Efficacy Of Rofecoxib Research Articles

(204) Rofecoxib Was More Effective than Codeine with Acetaminophen in the Treatment of Acute Pain

Rofecoxib (VIOXX®) is a selective inhibitor of cyclo-oxygenase-2 and is indicated for the treatment of acute pain. Prior acute pain studies showed similar analgesic efficacy of rofecoxib 50 mg compared with analgesics doses of non-selective NSAIDs. We performed a randomized, double-blind trial to evaluate the efficacy and safety of rofecoxib, a standard fixed formulation of codeine with acetaminophen, and placebo in the treatment of acute pain. Three-hundred ninety-three patients with moderate or severe pain after surgical extraction of at least two 3rd molars were randomized to receive a single dose of rofecoxib 50 mg (n = 182), codeine 60 mg with acetaminophen 600 mg (n = 180), or placebo (n = 31). Efficacy was assessed at 11 pre-specified time points after dosing by pain relief and pain intensity scores. Patient global assessment of study medication was also performed. Baseline characteristics were similar among the groups. The mean age was 21 years; 69.0% were female; and 78.6% had a pain intensity score of “moderate.” For the primary endpoint, total pain relief over 6 hours, rofecoxib was more effective than codeine/acetaminophen (p codeine/acetaminophen; p < 0.001). The time to rescue medication was longer for rofecoxib compared to codeine/acetaminophen (p < 0.001). More patients on codeine/acetaminophen experienced clinical adverse events than rofecoxib (p < 0.05). Patients receiving codeine/acetaminophen versus rofecoxib had higher incidences of nausea (25.0% vs 6.0%; p < 0.001) and vomiting (18.3% vs 3.8%; p < 0.001). In this study, rofecoxib had superior efficacy and gastrointestinal safety compared to codeine/acetaminophen, which provides support for the use of rofecoxib as an alternative option to opioid analgesics in the treatment of acute post-surgical pain.

Correction: Short-Term Efficacy of Rofecoxib and Diclofenac in Acute Shoulder Pain: A Placebo-Controlled Randomized Trial

Correction: Short-Term Efficacy of Rofecoxib and Diclofenac in Acute Shoulder Pain: A Placebo-Controlled Randomized Trial

The efficacy of rofecoxib 50 mg and hydrocodone/acetamino­phen 7.5/750 mg in patients with post-arthroscopic pain

ABSTRACTObjective: To compare the efficacy and tolerability of rofecoxib, hydrocodone/acetaminophen 7.5 mg/750 mg (H/A) and placebo in treating pain after arthroscopy of the knee.Methods: A randomized, double-blind, placebo-controlled, single dose study enrolling patients experiencing moderate or severe pain after knee arthroscopy. Patients with moderate-to-severe postoperative pain received either rofecoxib 50 mg (n = 151), H/A (n = 145), or placebo (n = 147). Pain was measured over 24 h. The primary endpoint was total pain relief at 6 h for rofecoxib 50 mg compared with placebo.Results: H/A ( p = 0.003), but not rofecoxib ( p = 0.256) was significantly more effective than placebo for total pain relief at 6 h (TOPAR6). Although analgesic onset and peak were significantly better for H/A than for both rofecoxib ( p < 0.01, p < 0.05, respectively) and placebo ( p < 0.05, p < 0.001, respectively), rofecoxib patients used significantly less rescue analgesia ( p < 0.001) over 24 h. Rofecoxib also provided better Brief Pain Inventory Severity ( p = 0.008) and Interference Domain ( p = 0.045) scores at 24 h compared to placebo and had lower 24‑h Pain Severity scores than H/A ( p < 0.05). Treatments were generally well tolerated, with no significant difference in the frequency of patient-reported adverse events between groups.Conclusions: Rofecoxib 50 mg did not provide significantly different pain relief than placebo at 6 h, and the primary endpoint TOPAR was not attained, although it did show several efficacy benefits at 24 h, including a significant opioid-sparing effect. All treatments were well tolerated, with no significant differences observed. The limited efficacy of rofecoxib in this study contrasts to the results of previous surgical studies evaluating rofecoxib, and may be partially explained by the postoperative dosing in this arthroscopic surgical model.

Physical Activity of Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome Not Satisfied With Conventional Treatments—Could it Represent a Valid Option? The Physical Activity and Male Pelvic Pain Trial: A Double-Blind, Randomized Study

Chronic prostatitis/chronic pelvic pain syndrome is a major healthcare burden. Affected patient quality of life is poor and currently no investigated treatments have significant long-term benefit. We performed a preliminary investigation of the role of physical activity and its effects on select patients with chronic prostatitis/chronic pelvic pain syndrome. Between 2002 and 2004 we recruited a volunteer sample of 231 eligible males 20 to 50 years old with chronic prostatitis/chronic pelvic pain syndrome who were unresponsive to conventional treatments and free of any contraindication for moderate intensity physical exercise. This group was screened and, if in accordance with study inclusion/exclusion criteria, patients were randomized into 2 groups. Participants were randomly assigned to the aerobic exercise group (52) and the placebo/stretching and motion exercises group (51). Main outcome measures were the Italian version of the National Institutes of Health Chronic Prostatitis Symptom Index, Beck Depression Inventory, State Anxiety Inventory-Y and a pain intensity visual analog scale administered at baseline, and 6 and 18 weeks. At 18 weeks 36 subjects (75%) in the aerobic exercise group vs 40 (81.63%) in the placebo/stretching and motion exercises group completed the 18-week program and evaluation. Differences between the 2 groups were found in total National Institutes of Health Chronic Prostatitis Symptom Index, pain and quality life impact subscales, and pain visual analog score (ANCOVA p = 0.006, 0.0009, 0.02 and 0.003, respectively). Improvements in the aerobic exercise group were significantly superior compared to those in the placebo/stretching and motion exercises group. Aerobic exercise represents a valid treatment option and it should be further investigated in a larger study with longer followup.

Rofecoxib provides relief of pain following third molar extractions

Article Title and Bibliographic Information Analgesic efficacy of rofecoxib compared with codeine/acetaminophen using a model of acute dental pain. Chang DJ, Bird SR, Bohidar NR, King T. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2005;100(4):e74-80. Level of Evidence 1b Purpose/Question The authors of this study planned to demonstrate the clinical advantage of single-dose rofecoxib 50 mg to single-dose APAP 600 mg/codeine 60 mg. Source of Funding Industry Type of Study/Design Randomized controlled trial

Rofecoxib 12.5 mg, rofecoxib 25 mg, and celecoxib 200 mg in the treatment of symptomatic osteoarthritis: results of two similarly designed studies

ABSTRACTObjective: To compare the efficacy of rofecoxib and celecoxib for the treatment of knee or hip OA over 6 weeks.Methods: Two similarly designed, multicenter, randomized, double-blind, placebo-controlled studies. Patients were randomly assigned 3:3:3:1 in Study 1 to once daily (QD) rofecoxib 12.5 mg (N = 456), rofecoxib 25 mg (N = 459), celecoxib 200 mg (N = 456), or placebo (N = 150) and 3:3:1 in Study 2 to QD rofecoxib 25 mg (N = 471), celecoxib 200 mg (N = 460), or placebo (N = 151). There was no rofecoxib 12.5 mg arm in Study 2. The primary outcome measure of both studies was pain at night over 6 weeks for rofecoxib 25 mg vs. celecoxib 200 mg. Efficacy comparisons with rofecoxib 12.5 mg in Study 1 were included as pre-specified study objectives but not as pre-specified study hypotheses. Secondary endpoints included Patient Global Assessment of Response to Therapy (PGART) over 6 weeks and over 1 week. Safety was evaluated through the assessment of spontaneously reported adverse experiences (AEs), evaluation of vital signs, and laboratory data reported by investigators and patients.Results: For the primary endpoint, reduction in pain at night over 6 weeks in Study 1 was not significantly different between active treatments; in Study 2 rofecoxib 25 mg significantly ( p = 0.023) reduced pain at night compared with celecoxib 200 mg over 6 weeks. For the secondary endpoints, in both studies, significantly ( p < 0.05) more patients treated with rofecoxib 25 mg than celecoxib 200 mg had a good or excellent PGART over 6 weeks, and over the first week ( p < 0.01). In both studies, there were no significant differences between active medications in the incidence of reported overall, serious, or drug-related AEs. The reported AE rates with the active treatments were generally similar to those with placebo in the two studies.Conclusions: Rofecoxib 25 mg was significantly better than celecoxib 200 mg in relieving night pain at 6 weeks in one study; this was not confirmed in the accompanying study.

Rofecoxib in migraine

Migraine is a highly prevalent primary headache. The disability of migraine attacks results in considerable economic and social losses. The acute treatment of migraine aims to rapidly and consistently alleviate the head pain and associated symptoms, therefore reducing the headache-related disability, ideally without side effects and recurrence of the attack within 24 h. Although several drug options and different formulations are available, the choice of a specific medication should depend on an individual patient’s characteristics. Among the available drugs, nonsteroidal anti-inflammatory drugs still represent effective options and a new class of nonsteroidal anti-inflammatory drugs known as selective cyclooxygenase-2 inhibitors may represent an even better-tolerated therapy with regard to gastrointestinal side effects. This article aims to discuss the role of rofecoxib in the acute treatment of migraine. Although this drug was recently withdrawn from the market, it provides a good model to understand the role of the cyclooxygenase-2 inhibitors in migraine therapy overall. The pharmacologic profile and therapeutic use in the acute treatment of migraine of rofecoxib is reviewed. In addition, the limitations of a monotherapeutic orally administered approach and possible ways of raising the efficacy of rofecoxib and other acute migraine treatments are reviewed.

A randomized controlled study comparing rofecoxib, diclofenac sodium, and placebo in post-bunionectomy pain

SUMMARYObjective: The relative efficacy of rofecoxib, diclofenac sodium, and placebo were compared in the treatment of acute pain after bunionectomy surgery.Research design and methods: This was a double-blind, randomized, two-part study of 252 patients with moderate-to-severe pain the day after first metatarsal bunionectomy. Patients were treated with a single dose of rofecoxib 50 mg (N = 85), enteric-coated diclofenac sodium 100 mg (N = 85), or placebo (N = 82) on study Day 1 (Part I), and subsequently with daily rofecoxib 50 mg or placebo (diclofenac patients switched to placebo) over study Days 2–5 (Part II). Patients rated their pain at 16 time points over the first 24 h. Primary endpoint was total pain relief over 8 h (TOPAR8). Pre-specified secondary endpoints on Day 1 included onset of analgesia, peak pain relief, and duration of response. For Part II, supplemental analgesia use with rofecoxib compared to placebo was pre-specified for analysis over Days 2–5, with the focus on Days 2–3. Adverse experiences were recorded over Days 1–5.Results: For TOPAR8 scores, rofecoxib 50 mg was significantly more effective than placebo (9.5 vs. 3.7, p < 0.001) and diclofenac (9.5 vs. 5.0, p < 0.001). Onset of analgesia was more rapid with rofecoxib than placebo ( p = 0.003) and diclofenac ( p = 0.019); proportion of patients achieving onset within 4 h with rofecoxib, diclofenac, and placebo was 46%, 27%, and 23%, respectively. Peak pain relief was greater with rofecoxib (1.8) than diclofenac (1.2, p = 0.004) and placebo (1.0, p < 0.001). Diclofenac and placebo patients required supplemental analgesia sooner than rofecoxib patients (2:03 h vs. 4:02 h, p < 0.001 and 1:41 h vs. 4:02 h, p < 0.001). Rofecoxib patients used significantly less ( p < 0.001) supplemental analgesia than placebo patients over Days 2–3 (1.1 tablets/day vs. 2.1 tablets/day) and Days 2–5 (0.9 tablets/day vs. 1.8 tablets/day). No significant differences in adverse experiences between treatments were seen.Conclusion: Rofecoxib 50 mg was significantly more effective than placebo on all measures of treatment of post-bunionectomy pain. Rofecoxib 50 mg was significantly more effective than diclofenac sodium 100 mg based on Day 1 endpoints of total pain relief, onset time, and duration of response. All study medications were generally well tolerated.

The treatment with a COX-2 specific inhibitor is effective in the management of pain related to endometriosis

Objective: To evaluate the efficacy and safety of a cyclooxygenase (COX)-2 specific inhibitors versus placebo in the treatment of endometriosis-associated pelvic pain. Study design: A group of women ( n=28) with pelvic pain after conservative surgery for symptomatic endometriosis (Stage I and II) were enrolled at the Department of Pediatric, Obstetrics and Reproductive Medicine of University of Siena. A treatment with a COX-2 specific inhibitors (rofecoxib, 25 mg per day) ( n=16) or placebo ( n=12) was given for 6 months. Pelvic pain quantification with a clinical evaluation, including Visual Analogue Scale (VAS) for pain, was performed before and up to 6 months after treatment. Results: A significant improvement of both pelvic pain and dyspareunia was observed after a 6 months persisting since the end of the treatment ( P<0.0001). The efficacy of rofecoxib was higher than placebo and no recurrence occurred, while in the placebo-treatment a 16% (2/12) occurred. No significant side effects have been found with the use of rofecoxib. Conclusions: The use of COX-2 specific inhibitors was effective, safe and low cost therapy in the management of pelvic pain associated to endometriosis and might be also proposed in early stage of endometriosis.

The Efficacy of Rofecoxib vs. Valdecoxib on Pain and Narcotic Use After Arthroscopic Meniscectomy

The Efficacy of Rofecoxib vs. Valdecoxib on Pain and Narcotic Use After Arthroscopic Meniscectomy

The Efficacy of Rofecoxib vs. Valdecoxib on Pain and Narcotic Use After Arthroscopic Meniscectomy

The Efficacy of Rofecoxib vs. Valdecoxib on Pain and Narcotic Use After Arthroscopic Meniscectomy

Onset of pain relief with rofecoxib in chronic low back pain: results of two four-week, randomized, placebo-controlled trials

SUMMARYObjective: We recently reported the efficacy of rofecoxib in two randomized controlled trials in chronic low back pain (CLBP). The objectives of this report are to present data regarding the onset of efficacy of rofecoxib from these trials and propose methods for reporting onset.Research design and methods: Patients were aged 18-75, with non-radicular CLBP for >3 months. Patients were randomized to rofecoxib 25 mg, 50 mg, or placebo once daily for 4 weeks. Assessments included Low Back Pain and Bothersomeness scales every morning and Relief from Starting Pain after the first dose at 0.5,1, 2, 3,4h, bedtime, and next morning. Onset of meaningful relief was measured by Time to Confirmed 50% Reduction in Pain and Time to Confirmed 'Slightly' or 'Not At All' Bothersome Pain. Onset of perceptible pain relief was measured by Time to At Least 'A Little' Confirmed Pain Relief.Results: 690 patients entered. Significantly more patients treated with rofecoxib had meaningful relief compared to placebo: 60.4,58.4, and 34.7% for rofecoxib 25mg, 50mg, and placebo (p < 0.001). Median time to meaningful relief for rofecoxib was 2 days, 1 day sooner than placebo. Rofecoxib was superior to placebo by bedtime after the first dose.Conclusions: Approximately 2/3 of patients achieved meaningful pain relief with rofecoxib compared with 1/3 receiving placebo. Median time to onset of meaningful relief was about 2 days, but superior relief over placebo was seen by bedtime after the first dose. Onset of perceptible pain relief was within 2 h. We propose that measures of onset of analgesic effect include the proportion of patients who achieve meaningful pain relief and in this subgroup, the time-to-onset of confirmed meaningful reduction in pain intensity, time-to-onset of confirmed pain relief, and time to first separation from placebo in the proportion of patients who achieve meaningful pain relief.

Benefit-risk assessment of rofecoxib in the treatment of osteoarthritis.

NSAIDs are widely used to treat pain and inflammation in osteoarthritis. Their use in this indication is generally intermittent and fluctuates with the intensity of the disease. Nonetheless, success of the therapy is frequently limited by injury to the gastrointestinal mucosa and complications such as bleeding, ulceration and perforation. A careful and detailed evaluation of these aspects in regard to the newly introduced NSAIDs is of considerable clinical importance. This review focuses on the NSAID rofecoxib, one of the selective cyclo-oxygenase (COX)-2 inhibitors, which are claimed to be as effective as nonselective NSAIDs with better gastrointestinal tolerability. Indeed, phase II, phase III and epidemiological studies have revealed that the efficacy of rofecoxib is comparable to that of conventional NSAIDs but with lower gastrointestinal toxicity, although this advantage may not be demonstrable in every patient. In patients treated with low-dose aspirin (acetylsalicylic acid) for cardiovascular prophylaxis, celecoxib (another selective COX-2 inhibitor) seems to have no obvious advantages over conventional NSAIDs, and similar conclusions may be applied to rofecoxib. A comparison of NSAID therapy +/- concomitant low-dose aspirin was not a primary outcome in this trial with celecoxib and there is thus a need for further studies which compare the gastrointestinal risk of a selective COX-2 inhibitor plus aspirin versus a conventional NSAID. Recent debate has emerged regarding the cardiovascular safety of rofecoxib. Although there is evidence both for and against higher cardiovascular risk with rofecoxib, a retrospective cohort study recently published suggested that there is no increased risk of acute myocardial infarction in the short-term when compared with non-selective NSAIDs. The renal toxicity of rofecoxib has been thoroughly investigated. Clinical studies revealed renal effects of rofecoxib similar to those of conventional NSAIDs. Since adverse effects increase with the degree of renal impairment, monitoring of renal function should be carried out in patients at risk. Although there are still insufficient data concerning certain important adverse effects of rofecoxib, this drug is becoming an important alternative in the therapy of osteoarthritis, especially in high-risk patients. Clinicians need to weigh up the benefits and risks of rofecoxib on a case-by-base basis.

Efficacy of rofecoxib and nimesulide in controlling post-extraction pain in oral surgery: a randomised comparative study

SUMMARYRofecoxib 50 mg day−1 for 6 days provided better postoperative analgesia than nimesulide 200 mg day−1 in a randomised trial in patients (n = 130) undergoing surgical extraction of third molars. The superiority of rofecoxib over nimesulide was especially marked during the first 2–3 postoperative days and in patients with fullyimpacted molars. The drugs had similar effects on clinical signs of local postoperative inflammation. The effectiveness of rofecoxib in this study, plus considerations of the toxicity profile of nimesulide, support the conclusion that rofecoxib is preferable to nimesulide for relief of post-operative pain in patients undergoing surgical extraction of molars.

A Randomized, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rofecoxib in the Treatment of Chronic Nonbacterial Prostatitis

We determine the effects of treatment with rofecoxib and placebo in patients with chronic prostatitis. Patients diagnosed with chronic nonbacterial prostatitis were randomized to 6 weeks of 25 or 50 mg., rofecoxib or placebo in a double-blind multicenter study with a 1-week run in of placebo. End points included the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) (average pain score item 4 primary end point), and patient global assessment questions of pain, disease activity and response to therapy. A total of 161 patients were randomized in the study. The NIH-CPSI total, domain and pain scores significantly decreased from baseline in all groups and, although the mean scores numerically favored the rofecoxib groups, the difference was not significantly different among groups. There was a trend for the percentage of patients with a 25% (or 6 point) improvement in total score being superior on rofecoxib versus placebo with the difference being significantly different (p <0.05) for the 50 mg. rofecoxib group. Patient global assessment of pain, response to therapy and disease activity also favored rofecoxib over placebo (p <0.05, p = 0.07, p = 0.06, respectively). Of the patients 79% on 50 mg. rofecoxib versus 59% on placebo reported no or mild pain, and 56% of patients on 50 mg. rofecoxib versus 27% on placebo experienced significant improvement in quality of life (p <0.005). Rofecoxib was generally well tolerated. To our knowledge this study is the first to evaluate rofecoxib versus placebo in patients with prostatitis and the first large multicenter treatment study to use the NIH-CPSI. Subjective assessment with patient global questions may be more sensitive to change than the NIH-CPSI and, therefore, may be a better tool to use in future therapeutic trials. Although 6 weeks of rofecoxib treatment appear to benefit many men diagnosed with chronic prostatitis/chronic pelvic pain syndrome further studies are needed.

The role of rofecoxib, a cyclooxygenase-2-specific inhibitor, for the treatment of non-cancer pain: A review

Abstract: Rofecoxib was the first specific inhibitor of cyclooxygenase-2 (COX-2) approved for the treatment of acute pain. It has been shown to provide analgesia that is significantly better than placebo and has an onset of action and efficacy similar to that of traditional nonselective nonsteroidal anti-inflammatory drugs (NSAIDs), such as naproxen and ibuprofen. In addition, the analgesic efficacy of rofecoxib has been demonstrated to be superior to that of the opioid combination of codeine 60 mg/acetaminophen 600 mg in an acute dental pain model. For the treatment of acute pain, the efficacy of rofecoxib was further demonstrated in a study of patients who had undergone orthopedic surgery. Rofecoxib has been found to be as effective as naproxen sodium and more effective than placebo in studies evaluating its use for the treatment of primary dysmenorrhea. In patients with osteoarthritis (OA) of the knee or hip, rofecoxib is superior to placebo and similar to diclofenac and ibuprofen in relieving OA pain and improving physical function. Rofecoxib has also been shown to be superior to acetaminophen and celecoxib after 6 weeks of treatment for OA. The efficacy of rofecoxib has also been demonstrated in patients with rheumatoid arthritis and low back pain. The advantages of using COX-2-specific NSAIDs include convenient once-daily dosing schedule and improved safety compared with traditional NSAIDs. Two large outcomes studies, VIGOR and CLASS, have shown that gastric mucosal ulceration occurs significantly less often in patients taking COX-2-specific inhibitors than in those treated with ibuprofen, diclofenac, or naproxen and occurs with a similar incidence to that of placebo. Absence of any effect on platelet aggregation and bleeding time further distinguishes these agents from traditional NSAIDs. Because COX-2-specific inhibitors do not have an antiplatelet effect, they cannot be used as a substitute for low-dose aspirin for cardiovascular prophylaxis. Rofecoxib is a safe and highly effective alternative to previously available NSAIDs and should be considered for the treatment of acute pain conditions in adult patients, especially those at risk for developing gastrointestinal complications. It is preferred in the perioperative setting because of its analgesic efficacy and lack of platelet effects. Because of its more favorable gastrointestinal toxicity profile compared with nonselective NSAIDs, rofecoxib is safer in patients, especially older patients, for whom chronic anti-inflammatory or analgesic therapy is indicated. © 2002 by the American Pain Society

Rofecoxib, 25 mg/day, was more effective than rofecoxib, 12.5 mg/day, celecoxib, or acetaminophen in osteoarthritis of the knee

(2002) JAMA 287, 64; Geba GP, Weaver AL, Polis AB, et al, for the VACT Group. . Efficacy of rofecoxib, celecoxib, and acetaminophen in osteoarthritis of the knee. A randomized...

PREVALENCE OF PROSTATITIS-LIKE SYMPTOMS IN A POPULATION BASED STUDY USING THE NATIONAL INSTITUTES OF HEALTH CHRONIC PROSTATITIS SYMPTOM INDEX

The National Institutes of Health (NIH) chronic prostatitis symptom index was used to determine the prevalence of prostatitis-like symptoms among men (age 20 to 74 years) at risk in a community based study. The study was a cross-sectional postal survey of men age 20 to 74 years in Lennox and Addington counties, which included a large rural area, 1 major town and a suburban area with a stable population of men representative of Canadian demographics. The questionnaire collected information on 2 domains of chronic prostatitis identified in the NIH chronic prostatitis symptom index, including pain (location, severity and frequency), voiding function (irritative, obstructive), demographics, quality of life, general health and health seeking behavior. The self-reported pain score was used to identify prostatitis-like symptoms in the most discriminating domain. Based on analysis of the index final validation study comparing patients with prostatitis to normal controls and those with benign prostatic hyperplasia, the 2 questions most specific for prostatitis, including perineal and/or ejaculatory pain/discomfort, and a total pain score (0 to 21) 4 or greater were used to identify men with significant prostatitis-like symptoms. A total of 2,987 eligible men received the survey, and it was completed by 868 (29%). Of the men 84 (9.7%) were identified as having chronic prostatitis-like symptoms (mean NIH chronic prostatitis symptom index pain score 9.1 +/- 0.3). The average age of the prostatitis population was 50 years compared with 52 years for men without prostatitis-like symptoms. Prevalence was 11.5% in men younger than 50 years and 8.5% in men 50 years or older. Of the sampled population 57 (6.6%) men had prostatitis-like symptoms and an index pain score 8 or greater (moderate to severe). The index voiding score (0 to 10) was 4.1 +/- 0.5 in men younger than 50 years compared with 1.5 +/- 0.1 for normal controls, and 4.7 +/- 0.4 in those 50 years or older compared with 1.9 +/- 0.1 for normal controls. Of the prostatitis group 60% sought medical help for their symptoms. In our opinion this community based study using the new prostatitis symptom index confirms that chronic prostatitis-like symptoms are common.

THE OPTIMAL ANALGESIC DOSE OF ROFECOXIB: OVERVIEW OF SIX RANDOMIZED CONTROLLED TRIALS

Rofecoxib, which specifically inhibits cyclooxygenase-2, is indicated for relief of the signs and symptoms of osteoarthritis and for the management of acute pain in adults. The authors present an overview of six placebo-controlled trials designed to evaluate the single-dose analgesic efficacy of a range of doses of rofecoxib in the treatment of postoperative dental pain. The six studies included doses of rofecoxib ranging from 7.5 to 500 milligrams. Maximal analgesic doses of a nonsteroidal anti-inflammatory drug, or NSAID, either naproxen sodium (550 mg) or ibuprofen (400 mg), were used as active comparators in each study. Analgesic efficacy was assessed with the use of validated self-administered questionnaires. The primary endpoint in each study was the total pain relief over the eight-hour postdose period. Additional endpoints were used to characterize the onset of analgesia and peak analgesic effect. The results of these studies demonstrated that the efficacy of rofecoxib was dose-related, with 50 mg being consistently more effective than placebo for all measures of analgesic efficacy. Moreover, 50 mg was the lowest dose that reproducibly demonstrated an analgesic effect comparable to the effect of maximum single analgesic doses of NSAIDs. The results of these studies support the recommended dose of 50 mg of rofecoxib once daily for the management of pain. Rofecoxib, at a dose of 50 mg, is effective in the management of postoperative dental pain.

Rofecoxib: a specific cyclooxygenase inhibitor.

Rofecoxib is a new specific cyclooxygenase-2 inhibitor. The efficacy of rofecoxib has been established in the treatment of osteoarthritis, rheumatoid arthritis and acute pain. Rofecoxib has been approved in the United States for the treatment of osteoarthritis and acute pain. Endoscopically proven gastrointestinal ulceration is much less with rofecoxib than standard nonsteroidal antiinflammatory drugs (NSAIDs) and the ulceration rate with rofecoxib is similar to that seen with placebo. Rofecoxib appears to provide clinical benefit equivalent to standard NSAIDs with less toxicity.