Pacira Pharmaceuticals, Inc. announces publication of its Phase IV PILLAR study of Exparel (bupivacaine liposome injectable suspension) in total knee arthroplasty.
Pacira Pharmaceuticals, Inc. announced the publication of its Phase IV PILLAR study of Exparel (bupivacaine liposome injectable suspension) in total knee arthroplasty (TKA). The results, which demonstrate a statistically significant reduction in opioid requirements and pain scores for Exparel admixed with bupivacaine HCl versus bupivacaine HCl alone, were published in The Journal of Arthroplasty.
The study�s co-primary efficacy endpoints compared the magnitude and duration of postsurgical analgesia and associated impact on opioid consumption for 139 TKA patients randomized into two groups at 16 centers across the United States. Seventy patients received surgical site infiltration with Exparel admixed with bupivacaine HCl; 69 patients received infiltration with bupivacaine HCl alone. Patients in both groups received an identical oral, cost-effective multimodal pain management protocol before and after surgery and had access to rescue opioids as needed.
Patients in the Exparel arm demonstrated a statistically significant: 1.Decrease in total opioid consumption by 78 percent (18.7 mg versus 84.9 mg in the bupivacaine group; P=0.0048) expressed as morphine equivalents from zero to 48 hours after surgery. 2.Reduction in pain scores (180.8 versus 209.3 in the bupivacaine group; P=0.0381), measured using the area under the curve of the pain intensity scores measured on a visual analog scale from 12 to 48 hours after surgery. 3. Exparel also achieved statistical significance for the study�s key secondary endpoints related to opioid reduction. 4. Patients in the Exparel arm required 77.6 percent fewer opioids through 72 hours than those in the bupivacaine arm (20.9 mg versus 93.6 mg, respectively; P=0.0108), with 10 percent remaining opioid-free through 48 and 72 hours (compared to zero patients in the bupivacaine arm; P<0.01). 5.time to first opioid rescue was analyzed using logistic regression and kaplan-meier methods, with a significant difference between the exparel group versus the bupivacaine group; p="0.0230." exparel and bupivacaine infiltrations both were well tolerated throughout the study duration.the most common treatment-emergent adverse events (teaes) in each group were nausea, dizziness and muscle spasms; all were mild to moderate in severity. no patients discontinued the study because of a teae.>0.01).>
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