Weight change with long-term duloxetine use in chronic painful conditions: An analysis of 16 clinical studies

United States Medical Division, Lilly USA, LLC, Indianapolis, IN 46285, USA.
International Journal of Clinical Practice (Impact Factor: 2.57). 03/2011; 65(3):341-9. DOI: 10.1111/j.1742-1241.2011.02635.x
Source: PubMed

ABSTRACT Report weight change baseline up to 12-15 months in duloxetine-treated patients during clinical trials of chronic painful conditions of diabetic peripheral neuropathic pain (DPNP), fibromyalgia, chronic low back pain (CLBP) and chronic knee pain as a result of osteoarthritis.
Weight change data from 16 duloxetine studies in chronic painful conditions were pooled by pain condition and duration, creating 10 datasets. Datasets included placebo-controlled, open-label and routine-care-controlled designs. Assessments included mean weight change from baseline, baseline body mass index category, potentially clinically significant (PCS) weight change and weight-related treatment-emergent adverse events.
Total number of patients was 5111 with mean baseline weight ranging from 70 to 97 kg. All duloxetine groups had significant mean weight loss compared with placebo at acute phase completion (p ≤ 0.001). In studies > 3 months, patients from fibromyalgia and CLBP studies had overall mean weight increase (up to 1.1 kg), whereas patients in DPNP studies had overall mean weight loss (-0.33 to -1.7 kg) at end-point. Overall, the percentage of patients with PCS weight gain was 0.4-16% and PCS weight loss was 2.5-9.9%.
Weight change data in clinical trials of patients with fibromyalgia or CLBP treated with duloxetine for up to 15 months were consistent with data reported in 10 clinical trials of patients with major depressive disorder (MDD) using duloxetine up to 52 weeks. Patients with DPNP had weight loss at end-point.
Mean weight changes and percentages of patients with PCS weight loss and weight gain observed in DPNP, fibromyalgia and CLBP with long-term duloxetine treatment were consistent with those reported previously for MDD studies.

Download full-text


Available from: Héctor Dueñas, Oct 16, 2014
14 Reads
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Individuals with musculoskeletal pain exhibit abnormal movement patterns, including antalgic gait, postural dysfunction, increased thoracolumbar stiffness, decreased proprioception, and altered activation of abdominal and extensor muscles. Additionally, aberrant or increased biomechanical forces over time produce joint or structural damage that results in pain. A large body habitus resulting from excessive weight can accelerate these musculoskeletal complaints. Irrespective of age, obesity contributes to chronic musculoskeletal pain, impairment of mobility, and eventual physical disability. Potential mechanisms that may mediate the relationships between obesity-related pain and functional decline include skeletal muscle strength deterioration, systemic inflammation, and psychosocial characteristics (eg, pain catastrophizing, kinesiophobia, and depression). Treatment considerations for obese patients with musculoskeletal pain include assessment of kinesiophobia levels, biomechanical analysis, and pain medication use. Ideally, a multidisciplinary team of physicians, psychologists, and physical therapists should optimize the design of interventions specific to the patient. In some cases, the use of appropriate pain medications or intra-articular injectable agents may help control pain, fostering sustained activity, caloric expenditure, and weight loss. Morbid obesity is a medical condition that alters biomechanical forces on the tissues of the body. This condition provides the opportunity to examine accelerated development of musculoskeletal pain syndromes and etiology. The proposed therapeutic interventions can have multiple benefits in the obese population including weight loss, improved psychological outlook and self-efficacy, reduced kinesiophobia levels, reduced risk of functional dependence, and improved quality of life.
    Regional anesthesia and pain medicine 11/2013; 38(6):481-91. DOI:10.1097/AAP.0000000000000013 · 3.09 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: SUMMARY Cross-sectional and longitudinal evidence strongly indicate that obesity is related to physical impairment and joint pain, particularly in the lumbar spine, sacroiliac and knee joints. What is most disturbing is that obese children under 15 years are now reporting joint pain and cannot perform functional tasks as well as their nonobese counterparts. As the prevalence of obesity rises, so do the rates of musculoskeletal disease and physical dysfunction. Functional tasks that involve supporting or transferring body weight are typically painful and difficult to perform. Of most concern is that some of these tasks are simply impossible depending on the severity of obesity. As a consequence, the individual's quality of life suffers. A BMI of 35 kg/m(2) is emerging as the threshold at which functional impairment rates rise dramatically. To restore functional independence and optimize functional gains over the long term, a combination of treatments for the obese patient with joint pain may be effective. The initial use of physical therapy, pain medications or joint viscosupplementation, coupled with diet, exercise, or bariatric surgery are options for weight loss and reduction of pain symptoms. Irrespective of age, weight loss can reduce or eliminate joint pain. As body weight is reduced, so should the reliance on medication with a concomitant improvement in functional mobility.
    09/2011; 1(5):427-39. DOI:10.2217/pmt.11.39
  • [Show abstract] [Hide abstract]
    ABSTRACT: Background: Duloxetine is a selective dual neuronal serotonin (5-Hydroxytryptamine, 5-HT) and norepinephrine reuptake inhibitor (SSNRI). It is indicated in the United States for treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), and several chronic pain conditions, including management of diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain due to chronic osteoarthritis (OA) pain and chronic low back pain (LBP). Its use for antidepressant and anxiolytic actions has been extensively reviewed previously. We here review the evidence for the efficacy of 60 mg once-daily dosing of duloxetine for chronic pain conditions. Method: The literature was searched for clinical trials in humans conducted in the past 10 years involving duloxetine. Results: There were 199 results in the initial search. Studies not in the English language were excluded. We then included only studies of diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain (OA and LBP). Studies of painful symptoms reported in mental health studies were excluded. This resulted in 32 studies. Articles that did not include a 60 mg/day daily dose as a study arm were excluded. This resulted in 30 studies, broken down as follows: 12 for diabetic peripheral neuropathy, 9 for fibromyalgia, 6 for LBP, and 3 for OA pain. Conclusions: The studies reviewed report that duloxetine 60 mg once-daily dosing is an effective option for the management of diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain due to chronic OA pain and chronic LBP. As these pains are often comorbid with MDD or GAD, duloxetine might possess the pharmacologic properties to be a versatile agent able to address several symptoms in these patients. With adequate attention to FDA prescribing guidance regarding safety and drug–drug interactions, duloxetine 60 mg once-daily dosing appears to be an effective option in the appropriate pain patient population.
    Pain Practice 06/2012; 13(3). DOI:10.1111/j.1533-2500.2012.00578.x · 2.36 Impact Factor
Show more