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Efficacy and safety of the seven-day buprenorphine transdermal system in opioid-naïve patients with moderate to severe chronic low back pain: an enriched, randomized, double-blind, placebo-controlled study.
J Pain Symptom Manage. 2011 Dec; 42(6):903-17.JP

Abstract

CONTEXT

This article presents the 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. In this randomized, placebo-controlled study with an enriched enrollment design, the buprenorphine transdermal system (BTDS) was found to be efficacious and generally well tolerated.

OBJECTIVES

This enriched, multicenter, randomized, double-blind study evaluated the efficacy, tolerability, and safety of BTDS in opioid-naïve patients who had moderate to severe chronic low back pain.

METHODS

Patients who tolerated and responded to BTDS (10 or 20 mcg/hour) during an open-label run-in period were randomized to continue BTDS 10 or 20 mcg/hour or receive matching placebo. The primary outcome was "average pain over the last 24 hours" at the end of the 12-week double-blind phase, collected on an 11-point scale (0=no pain, 10=pain as bad as you can imagine). Sleep disturbance (Medical Outcomes Study subscale) and total number of supplemental analgesic tablets used were secondary efficacy variables.

RESULTS

Fifty-three percent of patients receiving open-label BTDS (541 of 1024) were randomized to receive BTDS (n=257) or placebo (n=284). Patients receiving BTDS reported statistically significantly lower pain scores at Week 12 compared with placebo (least square mean treatment difference: -0.58, P=0.010). Sensitivity analyses of the primary efficacy variable and results of the analysis of secondary efficacy variables supported the efficacy of BTDS relative to placebo. During the double-blind phase, the incidence of treatment-emergent adverse events was 55% for the BTDS treatment group and 52% for the placebo treatment group. Laboratory, vital sign, and electrocardiogram evaluations did not reveal unanticipated safety findings.

CONCLUSION

BTDS was efficacious in the treatment of opioid-naïve patients with moderate to severe chronic low back pain. Most treatment-emergent adverse events observed were consistent with those associated with the use of opioid agonists and transdermal patches.

Authors+Show Affiliations

Purdue Pharma L.P., Stamford, Connecticut 06901-3431, USA. Deborah.Steiner@pharma.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

21945130

Citation

Steiner, Deborah J., et al. "Efficacy and Safety of the Seven-day Buprenorphine Transdermal System in Opioid-naïve Patients With Moderate to Severe Chronic Low Back Pain: an Enriched, Randomized, Double-blind, Placebo-controlled Study." Journal of Pain and Symptom Management, vol. 42, no. 6, 2011, pp. 903-17.
Steiner DJ, Sitar S, Wen W, et al. Efficacy and safety of the seven-day buprenorphine transdermal system in opioid-naïve patients with moderate to severe chronic low back pain: an enriched, randomized, double-blind, placebo-controlled study. J Pain Symptom Manage. 2011;42(6):903-17.
Steiner, D. J., Sitar, S., Wen, W., Sawyerr, G., Munera, C., Ripa, S. R., & Landau, C. (2011). Efficacy and safety of the seven-day buprenorphine transdermal system in opioid-naïve patients with moderate to severe chronic low back pain: an enriched, randomized, double-blind, placebo-controlled study. Journal of Pain and Symptom Management, 42(6), 903-17. https://doi.org/10.1016/j.jpainsymman.2011.04.006
Steiner DJ, et al. Efficacy and Safety of the Seven-day Buprenorphine Transdermal System in Opioid-naïve Patients With Moderate to Severe Chronic Low Back Pain: an Enriched, Randomized, Double-blind, Placebo-controlled Study. J Pain Symptom Manage. 2011;42(6):903-17. PubMed PMID: 21945130.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of the seven-day buprenorphine transdermal system in opioid-naïve patients with moderate to severe chronic low back pain: an enriched, randomized, double-blind, placebo-controlled study. AU - Steiner,Deborah J, AU - Sitar,Steve, AU - Wen,Warren, AU - Sawyerr,Gosford, AU - Munera,Catherine, AU - Ripa,Steven R, AU - Landau,Craig, Y1 - 2011/09/25/ PY - 2010/09/20/received PY - 2011/04/18/revised PY - 2011/04/20/accepted PY - 2011/9/28/entrez PY - 2011/9/29/pubmed PY - 2012/4/6/medline SP - 903 EP - 17 JF - Journal of pain and symptom management JO - J Pain Symptom Manage VL - 42 IS - 6 N2 - CONTEXT: This article presents the 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. In this randomized, placebo-controlled study with an enriched enrollment design, the buprenorphine transdermal system (BTDS) was found to be efficacious and generally well tolerated. OBJECTIVES: This enriched, multicenter, randomized, double-blind study evaluated the efficacy, tolerability, and safety of BTDS in opioid-naïve patients who had moderate to severe chronic low back pain. METHODS: Patients who tolerated and responded to BTDS (10 or 20 mcg/hour) during an open-label run-in period were randomized to continue BTDS 10 or 20 mcg/hour or receive matching placebo. The primary outcome was "average pain over the last 24 hours" at the end of the 12-week double-blind phase, collected on an 11-point scale (0=no pain, 10=pain as bad as you can imagine). Sleep disturbance (Medical Outcomes Study subscale) and total number of supplemental analgesic tablets used were secondary efficacy variables. RESULTS: Fifty-three percent of patients receiving open-label BTDS (541 of 1024) were randomized to receive BTDS (n=257) or placebo (n=284). Patients receiving BTDS reported statistically significantly lower pain scores at Week 12 compared with placebo (least square mean treatment difference: -0.58, P=0.010). Sensitivity analyses of the primary efficacy variable and results of the analysis of secondary efficacy variables supported the efficacy of BTDS relative to placebo. During the double-blind phase, the incidence of treatment-emergent adverse events was 55% for the BTDS treatment group and 52% for the placebo treatment group. Laboratory, vital sign, and electrocardiogram evaluations did not reveal unanticipated safety findings. CONCLUSION: BTDS was efficacious in the treatment of opioid-naïve patients with moderate to severe chronic low back pain. Most treatment-emergent adverse events observed were consistent with those associated with the use of opioid agonists and transdermal patches. SN - 1873-6513 UR - https://www.unboundmedicine.com/medline/citation/21945130/Efficacy_and_safety_of_the_seven_day_buprenorphine_transdermal_system_in_opioid_naïve_patients_with_moderate_to_severe_chronic_low_back_pain:_an_enriched_randomized_double_blind_placebo_controlled_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0885-3924(11)00369-1 DB - PRIME DP - Unbound Medicine ER -