Safety Study of Lumiracoxib vs Rofecoxib in Osteoarthritis Patients
Author Information
Author(s): Kirstin Stricker, Sue Yu, Gerhard Krammer
Primary Institution: Novartis Pharma AG
Hypothesis
Does lumiracoxib have a better gastrointestinal safety profile and blood pressure profile compared to rofecoxib in osteoarthritis patients?
Conclusion
Lumiracoxib 400 mg od provided a comparable GI safety profile to rofecoxib 25 mg od, but with a significantly better blood pressure profile.
Supporting Evidence
- Both drugs displayed similar GI safety profiles with no significant difference in predefined GI adverse events.
- At Week 6, lumiracoxib showed significantly lower mean sitting systolic and diastolic blood pressure compared to rofecoxib.
- The incidence of peripheral oedema was low and identical in both groups.
Takeaway
This study looked at two medications for arthritis and found that one was just as safe for the stomach but better for blood pressure.
Methodology
309 patients aged 50 and older were randomly assigned to receive either lumiracoxib 400 mg or rofecoxib 25 mg for 6 weeks, with assessments at Weeks 3 and 6.
Potential Biases
Potential bias due to funding from Novartis, the manufacturer of lumiracoxib.
Limitations
The study was limited to a 6-week duration and may not reflect long-term safety.
Participant Demographics
Patients aged 50 and older with primary osteoarthritis, predominantly Caucasian.
Statistical Information
P-Value
p<0.05
Confidence Interval
95% CI: -6.17, -0.10 for msSBP; 95% CI: -3.43, -0.03 for msDBP
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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