as early as one week.
Impairment of cognitive functioning is a bigger issue among the elderly
with depression than younger adults, one analysis suggests.(i) It is not
uncommon for these patients to have short-term memory issues, like forgetting
where they placed their keys, or to experience a delay in recalling
information.(ii)
"Treating and diagnosing depression in elderly patients can be complicated
-- their condition presents differently from younger patients, making it more
difficult to diagnose, and their response to medication is less predictable,"
stated Alan Siegal, MD, associate clinical professor of psychiatry, Yale
University. "Depression-related cognitive impairment, along with a greater
sensitivity to medication side effects, often make it more difficult for older
patients to comply with treatment recommendations."
Depression is a common illness among the aging, affecting two million
Americans aged 65 and older.(iii) Often minimized by the patient and their
doctor,(iv,v) undiagnosed and untreated elderly depression leads to
unnecessary pain and suffering(vi) and increased healthcare costs.(vii) The
elderly are predisposed to this condition for many reasons, including failing
health, loss of loved ones and frustration with memory loss.(viii)
"Previous clinical trials using other antidepressants in this patient
population showed cognitive dysfunction persisted even after the depression
had responded to treatment,"(ix) explained Joel Raskin, MD, FRCPC, medical
advisor, Eli Lilly and Company. "In this study, significant improvements in
both cognition and depression were seen."
-----------------------------====================------------------------------
Page 2 of 5
Additional study highlights
* By 8 weeks, significantly more patients experienced a response in
depressive symptoms to treatment with Cymbalta than to a sugar pill (37.3 vs.
18.6 percent, respectively).
* In comparison with those treated with a sugar pill, significantly fewer
Cymbalta-treated patients stopped treatment due to lack of efficacy (9.6 vs.
2.9 percent, respectively).
* Discontinuation rates due to adverse events were similar for both
treatment groups (9.7 percent Cymbalta; 8.7 percent placebo).
* The most common adverse events experienced by patients treated with
Cymbalta in this study included dry mouth (14.5 percent), nausea (12.6
percent), constipation (10.1 percent), dizziness (8.2 percent), diarrhea (8.2
percent), fatigue (6.3 percent), and somnolence (5.3 percent).
Methods
Data were gathered from 311 patients aged 65 and older who participated in
a multicenter, double-blind, placebo-controlled study. After a one-week
screening and a one-week, double-blind placebo phase, patients were randomly
chosen to receive either Cymbalta 60 mg once daily (n=207) or a sugar pill
(n=104) for eight weeks.
Patients then entered a one-week, double-blind discontinuation phase where
the dose of the study medication was tapered.
The primary outcome measure was a composite cognitive score based on four
tests that measured verbal learning and memory, selective attention and
executive functioning. Secondary measures included the Geriatric Depression
Scale and the Hamilton Depression Scale (HAMD17). Response in depression
symptoms at endpoint was defined as a greater than 50 percent decrease in the
HAMD17 Total Score from baseline. Remission of depression symptoms at
endpoint was defined as a HAMD17 Total Score of less than 7.
About Cymbalta
Serotonin and norepinephrine are two neurotransmitters, or chemical
messengers, believed to help regulate a person's emotions and sensitivity to
pain. Research suggests that increasing levels of serotonin and
norepinephrine in the brain and spinal cord can reduce the body's sensation of
pain from the nerve damage caused by diabetes.
Based on preclinical data, Cymbalta (pronounced sim-BAWL'-tuh) is a
balanced and potent reuptake inhibitor of serotonin and norepinephrine.(x) It
is indicated in the United States for the treatment of major depression and
-----------------------------====================------------------------------
Page 3 of 5
the management of diabetic peripheral neuropathic pain. The European
Commission has also approved duloxetine for the treatment of major depression
and moderate-to-severe stress urinary incontinence in adults. As duloxetine
has not been studied in children, Lilly discourages its use in those under 18.
Cymbalta should not be confused with Symbyax(TM) (pronounced SIMM-bee-ax),
a medicine for bipolar depression also marketed by Lilly. Symbyax is a
combination of olanzapine, the active ingredient in Zyprexa(R), and
fluoxetine, the active ingredient in Prozac(R). Symbyax is available in
capsules of 6 mg/25 mg (olanzapine/fluoxetine), 12 mg/25 mg, 6 mg/50 mg and 12
mg/50 mg. Cymbalta is available in 20 mg, 30 mg and 60 mg capsules.
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.
Families and caregivers should discuss with the doctor any observations of
worsening depression symptoms, suicidal thinking and 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 are severe or occur suddenly. Be especially observant at the
beginning of treatment or whenever there is a change in dose.
Prescription Cymbalta is not for everyone. People who are allergic to
duloxetine hydrochloride 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 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. Breast-feeding while taking Cymbalta is not
recommended.
In clinical studies of Cymbalta for depression, the most common side
effects were nausea, dry mouth, constipation, decreased appetite, fatigue,
sleepiness, and increased sweating. Cymbalta also is 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
-----------------------------====================------------------------------
Page 4 of 5
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 prescribing information, including Boxed Warning, visit
http://www.Cymbalta.com/ .
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 www.lilly.com .
P-LLY
This press release contains forward-looking statements about the potential
of Cymbalta for the treatment of cognition, in addition to 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 prove 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) Serby, Michael, et al. "Overview: Depression in the Elderly." The
Mount Sinai Journal Of Medicine, Vol. 70 No. 1 January 2003.
(ii) Maynard, Carolyn K. "Differentiate Depression From Dementia," The
Nurse Practitioner: The American Journal of Primary Health Care Vol. 28 No. 2
March 2003.
(iii) Kim, Crystal. "Major Depression in the Elderly," Johns Hopkins
University, Spring 2003. Available at
http://www.jhu.edu/hurj/issue2/07C MajorDepress.pdf. Accessed 1/5/05.
(iv) Kim, Crystal. "Major Depression in the Elderly," Johns Hopkins
University, Spring 2003. Available at
http://www.jhu.edu/hurj/issue2/07C MajorDepress.pdf. Accessed 1/5/05.
(v) Birrer, Richard B, et al. "Depression in Later Life: A Diagnostic
-----------------------------====================------------------------------
Page 5 of 5
and Therapeutic Challenge." Am Fam
Physician 2004;69:2375-82. http://www.aafp.org/afp/20040515/2375.pdf
(vi) Serby, Michael, et al. "Overview: Depression in the Elderly." The
Mount Sinai Journal Of Medicine, Vol. 70 No. 1 January 2003.
(http://www.mssm.edu/msjournal/70/v70_1_page_39_44.pdf)
(vii) Serby, Michael, et al. "Overview: Depression in the Elderly."
The Mount Sinai Journal Of Medicine, Vol. 70 No. 1 January 2003.
(http://www.mssm.edu/msjournal/70/v70_1_page_39_44.pdf)
(viii) "Depression - Elderly." National Institutes of Health. Available
at http://www.nlm.nih.gov/medlineplus/ency/article/001521.htm. Accessed
1/14/04.
(ix) Nebes RD, Pollock BG, Houck PR, Butters MA, Mulsant BH, Zmuda MD,
Reynolds CF 3rd. J Psychiatr Res. 2003 Mar-Apr;37(2):99-108
(x) Bymaster F, Dreshfield-Ahmad L, Threlkeld P, Shaw J, Thompson B,
Nelson D, et al. Comparative affinity of duloxetine and venlafaxine for
serotonin and norepinephrine transporters in vitro and in vivo, human
serotonin receptor subtypes, and other neuronal receptors.
Neuropsychopharmacology. 2001;25(6):871-880.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
SOURCE Eli Lilly and Company
CONTACT:
Carole Witsken Puls (US), +1-317-277-1421, pager: +1-888-431-8355, or Jennifer
Yoder (OUS), +1-317-433-3445, pager: +1-888-274-0289, both of Eli Lilly and
Company
-0- (PRN) Mar/07/2005 13:58 GMT
-----------------------------====================------------------------------
############################ END OF STORY 1 ##############################
