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A comparison of rofecoxib versus celecoxib in treating pain after dental surgery: a single-center, randomized, double-blind, placebo- and active-comparator-controlled, parallel-group, single-dose study using the dental impaction pain model.

Abstract

BACKGROUND

Rofecoxib and celecoxib, selective cyclooxygenase-2 inhibitors, have analgesic efficacy similar to that of nonselective nonsteroidal anti-inflammatory drugs.

OBJECTIVE

This study was designed to confirm earlier findings that the overall analgesic efficacy of rofecoxib 50 mg was superior to that of celecoxib 200 mg and to extend the comparison to include celecoxib 400 mg.

METHODS

In this single-center, randomized, double-blind, placebo- and active-comparator-controlled, parallel-group, single-dose study, patients who experienced moderate or severe pain after surgical extraction of at least 2 third molars received a single oral dose of either rofecoxib 50 mg, celecoxib 400 mg, celecoxib 200 mg, ibuprofen 400 mg, or placebo. Patients recorded scores of pain intensity, pain relief, and global assessment at prespecified time intervals throughout the 24-hour period after dosing. The end points were total pain relief (TOPAR) score over 8 hours (TOPAR8; primary end point), TOPAR score over 12 hours (TOPAR12), sum of pain intensity difference (SPID) over 8 and 12 hours (SPID8 and SPID12), patient's global assessment of study drug at 8 hours, time to confirmed perceptible pain relief (ie, time to onset of analgesic effect), peak pain intensity difference (PID), peak pain relief, time to first dose of rescue medication (ie, duration of analgesic effect), and percentage of patients using rescue medication.

RESULTS

A total of 482 patients (358 females, 124 males; mean age, 22.1 years) were enrolled. Rofecoxib 50 mg (n = 151 patients) demonstrated significantly greater overall analgesic efficacy compared with celecoxib 400 mg (n = 151), as measured by TOPAR8 (least squares mean [SE] 17.2 [0.8] vs 15.0 [0.8]; P < 0.05) and TOPAR12 (25.3 [1.2] vs 21.0 [1.2]; P < 0.05), as well as a significantly longer duration of analgesic effect (P < 0.05). Time to onset of analgesic effect and peak analgesic effect were similar for rofecoxib 50 mg and celecoxib 400 mg. Rofecoxib also showed significantly greater overall analgesic efficacy than did celecoxib 200 mg (n = 90), including greater TOPAR8 scores (17.2 [0.8] vs 11.5 [1.1]; P < 0.001), faster onset of analgesic effect (P < 0.001), greater peak analgesic effect (P < 0.001 for peak pain relief and peak PID), and longer duration of analgesic effect (P < 0.001). The overall analgesic efficacy of rofecoxib 50 mg was similar to that of ibuprofen 400 mg (n = 45), except that the duration of analgesic effect of rofecoxib 50 mg was significantly longer (P < 0.001). All active treatments produced significantly greater overall analgesic efficacy compared with that of placebo (P < 0.001 for all scores [TOPAR8, TOPAR12, SPID8, SPID12, and patient's global assessment] for all study drugs). The adverse-events (AE) profile was generally similar in all treatment groups. The 3 most common AEs were nausea, postextraction alveolitis, and vomiting.

CONCLUSIONS

In this study, rofecoxib 50 mg provided generally superior overall analgesic efficacy compared with that of celecoxib 400 and 200 mg, including a significantly longer duration of analgesic effect. The overall analgesic efficacy of rofecoxib 50 mg was generally similar to that of ibuprofen 400 mg, except for a significantly longer duration of analgesic effect.

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  • Authors+Show Affiliations

    ,

    Department of Clinical Immunology and Analgesia, and Biostatistics, Merck & Co., Inc., Merck Research Laboratories, Rahway, New Jersey 07065, USA. kerstin_malmstrom@merck.com

    , , ,

    Source

    Clinical therapeutics 24:10 2002 Oct pg 1549-60

    MeSH

    Adolescent
    Adult
    Analgesics, Non-Narcotic
    Celecoxib
    Cyclooxygenase 2
    Cyclooxygenase 2 Inhibitors
    Cyclooxygenase Inhibitors
    Dose-Response Relationship, Drug
    Double-Blind Method
    Female
    Humans
    Ibuprofen
    Isoenzymes
    Lactones
    Male
    Membrane Proteins
    Pain, Postoperative
    Prostaglandin-Endoperoxide Synthases
    Pyrazoles
    Sulfonamides
    Sulfones
    Tooth Extraction

    Pub Type(s)

    Case Reports
    Clinical Trial
    Comparative Study
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    12462285

    Citation

    Malmstrom, Kerstin, et al. "A Comparison of Rofecoxib Versus Celecoxib in Treating Pain After Dental Surgery: a Single-center, Randomized, Double-blind, Placebo- and Active-comparator-controlled, Parallel-group, Single-dose Study Using the Dental Impaction Pain Model." Clinical Therapeutics, vol. 24, no. 10, 2002, pp. 1549-60.
    Malmstrom K, Fricke JR, Kotey P, et al. A comparison of rofecoxib versus celecoxib in treating pain after dental surgery: a single-center, randomized, double-blind, placebo- and active-comparator-controlled, parallel-group, single-dose study using the dental impaction pain model. Clin Ther. 2002;24(10):1549-60.
    Malmstrom, K., Fricke, J. R., Kotey, P., Kress, B., & Morrison, B. (2002). A comparison of rofecoxib versus celecoxib in treating pain after dental surgery: a single-center, randomized, double-blind, placebo- and active-comparator-controlled, parallel-group, single-dose study using the dental impaction pain model. Clinical Therapeutics, 24(10), pp. 1549-60.
    Malmstrom K, et al. A Comparison of Rofecoxib Versus Celecoxib in Treating Pain After Dental Surgery: a Single-center, Randomized, Double-blind, Placebo- and Active-comparator-controlled, Parallel-group, Single-dose Study Using the Dental Impaction Pain Model. Clin Ther. 2002;24(10):1549-60. PubMed PMID: 12462285.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - A comparison of rofecoxib versus celecoxib in treating pain after dental surgery: a single-center, randomized, double-blind, placebo- and active-comparator-controlled, parallel-group, single-dose study using the dental impaction pain model. AU - Malmstrom,Kerstin, AU - Fricke,James R, AU - Kotey,Paul, AU - Kress,Barbara, AU - Morrison,Briggs, PY - 2002/12/5/pubmed PY - 2003/4/9/medline PY - 2002/12/5/entrez SP - 1549 EP - 60 JF - Clinical therapeutics JO - Clin Ther VL - 24 IS - 10 N2 - BACKGROUND: Rofecoxib and celecoxib, selective cyclooxygenase-2 inhibitors, have analgesic efficacy similar to that of nonselective nonsteroidal anti-inflammatory drugs. OBJECTIVE: This study was designed to confirm earlier findings that the overall analgesic efficacy of rofecoxib 50 mg was superior to that of celecoxib 200 mg and to extend the comparison to include celecoxib 400 mg. METHODS: In this single-center, randomized, double-blind, placebo- and active-comparator-controlled, parallel-group, single-dose study, patients who experienced moderate or severe pain after surgical extraction of at least 2 third molars received a single oral dose of either rofecoxib 50 mg, celecoxib 400 mg, celecoxib 200 mg, ibuprofen 400 mg, or placebo. Patients recorded scores of pain intensity, pain relief, and global assessment at prespecified time intervals throughout the 24-hour period after dosing. The end points were total pain relief (TOPAR) score over 8 hours (TOPAR8; primary end point), TOPAR score over 12 hours (TOPAR12), sum of pain intensity difference (SPID) over 8 and 12 hours (SPID8 and SPID12), patient's global assessment of study drug at 8 hours, time to confirmed perceptible pain relief (ie, time to onset of analgesic effect), peak pain intensity difference (PID), peak pain relief, time to first dose of rescue medication (ie, duration of analgesic effect), and percentage of patients using rescue medication. RESULTS: A total of 482 patients (358 females, 124 males; mean age, 22.1 years) were enrolled. Rofecoxib 50 mg (n = 151 patients) demonstrated significantly greater overall analgesic efficacy compared with celecoxib 400 mg (n = 151), as measured by TOPAR8 (least squares mean [SE] 17.2 [0.8] vs 15.0 [0.8]; P < 0.05) and TOPAR12 (25.3 [1.2] vs 21.0 [1.2]; P < 0.05), as well as a significantly longer duration of analgesic effect (P < 0.05). Time to onset of analgesic effect and peak analgesic effect were similar for rofecoxib 50 mg and celecoxib 400 mg. Rofecoxib also showed significantly greater overall analgesic efficacy than did celecoxib 200 mg (n = 90), including greater TOPAR8 scores (17.2 [0.8] vs 11.5 [1.1]; P < 0.001), faster onset of analgesic effect (P < 0.001), greater peak analgesic effect (P < 0.001 for peak pain relief and peak PID), and longer duration of analgesic effect (P < 0.001). The overall analgesic efficacy of rofecoxib 50 mg was similar to that of ibuprofen 400 mg (n = 45), except that the duration of analgesic effect of rofecoxib 50 mg was significantly longer (P < 0.001). All active treatments produced significantly greater overall analgesic efficacy compared with that of placebo (P < 0.001 for all scores [TOPAR8, TOPAR12, SPID8, SPID12, and patient's global assessment] for all study drugs). The adverse-events (AE) profile was generally similar in all treatment groups. The 3 most common AEs were nausea, postextraction alveolitis, and vomiting. CONCLUSIONS: In this study, rofecoxib 50 mg provided generally superior overall analgesic efficacy compared with that of celecoxib 400 and 200 mg, including a significantly longer duration of analgesic effect. The overall analgesic efficacy of rofecoxib 50 mg was generally similar to that of ibuprofen 400 mg, except for a significantly longer duration of analgesic effect. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/12462285/A_comparison_of_rofecoxib_versus_celecoxib_in_treating_pain_after_dental_surgery:_a_single_center_randomized_double_blind_placebo__and_active_comparator_controlled_parallel_group_single_dose_study_using_the_dental_impaction_pain_model_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149291802800595 DB - PRIME DP - Unbound Medicine ER -