| Efficacy and safety of rofecoxib in patients with chronic low back pain: results from two 4-week, randomized, placebo-controlled, parallel-group, double-blind trials. | |
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MedLine Citation:
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PMID: 12941996 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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STUDY DESIGN: Two replicate, 4-week, randomized, double-blind, placebo-controlled, trials of rofecoxib 25 and 50 mg versus placebo for chronic low back pain. OBJECTIVES: To determine the efficacy and safety of two doses of rofecoxib compared to placebo in the treatment of chronic low back pain. SUMMARY OF BACKGROUND DATA: Although nonsteroidal anti-inflammatory drugs are commonly prescribed for chronic low back pain, their efficacy is unproven and toxicity can be serious. These studies evaluated the efficacy and tolerability of rofecoxib, a selective COX-2 inhibitor, in the treatment of chronic low back pain. METHODS: Patients with chronic low back pain were randomized 1:1:1 to rofecoxib 25 mg, 50 mg, or placebo once daily. Primary endpoint: Low Back Pain Intensity. Secondary endpoints: Pain Bothersomeness, Global Assessments of Response to Therapy, Global Assessment of Disease Status, Roland-Morris Disability Questionnaire, SF-12 Health Survey, Use of Rescue Acetaminophen, and Discontinuations Due to Lack of Efficacy. RESULTS: Combining both studies, 690 patients were randomized to placebo (N = 228), rofecoxib 25 mg (N = 233), or rofecoxib 50 mg (N = 229). Mean (+/- SD) age was 53.4 (+/- 12.9) years, pain duration 12.1 (+/- 11.8) years, 62.3% female. Both rofecoxib groups improved significantly. Mean differences from placebo in pain intensity were -13.50 mm, -13.81 mm (25, 50 mg doses) respectively (P < 0.001). Both regimens were superior to placebo in eight of nine secondary endpoints. Fifty mg provided no advantage over 25 mg. Both rofecoxib regimens were well tolerated, although 25 mg had a slightly better safety profile. CONCLUSIONS: Rofecoxib significantly reduced chronic low back pain in adults and was well tolerated. |
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Authors:
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Nathaniel Katz; William D Ju; David A Krupa; Rhoda S Sperling; Diana Bozalis Rodgers; Barry J Gertz; Joseph Gimbel; Spencer Coleman; Chester Fisher; Shahriar Nabizadeh; David Borenstein; |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Spine Volume: 28 ISSN: 1528-1159 ISO Abbreviation: Spine Publication Date: 2003 May |
Date Detail:
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Created Date: 2003-08-27 Completed Date: 2004-02-25 Revised Date: 2009-07-09 |
Medline Journal Info:
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Nlm Unique ID: 7610646 Medline TA: Spine (Phila Pa 1976) Country: United States |
Other Details:
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Languages: eng Pagination: 851-8; discussion 859 Citation Subset: IM |
Affiliation:
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Pain Trials Center, Brigham & Women's Hospital, Boston, Massachusetts, USA. NatPaulKatz@aol.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Aged Anti-Inflammatory Agents, Non-Steroidal / adverse effects, therapeutic use* Chronic Disease Cyclooxygenase Inhibitors / adverse effects, therapeutic use* Disability Evaluation Dose-Response Relationship, Drug Double-Blind Method Female Health Status Humans Lactones / adverse effects, therapeutic use* Low Back Pain / drug therapy* Male Middle Aged Pain Measurement / drug effects Questionnaires Sulfones Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Anti-Inflammatory Agents, Non-Steroidal; 0/Cyclooxygenase Inhibitors; 0/Lactones; 0/Sulfones; 0/rofecoxib |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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