In a new study designed to examine the analgesic effects of Merck's acute pain medicine Vioxx® (rofecoxib), Vioxx 50 mg provided superior pain relief over six hours compared to oxycodone 5 mg combined with acetaminophen 325 mg in patients with moderate to severe acute pain following dental surgery. The total pain relief score over the first six hours for patients taking Vioxx was 11.7 compared to 5.9 for those who took oxycodone with acetaminophen based on a standard patient response to therapy reporting scale. The study results were presented during the 18th Annual Meeting of the American Academy of Pain Medicine.
The study compared a single dose of Vioxx 50 mg, the recommended dose for the management of acute pain in adults, to a single dose of oxycodone 5 mg combined with acetaminophen 325 mg, and to placebo. For acute pain, Vioxx 50 mg is dosed once daily, as needed. The management of acute pain beyond five days has not been studied. For acute pain in adults, oxycodone with acetaminophen is available in formulations from 2.5/325 mg to 10/650 mg; doses may be repeated every six hours as needed.
A total of 212 patients who experienced moderate to severe acute pain following the surgical removal of at least two wisdom teeth, of which at least one was impacted, were randomly assigned to receive either Vioxx (n=90), oxycodone with acetaminophen (n=91) or placebo (n=31). The primary endpoint of the study was total pain relief over the first six hours after dosing as measured by TOPAR6 , a measure of overall pain relief. Other measures included patients' assessment of the medicines and the use of additional pain-relieving medicine ("rescue medication"). Patients rated pain intensity and pain relief at prescribed times and recorded time to perceptible pain relief and time to meaningful pain relief. Patients were allowed to take an additional pain reliever during the study if needed, but were encouraged not to do so in the first 90 minutes of the study.
Multiple endpoints evaluated
In this study, Vioxx (rofecoxib) achieved its primary endpoint, reducing pain to a greater degree over six hours compared to oxycodone with acetaminophen. For all measurements, both Vioxx and oxycodone with acetaminophen reduced pain to a greater degree compared to placebo. A second study confirming these results has been completed but not yet presented.
More specifically, results of the study were:
Important Information about Vioxx
In rare cases, serious stomach problems, such as bleeding, can occur without warning symptoms. People who have had an allergic reaction, such as asthma, to Vioxx, aspirin or other arthritis medicines should not take Vioxx. People who have had liver or kidney problems, or are pregnant, should tell their doctors. Also, Vioxx should not be used by women in late pregnancy. Vioxx is not a substitute for aspirin for cardiovascular prophylaxis. Vioxx does not interfere with the effects of low-dose aspirin on platelets.
Common side effects reported in osteoarthritis clinical trials with Vioxx were upper-respiratory infection, diarrhea, nausea and high blood pressure.
Vioxx is approved in the United States for the relief of the signs and symptoms of osteoarthritis, management of acute pain in adults, and treatment of menstrual pain. Merck & Co., Inc. is a leading research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures. Merck-Medco manages pharmacy benefits for employers, insurers and other plan sponsors, encouraging the appropriate use of medicines and providing disease management programs.
