Patients Taking Cymbalta� Experienced Reduced Chronic Low Back Pain In New Study

�Data from a new study suggest that Cymbalta (duloxetine HCl) 60-120 mg once everyday significantly decreased chronic low-pitched back pain, as measured by the Brief Pain Inventory (BPI) 24-hour ordinary 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 heaps than placebo-treated patients. Thirty-one percent of duloxetine-treated patients experienced a 50 percentage reduction in pain, compared with 19 percent of placebo-treated patients, as careful by an 11-point Likert pain scale. Physicians take a bother reduction of at least 30 percentage as clinically significant.(2)


Treatment with duloxetine too was associated with improved patient outcomes as calculated 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 contrary events. In this study, the most common adverse events (those occurring in more than 5 pct of patients in the duloxetine group) were nausea, dry mouth, fatigue, looseness of the bowels, excessive sweating (hyperhidrosis), giddiness and irregularity. Adverse events were similar to those seen in previous duloxetine studies in other disease states.


"Chronic low back pain can have got a important impact on a person's ability to do the things they enjoy," said Vladimir Skljarevski, lead study author and a brain doctor and medical fellow at Lilly Research Laboratories. "This research whitethorn offer hope to those dealing with this debilitating condition."

Additional Study Highlights


-- The recurrent measures analysis using the patient diary demonstrated a
significantly greater reduction in pain in the first gear week after
starting the 60 mg daily venereal infection, 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 in the neck score,
weekly 24-hour worst pain and weekly 24-hour night pain in the ass) was discovered.


-- Superiority to placebo was non observed in two BPI items: bother
interference with general action and nuisance interference with sleep.
-- Statistically meaning differences in three single items in the


Short Form-36 of the Medical Outcomes Study (SF-36) - bodily annoyance,
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 factor summary, physical component drumhead,
mental health, physical operation, role-emotion, role-physical and
societal functioning.


-- The duloxetine treatment grouping experienced a significantly greater
improvement on the work-activity impairment score compared with the
placebo treatment group as deliberate by the Work Productivity and
Impairment Scale (WPAI).

Study Methods


Adult patients given duloxetine (n=115) and those minded placebo (n=121) with a history of non-neuropathic chronic low back pain for more than six months with a weekly mean 24-hour mean pain grade greater than or equal to 4 at baseline (0-10 scale) and without major depressive disorder were initially treated with duloxetine 60 mg once everyday for the first seven-spot weeks in this randomised placebo-controlled trial. After seven weeks of duloxetine treatment, patients reporting less than 30 percentage 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 step-down of the BPI 24-hour average nuisance score. Secondary measures included RMDQ-24, PGI-I, BPI Severity portion (BPI-S) and BPI Interference lot (BPI-I), diary-based weekly hateful of the 24-hour modal pain sexual conquest, Clinical Global Impression of Severity (CGI-S), and reaction rates. Health outcomes, safety and tolerability also were assessed. Continuous efficacy variables were analyzed using aNOVA (ANOVA) with treatment and investigator in the model, or depth psychology of covariance, with baseline, treatment and investigator in the example, and the stratifying variable of NSAID use (Yes/No). Mixed-model recurrent measures (MMRM) analysis also was used to standard improvement at all clip points. Treatment groups were compared based on the difference between least-squares means using bilateral testing at the 0.05 import level. Safety analyses were conducted to compare discussion groups exploitation Fisher's exact test.


Duloxetine data also presented at 12th World Congress of Pain


Data from a separate duloxetine chronic low-toned back pain in the ass study were presented on Aug. 21 at the 12th World Congress of Pain in Glasgow, Scotland. At study endpoint, duloxetine did non significantly differ from placebo on the primary bill of weekly mean 24-hour average hurting score.(3) However, patients taking duloxetine 60 mg once day-after-day showed significant pain reductions compared with placebo from week three through hebdomad 11 of the 13-week trial.(3) This was the first study designed to assess the core 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 experient statistically significant improvements in several secondary outcome measures compared with placebo. Patients taking duloxetine 60 mg once day-to-day 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, cephalalgia, diarrhea, giddiness, 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), bother is an unpleasant sensorial and emotional experience associated with actual or voltage tissue price, or described in damage of such damage.(5) Chronic pain is defined as pain that persists beyond acute pain or beyond the expected fourth dimension for an injury to heal.(6) Men and women are equally touched by continuing low back up 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 magnetic core mood symptoms and help regulate the perception of pain. Based on presymptomatic studies, Cymbalta is a balanced and potent re-uptake inhibitor of serotonin and norepinephrine that is believed to potentiate the activity of these chemicals in the primal nervous system (brain and spinal cord). While the mechanism of action of Cymbalta is not amply 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 cardinal nervous system.


Cymbalta is sanctioned in the United States for the acute and maintenance treatment of major depressive upset, the sharp treatment of generalized anxiety disorder, and the direction of fibromyalgia and diabetic peripheral neuropathic pain in adults old age 18 days and aged. Cymbalta is not sanctioned for function in pediatric patients.

Important Safety Information


Cymbalta is approved to treat major depressive upset and generalised anxiety disorder, and to manage diabetic peripheral neuropathic pain and fibromyalgia. Antidepressants can increment suicidal thoughts and behaviors in children, adolescents, and ung adults. Patients should call their doctor right away if they feel new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Be especially observing within the first few months of treatment or after a change in dose. Cymbalta is sanctioned only for adults 18 and over.


Cymbalta is non for everyone. Patients should not take Cymbalta if they have recently taken a type of antidepressant drug called a monoamine oxidase inhibitor (MAOI), are pickings Mellaril� (thioridazine), or experience uncontrolled glaucoma. Patients should speak with their doctor about whatsoever medical conditions they may have including kidney problems, glaucoma, or diabetes. Patients should talk to their doctor if they have itching, correct upper belly pain, glowering 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 almost alcohol using up. Patients should tell their doctor around all their medicines, including those for migraine, to avoid a potentially severe condition. Taking Cymbalta with NSAID painfulness relievers, acetylsalicylic acid, or blood thinners may increase haemorrhage risk. Patients should confer with with their doctor earlier stopping Cymbalta or changing the dosage and if they ar pregnant or nursing.


Patients pickings Cymbalta crataegus laevigata experience dizziness or fainting upon standing. The nearly common side effects of Cymbalta include nausea, dry mouth, sleepiness, and stultification. This is not a complete heel of side effects.


For replete 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 in style research from its possess 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 nearly Lilly is available at http://www.lilly.com.

P-LLY


This weight-lift release contains forward-looking statements about the potential of Cymbalta for chronic pain sensation including the management of chronic downcast back pain and reflects Lilly's stream beliefs. However, as with any pharmaceutical product, at that place are real risks and uncertainties in the action of development and commercialization. There is no undertake that the product will continue to be commercially successful. For further discussion of these and early risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

References


(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 saturation measured on an 11-point numerical pain rating ordered series. 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"


(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: hypertext transfer protocol://www.ninds.nih.