Authors' objectives:

This study aims to assess the available evidence on the efficacy/effectiveness and safety of COX-2 inhibitors for the treatment of non-malignant chronic low back pain.

Authors' recommendations: Evidence on the efficacy/effectiveness and safety of COX-2 inhibitors for the treatment of CLBP was obtained from one multicentre RCT which is considered to be a good level of evidence. In this RCT the COX-2 inhibitor involved was etoricoxib. The comparator was placebo and not another active treatment (selective or non-selective NSAID). This study was funded by Merck and Co. Inc., the company that produces this drug. Etoricoxib, is a relatively new COX-2 inhibitor used for the treatment of signs and symptoms of rheumatoid arthritis and osteoarthritis and for pain and signs of inflammation associated with acute gouty arthritis, in countries from the European Union and South America. Etoricoxib is not yet approved and marketed in Canada and the United States. Both doses of Etoricoxib (60 mg and 90 mg daily) showed similar results in terms of efficacy and safety and showed improvement on the outcome measures used compared to placebo at up to 12 weeks of follow up. The statistical analysis of efficacy employed a modified intention-to-treat approach, that is all patients who received at least one dose of therapy and their outcome data were available were included. This approach raises uncertainty about the true magnitude of the treatment effect. All patients randomized were included in the analysis of AEs. The most commonly reported AEs in patients treated with Etoricoxib were diarrhea (16 patients), headache (15 patients), and worsening of low back pain (11 patients). One patient taking rofecoxib 90 mg daily, with an active history of hypertension and chest pain, developed a cerebrovascualar accident and congestive heart failure. Patients with chronic pain are likely to take drugs for extended periods of time. COX-2 inhibitors may be appropriate for the patients who are at high risk for developing GI AEs such as perforation, ulcers or bleeds from anti-inflammatory drugs. However, COX-2 inhibitors are relatively new drugs and physicians must be attentive to possible AEs associated with the treatment especially during long-term administration. Recent evidence showed an increased risk for cardiovascular events associated with both selective and non-selective NSAIDs. Good quality studies with long periods of follow-up (beyond three months), comparing COX-2 inhibitors with non-selective NSAIDs for the treatment of chronic low back pain in terms of efficacy, effectiveness, safety as well as cost-consequences analysis are needed. As COX-2 inhibitors are currently under close scrutiny and based on the limited evidence of one RCT of relatively small sample size, etoricoxib should be considered for use in patients who consent to be enrolled in clinical studies.

Authors' methods: Overview

Project Status: Completed

Year Published: 2005

URL for published report: https://www.ihe.ca/advanced-search?type=1020

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: Institute of Health Economics

Contact Address: 1200, 10405 Jasper Avenue, Edmonton, Alberta, Canada, T5J 3N4. Tel: +1 780 448 4881; Fax: +1 780 448 0018;

Contact Name: djuzwishin@ihe.ca

Contact Email: djuzwishin@ihe.ca

Copyright: <p>Alberta Heritage Foundation for Medical Research (AHFMR)</p>