Patients Taking Cymbalta(R) Experienced Reduced Chronic Low Back Pain in New Study
August 25 2008 - 6:30AM
PR Newswire (US)
INDIANAPOLIS, Aug. 25 /PRNewswire/ -- Data from a new study suggest
that Cymbalta (duloxetine HCl) 60-120 mg once daily significantly
reduced chronic low back pain, as measured by the Brief Pain
Inventory (BPI) 24-hour average pain score, compared with
placebo.(1) Results from the double-blind, 13-week,
placebo-controlled study of 236 patients were presented today at
the annual congress of the European Federation of Neurological
Societies (EFNS) in Madrid, Spain. Duloxetine-treated patients
reported significantly greater reduction in pain scores than
placebo-treated patients. Thirty-one percent of duloxetine-treated
patients experienced a 50 percent reduction in pain, compared with
19 percent of placebo-treated patients, as measured by an 11-point
Likert pain scale. Physicians consider a pain reduction of at least
30 percent as clinically significant.(2) Treatment with duloxetine
also was associated with improved patient outcomes as measured by
the Patient Global Impressions of Improvement (PGI-I), and physical
functioning as measured by the Roland Morris Disability
Questionnaire (RMDQ-24). Significantly more patients in the
duloxetine group discontinued because of adverse events. In this
study, the most common adverse events (those occurring in more than
5 percent of patients in the duloxetine group) were nausea, dry
mouth, fatigue, diarrhea, excessive sweating (hyperhidrosis),
dizziness and constipation. Adverse events were similar to those
seen in previous duloxetine studies in other disease states.
"Chronic low back pain can have a significant impact on a person's
ability to do the things they enjoy," said Vladimir Skljarevski,
lead study author and a neurologist and medical fellow at Lilly
Research Laboratories. "This research may offer hope to those
dealing with this debilitating condition." Additional Study
Highlights -- The repeated measures analysis using the patient
diary demonstrated a significantly greater reduction in pain in the
first week after starting the 60 mg daily dose, which continued
throughout the 13 weeks of the acute therapy phase. -- Superiority
to placebo in most secondary analyses including eight out of the
remaining 10 BPI items (e.g., weekly 24-hour average pain score,
weekly 24-hour worst pain and weekly 24-hour night pain) was
observed. -- Superiority to placebo was not observed in two BPI
items: pain interference with general activity and pain
interference with sleep. -- Statistically significant differences
in three individual items in the Short Form-36 of the Medical
Outcomes Study (SF-36) - bodily pain, general health and vitality -
were observed. -- Statistically significant differences were not
observed in the remaining items in the Short Form-36 of the Medical
Outcomes Study, including mental component summary, physical
component summary, mental health, physical functioning,
role-emotion, role-physical and social functioning. -- The
duloxetine treatment group experienced a significantly greater
improvement on the work-activity impairment score compared with the
placebo treatment group as measured by the Work Productivity and
Impairment Scale (WPAI). Study Methods Adult patients given
duloxetine (n=115) and those given placebo (n=121) with a history
of non-neuropathic chronic low back pain for more than six months
with a weekly mean 24-hour average pain score greater than or equal
to 4 at baseline (0-10 scale) and without major depressive disorder
were initially treated with duloxetine 60 mg once daily for the
first seven weeks in this randomized placebo-controlled trial.
After seven weeks of duloxetine treatment, patients reporting less
than 30 percent pain reduction (non-responders) had their dose
increased to 120 mg once daily. Responders continued on 60 mg once
daily. The study's primary objective was the reduction of the BPI
24-hour average pain score. Secondary measures included RMDQ-24,
PGI-I, BPI Severity portion (BPI-S) and BPI Interference portion
(BPI-I), diary-based weekly mean of the 24-hour average pain score,
Clinical Global Impression of Severity (CGI-S), and response rates.
Health outcomes, safety and tolerability also were assessed.
Continuous efficacy variables were analyzed using
analysis-of-variance (ANOVA) with treatment and investigator in the
model, or analysis of covariance, with baseline, treatment and
investigator in the model, and the stratifying variable of NSAID
use (Yes/No). Mixed-model repeated measures (MMRM) analysis also
was used to measure improvement at all time points. Treatment
groups were compared based on the difference between least-squares
means using two-sided testing at the 0.05 significance level.
Safety analyses were conducted to compare treatment groups using
Fisher's exact test. Duloxetine data also presented at 12th World
Congress of Pain Data from a separate duloxetine chronic low back
pain study were presented on Aug. 21 at the 12th World Congress of
Pain in Glasgow, Scotland. At study endpoint, duloxetine did not
significantly differ from placebo on the primary measure of weekly
mean 24-hour average pain score.(3) However, patients taking
duloxetine 60 mg once daily showed significant pain reductions
compared with placebo from week three through week 11 of the
13-week trial.(3) This was the first study designed to assess the
effect of duloxetine on the reduction of chronic low back pain
compared with placebo. In the 13-week, double-blind, randomized,
placebo-controlled study (n=404), patients taking duloxetine 60 mg
once daily experienced statistically significant improvements in
several secondary outcome measures compared with placebo. Patients
taking duloxetine 60 mg once daily also experienced a statistically
significant improvement in patient outcomes as measured by the
PGI-I and physical functioning as measured by the RMDQ-24.(3) In
this study, the most common adverse events (those occurring in more
than 5 percent of patients in the duloxetine group) were nausea,
insomnia, dry mouth, constipation, headache, diarrhea, dizziness,
somnolence (drowsiness) and fatigue. It is estimated that at least
15 million adults in the United States have chronic low back
pain.(4) According to the International Association for the Study
of Pain (IASP), pain is an unpleasant sensory and emotional
experience associated with actual or potential tissue damage, or
described in terms of such damage.(5) Chronic pain is defined as
pain that persists beyond acute pain or beyond the expected time
for an injury to heal.(6) Men and women are equally affected by
chronic low back pain, and it occurs most often between ages 30 and
50.(7) 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 fibromyalgia and diabetic peripheral neuropathic
pain in adults age 18 years and older. 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 to manage diabetic peripheral neuropathic pain and
fibromyalgia. 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 kidney problems, glaucoma, or
diabetes. Patients should talk to their doctor if they have
itching, right upper belly pain, dark urine, yellow skin or eyes,
or unexplained flu-like symptoms, which may be signs of liver
problems. Severe liver problems, sometimes fatal, have been
reported. They should also talk to their doctor about alcohol
consumption. 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.
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
http://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 http://www.lilly.com/. P-LLY This press
release contains forward-looking statements about the potential of
Cymbalta for chronic pain including the management of chronic low
back pain 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. (1) Skljarevski, V. et al.
Efficacy of Duloxetine in Chronic Low Back Pain. Poster presented
at the European Federation of Neurological Societies Annual
Congress. 25 August 2008. (2) Farrar JT, JP Young Jr., L LaMoreaux,
JL Werth, RM Poole. Clinical importance of changes in chronic pain
intensity measured on an 11-point numerical pain rating scale.
2001. Pain (94):149-158. (3) Skljarevski, V. et al. Duloxetine
versus Placebo in the Treatment of Chronic Low Back Pain. Poster
presented at the 12th World Congress of Pain. 21 August 2008. (4)
Praemer A, Furnes S, Rice DP. Musculoskeletal conditions in the
United States. Rosemont: AAUS, 1992: 1-99. (5) International
Association for the Study of Pain. "IASP Pain Terminology"
Available at: http://www.iasp-/
pain.org/AM/Template.cfm?Section=General_Resource_Links&Template=/CM/HTMLDispl
ay.cfm&ContentID=3058#Pain. Accessed on 5/27/08. (6) American
Pain Society. "Pain Control in the Primary Care Setting." 2006:15.
(7) National Institute of Neurological Disorders and Stroke. "Low
Back Pain Fact Sheet." Available at:
http://www.ninds.nih.gov/disorders/backpain/detail_backpain.htm.
Accessed on June 25, 2008. (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: Sonja Popp-Stahly of Eli Lilly and
Company, +1-317-655-2993,
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