Randomized, Double Blind Trial of Rofecoxib compared to Diclofenac
in Osteoarthritis (OA) knees: An Abstracts – 10th Asia
Pacific League of Associations for Rheumatology Congress 2002;
142
CHOPRA A, SALUJA M, GOREGAONKAR AB, MAROLI S, GHAI
H, VARTAK M, PAWAR D.
Betacyclodextrin (BCD) forms inclusion complexes to
modify the physicochemical and biological properties
of parent drug.
Aim
to compare the efficacy and safety of Rofecoxib-betacyclodextrin
(ROFFBCD) with plain Rofecoxib (ROFF) in OA knees.
Methods
86 patients of OA knees were randomized into a multicentric,
double blind drug trial of 4 weeks duration as per the
protocol. ROFFBCD (25 mg of ROFECOXIB daily) was compared
to ROFF (25 mg daily); 43 patients in each arm. Paracetamol
on prn basis was permitted and use monitored; nil else
allowed. Eligibility criteria (pain VAS>4cms) ensured
active symptomatic disease. Standard ACR efficacy measures,
including WOMAC (modified and validated for Indian use)
were used. Sample size was driven by the hypothesis
of equal efficacy and regulatory needs. An intent to
treat analysis at p<0.05 significance was done.
Results
Though not significant (p>0.05), ROFFBCD showed
better efficacy response than ROFF in all efficacy
measures, including pain VAS & WOMAC change,
at all end points
16.3% ROFFBCD
and 14.6% ROFF reported AE(P>0.05); nausea,
vomiting and diarrhoea reported
in within
group analysis, both the drugs showed improvement
in several efficacy measures, including walking
time & global improvements
percent
reduction in mean WOMAC pain was better in ROFFBCD
at 1 week (20.44% Vs 14.42% ROFF; p<0.05) and
4 week end point (36.57% Vs 31.62% ROFF)
percent
reduction at 4 week endpoint in pain VAS on weight
bearing was better in ROFFBCD (45.56% Vs 40.87%
ROFF).
Conclusion
ROFFBCD when compared to ROFF has a promising
and a better overall efficacy profile in the symptomatic
management of OA knees, and complexation with betacyclodextrin
appears to confer a visible clinical advantage.
Abstracts – 10th Asia Pacific
League of Associations for Rheumatology Congress 2002;
115
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