Tolerability profiles of rofecoxib (Vioxx) and Arthrotec. A comparison of six weeks treatment in patients with osteoarthritis.
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.


CONCLUSIONS
Rofecoxib 12.5 mg qd has improved GI tolerability and similar efficacy compared to Arthrotec (diclofenac 50 mg/misoprostol 200 mcg bid).
Acevedo
E
E
Clínica San Felipe, Lima, Peru.
Castañeda
O
O
Ugaz
M
M
Beaulieu
A D
AD
Pons-Estel
B
B
Caeiro
F
F
Casas
N
N
Garza-Elizondo
M
M
Irazoque
F
F
Hinojosa
W
W
Gutierrez-Ureña
S
S
Vandormael
K
K
Rodgers
D B
DB
Laurenzi
M
M
D015746:Abdominal Pain / Q000139:chemically induced; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects*; D003967:Diarrhea / Q000139:chemically induced; D004008:Diclofenac / Q000009:adverse effects*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007783:Lactones / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D016595:Misoprostol / Q000009:adverse effects*; D010003:Osteoarthritis / Q000188:drug therapy* / Q000503:physiopathology; D012720:Severity of Illness Index; D013450:Sulfones; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; C078133:Arthrotec; D016861:Cyclooxygenase Inhibitors; D004338:Drug Combinations; D007783:Lactones; D013450:Sulfones; D016595:Misoprostol; C116926:rofecoxib; D004008:Diclofenac