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Efficacy and safety of buprenorphine transdermal system (BTDS) for chronic moderate to severe low back pain: a randomized, double-blind study.
J Pain. 2011 Nov; 12(11):1163-73.JP

Abstract

In this enriched design study, 1,160 opioid-experienced patients with chronic, moderate to severe low back pain entered an open-label run-in period; 660 demonstrated analgesic benefit from and tolerability to buprenorphine transdermal system 20 mcg/hour (BTDS 20) treatment and were randomized to receive either BTDS 20, BTDS 5 mcg/hour (BTDS 5), or the active control (immediate release oxycodone 40-mg/day) during an 84-day double-blind phase. The primary endpoint, "average pain in the last 24 hours" during double-blind weeks 4, 8, and 12, was significantly lower for patients receiving BTDS 20 compared with patients receiving BTDS 5 (P < .001, treatment difference of -.67). A treatment difference of -.75 in favor of oxycodone 40 mg/day versus BTDS 5 (P < .001) indicated the assay sensitivity of the study. Four sensitivity analyses, secondary, and exploratory analyses supported the results of the primary analysis. Incidences of treatment-emergent adverse events were 56% during the open-label period, and 59, 77, and 73% for the BTDS 5, BTDS 20, and oxycodone 40 mg/day treatment groups, respectively, during the double-blind phase. One death considered unrelated to study treatment occurred in a patient receiving BTDS 10 during the run-in period. BTDS 20 treatment was demonstrated to be efficacious and generally well tolerated.

PERSPECTIVE

This article presents results of a pivotal Phase 3 study that assesses a new treatment for the management of chronic low back pain: a transdermal patch containing the opioid buprenorphine (BTDS). In this active controlled, superiority study with an enriched design, BTDS 20 was found to be efficacious and generally well tolerated.

Authors+Show Affiliations

Medical Research, Purdue Pharma, LP, Stamford, Connecticut 06901, USA. Deborah.Steiner@pharma.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

21807566

Citation

Steiner, Deborah, et al. "Efficacy and Safety of Buprenorphine Transdermal System (BTDS) for Chronic Moderate to Severe Low Back Pain: a Randomized, Double-blind Study." The Journal of Pain : Official Journal of the American Pain Society, vol. 12, no. 11, 2011, pp. 1163-73.
Steiner D, Munera C, Hale M, et al. Efficacy and safety of buprenorphine transdermal system (BTDS) for chronic moderate to severe low back pain: a randomized, double-blind study. J Pain. 2011;12(11):1163-73.
Steiner, D., Munera, C., Hale, M., Ripa, S., & Landau, C. (2011). Efficacy and safety of buprenorphine transdermal system (BTDS) for chronic moderate to severe low back pain: a randomized, double-blind study. The Journal of Pain : Official Journal of the American Pain Society, 12(11), 1163-73. https://doi.org/10.1016/j.jpain.2011.06.003
Steiner D, et al. Efficacy and Safety of Buprenorphine Transdermal System (BTDS) for Chronic Moderate to Severe Low Back Pain: a Randomized, Double-blind Study. J Pain. 2011;12(11):1163-73. PubMed PMID: 21807566.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of buprenorphine transdermal system (BTDS) for chronic moderate to severe low back pain: a randomized, double-blind study. AU - Steiner,Deborah, AU - Munera,Catherine, AU - Hale,Martin, AU - Ripa,Steven, AU - Landau,Craig, Y1 - 2011/07/31/ PY - 2010/10/19/received PY - 2011/05/18/revised PY - 2011/06/03/accepted PY - 2011/8/3/entrez PY - 2011/8/3/pubmed PY - 2012/3/1/medline SP - 1163 EP - 73 JF - The journal of pain : official journal of the American Pain Society JO - J Pain VL - 12 IS - 11 N2 - UNLABELLED: In this enriched design study, 1,160 opioid-experienced patients with chronic, moderate to severe low back pain entered an open-label run-in period; 660 demonstrated analgesic benefit from and tolerability to buprenorphine transdermal system 20 mcg/hour (BTDS 20) treatment and were randomized to receive either BTDS 20, BTDS 5 mcg/hour (BTDS 5), or the active control (immediate release oxycodone 40-mg/day) during an 84-day double-blind phase. The primary endpoint, "average pain in the last 24 hours" during double-blind weeks 4, 8, and 12, was significantly lower for patients receiving BTDS 20 compared with patients receiving BTDS 5 (P < .001, treatment difference of -.67). A treatment difference of -.75 in favor of oxycodone 40 mg/day versus BTDS 5 (P < .001) indicated the assay sensitivity of the study. Four sensitivity analyses, secondary, and exploratory analyses supported the results of the primary analysis. Incidences of treatment-emergent adverse events were 56% during the open-label period, and 59, 77, and 73% for the BTDS 5, BTDS 20, and oxycodone 40 mg/day treatment groups, respectively, during the double-blind phase. One death considered unrelated to study treatment occurred in a patient receiving BTDS 10 during the run-in period. BTDS 20 treatment was demonstrated to be efficacious and generally well tolerated. PERSPECTIVE: This article presents results of a pivotal Phase 3 study that assesses a new treatment for the management of chronic low back pain: a transdermal patch containing the opioid buprenorphine (BTDS). In this active controlled, superiority study with an enriched design, BTDS 20 was found to be efficacious and generally well tolerated. SN - 1528-8447 UR - https://www.unboundmedicine.com/medline/citation/21807566/Efficacy_and_safety_of_buprenorphine_transdermal_system__BTDS__for_chronic_moderate_to_severe_low_back_pain:_a_randomized_double_blind_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1526-5900(11)00631-6 DB - PRIME DP - Unbound Medicine ER -