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A Subgroup Analysis Found no Diminished Response to Buprenorphine Transdermal System Treatment for Chronic Low Back Pain Patients Classified with Depression.
Pain Pract. 2016 Apr; 16(4):473-85.PP

Abstract

BACKGROUND

Chronic pain (CP) patients with depression typically exhibit worse post-treatment outcomes than nondepressed CP patients. The cause is often assumed to reflect a differential response to treatment, neglecting other potential explanations, such as the continuation of differences in pretreatment outcomes. This post hoc analysis examines whether worse post-treatment outcomes for depressed patients with chronic low back pain (CLBP) are driven by reduced treatment efficacy.

METHODS

Data were from opioid-naïve adult patients with moderate-to-severe CLBP who participated in a randomized, placebo-controlled, double-blind clinical trial of Butrans(®) (buprenorphine) Transdermal System (BTDS) for pain relief. Depression screening was based on baseline SF-36v2 Mental Health subscale scores. Patient-reported measures of pain severity, pain interference, quality of life, sleep problems, and functional disability were administered at screening and during the study. Differential treatment efficacy for each outcome was examined using analysis of covariance models that included interaction terms between treatment arm and depression status.

RESULTS

At baseline, patients classified as depressed showed greater pain interference, lower quality of life, more sleep problems, and greater functional disability than nondepressed patients; the two groups did not differ in pain severity. No statistically significant interactions between treatment arm and depression status were observed. The direction of improvement post-treatment favored the depressed group on nine of seventeen outcomes.

CONCLUSIONS

Results do not support a differential response to BTDS treatment between depressed and nondepressed CLBP patients across a variety of patient-reported outcomes. These findings raise the question of whether depressed mood actually moderates the effectiveness of treatment in CP patients.

Authors+Show Affiliations

Optum, Lincoln, Rhode Island, U.S.A.Optum, Lincoln, Rhode Island, U.S.A.Purdue Pharma LP, Stamford, Connecticut, U.S.A.Purdue Pharma LP, Stamford, Connecticut, U.S.A.Purdue Pharma LP, Stamford, Connecticut, U.S.A.Purdue Pharma LP, Stamford, Connecticut, U.S.A.Department of Medicine, Johns Hopkins University, Baltimore, Maryland, U.S.A. Department of Anesthesiology, Georgetown University School of Medicine, Washington, District of Columbia, U.S.A. Department of Pharmacology, Temple University School of Medicine, Philadelphia, Pennsylvania, U.S.A.Department of Pharmaceutical Sciences, Temple University School of Pharmacy, Philadelphia, Pennsylvania, U.S.A.Purdue Pharma LP, Stamford, Connecticut, U.S.A.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25865734

Citation

Yarlas, Aaron, et al. "A Subgroup Analysis Found No Diminished Response to Buprenorphine Transdermal System Treatment for Chronic Low Back Pain Patients Classified With Depression." Pain Practice : the Official Journal of World Institute of Pain, vol. 16, no. 4, 2016, pp. 473-85.
Yarlas A, Miller K, Wen W, et al. A Subgroup Analysis Found no Diminished Response to Buprenorphine Transdermal System Treatment for Chronic Low Back Pain Patients Classified with Depression. Pain Pract. 2016;16(4):473-85.
Yarlas, A., Miller, K., Wen, W., Lynch, S. Y., Munera, C., Dain, B., Pergolizzi, J. V., Raffa, R., & Ripa, S. R. (2016). A Subgroup Analysis Found no Diminished Response to Buprenorphine Transdermal System Treatment for Chronic Low Back Pain Patients Classified with Depression. Pain Practice : the Official Journal of World Institute of Pain, 16(4), 473-85. https://doi.org/10.1111/papr.12298
Yarlas A, et al. A Subgroup Analysis Found No Diminished Response to Buprenorphine Transdermal System Treatment for Chronic Low Back Pain Patients Classified With Depression. Pain Pract. 2016;16(4):473-85. PubMed PMID: 25865734.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Subgroup Analysis Found no Diminished Response to Buprenorphine Transdermal System Treatment for Chronic Low Back Pain Patients Classified with Depression. AU - Yarlas,Aaron, AU - Miller,Kate, AU - Wen,Warren, AU - Lynch,Shau Yu, AU - Munera,Catherine, AU - Dain,Bradley, AU - Pergolizzi,Joseph V,Jr AU - Raffa,Robert, AU - Ripa,Steven R, Y1 - 2015/04/11/ PY - 2014/03/31/received PY - 2014/09/22/revised PY - 2015/02/11/accepted PY - 2015/4/14/entrez PY - 2015/4/14/pubmed PY - 2016/12/15/medline KW - back pain KW - buprenorphine KW - depression KW - low back pain KW - opioids KW - transdermal system SP - 473 EP - 85 JF - Pain practice : the official journal of World Institute of Pain JO - Pain Pract VL - 16 IS - 4 N2 - BACKGROUND: Chronic pain (CP) patients with depression typically exhibit worse post-treatment outcomes than nondepressed CP patients. The cause is often assumed to reflect a differential response to treatment, neglecting other potential explanations, such as the continuation of differences in pretreatment outcomes. This post hoc analysis examines whether worse post-treatment outcomes for depressed patients with chronic low back pain (CLBP) are driven by reduced treatment efficacy. METHODS: Data were from opioid-naïve adult patients with moderate-to-severe CLBP who participated in a randomized, placebo-controlled, double-blind clinical trial of Butrans(®) (buprenorphine) Transdermal System (BTDS) for pain relief. Depression screening was based on baseline SF-36v2 Mental Health subscale scores. Patient-reported measures of pain severity, pain interference, quality of life, sleep problems, and functional disability were administered at screening and during the study. Differential treatment efficacy for each outcome was examined using analysis of covariance models that included interaction terms between treatment arm and depression status. RESULTS: At baseline, patients classified as depressed showed greater pain interference, lower quality of life, more sleep problems, and greater functional disability than nondepressed patients; the two groups did not differ in pain severity. No statistically significant interactions between treatment arm and depression status were observed. The direction of improvement post-treatment favored the depressed group on nine of seventeen outcomes. CONCLUSIONS: Results do not support a differential response to BTDS treatment between depressed and nondepressed CLBP patients across a variety of patient-reported outcomes. These findings raise the question of whether depressed mood actually moderates the effectiveness of treatment in CP patients. SN - 1533-2500 UR - https://www.unboundmedicine.com/medline/citation/25865734/A_Subgroup_Analysis_Found_no_Diminished_Response_to_Buprenorphine_Transdermal_System_Treatment_for_Chronic_Low_Back_Pain_Patients_Classified_with_Depression_ L2 - https://doi.org/10.1111/papr.12298 DB - PRIME DP - Unbound Medicine ER -