In a new study with Vioxx® (rofecoxib),
the osteoarthritis and acute pain medicine from Merck, Vioxx 50 mg
significantly reduced moderate to severe acute pain after dental surgery to a
greater degree compared to codeine 60 mg combined with acetaminophen 600 mg.
Results of this study were presented at the 19th Annual Meeting of
the American Pain Society.
The study compared a single dose of Vioxx 50 mg, the recommended dose for
the treatment of acute pain in adults, to a single dose of codeine 60 mg with
acetaminophen 600 mg, and to placebo. For acute pain, Vioxx 50 mg is dosed
once-daily, as needed. For mild to moderately severe pain, the dose range for
codeine is 15 mg to 60 mg and 300 mg to 1,000 mg for acetaminophen; doses may
be repeated up to every four hours.
The 393 patients in the study (182 taking Vioxx, 180 taking codeine with
acetaminophen and 31 taking placebo) experienced moderate or severe pain after
the surgical removal of two or more molars, at least one of which was
impacted. Patients were allowed to take an additional pain reliever during
the study if needed.(1)
The study evaluated pain relief using a number of measures. The primary
endpoint of the study was total pain relief over the first six hours after
dosing; other measures included patients' assessment of the medicines and the
use of additional pain-relieving medicine.
In this study, Vioxx reduced pain to a greater degree than codeine with
acetaminophen and to a greater degree than placebo, and codeine with
acetaminophen reduced pain to a greater degree than placebo, as noted below:
- -- Overall pain relief: Vioxx was superior to codeine with acetaminophen
and to placebo in providing overall pain relief over 6 hours (both
p<0.001) as measured by TOPAR6, a measurement of overall pain relief.
The mean TOPAR6 score(2) for Vioxx was 12.4 compared to 7.0 for codeine
with acetaminophen and 3.4 for placebo (codeine with acetaminophen
compared to placebo, p<0.010).
- -- Use of additional medication: over the 24 hours after dosing, patients
taking codeine with acetaminophen or placebo took additional pain
relief medication sooner than patients taking Vioxx, and patients
taking placebo took additional pain relief medication sooner than
patients taking codeine with acetaminophen (all p<0.001). The median
(50th percentile) length of time for patients to take additional
medication was 1.6 hours for placebo, 2.3 hours for codeine with
acetaminophen and 9.6 hours for Vioxx.
- -- Patient assessment of study medication: significantly more patients
taking Vioxx reported good, very good or excellent response six hours
after initial dosing compared to patients taking codeine with
acetaminophen and compared to patients taking placebo (both p<0.001).
Of patients taking Vioxx, 64.6 percent reported a good to excellent
response to the study medication at six hours, versus 36.4 percent of
patients taking codeine with acetaminophen and 10.3 percent of patients
taking placebo (codeine with acetaminophen compared to placebo,
This new study is the first to compare the efficacy and safety of Vioxx to
codeine with acetaminophen, a medicine commonly prescribed by dentists and
oral surgeons to relieve pain after dental surgery. Additional studies are
Fewer patients taking Vioxx experienced nausea, vomiting in study
Overall, Vioxx was well tolerated in this study, and the overall rate of
side effects on Vioxx was generally similar to placebo. Significantly fewer
patients taking Vioxx experienced side effects than patients taking codeine
with acetaminophen (p<0.05). In particular, nausea and vomiting occurred less
frequently in patients taking Vioxx than in patients taking codeine with
acetaminophen. Of patients taking Vioxx, 6 percent experienced nausea
compared to 25 percent of codeine with acetaminophen patients and 10 percent
of placebo patients, and 4 percent of patients taking Vioxx experienced
vomiting compared to 18 percent of codeine with acetaminophen patients and
6 percent of placebo patients. There were no serious adverse events in any