PMID- 11252687
OWN - NLM
STAT- MEDLINE
DCOM- 20010329
LR  - 20190910
IS  - 0300-9742 (Print)
IS  - 0300-9742 (Linking)
VI  - 30
IP  - 1
DP  - 2001
TI  - Tolerability profiles of rofecoxib (Vioxx) and Arthrotec. A comparison of six 
      weeks treatment in patients with osteoarthritis.
PG  - 19-24
AB  - 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).
FAU - Acevedo, E
AU  - Acevedo E
AD  - Clinica San Felipe, Lima, Peru.
FAU - Castaneda, O
AU  - Castaneda O
FAU - Ugaz, M
AU  - Ugaz M
FAU - Beaulieu, A D
AU  - Beaulieu AD
FAU - Pons-Estel, B
AU  - Pons-Estel B
FAU - Caeiro, F
AU  - Caeiro F
FAU - Casas, N
AU  - Casas N
FAU - Garza-Elizondo, M
AU  - Garza-Elizondo M
FAU - Irazoque, F
AU  - Irazoque F
FAU - Hinojosa, W
AU  - Hinojosa W
FAU - Gutierrez-Urena, S
AU  - Gutierrez-Urena S
FAU - Vandormael, K
AU  - Vandormael K
FAU - Rodgers, D B
AU  - Rodgers DB
FAU - Laurenzi, M
AU  - Laurenzi M
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Scand J Rheumatol
JT  - Scandinavian journal of rheumatology
JID - 0321213
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Arthrotec)
RN  - 0 (Cyclooxygenase Inhibitors)
RN  - 0 (Drug Combinations)
RN  - 0 (Lactones)
RN  - 0 (Sulfones)
RN  - 0E43V0BB57 (Misoprostol)
RN  - 0QTW8Z7MCR (rofecoxib)
RN  - 144O8QL0L1 (Diclofenac)
SB  - IM
MH  - Abdominal Pain/chemically induced
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Inflammatory Agents, Non-Steroidal/*adverse effects
MH  - Cyclooxygenase Inhibitors/*adverse effects
MH  - Diarrhea/chemically induced
MH  - Diclofenac/*adverse effects
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Lactones/*adverse effects
MH  - Male
MH  - Middle Aged
MH  - Misoprostol/*adverse effects
MH  - Osteoarthritis/*drug therapy/physiopathology
MH  - Severity of Illness Index
MH  - Sulfones
MH  - Treatment Outcome
EDAT- 2001/03/17 10:00
MHDA- 2001/04/03 10:01
CRDT- 2001/03/17 10:00
PHST- 2001/03/17 10:00 [pubmed]
PHST- 2001/04/03 10:01 [medline]
PHST- 2001/03/17 10:00 [entrez]
AID - 10.1080/030097401750065274 [doi]
PST - ppublish
SO  - Scand J Rheumatol. 2001;30(1):19-24. doi: 10.1080/030097401750065274.