Editor note: On 09/30/2004, Merck the maker of Vioxx, issued a worldwide recall, halting sales of the drug. On 04/07/2005, Following scrutiny of the class of arthritis drugs known as NSAIDs and COX-2 inhibitors, the FDA announced planned regulatory actions. See: Questions & Answers: FDA Actions On COX-2 Inhibitors & NSAIDs Fallout from the Vioxx recall will continue for years to come.
Dateline: June 22, 2003
Chronic back pain is a common problem
Five to 10 percent of the population are affected by chronic back pain. Defined as pain lasting three months or longer, chronic back pain also is major cause of disability and absence from work. To fend off the debilitating aspect of chronic back pain, most patients are prescribed traditional pain relievers such as aspirin and ibuprofen. Known as non-steroidal anti-inflammatory drugs or NSAIDs, they have the potential to cause stomach or gastrointestinal problems such as ulcers or bleeding. The COX-2 selective inhibitors are a newer class of NSAIDs which can still relieve pain and inflammation with less risk of gastrointestinal irritation. The COX-2 selective inhibitors include:
About the study
Two replicate, 4-week, randomized, double-blind, placebo-controlled, trials of Vioxx (rofecoxib) 25 mg and 50 mg versus placebo were studied for their safety and efficacy in the treatment of chronic low back pain. The results were reported in Spine 2003;28:851-859. The study led by Dr. Nathaniel Katz of Brigham and Women's Hospital in Boston, included 690 patients (combining both studies) taking daily medications for chronic back pain. All of the study participants had moderate to severe pain which averaged 76 on a 100-point scale. Their mean age was 53.4 years, pain duration averaged 12.1 years, and 62.3% were female.
The group was randomized to receive either Vioxx 25 mg, Vioxx 50 mg, or placebo once daily. The primary endpoint of the study: Low Back Pain Intensity. Secondary endpoints were 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.
Study results
Both Vioxx groups showed significant improvement. Although individual responses varied, at both doses of Vioxx the pain scores averaged approximately 14 points below the pain scores associated with placebo. Both dosages of Vioxx were superior to placebo in eight of nine secondary endpoints. Compared to the placebo group, patients taking Vioxx were nearly twice as likely to rate their treatment as good or excellent.
Fifty mg seemed to provide no advantage over the lower dose of 25 mg Vioxx. Both dosages were reportedly well tolerated, though 25 mg had a slightly better safety profile. The side effects were no more frequent with Vioxx than were observed with the placebo group.
Related Resources
Sources: Spine 2003;28:851-859 Abstract: 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, Katz et al.; Rofecoxib Is Safe and Effective for Chronic Low Back Pain, NEWSWISE, June 11, 2003
First published: 6/22/2003
