Duloxetine Metabolism and Fibromyalgia
University of Utah
Summary
People with fibromyalgia report generalized body pain ("pain all over"), increased sensitivity to painful stimulation, chronic tiredness or low energy, sleep problems, and other physical and functional problems. The exact cause of the disorder is poorly understood, and treatment can be difficult. The degree to which duloxetine is helpful for people with fibromyalgia varies greatly. For some people, it is very helpful for managing fibromyalgia symptoms. For others, people may not notice any benefit. Yet for some, it is a little helpful and the effect is noticeable only when people forget to take the medicine. The purpose of this study is to collect data to better understand the relationship among gene types that control those enzymes, blood concentrations of duloxetine, and how it helps the symptoms.
Description
Study Purpose: To study the variability of response in patients with fibromyalgia to treatment with duloxetine Duloxetine is a common FDA-approved pharmacotherapy for fibromyalgia. However, there is significant treatment response variability. Prior work has explored the role of liver drug-metabolizing enzymes CYP2D6 and CYP1A2 in the biotransformation of duloxetine. The genes coding for these enzymes have many variants; some variants are rapid metabolizers, whereas others are slow metabolizers of duloxetine. The different variants may contribute to the wide range of treatment responses to dul…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults 18+ * Meeting diagnostic criteria for Fibromyalgia * Patients taking Duloxetine 60 mg/day for at least 8 weeks Exclusion Criteria: * Pregnant patients per verbal confirmation * Patients that have a history of physician diagnosed kidney or liver disfunction or history of renal dialysis. * Patients requiring an interpreter to communicate * Patient's with progressive illnesses other than fibromyalgia that have a chronic pain and fatigue component (e.g., cancer patients receiving antineoplastic treatment, Parkinson's disease, Multiple Sclerosis).
Interventions
- DrugObservational
In a cohort of patients treated with duloxetine for fibromyalgia, participants vitals signs (blood pressure, heart rate, oxygen saturation level, temperature) will be taken as well as height and weight. Participants will fill out a questionnaire regarding their fibromyalgia diagnosis and symptoms. Lastly, participants will complete two sets of blood samples. One blood sample will evaluate genetic variants for duloxetine metabolizing capacity. The other sample will be used to analyze the level of concentration of duloxetine.
Location
- Pain Management Center and Pain Research Center at the University of UtahSalt Lake City, Utah