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Diclofenac is used for the treatment of osteoarthritis (OA); however, like other nonsteroidal anti-inflammatory drugs (NSAIDs) it can be associated with serious dose-related adverse events (AEs).
This research
article deals with potency of low-dose SoluMatrix diclofenac. The safety of
SoluMatrix diclofenac was similar to findings for other diclofenac drug
products. Long term studies should be followed to draw the long term benefits.
Diclofenac is
used for the treatment of osteoarthritis (OA); however, like other nonsteroidal
anti-inflammatory drugs (NSAIDs) it can be associated with serious dose-related
adverse events (AEs). Low-dose diclofenac has been developed to
provide efficacy at lower diclofenac doses. A recently published Phase III
study evaluated the efficacy and safety of diclofenac 35 mg twice
daily (b.i.d.) and thrice daily (t.i.d.) in patients with OA pain treated for
12 weeks.
This Phase III
multicenter, open-label study assessed the safety of diclofenac in
patients with OA dosed up to 52 weeks (ClinicalTrials.gov: NCT01510912). The
study enrolled 602 chronic NSAID/acetaminophen users, aged ≥40 years with OA of
the knee or hip. Patients received diclofenac 35 mg b.i.d., which
could be increased to t.i.d. and subsequently reduced to b.i.d. as needed.
Safety assessments included AEs, vital signs, physical examination findings,
12-lead electrocardiogram, and clinical laboratory test results.
Patient-reported outcomes were evaluated by the Short Form-36 (SF-36).
A total of 601
patients received diclofenac; 373 of 601 patients (62.1%) received
treatment for ≥11 months. The most frequent AEs included upper respiratory
tract infection, headache, urinary tract infection, diarrhea, nasopharyngitis,
and nausea. Serious gastrointestinal, cardiovascular, renal, and hepatic AEs
were uncommon. A small proportion (99 patients, 16.5%) of patients discontinued
participation in the study due to AEs. Clinically meaningful improvements from
baseline in Physical Component Summary Scores of the SF-36 were noted at week
12 and were sustained through week 52. Improvements in six of the eight
individual physical and mental SF-36 domains were also noted.
Diclofenac treatment for up to 1 year was generally well tolerated in patients
with OA pain and associated with improvement in quality of life measures.
Postgrad Med. 2015 Jun;127(5):517-28
Low-dose SoluMatrix diclofenac in the treatment of osteoarthritis: A 1-year, open-label, Phase III safety study.
Altman RD et al.
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