Safety and Efficacy of Bupivacaine HCl Collagen-Matrix Implant (INL-001) in Open Inguinal Hernia Repair : Results from Two Randomized Controlled Trials
INTRODUCTION: Surgical site infiltration with bupivacaine results in short-lived analgesia. The MATRIX-1 and MATRIX-2 studies examined the efficacy and safety of the bioresorbable bupivacaine HCl collagen-matrix implant (INL-001) for postsurgical pain after open inguinal hernia repair. INL-001, designed to provide early and extended delivery of bupivacaine, provides prolonged duration of perioperative analgesia.
METHODS: In two phase 3 double-blind studies [MATRIX-1 (ClinicalTrials.gov identifier, NCT02523599) and MATRIX-2 (ClinicalTrials.gov identifier, NCT02525133)], patients undergoing open tension-free mesh inguinal hernia repair were randomized to receive 300-mg bupivacaine (three INL-001 100-mg bupivacaine HCl collagen-matrix implants) (MATRIX-1 n = 204; MATRIX-2 n = 213) or three placebo collagen-matrix implants (MATRIX-1 n = 101; MATRIX-2 n = 106) during surgery. Postsurgical medication included scheduled acetaminophen and as-needed opioids.
RESULTS: Patients who received INL-001 in both studies reported statistically significantly lower pain intensity (P ≤ 0.004; primary end point) and opioid analgesic use (P < 0.0001) through 24-h post-surgery versus those who received a placebo collagen-matrix. Patients who received INL-001 reported lower pain intensity through 72 h (P = 0.0441) for the two pooled studies. In both studies, more of the patients (28-42%) who received INL-001 used no opioid medication 0-24, 0-48, and 0-72 h post-surgery versus those who received a placebo collagen-matrix (12-22%). Among patients who needed opioid medication, patients receiving INL-001 used fewer opioids than those who received a placebo collagen-matrix through 24 h in both studies (P < 0.0001) and through 48 h in MATRIX-2 (P = 0.0003). Most adverse events were mild or moderate, without evidence of bupivacaine toxicity or deleterious effects on wound healing.
CONCLUSION: These findings indicate that INL-001 results in post-inguinal hernia repair analgesia that is temporally aligned with the period of maximal postsurgical pain and may reduce the need for opioids while offering a favorable safety profile.
TRIAL REGISTRATION: ClinicalTrials.gov identifiers, NCT02523599; NCT02525133.
FUNDING: Innocoll Pharmaceuticals. Plain language summary available for this article.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:36 |
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| Enthalten in: |
Advances in therapy - 36(2019), 1 vom: 22. Jan., Seite 200-216 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Velanovich, Vic [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 15.01.2020 Date Revised 09.03.2020 published: Print-Electronic ClinicalTrials.gov: NCT02523599, NCT02525133 figshare: 10.6084/m9.figshare.7297253 Citation Status MEDLINE |
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| doi: |
10.1007/s12325-018-0836-4 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM290992524 |
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| 100 | 1 | |a Velanovich, Vic |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Safety and Efficacy of Bupivacaine HCl Collagen-Matrix Implant (INL-001) in Open Inguinal Hernia Repair |b Results from Two Randomized Controlled Trials |
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| 500 | |a Date Revised 09.03.2020 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02523599, NCT02525133 | ||
| 500 | |a figshare: 10.6084/m9.figshare.7297253 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a INTRODUCTION: Surgical site infiltration with bupivacaine results in short-lived analgesia. The MATRIX-1 and MATRIX-2 studies examined the efficacy and safety of the bioresorbable bupivacaine HCl collagen-matrix implant (INL-001) for postsurgical pain after open inguinal hernia repair. INL-001, designed to provide early and extended delivery of bupivacaine, provides prolonged duration of perioperative analgesia | ||
| 520 | |a METHODS: In two phase 3 double-blind studies [MATRIX-1 (ClinicalTrials.gov identifier, NCT02523599) and MATRIX-2 (ClinicalTrials.gov identifier, NCT02525133)], patients undergoing open tension-free mesh inguinal hernia repair were randomized to receive 300-mg bupivacaine (three INL-001 100-mg bupivacaine HCl collagen-matrix implants) (MATRIX-1 n = 204; MATRIX-2 n = 213) or three placebo collagen-matrix implants (MATRIX-1 n = 101; MATRIX-2 n = 106) during surgery. Postsurgical medication included scheduled acetaminophen and as-needed opioids | ||
| 520 | |a RESULTS: Patients who received INL-001 in both studies reported statistically significantly lower pain intensity (P ≤ 0.004; primary end point) and opioid analgesic use (P < 0.0001) through 24-h post-surgery versus those who received a placebo collagen-matrix. Patients who received INL-001 reported lower pain intensity through 72 h (P = 0.0441) for the two pooled studies. In both studies, more of the patients (28-42%) who received INL-001 used no opioid medication 0-24, 0-48, and 0-72 h post-surgery versus those who received a placebo collagen-matrix (12-22%). Among patients who needed opioid medication, patients receiving INL-001 used fewer opioids than those who received a placebo collagen-matrix through 24 h in both studies (P < 0.0001) and through 48 h in MATRIX-2 (P = 0.0003). Most adverse events were mild or moderate, without evidence of bupivacaine toxicity or deleterious effects on wound healing | ||
| 520 | |a CONCLUSION: These findings indicate that INL-001 results in post-inguinal hernia repair analgesia that is temporally aligned with the period of maximal postsurgical pain and may reduce the need for opioids while offering a favorable safety profile | ||
| 520 | |a TRIAL REGISTRATION: ClinicalTrials.gov identifiers, NCT02523599; NCT02525133 | ||
| 520 | |a FUNDING: Innocoll Pharmaceuticals. Plain language summary available for this article | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Bupivacaine HCl collagen-matrix implant | |
| 650 | 4 | |a INL-001 | |
| 650 | 4 | |a Postoperative pain intensity | |
| 650 | 4 | |a Rescue opioid analgesia | |
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| 700 | 1 | |a Leiman, David |e verfasserin |4 aut | |
| 700 | 1 | |a Jones, Nigel |e verfasserin |4 aut | |
| 700 | 1 | |a Niebler, Gwendolyn |e verfasserin |4 aut | |
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