Rheumatoid arthritis is a chronic disease
in which the body's immune system attacks the
joints of the body, ultimately destroying them
and rendering them immobile. The disease affects
approximately one percent of the world's population,
and occurs more often in men than in women.
Benefits of rofecoxib in Dental Surgery Pain
The powerful pain relief of rofecoxib also was
proven in two randomized studies of patients developing
moderate to severe pain after having undergone
dental surgery to remove more than two molars
impacted in the bone. A total of 390 patients
were randomized in one study to either rofecoxib
at the recommended starting dose for acute pain,
a combination of codeine and paracetamol using
maximum doses of these medications, or placebo,
while 393 patients were enrolled in a second study
with randomization to the same treatment groups.
In the studies, significantly more patients treated
with rofecoxib had total pain relief (p<0.001
for both studies) and reported good to excellent
responses to treatment (p<0.001 for both studies),
than those receiving the combination of codeine/paracetamol.
Importantly, though there was similar time to
onset of initial pain relief between the two groups,
significantly fewer patients treated with rofecoxib
required additional pain relief medication within
24 hours compared to those receiving the combination
treatment (p<0.001 for both studies). Both rofecoxib
and the codeine/paracetamol combination were superior
to placebo.
In addition to providing consistently superior
efficacy, treatment with rofecoxib led to a lower
incidence of adverse experiences, compared to
the codeine/paracetamol combination. Patients
receiving codeine/paracetamol had a substantially
higher incidence of vomiting (p<0.001) and nausea
(p<0.001).
Dental surgery - such as extraction of more than
two molars - can produce tissue trauma resulting
in acute pain and inflammation. The degree of
dental pain may depend on the type of procedure
being performed, as well as the patient's own
assessment - generally the most accurate and reliable
indicator. Even when procedures are performed
with great skill and care, most patients experience
pain and inflammation after dental anesthesia
wears off. Dental surgery pain is a commonly used
model to assess patient response to pain medication.
About Rofecoxib and MSD
Rofecoxib has been approved by regulatory agencies
in more than 60 countries for treating the signs
and symptoms of osteoarthritis, pain and inflammation,
based on efficacy and safety studies involving
nearly 4,000 patients during the clinical development
of this important new therapy. To date, more than
33 million prescriptions have been written for
rofecoxib in the United States alone.
Common side effects reported in osteoarthritis
clinical trials with rofecoxib included upper-respiratory
infection, diarrhea, and nausea. People who have
had an allergic reaction to rofecoxib, aspirin
or NSAIDs should not take rofecoxib. Safety and
effectiveness in children below the age of 18
have not been studied.
In the Philippines, rofecoxib has been approved
by the Bureau of Food and Drug (BFAD) for the
treatment of the acute and chronic signs and symptoms
of osteoarthritis and rheumatoid arthritis, the
relief of pain, and treatment of menstrual pain.
Rofecoxib is a prescription medicine. Patients
are encouraged to always consult their doctor.
Merck and & Co., Inc. which operates in many
countries as Merck Sharp & Dohme (MSD), is a global,
research-driven pharmaceutical company that discovers,
develops, manufactures and markets a broad range
of human health products.