Valdecoxib (Bextra, Pharmacia) is the newest addition to the class of cyclooxygenase-2 inhibitors, which also includes celecoxib (Pharmacia/Pfizer Inc.) and rofecoxib (Vioxx, Merck). Valdecoxib received FDA approval in November 2001 for treating the signs and symptoms of osteoarthritis (OA) and adult rheumatoid arthritis (RA) and the treatment of pain associated with menstrual cramping (primary dysmenorrhea), as shown in Table 1. Valdecoxib is not approved for use in the pediatric population (<18 years of age) and unlike the others in this class, valdecoxib is not indicated for the management of acute pain in adults (Table 2).
OA currently affects approximately 43 million people and this number is expected to rise to 60 million (i.e., 1 in 5 people) in the year 2020. Although OA predominately affects women and older people, is not limited to the elderly population, and can be seen in patients younger than 65 years of age. OA is the leading cause of disability in the U.S. and results in approximately 750,000 hospitalizations each year. The estimated cost of treating arthritis, including indirect costs (i.e., rehabilitation and lost productivity) exceeds $65 billion each year. By comparison, RA primarily affects women (i.e., 1.5 million women vs. 600,000 men) and approximately 2.1 million people in the U.S. buy generic cialis
Table 1 Valdecoxib Dosing and Indications
|Indication Dosing recommendationsRelief of signs and symptoms of osteoarthritis 10 mg once daily Relief of signs and symptoms of rheumatoid arthritis in adults 10 mg once daily Primary dysmenorrhea 20 mg twice daily, as needed|
Despite the presentation differences between RA and OA, joint swelling, pain, and tenderness are clinical features of both. The pathology of both conditions involves an inflammatory process mediated by growth factors, cytokines and prostaglandins. Nonsteroidal anti-inflammatory drugs (NSAIDs) have been considered the drugs of choice for these patients because of their prostaglandin inhibitory effects. Because of the high incidence of gastrointestinal complications (i.e., dyspepsia, ulcers, or hemorrhages), long-term use of this drug class might not be appropriate, especially for those at risk of NSAID-induced ulcers (Table 3). In the U.S., there are an estimated 16,500 NSAID-related deaths annually among patients with RA and OA. With the advent of the selective COX-2 inhibitors, patients and physicians have additional options for those patients for whom traditional NSAID therapy is contraindicated.
Table 2 Comparison of COX-2 Indications
|Indication Valdecoxib Celecoxib canadian RifecoxibRelief of signs and symptoms of osteoarthritis ✓ ✓ ✓ Relief of signs and symptoms of rheumatoidarthritis in adults ✓ ✓ ✓ Management of acute pain in adults ✓ ✓ Primary dysmenorrhea ✓ ✓ ✓ Familial adenomatous polyposis (FAP) ✓|
Traditional NSAIDS (i.e., ibuprofen) are considered first-line therapy for women with primary dysmenorrhea. However, because of the frequency of adverse effects and the risk of ulceration with traditional NSAIDs, the COX-2 inhibitors have become an alternative treatment option. Dysmenorrhea is a common problem in young women characterized by painful menstrual periods and dull or throbbing pain in the abdominal area that radiates to the lower back. Dysmenorrhea is thought to be caused by high levels of prostaglandins, which cause the stimulation of uterine smooth muscle, ischemia and sensitized nerve endings, as well as systemic symptoms (i.e., nausea and diar-rhea). Medications that promote prostaglandin inhibition, such as the NSAIDs, are an ideal therapy for treating this condition.
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Table 3 Risk Factor for NSAID-Induced Ulcers
|Established risk factors✓ Advanced age|
✓ History of ulcer
✓ Concomitant use of steroids
✓ Use of high-dose NSAID
✓ Use of more than one NSAID
✓ Concomitant use of anticoagulants
Possible risk factors
✓ Cigarette smoking
✓ Alcohol use
✓ Concomitant infection with Helicobacter pylori