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Title: Vioxx (Rofecoxib) Provides Acute Pain Relief as Effective as a Commonly Prescribed Narcotic: Presented at APS

"Vioxx (Rofecoxib) Provides Acute Pain Relief as Effective as a Commonly Prescribed Narcotic: Presented at APS"

Single Dose of Vioxx 50 mg was as Effective as Both Single- and Multi-dose Narcotic-based Regimen Over 6 and 24 Hours CHICAGO, IL -- March 20, 2003 -- In a new study comparing Merck & Co., Inc.'s arthritis and acute pain medicine Vioxx® (rofecoxib) to a commonly used narcotic, a single dose of Vioxx 50 mg provided relief from acute dental pain that was as effective as a single dose of the narcotic analgesic agent oxycodone/acetaminophen 10/650 mg over six hours. In addition, a single dose of Vioxx 50 mg was as effective as a multi-dose regimen of oxycodone/acetaminophen (10/650 mg followed by oxycodone/acetaminophen 5/325 mg every six hours as needed) in providing pain relief over 24 hours in these patients following dental surgery. Researchers will present the study results here this week at the 22nd Annual Scientific Meeting of the American Pain Society (APS). "The study showed that a single dose of Vioxx 50 mg was as effective as both a single- and a multi-dose regimen of the narcotic analgesic oxycodone/acetaminophen for the management of acute postoperative dental pain," said David J. Chang, M.D., study investigator and director of Clinical Development, Merck & Co., Inc. "Additionally, fewer patients taking Vioxx experienced the adverse events of nausea, vomiting and dizziness, which are well-known side effects of narcotic pain relievers." Study design A total of 270 patients who had experienced moderate to severe acute pain following the surgical removal of at least two wisdom teeth participated in this double-blind, placebo-controlled study. Patients were randomly assigned to Vioxx (n=118), oxycodone/ acetaminophen (n=122) or placebo (n=30). The primary endpoint was total pain relief over the first six hours after dosing with a single dose of Vioxx 50 mg versus oxycodone/acetaminophen 10/650 mg versus placebo as measured by TOPAR6. The key secondary endpoint was the sum of pain intensity difference over 24 hours (SPID24) with a single dose of Vioxx 50 mg versus an initial dose of oxycodone/acetaminophen 10/650 mg followed by 5/325 mg every six hours as needed, versus placebo. Other endpoints included patients' global assessment of the medication, time to onset of analgesic effect, peak analgesic effect and duration of analgesic effect as determined by the time to use of additional pain relief medication. Study results Both Vioxx and oxycodone/acetaminophen reduced pain to a significantly greater degree than placebo for all measurements of efficacy (p<0.001). Specific results of the study were as follows: · Total pain relief over six hours (TOPAR6) (primary endpoint): Vioxx was as effective as oxycodone/acetaminophen in providing total pain relief in the single-dose portion of the study. The mean TOPAR6 score was 14.6 for Vioxx compared with 12.8 for oxycodone/acetaminophen (p<0.05) and 3.9 for placebo. · Sum of pain intensity difference (SPID24) (key secondary endpoint): Vioxx was as effective as the multiple dose regimen of oxycodone/acetaminophen in providing pain relief as measured by SPID24. The sum of pain intensity difference over 24 hours (SPID24) was 30.5 for Vioxx compared with 25.1 for oxycodone/acetaminophen (p<0.05) and 6.1 for placebo. · Patient assessment of study medication: In the single-dose phase, 80.9 percent of patients taking Vioxx reported a "good" to "excellent" response to the study medication at six hours compared with 73.1 percent of patients taking oxycodone/acetaminophen (p=0.062) and 21.4 percent of patients taking placebo (p=0.001). In the multi-dose phase, 82.2 percent of patients taking one dose of Vioxx reported a "good" to "excellent" response to the study medication at 24 hours compared with 74.6 percent of patients taking the multi-dose regimen of oxycodone/acetaminophen (p=0.004) and 20.7 percent of patients taking placebo (p<0001). · Time to onset of pain relief: With onset of pain relief defined as the median time to patients' confirmed perceptible pain relief, in this study patients taking Vioxx in the single-dose phase had an onset of pain relief of 38 minutes and those taking oxycodone/acetaminophen had an onset of 22 minutes (p<0.001). Both treatments provided an onset of pain relief in shorter time than placebo (>4 hours). · Peak analgesic effect: Vioxx and oxycodone/acetaminophen demonstrated similar peak pain relief. In the single-dose phase, the peak pain relief within six hours (0 to 4 scale) was 3.0 for Vioxx compared with 3.1 for oxycodone/acetaminophen and 1.2 for placebo. In the multi-dose phase, the peak pain relief within 24 hours was 3.1 for Vioxx compared with 3.2 for oxycodone/acetaminophen and 1.3 for placebo. · Duration of analgesic effect: The median time until patients required the use of additional pain relief medication was more than 24 hours for both Vioxx and multi-dose oxycodone/acetaminophen compared with one hour and 50 minutes for placebo. Vioxx was well tolerated Overall, Vioxx was generally well tolerated in this study. Significantly fewer patients treated with Vioxx compared with patients taking oxycodone/acetaminophen experienced clinical adverse experiences (41.5 percent vs. 77.0 percent; p<0.001) or drug-related adverse experiences (14.4 percent vs. 63.9 percent; p<0.001). Patients receiving Vioxx had significantly lower rates of nausea (8.5 percent vs. 37.7 percent; p<0.001), vomiting (2.5 percent vs. 23.8 percent; p<0.001) and dizziness (12.7 percent vs. 35.2 percent; p<0.001) compared with patients taking oxycodone/acetaminophen. Combined analyses of Vioxx dental pain studies presented at APS A new meta-analysis of 13 placebo-controlled studies of Vioxx 50 mg in relieving acute postoperative dental pain was also presented for the first time here at the American Pain Society. In the analysis of analgesic effect in 13 qualifying studies involving 1,329 patients treated with Vioxx 50 mg, nearly three-fourths of patients (73 percent) who took a single dose of Vioxx 50 mg for the treatment of acute pain after dental surgery reported "excellent", "very good" or "good" relief from acute pain at 24 hours (range: 60.0 percent to 84.4 percent) compared with 16.2 percent of the 570 patients who took placebo (range: 3.3 percent to 36.7 percent). This difference was statistically significant (p<0.001). In the analysis of onset in 11 qualifying studies involving 1,219 patients treated with Vioxx 50 mg, the median time to onset of pain relief with a single dose of Vioxx 50 mg was within 45 minutes (range: 27 to 50 minutes). Among the 483 patients who took placebo, less than half of the patients achieved onset of pain relief within the four hours that the data were collected; consequently the median time to onset of pain relief was greater than four hours (p<0.001). Important information about Vioxx People with allergic reactions, such as asthma, to aspirin or other arthritis medicines should not take Vioxx. In rare cases, serious stomach problems, such as bleeding, can occur without warning. Patients should inform their physicians if they have liver or kidney disease, or a history of angina, heart attack or a blocked artery in their heart. Vioxx cannot take the place of aspirin for the prevention of heart attack or stroke. Vioxx should not be used by women in late pregnancy. Vioxx has been extensively studied in large, clinical trials. Commonly reported side effects included upper-respiratory infections, diarrhea, nausea and high blood pressure. The recommended starting dose of Vioxx for the treatment of osteoarthritis is 12.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 25 mg once daily. For rheumatoid arthritis, the recommended dose is 25 mg once daily. The maximum daily dose for osteoarthritis and rheumatoid arthritis is 25 mg once daily. Vioxx 50 mg once daily is the recommended dose for acute pain and menstrual pain. The chronic use of Vioxx 50 mg is not recommended; use of Vioxx 50 mg for more than five days in the management of pain has not been studied. About Merck Merck & Co., Inc. is a global 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. SOURCE: Merck & Co., Inc

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