Nonsteroidal anti-inflammatory drugs (NSAIDs) are
effective for pain caused by osteoarthritis, but their usefulness
is limited by side effects. Tramadol combined with acetaminophen
is recommended, according to the new American Pain Society guidelines,
for the treatment of osteoarthritis pain when NSAIDs alone cannot
provide adequate pain relief. This study is an extension of an earlier
study evaluating the efficacy of tramadol/acetaminophen in the treatment
of osteoarthritis flares. Rosenthal and colleagues hypothesized
that the combination of tramadol/acetaminophen would be safe and
effective in a subset of elderly patients.
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Eligible patients 65 years and older had symptomatic osteoarthritis
of the hip or knee for one year or longer, were taking a stable
dosage of an NSAID or a cyclooxy-genase-2 inhibitor, and were
in general good health. Patients were randomized to receive an
initial single dose of one to two pills of tramadol/acetaminophen
or placebo at the first sign of an osteoarthritis flare. After
that, patients could take one to two pills up to four times a
day as needed, while continuing their regular NSAID regimen.
Primary outcomes were pain intensity and pain relief, scored
according to a four-point assessment. Secondary outcomes included
overall medication assessment, efficacy over time, and osteoarthritis
symptoms, with the latter assessed using a specialized scoring
system, the Western Ontario and McMaster Universities Osteoarthritis
Index (WOMAC), based on a five-point scale. Patients assessed
pain before the first dose and at regular intervals up to four
hours after the dose.
The subset studied included 113 elderly patients, with a dropout
rate of 17.4 percent in the tramadol/acetaminophen group and 9.1
percent in the placebo group, primarily because of adverse events.
Pain intensity scores decreased by 2.10 in the tramadol/acetaminophen
group and by 1.63 in the placebo group. Decreases in pain intensity
and pain relief scores showed statistically significant improvement
in the tramadol/acetaminophen group compared with the placebo
group. WOMAC scores were significantly better in the treated group
in two of three subscales and in an overall derived score, as
were investigator and patient overall medication assessments.
These results were similar to those of the study group as a whole.
Common adverse events among the treated group were nausea, vomiting,
and dizziness.
The authors conclude that treating osteoarthritis flares with
tramadol/acetaminophen provides significant pain relief over placebo
in patients taking a stable dosage of an NSAID.
Rosenthal NR, et al., for the CAPSS-105 Study Group. Tramadol/acetaminophen
combination tablets for the treatment of pain associated with
osteoarthritis flare in an elderly patient population. J Am Geriatr
Soc March 2004;52:374-80.
COPYRIGHT 2005 American Academy of Family Physicians
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