An enhanced bunionectomy model as a potential tool for early decision-making in the development of new analgesics

Background Bunionectomy has been used as a model of postoperative pain for opioids and nonsteroidal anti-inflammatory drugs/cyclooxygenase-2 inhibitors with a fast onset of analgesia. The present study was conducted to assess whether the utility of the model can be broadened in assessing the efficac...

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Bibliographic Details
Published in:Advances in therapy 2010-12, Vol.27 (12), p.963-980
Main Authors: Wang, Hao, Gargano, Cynthia, Lukac, Suzanne, Jackson, Alice, Beals, Chan, Smiley, Patricia, Drexel, Melissa, Ruddy, Marcella, Herman, Gary, Johnson-Levonas, Amy O., Medve, Robert, Webster, Lynn, Reicin, Alise
Format: Article
Language:English
Subjects:
Adult
Aged
Analgesics - administration & dosage
Anti-Inflammatory Agents, Non-Steroidal - administration & dosage
Cardiology
Cyclooxygenase 2 Inhibitors - administration & dosage
Double-Blind Method
Drug Administration Schedule
Endocrinology
Female
gamma-Aminobutyric Acid - administration & dosage
gamma-Aminobutyric Acid - analogs & derivatives
Hallux Valgus - surgery
Health technology assessment
Humans
Internal Medicine
Male
Medicine
Medicine & Public Health
Middle Aged
Naproxen - administration & dosage
Oncology
Original Research
Pain Measurement - methods
Pain, Postoperative - drug therapy
Pharmacology/Toxicology
Pregabalin
Rheumatology
Treatment Outcome
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Summary:Background Bunionectomy has been used as a model of postoperative pain for opioids and nonsteroidal anti-inflammatory drugs/cyclooxygenase-2 inhibitors with a fast onset of analgesia. The present study was conducted to assess whether the utility of the model can be broadened in assessing the efficacy of analgesics with diverse mechanisms and pharmacokinetic profiles in drug development and to enhance the sensitivity of a bunionectomy model. Methods This was a single center, randomized, double-blind, placebo-controlled, three-arm, parallel group methodology study to evaluate the effects of pregabalin and naproxen sodium on postoperative pain following bunionectomy. Patients ( n =100) were randomized 1:1:1 to three treatments (administered 1 hour before and at defined intervals after surgery): pregabalin 300 mg before surgery and 150 mg every 8 hours; naproxen sodium 550 mg before surgery and 550 mg every 12 hours; or placebo in a double-dummy fashion. Primary endpoints were patient-controlled analgesic (PCA) hydromorphone consumption and the time to first PCA hydromorphone use postsurgery over 24 hours. Results Of the 100 patients randomized, 96 completed the study. Relative to placebo, pregabalin and naproxen sodium, respectively, reduced PCA hydromorphone consumption by 51% ( P =0.005) and 65% ( P
ISSN:0741-238X
1865-8652
DOI:10.1007/s12325-010-0084-8