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l):35-38
SUMMARY
Meloxicam 15 mg once daily (n = 128) was compared with piroxicam 20 mg (n = 127) in this 6 week, double-blind, parallel-group,
randomized, multicentre study in out-patients with symptomatic osteoarthritis (OA) of the hip. Assessments of pain, global
efficacy and global tolerance were made on a 10 cm horizontal visual analogue scale; severity of OA was evaluated by Lequesne's
index. Efficacy results showed significant improvement compared with baseline, with no significant difference between meloxicam
15 mg and piroxicam 20 mg. The type and frequency of adverse events were comparable for the two drugs. The most frequent events
reported were gastrointestinal (GT) disorders, occurring in 21 and 23% of meloxicam and piroxicam patientsrespectively.The
global tolerance assessment by patients at the end of treatment favoured meloxicam. In conclusion, meloxicam at a dose of 15
mg/day is comparable in efficacy and safety to piroxicam 20 mg.
KEY WORDS: Meloxicam, Piroxicam, Osteoarthritis, NSAID, Cyclooxygenase.
TABLEn TABLE V
Mean levels of pain on movement as f""=*fW by the patient using a Advene events leading to withdrawal (intent-to-treat analysis)
100 mm VAS intent-to-txeat analysis
Adverse events Meloxicam 15 mg (n) Piroxicam 20 mg (n)
Meloxkam IS mg Piroxicam 20 mg
Days of treatment (mean ± sx>.) (mean ±SJX) Pain 1 0
Abdominal pain 2 2
0 59.7 ± 15.2 60.2 ± 14.7 Constipation 0 1
7 41.0 ± 20.4 42.4 ± 20.0 Diarrhoea 0 3
21 36.6 ± 2 2 7 38.2 ± 23.7 Duodenal ulcer 1 0
42 31.7 ±24.3 34.9 ± 24.4 perforated
Dyspepsia 6 3
Gastric ulcer perforated 0 1
Gastritis 1 0
TABLE HI Nausea 2 1
Angina pectoris 0 1
Mean levels of worst pain at rest in the previous 24 h as assessed by
Coughing 1 0
the patient (VAS 100 mm; intent-to-treat analysis) Dyspnoea 1 1
Meloxkam 15 mg Piroxicam 20 mg Rash 0 1
Day of treatment (mean ± SJ>.) (mean ± SJ>.) Lymphadenopathy 0 1
0 34.2 ± 2 2 34.1 ±21.5 Withdrawals due to 12 10
7 21.2 ±21.1 23.2 ±21.7 advene events (n = 22)
21 18.4 ±20.3 19.4 ±23.1 Total patients (n = 256) 129 127
42 17.4 ±22.9 17.8 ±21.6
TABLE IV
Global efficacy scores as assessed by the patient at the end of the
study and the total index of severity of OA of the hip after 6 weeks
of treatment (intent-to-treat analysis)
Meloxicam 15 ing Piroxicam 20 mg
(mean ± S.D. [mm]) (mean ± S.D. [mm])
Global efficacy scores 29.9 ± 25.4 32.2 ± 27.8
(VAS: 0 mm =
excellent; 100 mm =
useless)
Reduction in the total 3.7 ± 3.6 3.4 ± 3.8
index of severity
points
Meloxicam Piroxicam
O mm ~ •xo«n«nt
events. The most frequent adverse events were disorders
Fio. 1.—Mean (± S.D.) values of global tolerance assessed by the
of the GI system (20.9 and 22.8% in the meloxicam and patient using a 100 mm VAS (explanatory analysis).
piroxicam groups respectively) and the types of adverse
events reported were similar in both treatment groups.
There was one severe GI adverse event (perforated
duodenal ulcer) in the meloxicam 15 mg group and piroxicam groups, respectively, in the explanatory
three such events (one patient with a perforated gastric analysis (Fig. 1). The corresponding results from the
ulcer, one patient with duodenal ulcers and GI bleeding, intent-to-treat analysis were 9.1 ± 20.7 (meloxicam) and
and one patient with a gastric ulcer) in the piroxicam 20 10.7 ± 20.2 mm (piroxicam).
mg group. Twelve patients in the meloxicam group and
10 in the piroxicam group were withdrawn due to
adverse events; the events leading to withdrawal are DISCUSSION
summarized in Table V. Laboratory investigations NSAIDs are the most common form of treatment for
showed no clinically relevant changes. OA and will remain so for the foreseeable future. There
Tolerability of the study drugs, evaluated by the have been numerous studies demonstrating their
patient at each visit, showed that both study medi- efficacy in this condition [5-7, 10-13], and many
cations were well tolerated throughout the study. The millions of patients have benefited from reduced pain
mean (± S.D.) global tolerance values assessed by the and increased mobility associated with their use.
patient at the end of the study were 5.1 ± 13.5 mm However, patients do vary in their clinical response to
and 9.3 ± 18 mm (P = 0.054) in the meloxicam and NSAIDs and some will be non-responders to any given
38 STUDIES ON MELOXICAM (MOBIQ
agent [1]. For this reason, together with the requirement v. Reesema, The New Hospital, Warnsveld (three
for a NSAID with reduced GI toxicity, much research patients); Dr J. Moolenburgh, Medical Centre Alkmaar,
continues to be directed into the production of new Alkmaar (four patients); Dr L. Williame, General
drugs of this class. Hospital Middelheim, Antwerpen (nine patients); Dr C.
Piroxicam is an established therapy for OA and it is Baran, Dachau (eight patients); Dr W. Hiittemann,
imperative that any new agent is at least as effective. Aachen (16 patients); and the head of the clinical trial:
This study has shown that meloxicam compares well to Dr Wackermann, CRF Institute for Clinical Pharmac-
piroxicam in terms of both efficacy and tolerability. ology, Arnikastr.
With regard to the primary endpoint of this study, pain
on movement, meloxicam and piroxicam produced
considerable pain reduction during the first week of REFERENCES
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