1 / 12

Efficacy & Safety in Acute Pain Management

Efficacy & Safety in Acute Pain Management. 건국대학교의료원민중병원 우남식. CELEBREX Analgesic Efficacy Overall Conclusions. Demonstrated analgesic efficacy in various pain models compared to placebo (as required by FDA regulatory submission)

malachi-cooley
Download Presentation

Efficacy & Safety in Acute Pain Management

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Efficacy & Safety in Acute Pain Management 건국대학교의료원민중병원 우남식

  2. CELEBREX Analgesic EfficacyOverall Conclusions • Demonstrated analgesic efficacy in various pain models compared to placebo (as required by FDA regulatory submission) • Median onset of pain relief = 46 minutes (range 34-75 minutes)* • In post-surgical dental pain, CELEBREX was generally comparable to traditional NSAIDs in duration of pain relief • time to onset of pain relief and magnitude of relief favored traditional NSAID comparators • In primary dysmenorrhea, CELEBREX was comparable to naproxen sodium • In post-surgical pain, CELEBREX was comparable to narcotics (hydrocodone/acetaminophen) * In acute pain and primary dysmenorrhea, single doses of CELEBREX provided pain relief within 60 minutes (median 46 minutes, range 34 to 75 minutes).

  3. Efficacy in Post-surgical Dental Pain Single doses of CELEBREX 200 mg and 400 mg: • demonstrated consistent and significant analgesic efficacy compared to placebo in the management of acute pain • are generally comparable to conventional NSAID comparators (naproxen sodium 550 mg, ibuprofen 400 mg) in terms of duration of analgesia • onset of action and magnitude of pain relief favored the traditional NSAID comparators • median time to onset of analgesia was as early as 36 minutes for CELEBREX 200 mg and 400 mg* * In acute pain and primary dysmenorrhea, single doses of CELEBREX provided pain relief within 60 minutes (median 46 minutes, range 34 to 75 minutes).

  4. Efficacy in Primary Dysmenorrhea • CELEBREX 400 mg followed by 200 mg Q12 hr PRN was efficacious (based on onset, extent, and duration of analgesia) in the management of primary dysmenorrhea • Median Time to Onset of Analgesia was 52 minutes • An initial dose of CELEBREX 400 mg provided 24-hour analgesia to a significant number of patients. • CELEBREX 400 mg followed by 200 mg Q12 hr PRN was safe and well tolerated

  5. Efficacy in Post-Surgical Pain Study Design MD Assessment SD Assessment Celecoxib 200 mg SD Celecoxib 200 mg q 8 h PRN Orthopedic Surgery Placebo SD Hydrocodone 10 mg/ Acetaminophen 1000 mg q 8 hr PRN Hydrocodone 10 mg/ Acetaminophen 1000 mg SD 8 Hours 5 Days Gimbel JS, et al. Clin Ther 2001;23(2):228-241.

  6. Efficacy in Post-Surgical PainPain Intensity Difference Placebo 1 Celecoxib * * * Hydrocodone/Acetaminophen * * 0.8 * * * † * † * 0.6 * Mean Pain Intensity Difference Score * 0.4 0.2 0 B 1 2 3 4 5 6 7 8 Hours Single Dose Assessment *p<0.05, vs placebo †p<0.05, celecoxib vs hydrocodone/acetaminophen and placebo Gimbel JS, et al. Clin Ther 2001;23(2):228-241.

  7. Efficacy in Post-Surgical Pain % of Patients Achieving Analgesia 100 90 * 75% 80 70 64%* 60 % of Patients 45% 50 40 30 20 10 0 Placebo Celecoxib Hydrocodone/ Acetaminophen *p<0.05 versus placebo Single Dose Assessment Gimbel JS, et al. Clin Ther 2001;23(2):228-241.

  8. Efficacy in Post-Surgical Pain Maximum Pain Intensity in Past 24 Hours (MD Assessment) Best Score=0; Worst score=3 3 Celecoxib Hydrocodone/Acetaminophen 2.5 2 * * Mean Maximum Pain Improvement Intensity Score 1.5 * * 1 0.5 0 2 3 4 5 Day Multiple Dose Assessment * p <0.001, versus Hydrocodone/Acetaminophen Gimbel JS, et al. Clin Ther 2001;23(2):228-241.

  9. Efficacy in Post-Surgical Pain Percent of Patients Requiring Rescue Medication * p = 0.05 versus Hydrocodone/Acetaminophen Multiple Dose Assessment Gimbel JS, et al. Clin Ther 2001;23(2):228-241.

  10. Tolerability in Post-Surgical Pain Cumulative adverse events in the single- and multiple-dose assessment periods CELEBREX Hydrocodone 10mg/ 200mg Acetaminophen1000mg Adverse Event (n=195) (n=194) P Patients with 1 event 87 (45%) 125 (64%) <0.001 Nausea 22 (11) 53 (27) <0.001 Headache 20 (10) 23 (12) Somnolence 15 (8) 30 (15) 0.018 Vomiting 10 (5) 17 (9) Dizziness 7 (4) 31 (16) <0.001 Dyspepsia 7 (4) 1 (1) Dry Mouth 2 (1) 5 (3) Pruritis 2 (1) 6 (3) Constipation 0 (0) 6 (3) 0.015 Gimbel JS, et al. Clin Ther 2001;23(2):228-241.

  11. Efficacy in Post-Surgical Pain Conclusions • CELEBREX 200 mg (single dose) displayed similar analgesic activity in patients with moderate to severe post-orthopedic surgical pain compared to hydrocodone 10 mg/acetaminophen 1000 mg • The median onset of analgesia after a single dose of celecoxib was 35 minutes* • The majority of patients completed the single dose (8 hour) period without requiring another does of analgesic medication * In acute pain and primary dysmenorrhea, single doses of CELEBREX provided pain relief within 60 minutes (median 46 minutes, range 34 to 75 minutes). Gimbel JS, et al. Clin Ther 2001;23(2):228-241.

  12. Efficacy in Post-Surgical Pain Conclusions • CELEBREX 200 mg q8h PRN for 5 days demonstrated analgesic efficacy similar to hydrocodone 10 mg/acetaminophen 1000 mg • Significantly fewer CELEBREX patients required rescue medication compared to hydrocodone 10 mg/acetaminophen 1000 mg treated patients • Most patients required no more than two daily doses of CELEBREX 200 mg for the control of post-orthopedic surgical pain • CELEBREX 200 mg administered as a SD or 200 mg q8h PRN over a 5-day period was safe and well-tolerated and was associated with a significantly lower incidence of adverse events than hydrocodone/acetaminophen Gimbel JS, et al. Clin Ther 2001;23(2):228-241.

More Related