The meloxicam JRA development progr

The meloxicam JRA development program included an overall total of 378 patients with
pauci- and polyarticular course JRA treated with meloxicam in the three clinical trials:
107.235, 107.208, and 107.162.
The safety profile of meloxicam was comparable to that of naproxen over the course of
these trials. Adverse events were representative of those expected in a pediatric JRA
population. Analysis of AEs by subgroup including age, gender, concomitant use of
methotrexate, race, and disease course (pauci- and polyarticular), did not reveal any
differences between the meloxicam- and naproxen-treated groups.
Analysis of the safety profile for those patients treated in the trials (either double-blinded
or open-labeled) for up to 1 year did not suggest any duration–associated qualitative
differences in the AE profile (compared to the short-term data). Assessment for possible
growth and development-related adverse events or weight change over time for up to 1
year of treatment did not suggest that meloxicam or naproxen has a significant negative
effect on growth and development.

Kết quả (Java) 1:

Program pembangunan meloxicam JRA gawan lan gunggung sakabèhé saka 378 patients karo
pauci- lan polyarticular JRA mesthi dianggep karo meloxicam ing telung uji klinis:
. 107.235, 107,208, lan 107.162
Profil safety saka meloxicam iki iso dibandhingke menyang sing naproxen liwat Course saka
trials iki. Acara salabetipun padha wakil sing samesthine ing JRA pediatric
populasi. Analysis saka AES dening bagian kalebu umur, gender, nggunakake concomitant saka
L-Threonine, lomba, lan mesthi penyakit (polyarticular pauci- lan), durung mbukak sembarang
beda antarane meloxicam- lan kelompok naproxen-dianggep.
Analysis saka profil safety kanggo sing patients dianggep ing trials (salah siji pindho ngandika
utawa mbukak-labeled) kanggo nganti 1 taun ora suggest sembarang nurut kwalitase dadi-digandhengake
beda ing profil AE (dibandhingake kanggo data short-term). Assessment kanggo bisa
wutah lan acara salabetipun related pembangunan utawa owah-owahan bobot liwat wektu kanggo nganti 1
taun perawatan ora suggest meloxicam utawa naproxen wis negatif wujud
efek ing wutah lan pembangunan.