placebo was observed inthe first week of each study. Fifty-one percent and 55 percent of patientson Cymbalta had a 30 percent improvement on the BPI at endpoint (clinicallymeaningful relief is considered at least 30 percent pain reduction(viii)).
In addition, 65 percent and 66 percent of patients taking Cymbalta 60 mgdaily reported feeling better at endpoint as measured by the Patient GlobalImpression of Improvement (PGI-I). The PGI-I is a patient-rated scale thatevaluates how much improvement has occurred since beginning treatment.
Cymbalta 60 mg was superior to placebo on the Fibromyalgia ImpactQuestionnaire (FIQ) Total Score. The FIQ is a scale that is used to assessand evaluate the impact of fibromyalgia on aspects of health andfunctioning believed to be most affected by the disorder.
In four pooled studies, the most commonly observed adverse events inCymbalta-treated patients with fibromyalgia (greater than or equal to 5percent and at least twice placebo) were nausea (29 percent), dry mouth (18percent), constipation (15 percent), decreased appetite (11 percent),sleepiness (11 percent), increased sweating (7 percent) and agitation (6percent). In the placebo-controlled clinical trials, the overalldiscontinuation rates due to adverse events for Cymbalta vs. placebo were20 percent and 12 percent, respectively.(ix)
About Cymbalta
Serotonin and norepinephrine in the brain and spinal cord are believed toboth mediate core mood symptoms and help regulate the perception of pain.Based on preclinical studies, Cymbalta is a balanced and potent reuptakeinhibitor of serotonin and norepinephrine that is believed to potentiatethe activity of these chemicals in the central nervous system (brain andspinal cord). While the mechanism of action of Cymbalta is not fully known,scientists believe its effects on depression and anxiety symptoms, as wellas its effect on pain perception, may be due to increasing the activity ofserotonin and norepinephrine in the central nervous system.
Cymbalta is approved in the United States for the acute and maintenancetreatment of major depressive disorder, the acute treatment of generalizedanxiety disorder, and the management of fibromyalgia and diabeticperipheral neuropathic pain in adults age 18 years and older. Cymbalta isnot approved for use in pediatric patients.
Important Safety Information
Cymbalta is approved to treat major depressive disorder and generalizedanxiety disorder, and to manage diabetic peripheral neuropathic pain andfibromyalgia. Antidepressants can increase suicidal thoughts and behaviorsin children, adolescents, and young adults. Patients should call theirdoctor right away if they experience new or worsening depression symptoms,unusual changes in behavior, or thoughts of suicide. Be especiallyobservant within the first few months of treatment or after a change indose. Cymbalta is approved only for adults 18 and over.
Cymbalta is not for everyone. Patients should not take Cymbalta if theyhave recently taken a type of antidepressant called a monoamine oxidaseinhibitor (MAOI), are taking Mellaril® (thioridazine), or haveuncontrolled glaucoma. Patients should speak with their doctor about anymedical conditions they may have including kidney problems, glaucoma, ordiabetes. Patients should talk to their doctor if they have itching, rightupper belly pain, dark urine, yellow skin or eyes, or unexplained flu-likesymptoms, which may be signs of liver problems. Severe liver problems,sometimes fatal, have been reported. They should also talk to their doctorabout alcohol consumption. Patients should tell their doctor about alltheir medicines, including those for migraine, to avoid a potentiallylife-threatening condition.
