In an analysis presented at the
European League Against Rheumatism (EULAR), the renal safety profile of
Vioxx(R) (rofecoxib) was not statistically different from celecoxib. In a
separate analysis, Vioxx had a renal safety profile that is similar to that of
certain non-steroidal anti-inflammatory drugs (NSAIDs), Merck & Co., Inc.
confirmed today in response to a news release by a competitor. Vioxx is
Merck's medicine for osteoarthritis and acute pain.
In a new study presented at EULAR that evaluated the efficacy of Vioxx
12.5 mg once-daily, Vioxx 25 mg once-daily, celecoxib 200 mg once-daily and
acetaminophen 1,000 mg four-times daily in 382 patients with osteoarthritis,
Vioxx 25 mg was superior to celecoxib at relieving osteoarthritis pain at
night and at rest. Further data from this study, which was the subject of a
separate release, showed that all treatments were well tolerated. There were
no significant differences in the incidence of any adverse events between
treatment groups and there were no significant differences in the number of
patients who stopped participating in the study due to adverse experiences.
Of the 382 patients in this study, 160 (41 percent) had a history of
In particular, there were no significant differences in the incidence of
renal effects, such as hypertension and edema, and no significant differences
in the number of patients who stopped participating in the study due to renal
The renal safety profile of Vioxx also was demonstrated in Phase III
osteoarthritis safety and efficacy trials involving more than 4,000 patients.
In these studies, 2,829 patients took Vioxx (12.5 mg or 25 mg, the doses
approved for osteoarthritis), 847 patients took ibuprofen 2,400 mg and 498
took diclofenac 150 mg. The average age of patients was 63, and 39 percent
had a history of hypertension. These trials lasted up to 12 months.
In these studies, the incidences of increased blood pressure and lower
extremity edema among patients taking Vioxx were similar to those of the
comparator NSAIDs; there were no significant differences between the active
* Edema: 3.4 to 3.8 percent of patients taking either Vioxx or one of the
comparator NSAIDs reported lower extremity edema. Most patients reported that
the edema resolved while they continued to take their medicine, and few
patients (no more than 0.4 percent in any treatment group) stopped taking
their medicine because of edema.
* Blood pressure: The mean change in blood pressure among patients who
were taking either Vioxx or one of the comparator NSAIDs was negligible, with
a range of 1.1 mm decrease to a 1.1 mm increase in diastolic blood pressure
and a range of 0.7 mm increase to a 2 mm increase in systolic blood pressure.
Most cases of hypertension were mild and resolved while patients continued to
take the medicines; few patients (no more than 0.4 percent of patients in any
treatment group) stopped taking their medicine because of hypertension.
An additional study compared the renal effects of Vioxx 12.5 mg and 25 mg
to another comparator NSAID, indomethacin 150 mg, and placebo in 57 elderly
patients. In this study, there was no significant difference between Vioxx or
indomethacin and placebo in measures of renal function (glomerular filtration
rate, serum creatinine, serum electrolytes and blood pressure).