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Comparison of the effectiveness and tolerability of lidocaine patch 5% versus celecoxib for osteoarthritis-related knee pain: post hoc analysis of a 12 week, prospective, randomized, active-controlled, open-label, parallel-group trial in adults.
Clin Ther. 2008 Dec; 30(12):2366-77.CT

Abstract

BACKGROUND

Cyclooxygenase-2 (COX-2) selective inhibitors and nonselective NSAIDs are commonly used to treat osteoarthritis (OA) of the knee.

OBJECTIVE

The aim of this study was to compare the effectiveness of the lidocaine patch 5% with that of celecoxib 200 mg/d in the treatment of OA-related knee pain; however, the study was terminated prematurely by the sponsor because of tolerability concerns regarding the class of COX-2 selective inhibitors. A post hoc analysis of the available data is presented here.

METHODS

This multicenter, randomized, open-label, active-controlled, parallel-group study included patients >or=18 years of age with unilateral or bilateral moderate to severe OA of the knee. Patients were randomized to receive treatment with either the lidocaine patch 5% or celecoxib 200 mg/d. The primary efficacy end point was change from baseline to 12 weeks in the Western Ontario and McMaster Universities (WOMAC) OA Index pain subscale. Secondary end points included additional WOMAC subscales and Brief Pain Inventory (BPI) measures. Because this trial was prematurely terminated, a post hoc analysis was performed using a random pattern-mixture model of all observed cases of the intent-to-treat population.

RESULTS

A total of 143 patients were randomized to treatment (lidocaine patch 5%, 69 patients; mean [SD] age, 60.2 [11.4] years; 65.2% female; 66.7% white; weight, 94.1 [23.3] kg) or celecoxib 200 mg/d (74 patients; age, 58.2 [12.1] years; 63.5% female; 68.9% white; weight, 94.3 [22.5] kg). Baseline pain WOMAC OA subscale scores (lidocaine patch 5%, 12.087; celecoxib 200 mg/d, 12.514) and mean rates of change over time (baseline to week 2, -1.5916 vs -1.6513 per week; weeks 2-6, -0.0168 vs -0.119 per week; weeks 6-12, -0.1818 vs -0.1579 per week) were not significantly different between the 2 groups. Improvement in additional WOMAC subscales and in several BPI measures were not significantly different between the 2 groups. Treatment-related adverse events were reported in 8 patients in each treatment group (11.6% in the lidocaine patch 5% group and 10.8% in the celecoxib 200-mg/d group) and were considered mild or moderate in severity.

CONCLUSION

Statistically significant differences in effectiveness and tolerability were not found between these 2 treatments in these patients with OA knee pain.

Authors+Show Affiliations

Altoona Center for Clinical Research, 1125 Old Route 220 North, Duncansville, PA 16635, USA. akivitz@prodigy.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

19167595

Citation

Kivitz, Alan, et al. "Comparison of the Effectiveness and Tolerability of Lidocaine Patch 5% Versus Celecoxib for Osteoarthritis-related Knee Pain: Post Hoc Analysis of a 12 Week, Prospective, Randomized, Active-controlled, Open-label, Parallel-group Trial in Adults." Clinical Therapeutics, vol. 30, no. 12, 2008, pp. 2366-77.
Kivitz A, Fairfax M, Sheldon EA, et al. Comparison of the effectiveness and tolerability of lidocaine patch 5% versus celecoxib for osteoarthritis-related knee pain: post hoc analysis of a 12 week, prospective, randomized, active-controlled, open-label, parallel-group trial in adults. Clin Ther. 2008;30(12):2366-77.
Kivitz, A., Fairfax, M., Sheldon, E. A., Xiang, Q., Jones, B. A., Gammaitoni, A. R., & Gould, E. M. (2008). Comparison of the effectiveness and tolerability of lidocaine patch 5% versus celecoxib for osteoarthritis-related knee pain: post hoc analysis of a 12 week, prospective, randomized, active-controlled, open-label, parallel-group trial in adults. Clinical Therapeutics, 30(12), 2366-77. https://doi.org/10.1016/j.clinthera.2008.12.015
Kivitz A, et al. Comparison of the Effectiveness and Tolerability of Lidocaine Patch 5% Versus Celecoxib for Osteoarthritis-related Knee Pain: Post Hoc Analysis of a 12 Week, Prospective, Randomized, Active-controlled, Open-label, Parallel-group Trial in Adults. Clin Ther. 2008;30(12):2366-77. PubMed PMID: 19167595.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of the effectiveness and tolerability of lidocaine patch 5% versus celecoxib for osteoarthritis-related knee pain: post hoc analysis of a 12 week, prospective, randomized, active-controlled, open-label, parallel-group trial in adults. AU - Kivitz,Alan, AU - Fairfax,Michael, AU - Sheldon,Eric A, AU - Xiang,Qinfang, AU - Jones,Beverly A, AU - Gammaitoni,Arnold R, AU - Gould,Errol M, PY - 2008/10/31/accepted PY - 2009/1/27/entrez PY - 2009/1/27/pubmed PY - 2009/3/20/medline SP - 2366 EP - 77 JF - Clinical therapeutics JO - Clin Ther VL - 30 IS - 12 N2 - BACKGROUND: Cyclooxygenase-2 (COX-2) selective inhibitors and nonselective NSAIDs are commonly used to treat osteoarthritis (OA) of the knee. OBJECTIVE: The aim of this study was to compare the effectiveness of the lidocaine patch 5% with that of celecoxib 200 mg/d in the treatment of OA-related knee pain; however, the study was terminated prematurely by the sponsor because of tolerability concerns regarding the class of COX-2 selective inhibitors. A post hoc analysis of the available data is presented here. METHODS: This multicenter, randomized, open-label, active-controlled, parallel-group study included patients >or=18 years of age with unilateral or bilateral moderate to severe OA of the knee. Patients were randomized to receive treatment with either the lidocaine patch 5% or celecoxib 200 mg/d. The primary efficacy end point was change from baseline to 12 weeks in the Western Ontario and McMaster Universities (WOMAC) OA Index pain subscale. Secondary end points included additional WOMAC subscales and Brief Pain Inventory (BPI) measures. Because this trial was prematurely terminated, a post hoc analysis was performed using a random pattern-mixture model of all observed cases of the intent-to-treat population. RESULTS: A total of 143 patients were randomized to treatment (lidocaine patch 5%, 69 patients; mean [SD] age, 60.2 [11.4] years; 65.2% female; 66.7% white; weight, 94.1 [23.3] kg) or celecoxib 200 mg/d (74 patients; age, 58.2 [12.1] years; 63.5% female; 68.9% white; weight, 94.3 [22.5] kg). Baseline pain WOMAC OA subscale scores (lidocaine patch 5%, 12.087; celecoxib 200 mg/d, 12.514) and mean rates of change over time (baseline to week 2, -1.5916 vs -1.6513 per week; weeks 2-6, -0.0168 vs -0.119 per week; weeks 6-12, -0.1818 vs -0.1579 per week) were not significantly different between the 2 groups. Improvement in additional WOMAC subscales and in several BPI measures were not significantly different between the 2 groups. Treatment-related adverse events were reported in 8 patients in each treatment group (11.6% in the lidocaine patch 5% group and 10.8% in the celecoxib 200-mg/d group) and were considered mild or moderate in severity. CONCLUSION: Statistically significant differences in effectiveness and tolerability were not found between these 2 treatments in these patients with OA knee pain. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/19167595/Comparison_of_the_effectiveness_and_tolerability_of_lidocaine_patch_5_versus_celecoxib_for_osteoarthritis_related_knee_pain:_post_hoc_analysis_of_a_12_week_prospective_randomized_active_controlled_open_label_parallel_group_trial_in_adults_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(08)00450-5 DB - PRIME DP - Unbound Medicine ER -