Ec. Huskisson et al., A LONG-TERM STUDY TO EVALUATE THE SAFETY AND EFFICACY OF MELOXICAM THERAPY IN PATIENTS WITH RHEUMATOID-ARTHRITIS, British journal of rheumatology, 35, 1996, pp. 29-34
Meloxicam is a new non-steroidal anti-inflammatory drug (NSAID), which
has a higher activity against cyclooxygenase-2 (COX-2) than against c
yclooxygenase-1 (COX-1), with potentially high anti-inflammatory and a
nalgesic action. This study was designed to assess the long-term safet
y and efficacy of meloxicam 15 mg daily. Three hundred and fifty-seven
patients (aged 19-84 yr, mean 56 yr) with rheumatoid arthritis (RA) r
eceived meloxicam 15 mg orally once daily, for up to 18 months. Sixty-
six per cent of patients remained on therapy for 18 months. Mean globa
l efficacy, assessed by each patient on a visual analogue scale (0 cm
excellent, 10 cm = useless), was 3.32 +/- 3.1 cm at the last study vis
it (all patients included) and 2.33 +/- 2.25 cm after 18 months. Healt
h status, general condition, morning stiffness, grip strength of right
hand, Ritchie joint index, pain in the morning and pain at night all
improved significantly. Efficacy was maintained throughout the study.
Only 11.4% of patients discontinued prematurely due to lack of efficac
y. Mean global tolerance was good. Twenty-eight per cent of patients e
xperienced gastrointestinal (GI) adverse events, 21% musculoskeletal s
ystem disorders, 18% skin disorders and 15% respiratory disorders. Onl
y 13.7% of patients discontinued due to adverse events. Severe GI effe
cts, such as perforation, ulcer and bleeding, occurred in only three p
atients (0.8%). Withdrawals due to GI adverse events occurred in 3.9%
of patients. Meloxicam 15 mg once daily was effective and compared fav
ourably with standard NSAIDs regarding tolerance when administered to
patients with RA over an 18 month period.