Randomized double-blind clinical drug trials of meloxicam
in rheumatoid arthritis and osteoarthritis knees:
an Indian experience
ARVIND CHOPRA, L. BICHILE, A.G.RAJADHYAKSHA, D. GADGIL,
S. MAROLI, A.B. GOREGAONKAR and B.K. DHAON.
APLAR Journal of Rheumatology 2004; 7 : 108-116
Abstract
Background
Indian data from controlled drug trials on the use of
meloxicam (a new preferential COX –2 inhibitor)
and other non-steroidal anti-inflammatory drugs (NSAIDs)
in arthritis is sparse.
Aim
To evaluate the clinical efficacy and safety of meloxicam.
Patients
and methods
One hundred and twenty-one patients with rheumatoid
arthritis (RA) and 133 patients with osteoarthritis
(OA) knees were randomized into two different multicenric,
double-blind, drug trials of four-weeks duration each.
Meloxicam 7.5 mg(OA study) and 15 mg (RA study) was
compared to diclofenac 100 mg and piroxicam 20 mg. in
daily dosages, respectively. Strict eligibility criteria
ensured active symptomatic disease. Standard ACR efficacy
measures of pain and function (including validated Indian
versions of HAQ & WOMAC) were used. Protocol-driven
evaluations were carried out throughout the study. An
intent-to –treat efficacy analysis (significance
at P < 0.05) was carried out to test the hypothesis
of equal efficacy between meloxicam and comparator.
Results
There were no significant
differences between meloxicam and piroxicam in the
RA study.
While joint count for pain/tenderness
was improved (P< 0.05) by both meloxicam and
piroxicam, only meloxicam showed significant improvement
( 95% CI =0.7,5.6) in swollen joint count.
In the OA study, through pain
VAS reduction was marginally better (95% CI = -15,
-0.6) with diclofenac , both meloxicam and diclofenac
were equally effective (95% CI = -10,2.0) in improving
WOMAC physical function.
Overall, meloxicam demonstrated
a superior safety and gut tolerability profile as
compared to piroxicam (maximum adverse events, 29.3%)
and diclofenac. (iv) Maximum dyspepsia (6.2%) was
reported by the diclofenac group.
Overall, the drug toxicity seen
in the trials was mild, and only one patient (on
diclofenac) was withdrawn due to haematuria.
All treatment groups consumed
Paracetamol (p>0.05) as a rescue analgesic.
Conclusion
When compared to piroxicam and diclofenac, meloxicam
has equal clinical efficacy and a better safety profile.
Multicentric control drug trials are feasible in our
population.
Key Words
drug trials, meloxicam, NSAID, osteoarthritis
knee, rheumatoid arthritis.
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