| Title | Tolerability profiles of rofecoxib (Vioxx) and Arthrotec. A comparison of six weeks treatment in patients with osteoarthritis. | | Author(s) | Acevedo E, Castañeda O, Ugaz M, Beaulieu AD, Pons-Estel B, Caeiro F, Casas N, Garza-Elizondo M, Irazoque F, Hinojosa W, Gutierrez-Ureña S, Vandormael K, Rodgers DB, Laurenzi M | | Institution | Clínica San Felipe, Lima, Peru. | | Source | Scand J Rheumatol 2001; 30(1):19-24. | | MeSH | Abdominal Pain
Adult
Aged
Aged, 80 and over
Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors
Diarrhea
Diclofenac
Double-Blind Method
Drug Combinations
Female
Humans
Lactones
Male
Middle Aged
Misoprostol
Osteoarthritis
Severity of Illness Index
Sulfones
Treatment Outcome
| | Abstract | OBJECTIVE: To compare the incidence of selected spontaneously reported adverse events (AEs) in patients with osteoarthritis (OA) treated with rofecoxib (VIOXX, 12.5 mg qd) or Arthrotec (diclofenac 50 mg/misoprostol 200 mcg bid).
METHODS: Double-blind, parallel-group, 6-week study of patients aged > or = 40 years with a clinical diagnosis of OA treated with rofecoxib or Arthrotec. Primary endpoint: self-reported diarrhea; secondary endpoints: abdominal pain, discontinuations due to AEs, GI AEs and NSAID-type GI AEs (ie., acid reflux, dyspepsia, epigastric discomfort, heartburn, nausea, vomiting).
RESULTS: Among 483 patients (80.3% females, mean age 62.1), the rofecoxib group vs the Arthrotec group respectively reported diarrhea 6.2% vs 16.2% (p<0.001); drug-related diarrhea 3.7% vs 16.2% (p<0.001); one or more clinical AEs 52.9% vs 73.0% (p<0.001); GI AEs 28.9% vs 48.5% (p<0.001); NSAID-type GI AEs 18.6% vs 29.9% (p=0.004); discontinuations due to abdominal pain 0.4% vs 3.7% (p<0.05); and discontinuations due to any AE 4.1% vs 9.1% (p=0.029). No significant differences were observed in efficacy.
CONCLUSION: Rofecoxib 12.5 mg qd has improved GI tolerability and similar efficacy compared to Arthrotec (diclofenac 50 mg/misoprostol 200 mcg bid). | | Language | eng | | Pub Type(s) | Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
| | PubMed ID | 11252687 |
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