The COX-2 specific inhibitor, MK-0966, is effective in the treatment of primary dysmenorrhea

Brown, J.; Morrison, Briggs W.; Bitner, Mark; Woolsey, Carl; Sandler, Michael; Dunkley, Vickie; Kotey, Paul; Seldenberg, Beth

doi:10.1016/s0009-9236(99)80005-8

Cited by 5 publications

(7 citation statements)

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“…Overall, rofecoxib was significantly more effective than placebo (P < 0.009) and similar in efficacy to naproxen sodium in the evaluation of study drugs and re-medication. Similar findings were recorded in 127 patients with primary dysmenorrhoea, where mean TOPAR 8 scores were similar for both the doses of rofecoxib and of naproxen sodium (17.4, 18 and 18.4, respectively) and all were significantly better than placebo (12.5, P < 0.006) (Daniels et al 1999;M orrison et al 1999b). R ofecoxib at an init ial dose of 50 mg was similar in efficacy to naproxen sodium in the patient's overall evaluation of the study drug (mean 2.0 vs 1.9 for naproxen sodium ).…”

Section: Rofecoxibsupporting

confidence: 66%

“…R ofecoxib (25 or 50 mg) and naproxen sodium (550 mg) were significantly better than placebo in providing total pain relief up to 8 h after the onset of moderate to severe pain (P µ 0.006) (Brown et al 1999b;D aniels et al 1999;M orrison et al 1999b). In one trial conducted on 63 patients, taking all the primary and secondary endpoint s like TOPAR 8, SPID 8, peak pain relief, peak PID , time to re-medication and ranking of study drugs across cycles, rofecoxib was found to be superior to placebo (P < 0.004 for all the end points except P < 0.002 for TOPAR 8) (Brown et al 1999b). Overall, rofecoxib was significantly more effective than placebo (P < 0.009) and similar in efficacy to naproxen sodium in the evaluation of study drugs and re-medication.…”

Section: Rofecoxibmentioning

confidence: 98%

“…Therapeutic efficacy: dysmenorrhoea R ofecoxib can be used as a sole agent in alleviating the pain caused due to primary dysmenorr hoea (M orrison et al 1999b;Scott & Lamb 1999;Brooks & D ay 2000;M atheson & F iggitt 2001). It has been compared with naproxen sodium (550 mg) in two comparative, randomized, double-blind , placebo-controlled, crossover trials (Brown et al 1999b;Daniels et al 1999).…”

Section: Rofecoxibmentioning

confidence: 99%

“…It has been compared with naproxen sodium (550 mg) in two comparative, randomized, double-blind , placebo-controlled, crossover trials (Brown et al 1999b;Daniels et al 1999). In both the trials, rofecoxib was administered as a 50-mg initial dose followed by a maintenance dose of 25 mg daily as needed, and naproxen sodium was administered as a 550-mg init ial dose followed by 550 mg every 12 h as needed.…”

Section: Rofecoxibmentioning

confidence: 99%

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Rofecoxib: an update on physicochemical, pharmaceutical, pharmacodynamic and pharmacokinetic aspects

Ahuja

Singh

2003

Journal of Pharmacy and Pharmacology

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Rofecoxib (MK-966) is a new generation non-steroidal anti-inflammatory agent (NSAID) that exhibits promising anti-inflammatory, analgesic and antipyretic activity. It selectively inhibits cyclooxygenase (COX)-2 isoenzyme in a dose-dependent manner in man. No significant inhibition of COX-1 is observed with rofecoxib up to doses of 1000 mg. The pharmacokinetics of rofecoxib has been found to be complex and variable. Mean oral bioavailability after single dose of rofecoxib (12.5, 25 or 50 mg) is 93% with t m a x varying widely between 2 and 9 h. It is highly plasma-protein bound and is metabolized primarily by cytosolic reductases to inactive metabolites. Rofecoxib is eliminated predominantly by hepatic metabolism with a terminal half-life of approximately 17 h during steady state. Various experimental models and clinical studies have demonstrated rofecoxib to be superior, or at least equivalent, in anti-inflammatory, analgesic and antipyretic efficacy to comparator nonselective NSAIDs in osteoarthritis, rheumatoid arthritis and other pain models. Emerging evidence suggests that rofecoxib may also find potential use as supportive therapy in various pathophysiologic conditions like Alzheimer's disease, and in various malignant tumours and polyps, where COX-2 is overly expressed. Rofecoxib is generally well-tolerated. Analysis of data pooled from several trials suggests that rofecoxib is associated with fewer incidences of clinically symptomatic gastrointestinal ulcers and ulcer complications vis-a Á -vis conventional NSAIDs. However, this gastropreserving effect may be negated by concurrent use of low-dose aspirin for cardiovascular risk reduction. Rofecoxib tends to show similar tolerability for renal and cardiothrombotic events as compared with nonnaproxen nonselective NSAIDs. No clinically significant drug interaction has been reported for rofecoxib except with diuretics, where it reverses their salt-wasting effect and thus can be clinically exploited in electrolyte-wasting disorders. There is only modest information about the physicochemical and pharmaceutical aspects of rofecoxib. Being poorly water soluble, its drug delivery has been improved using varied formulation approaches. Although it is stable in solid state, rofecoxib is photosensitive and base-sensitive in solution form with its degradation mechanistics elucidated. Analytical determinations of rofecoxib and its metabolites in biological fluids employing HPLC with varied types of detectors have been reported. Isolated studies have also been published on the chromatographic and spectrophotometric assay of rofecoxib and its degradants in bulk samples and pharmaceutical dosage forms. The current article provides an updated overview on the physicochemical, pharmaceutical, pharmacokinetic and pharmacodynamic vistas of rofecoxib.

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Section: Rofecoxibsupporting

confidence: 66%

Section: Rofecoxibmentioning

confidence: 98%

Section: Rofecoxibmentioning

confidence: 99%

Section: Rofecoxibmentioning

confidence: 99%

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Rofecoxib: an update on physicochemical, pharmaceutical, pharmacodynamic and pharmacokinetic aspects

Ahuja

Singh

2003

Journal of Pharmacy and Pharmacology

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“…Rofecoxib's analgesic efficacy was also evaluated in replicate studies for primary dysmenorrhea, generally accepted as a sensitive model of acute pain. Subjects with a self-reported history of moderate to severe dysmenorrhea received rofecoxib 50 mg, naproxen 550 mg, or placebo in a cross-over study over three menstrual cycles (Brown et al, 1999b). Both rofecoxib and naproxen produced greater analgesia over 8 hrs as assessed by pain relief and pain intensity difference scores, time to onset of pain relief, and percent of patients requiring additional analgesic over the first 12 hrs.…”

Section: (Vi) Cox-2 Inhibitorsmentioning

confidence: 99%

Therapeutic Uses of Non-Steroidal Anti-Inflammatory Drugs in Dentistry

Dionne

Berthold

2001

Critical Reviews in Oral Biology & Medicine

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The non-steroidal anti-inflammatory drugs (NSAIDs) are among the most widely used classes of drugs for the management of acute and chronic pain in dentistry. Their therapeutic efficacy and toxicity are well-documented and provide evidence that NSAIDs generally provide an acceptable therapeutic ratio of pain relief with fewer adverse effects than the opioid-mild analgesic combination drugs that they have largely replaced for most dental applications. The great many studies done with the oral surgery model of acute pain indicate that a single dose of an NSAID is more effective than combinations of aspirin or acetaminophen plus an opioid, with fewer side-effects, thus making it preferable for ambulatory patients. The combination of an NSAID with an opioid generally results in marginal analgesic activity but with an increased incidence of side-effects, which limits its use to patients in whom the NSAID alone results in inadequate analgesia. The selective COX-2 inhibitors hold promise for clinical efficacy with less toxicity from chronic administration and may prove advantageous for the relief of chronic orofacial pain. The use of repeated doses of NSAIDs for chronic orofacial pain should be re-evaluated in light of a lack of documented efficacy and the potential for serious gastrointestinal and renal toxicity with repeated dosing.

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Rofecoxib: clinical pharmacology and clinical experience

Weaver

2001

Clinical Therapeutics

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The COX-2 specific inhibitor, MK-0966, is effective in the treatment of primary dysmenorrhea

Abstract: Clinical Pharmacology & Therapeutics (1999) 65, 118–118; doi:

Cited by 5 publications

References 0 publications

Rofecoxib: an update on physicochemical, pharmaceutical, pharmacodynamic and pharmacokinetic aspects

Rofecoxib: an update on physicochemical, pharmaceutical, pharmacodynamic and pharmacokinetic aspects

Therapeutic Uses of Non-Steroidal Anti-Inflammatory Drugs in Dentistry

Rofecoxib: clinical pharmacology and clinical experience

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