PMID- 18778469
OWN - NLM
STAT- MEDLINE
DCOM- 20081230
LR  - 20211020
IS  - 1471-2474 (Electronic)
IS  - 1471-2474 (Linking)
VI  - 9
DP  - 2008 Sep 8
TI  - A 6-week, multicentre, randomised, double-blind, double-dummy, active-controlled, 
      clinical safety study of lumiracoxib and rofecoxib in osteoarthritis patients.
PG  - 118
LID - 10.1186/1471-2474-9-118 [doi]
AB  - BACKGROUND: Lumiracoxib is a selective cyclooxygenase-2 inhibitor effective in 
      the treatment of osteoarthritis (OA) with a superior gastrointestinal (GI) safety 
      profile as compared to traditional non-steroidal anti-inflammatory drugs (NSAIDs, 
      ibuprofen and naproxen). This safety study compared the GI tolerability, the 
      blood pressure (BP) profile and the incidence of oedema with lumiracoxib and 
      rofecoxib in the treatment of OA. Rofecoxib was withdrawn worldwide due to an 
      associated increased risk of CV events and lumiracoxib has been withdrawn from 
      Australia, Canada, Europe and a few other countries following reports of 
      suspected adverse liver reactions. METHODS: This randomised, double-blind study 
      enrolled 309 patients (aged greater than or equal to 50 years) with primary OA 
      across 51 centres in Europe. Patients were randomly allocated to receive either 
      lumiracoxib 400 mg od (four times the recommended dose in OA) (n = 154) or 
      rofecoxib 25 mg od (n = 155). The study was conducted for 6 weeks and assessments 
      were performed at Weeks 3 and 6. The primary safety measures were the incidence 
      of predefined GI adverse events (AEs) and peripheral oedema. The secondary safety 
      measures included effect of treatment on the mean sitting systolic and diastolic 
      blood pressure (msSBP and msDBP). Tolerability of lumiracoxib 400 mg was assessed 
      by the incidence of AEs. RESULTS: Lumiracoxib and rofecoxib displayed similar GI 
      safety profiles with no statistically significant difference in predefined GI AEs 
      between the two groups (43.5% vs. 37.4%, respectively). The incidence and 
      severity of individual predefined GI AEs was comparable between the two groups. 
      The incidence of peripheral oedema was low and identical in both the groups (n = 
      9, 5.8%). Only one patient in the lumiracoxib group and three patients in the 
      rofecoxib group had a moderate or severe event. At Week 6 there was a 
      significantly lower msSBP and msDBP in the lumiracoxib group compared to the 
      rofecoxib group (p < 0.05). A similar percentage of patients in both groups 
      showed an improvement in target joint pain and disease activity. The tolerability 
      profile was similar in both the treatment groups. CONCLUSION: Lumiracoxib 400 mg 
      od (four times the recommended dose in OA) provided a comparable GI safety 
      profile to rofecoxib 25 mg od (therapeutic dose). However, lumiracoxib was 
      associated with a significantly better BP profile as compared to rofecoxib. TRIAL 
      REGISTRATION NUMBER: NCT00637949.
FAU - Stricker, Kirstin
AU  - Stricker K
AD  - Novartis Pharma AG Postfach, CH-4002, Basel, Switzerland. 
      kirstin.stricker@novartis.com
FAU - Yu, Sue
AU  - Yu S
FAU - Krammer, Gerhard
AU  - Krammer G
LA  - eng
SI  - ClinicalTrials.gov/NCT00637949
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20080908
PL  - England
TA  - BMC Musculoskelet Disord
JT  - BMC musculoskeletal disorders
JID - 100968565
RN  - 0 (Cyclooxygenase 2 Inhibitors)
RN  - 0 (Lactones)
RN  - 0 (Sulfones)
RN  - 0QTW8Z7MCR (rofecoxib)
RN  - 144O8QL0L1 (Diclofenac)
RN  - V91T9204HU (lumiracoxib)
SB  - IM
MH  - Aged
MH  - Arthralgia/etiology/physiopathology
MH  - Blood Pressure/drug effects
MH  - Cyclooxygenase 2 Inhibitors/*adverse effects/pharmacology/*therapeutic use
MH  - Diclofenac/adverse effects/*analogs & derivatives/pharmacology/therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Edema/chemically induced/epidemiology
MH  - Europe
MH  - Female
MH  - Gastrointestinal Tract/drug effects
MH  - Humans
MH  - Incidence
MH  - Kidney/drug effects
MH  - Lactones/*adverse effects/pharmacology/*therapeutic use
MH  - Longitudinal Studies
MH  - Male
MH  - Middle Aged
MH  - Osteoarthritis/complications/*drug therapy/physiopathology
MH  - Sulfones/*adverse effects/pharmacology/*therapeutic use
PMC - PMC2542997
EDAT- 2008/09/10 09:00
MHDA- 2008/12/31 09:00
PMCR- 2008/09/08
CRDT- 2008/09/10 09:00
PHST- 2008/02/19 00:00 [received]
PHST- 2008/09/08 00:00 [accepted]
PHST- 2008/09/10 09:00 [pubmed]
PHST- 2008/12/31 09:00 [medline]
PHST- 2008/09/10 09:00 [entrez]
PHST- 2008/09/08 00:00 [pmc-release]
AID - 1471-2474-9-118 [pii]
AID - 10.1186/1471-2474-9-118 [doi]
PST - epublish
SO  - BMC Musculoskelet Disord. 2008 Sep 8;9:118. doi: 10.1186/1471-2474-9-118.