Tags

Type your tag names separated by a space and hit enter

A randomized, placebo-controlled study of the impact of the 7-day buprenorphine transdermal system on health-related quality of life in opioid-naïve patients with moderate-to-severe chronic low back pain.
J Pain. 2013 Jan; 14(1):14-23.JP

Abstract

This study evaluated the impact of treatment with Buprenorphine Transdermal System (BTDS) on the health-related quality of life for patients with moderate-to-severe chronic low back pain (CLBP), and the correspondence between quality of life and pain. A multicenter, enriched, double-blind (DB), placebo-controlled, randomized trial evaluated BTDS 10 and 20 μg/hour for treatment of opioid-naïve patients with moderate-to-severe CLBP. The SF-36v2 survey, which measures 8 domains of quality of life, was administered at screening and following an open-label run-in period with BTDS and at weeks 4, 8, and 12 of the DB phase. Post hoc analyses compared SF-36v2 scores between BTDS and placebo groups during the DB phase. Condition burden was examined through comparisons with a U.S. general population sample. Correlations examined the correspondence between quality of life and pain measures. BTDS produced larger improvements than placebo at 12 weeks in all quality-of-life domains (Ps < .05). Treatment group differences in both physical and mental quality of life emerged by 4 weeks. Patients' pretreatment quality of life was worse than that in the general population (Ps < .05); only BTDS treatment eliminated deficits in pain, social functioning, and role limitations due to emotional health. Improvements in quality of life were moderately associated with pain reduction. These data suggest that moderate-to-severe CLBP patients receiving BTDS exhibited better quality of life than patients receiving placebo.

PERSPECTIVE

This post hoc analysis suggests that patients with moderate-to-severe CLBP treated with BTDS exhibit better health-related quality of life than those using placebo within 4 weeks of treatment, and were more likely to exhibit clinically meaningful improvements in quality of life following 12 weeks of treatment.

Authors+Show Affiliations

QualityMetric Inc, Lincoln, Rhode Island 02865, USA. ayarlas@qualitymetric.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23200931

Citation

Yarlas, Aaron, et al. "A Randomized, Placebo-controlled Study of the Impact of the 7-day Buprenorphine Transdermal System On Health-related Quality of Life in Opioid-naïve Patients With Moderate-to-severe Chronic Low Back Pain." The Journal of Pain : Official Journal of the American Pain Society, vol. 14, no. 1, 2013, pp. 14-23.
Yarlas A, Miller K, Wen W, et al. A randomized, placebo-controlled study of the impact of the 7-day buprenorphine transdermal system on health-related quality of life in opioid-naïve patients with moderate-to-severe chronic low back pain. J Pain. 2013;14(1):14-23.
Yarlas, A., Miller, K., Wen, W., Dain, B., Lynch, S. Y., Pergolizzi, J. V., Raffa, R. B., & Ripa, S. R. (2013). A randomized, placebo-controlled study of the impact of the 7-day buprenorphine transdermal system on health-related quality of life in opioid-naïve patients with moderate-to-severe chronic low back pain. The Journal of Pain : Official Journal of the American Pain Society, 14(1), 14-23. https://doi.org/10.1016/j.jpain.2012.09.016
Yarlas A, et al. A Randomized, Placebo-controlled Study of the Impact of the 7-day Buprenorphine Transdermal System On Health-related Quality of Life in Opioid-naïve Patients With Moderate-to-severe Chronic Low Back Pain. J Pain. 2013;14(1):14-23. PubMed PMID: 23200931.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, placebo-controlled study of the impact of the 7-day buprenorphine transdermal system on health-related quality of life in opioid-naïve patients with moderate-to-severe chronic low back pain. AU - Yarlas,Aaron, AU - Miller,Kate, AU - Wen,Warren, AU - Dain,Bradley, AU - Lynch,Shau Yu, AU - Pergolizzi,Joseph V, AU - Raffa,Robert B, AU - Ripa,Steven R, Y1 - 2012/11/29/ PY - 2012/04/16/received PY - 2012/09/13/revised PY - 2012/09/22/accepted PY - 2012/12/4/entrez PY - 2012/12/4/pubmed PY - 2013/6/1/medline SP - 14 EP - 23 JF - The journal of pain : official journal of the American Pain Society JO - J Pain VL - 14 IS - 1 N2 - UNLABELLED: This study evaluated the impact of treatment with Buprenorphine Transdermal System (BTDS) on the health-related quality of life for patients with moderate-to-severe chronic low back pain (CLBP), and the correspondence between quality of life and pain. A multicenter, enriched, double-blind (DB), placebo-controlled, randomized trial evaluated BTDS 10 and 20 μg/hour for treatment of opioid-naïve patients with moderate-to-severe CLBP. The SF-36v2 survey, which measures 8 domains of quality of life, was administered at screening and following an open-label run-in period with BTDS and at weeks 4, 8, and 12 of the DB phase. Post hoc analyses compared SF-36v2 scores between BTDS and placebo groups during the DB phase. Condition burden was examined through comparisons with a U.S. general population sample. Correlations examined the correspondence between quality of life and pain measures. BTDS produced larger improvements than placebo at 12 weeks in all quality-of-life domains (Ps < .05). Treatment group differences in both physical and mental quality of life emerged by 4 weeks. Patients' pretreatment quality of life was worse than that in the general population (Ps < .05); only BTDS treatment eliminated deficits in pain, social functioning, and role limitations due to emotional health. Improvements in quality of life were moderately associated with pain reduction. These data suggest that moderate-to-severe CLBP patients receiving BTDS exhibited better quality of life than patients receiving placebo. PERSPECTIVE: This post hoc analysis suggests that patients with moderate-to-severe CLBP treated with BTDS exhibit better health-related quality of life than those using placebo within 4 weeks of treatment, and were more likely to exhibit clinically meaningful improvements in quality of life following 12 weeks of treatment. SN - 1528-8447 UR - https://www.unboundmedicine.com/medline/citation/23200931/A_randomized_placebo_controlled_study_of_the_impact_of_the_7_day_buprenorphine_transdermal_system_on_health_related_quality_of_life_in_opioid_naïve_patients_with_moderate_to_severe_chronic_low_back_pain_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1526-5900(12)00835-8 DB - PRIME DP - Unbound Medicine ER -