Patients on Treatment Also Experienced Improved Physical Functioning INDIANAPOLIS, June 13
INDIANAPOLIS, June 13 /PRNewswire-FirstCall/ -- New data suggest that
patients with osteoarthritis pain of the knee treated with 60 mg and 120 mg
Cymbalta (duloxetine HCl) once daily experienced significant pain reduction.
Patients taking duloxetine reported significant pain improvement compared to
placebo within the first week of treatment that lasted throughout the 13-week
trial.(1) Results from the study of 231 patients were presented today at the
annual congress of the European League Against Rheumatism (EULAR) in Paris,
France.
Duloxetine showed statistically significant improvement in pain associated
with osteoarthritis of the knee according to the primary efficacy measure of
mean 24-hour average pain scores. Fifty-nine percent of duloxetine-treated
patients experienced a 30 percent improvement in pain compared with 45 percent
of patients taking placebo. Forty-seven percent of duloxetine-treated patients
experienced a 50 percent improvement in pain compared with 29 percent of
placebo-treated patients.
Treatment with duloxetine also was associated with improved patient
outcomes compared with placebo as measured by the Patient Global Impressions
of Improvement (PGI-I) and physical functioning as measured by the Western
Ontario and McMaster Universities (WOMAC) physical functioning subscale.
In this study, the most common adverse events (occurred at a rate of
greater than or equal to 3 percent and at least twice the rate of placebo)
were nausea, fatigue, somnolence, dizziness, hypertension, constipation and
decreased libido.
"These data are important because it's the first time duloxetine has been
studied in a large, placebo-controlled trial in what's classified as an
inflammatory disease state," said Amy Chappell, M.D., lead study author and
medical fellow II, Eli Lilly and Company. "Although the exact mechanism of
action is unknown, this study may provide important insights into the
treatment of pain in the central nervous system."
It is estimated that 27 million adults in the United States have
osteoarthritis and the prevalence increases with age.(2) Osteoarthritis of the
knee is a common type of this disorder, impacting the lives of approximately
10 million Americans.(2) Other symptoms of osteoarthritis in addition to pain
include aching, stiffness and limited range of motion of the joint.(3)
Additional Study Highlights:
- Compared with patients receiving placebo, patients receiving duloxetine
experienced significant improvement in symptom severity associated with
osteoarthritis pain of the knee, including:
* Significantly greater reduction in Brief Pain Inventory (BPI)
average pain severity (p<0.001) and WOMAC scores for pain
(p=0.003)
* Overall improved clinical global assessment according to Clinical
Global Impressions of Severity (CGI-S) (p=0.001)
- A total of 22 (9.5 percent) patients discontinued due to adverse events
- seven (5.8 percent) in the placebo-treated group and 15 (13.5
percent) in the duloxetine-treated group.
Methods
In this study, 111 patients were randomly assigned to receive 60 mg per
day of duloxetine; 120 patients received placebo. Patients were stratified by
whether or not they used non-steroidal anti-inflammatory drugs (NSAIDs) on a
regular basis. At week seven, those receiving active treatment were re-
randomized to either 60 mg duloxetine or 120 mg duloxetine per day. The
duloxetine groups were combined for overall analyses. The primary endpoint of
the study was reduction of pain severity as measured by the weekly mean of the
24-hour average pain scores. Changes from baseline to endpoint were analyzed
using a mixed-effects model repeated measures (MMRM) approach. Secondary
measures included effects on associated pain and functioning. Pain and
functional outcomes were assessed using Patient Global Impressions of
Improvement (PGI-I), Western Ontario and McMaster Universities (WOMAC) pain
and physical functioning subscales, Clinical Global Impressions of Severity
(CGI-S) and Brief Pain Inventory (BPI)-Severity. Patients with a recent
diagnosis (within six months) of major depressive disorder were excluded from
this study.
About Cymbalta
Serotonin and norepinephrine in the brain and spinal cord are believed to
both mediate core mood symptoms and help regulate the perception of pain.
Based on preclinical studies, Cymbalta is a balanced and potent reuptake
inhibitor of serotonin and norepinephrine that is believed to potentiate the
activity of these chemicals in the central nervous system (brain and spinal
cord). While the mechanism of action of Cymbalta is not fully known,
scientists believe its effects on depression and anxiety symptoms, as well as
its effect on pain perception, may be due to increasing the activity of
serotonin and norepinephrine in the central nervous system.
Cymbalta is approved in the United States for the acute and maintenance
treatment of major depressive disorder, the acute treatment of generalized
anxiety disorder and the management of diabetic peripheral neuropathic pain,
all in adults (18+). Cymbalta is not approved for use in pediatric patients.
Important Safety Information
Cymbalta is approved to treat major depressive disorder and generalized
anxiety disorder and manage diabetic peripheral neuropathic pain.
Antidepressants can increase suicidal thoughts and behaviors in children,
adolescents and young adults. Patients should call their doctor right away if
they experience new or worsening depression symptoms, unusual changes in
behavior, or thoughts of suicide. Be especially observant within the first few
months of treatment or after a change in dose. Cymbalta is approved only for
adults 18 and over.
Cymbalta is not for everyone. Patients should not take Cymbalta if they
have recently taken a type of antidepressant called a monoamine oxidase
inhibitor (MAOI), are taking Mellaril(R) (thioridazine) or have uncontrolled
glaucoma. Patients should speak with their doctor about any medical conditions
they may have, including liver or kidney problems, glaucoma, or diabetes.
Patients should tell their doctor about all their medicines, including those
for migraine, to avoid a potentially life-threatening condition. Taking
Cymbalta with NSAID pain relievers, aspirin, or blood thinners may increase
bleeding risk. They also should talk to their doctor about their alcohol
consumption. Patients should consult with their doctor before stopping
Cymbalta or changing the dose and if they are pregnant or nursing.
Patients taking Cymbalta may experience dizziness or fainting upon
standing. The most common side effects of Cymbalta include nausea, dry mouth,
sleepiness and constipation.
This is not a complete list of side effects.
For full Patient Information, visit www.cymbalta.com.
For full Prescribing Information, including Boxed Warning and medication
guide, visit http://www.cymbalta.com/.
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 www.lilly.com.
P-LLY
This press release contains forward-looking statements about the potential
of Cymbalta for chronic pain including the management of osteoarthritis pain
of the knee 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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
(1) Lilly HMEP study
(2) Lawrence, RC, et al. Estimates of the Prevalence of Arthritis and
Other Rheumatic Conditions in the United States. 2008. Arthritis and
Rheumatism (58):26-35.
(3) National Pain Foundation Website -
http://www.nationalpainfoundation.org/MyTreatment/articles/Arthritis_Types.asp
accessed on 5/5/08.
SOURCE Eli Lilly and Company
