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

Abstract

OBJECTIVE

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.

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  • Authors+Show Affiliations

    ,

    University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.

    , , ,

    Source

    Current medical research and opinion 23:1 2007 Jan pg 195-206

    MeSH

    Acetaminophen
    Adult
    Analgesics, Non-Narcotic
    Analgesics, Opioid
    Analysis of Variance
    Arthroscopy
    Cyclooxygenase 2 Inhibitors
    Double-Blind Method
    Drug Therapy, Combination
    Female
    Humans
    Hydrocodone
    Knee Joint
    Lactones
    Logistic Models
    Male
    Pain Measurement
    Pain, Postoperative
    Sulfones
    Treatment Outcome

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    17207303

    Citation

    Chelly, Jacques E., et al. "The Efficacy of Rofecoxib 50 Mg and Hydrocodone/acetaminophen 7.5/750 Mg in Patients With Post-arthroscopic Pain." Current Medical Research and Opinion, vol. 23, no. 1, 2007, pp. 195-206.
    Chelly JE, Nissen CW, Rodgers AJ, et al. The efficacy of rofecoxib 50 mg and hydrocodone/acetaminophen 7.5/750 mg in patients with post-arthroscopic pain. Curr Med Res Opin. 2007;23(1):195-206.
    Chelly, J. E., Nissen, C. W., Rodgers, A. J., Smugar, S. S., & Tershakovec, A. M. (2007). The efficacy of rofecoxib 50 mg and hydrocodone/acetaminophen 7.5/750 mg in patients with post-arthroscopic pain. Current Medical Research and Opinion, 23(1), pp. 195-206.
    Chelly JE, et al. The Efficacy of Rofecoxib 50 Mg and Hydrocodone/acetaminophen 7.5/750 Mg in Patients With Post-arthroscopic Pain. Curr Med Res Opin. 2007;23(1):195-206. PubMed PMID: 17207303.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - The efficacy of rofecoxib 50 mg and hydrocodone/acetaminophen 7.5/750 mg in patients with post-arthroscopic pain. AU - Chelly,Jacques E, AU - Nissen,Carl W, AU - Rodgers,Anthony J, AU - Smugar,Steven S, AU - Tershakovec,Andrew M, PY - 2007/1/9/pubmed PY - 2007/2/23/medline PY - 2007/1/9/entrez SP - 195 EP - 206 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 23 IS - 1 N2 - OBJECTIVE: 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. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/17207303/The_efficacy_of_rofecoxib_50_mg_and_hydrocodone/acetaminophen_7_5/750_mg_in_patients_with_post_arthroscopic_pain_ L2 - http://www.tandfonline.com/doi/full/10.1185/030079907X162647 DB - PRIME DP - Unbound Medicine ER -