Editor note: Vioxx was FDA approved in May 1999. 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: August 9, 1998
Vioxx Studies
Results from a new study were presented recently at the 11th EULAR conference (European League Against Rheumatism) which revealed that Vioxx, a new drug being developed by Merck & Co., Inc., provided significant improvement in osteoarthritis patients when assessing their ability to perform activities of daily life.
Vioxx is classified as a COX-2 selective inhibitor. Vioxx works by inhibiting the enzyme cyclooxygenase-2 which is responsible for producing pain and inflammation, while not inhibiting COX-1 which is an enzyme involved in the protection of the stomach lining. Inhibition of COX-1 can result in potential serious consequences such as stomach ulcers and perforation, a recognized side effect of non-steroidal anti-inflammatory drugs (NSAIDS).
Study looks at quality of life indicators
The newly reported results regarding Vioxx were based on a six week, randomized, placebo-controlled, double-blind study of 672 patients with osteoarthritis of the hip or knee.
Four doses of Vioxx (5, 12.5, 25, and 50 mg.) were compared to placebo. The study incorporated a widely used quality of life questionnaire known as the SF-36 Health Survey. The survey was completed by 565 patients and was used to assess functional disability and pain based on the ability of the patient to perform routine daily activities. Vitality, social functioning, and emotional well-being served as indicators of mental health functions.
Patients treated with Vioxx at all of the doses studied reported significant improvement in nearly all categories of physical functioning when compared to patients taking placebo. The categories included:
- bodily pain
- participation in sports
- housework
- walking
- lifting or carrying groceries
- climbing stairs
- bending, kneeling, or stooping
- other problems with work or other daily activities which contributed to physical health
Mental health functions were also positively affected by Vioxx. The difference in results between Vioxx and placebo patients was called "clinically significant and striking" by a health economist with Merck who co-authored the study.
Another study
Another study was presented of 472 patients with osteoarthritis of the knee or hip who took either 12.5 mg. or 25 mg. of Vioxx or 150 mg. of diclofenac, a popular NSAID, for 6 months. The study analyzed pain when walking on a flat surface, patient assessment of their condition, and physician assessment of the patient's condition. The study results indicated that Vioxx resulted in relief of pain and inflammation in osteoarthritis patients over time. No serious gastrointestinal complications were reported by anyone in this study.
Treatment with Vioxx has been generally well-tolerated among all studied doses. Among the most commonly reported side effects were:
- diarrhea
- headache
- insomnia
- upper respiratory infection
The same effects were observed in patients treated with placebo. Infrequent bouts of mild fluid retention were reported similarly in patients taking Vioxx and patients taking NSAIDS.
Phase III studies which evaluated clinical efficacy and safety of Vioxx for treatment of osteoarthritis and relief of pain have been completed. Merck will begin worldwide regulatory filings to support its use for osteoarthritis by the end of 1998. Studies are in progress to determine the value of Vioxx for the treatment of rheumatoid arthritis.
Related Resources
Source: Merck & Co, PRNewswire, September 5 and 6, 1998
First published: 9/09/1998
