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Franco-de la Torre L, Gómez-Sánchez E, Aragon-Martinez OH, Hernández-Gómez A, Franco-González DL, Guzmán-Flores JM, Alonso-Castro AJ, Granados-Soto V, Isiordia-Espinoza MA. Analgesic Efficacy and Safety of Tapentadol Immediate Release in Bunionectomy: A Meta-Analysis. Pharmaceuticals (Basel) 2023; 16:1287. [PMID: 37765095 PMCID: PMC10536393 DOI: 10.3390/ph16091287] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/09/2023] [Revised: 09/04/2023] [Accepted: 09/09/2023] [Indexed: 09/29/2023] Open
Abstract
The aim of this systematic review and meta-analysis was to evaluate the analgesic effect of different doses of tapentadol immediate release (IR) and its adverse effects after a bunionectomy. Pubmed, Cochrane, Lilacs, Medline, and Imbiomed were used to identify abstracts of scientific publications related to the keywords of this systematic review (PROSPERO ID CRD42023437295). Moreover, the risk of bias in all included articles was assessed using the Cochrane Collaboration risk of bias tool. Data on the sum of pain intensity, total pain relief, global assessment, and adverse effects were extracted. The statistical method of inverse variance with means difference was used to evaluate the numerical data and the Mantel-Haenszel and Odd Ratio test to analyze the dichotomous data. In addition, the number needed to treat, the number needed to harm, and the 95% confidence intervals were calculated. A qualitative evaluation (n = 2381) was carried out according to the conclusions of the authors. Tapentadol (n = 1772) was more effective in relieving postoperative pain than the placebo (n = 609) after a bunionectomy. In addition, the analgesic efficacy of IR tapentadol (n = 1323) versus the placebo (n = 390) was evaluated in a total of 1713 patients using a global evaluation of the treatments. All three doses of IR tapentadol showed better results compared to the placebo after a bunionectomy. Finally, the adverse effects have a direct relationship with the dose, and the greatest number of adverse effects are most observed with tapentadol IR 100 mg (n = 2381). It is concluded that tapentadol IR (100 mg) leads to the best satisfaction score in this meta-analysis.
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Affiliation(s)
- Lorenzo Franco-de la Torre
- Instituto de Investigación en Ciencias Médicas, Cuerpo Académico Terapéutica y Biología Molecular (UDG-CA-973), Departamento de Clínicas, División de Ciencias Biomédicas, Centro Universitario de los Altos, Universidad de Guadalajara, Tepatitlán de Morelos 47620, Mexico; (L.F.-d.l.T.); (A.H.-G.); (D.L.F.-G.)
| | - Eduardo Gómez-Sánchez
- División de Disciplinas Clínicas, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara 44340, Mexico;
| | - Othoniel Hugo Aragon-Martinez
- Laboratorio de Productos Naturales, Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí, San Luis Potosí 78210, Mexico;
| | - Adriana Hernández-Gómez
- Instituto de Investigación en Ciencias Médicas, Cuerpo Académico Terapéutica y Biología Molecular (UDG-CA-973), Departamento de Clínicas, División de Ciencias Biomédicas, Centro Universitario de los Altos, Universidad de Guadalajara, Tepatitlán de Morelos 47620, Mexico; (L.F.-d.l.T.); (A.H.-G.); (D.L.F.-G.)
- Departamento de Ciencias de la Salud, División de Ciencias Biomédicas, Centro Universitario de los Altos, Universidad de Guadalajara, Tepatitlán de Morelos 47620, Mexico;
| | - Diana Laura Franco-González
- Instituto de Investigación en Ciencias Médicas, Cuerpo Académico Terapéutica y Biología Molecular (UDG-CA-973), Departamento de Clínicas, División de Ciencias Biomédicas, Centro Universitario de los Altos, Universidad de Guadalajara, Tepatitlán de Morelos 47620, Mexico; (L.F.-d.l.T.); (A.H.-G.); (D.L.F.-G.)
| | - Juan Manuel Guzmán-Flores
- Departamento de Ciencias de la Salud, División de Ciencias Biomédicas, Centro Universitario de los Altos, Universidad de Guadalajara, Tepatitlán de Morelos 47620, Mexico;
| | - Angel Josabad Alonso-Castro
- Departamento de Farmacia, División de Ciencias Naturales y Exactas, Universidad de Guanajuato, Guanajuato 36040, Mexico;
| | - Vinicio Granados-Soto
- Neurobiology of Pain Laboratory, Departamento de Farmacobiología, Cinvestav, South Campus, Mexico City 14330, Mexico;
| | - Mario Alberto Isiordia-Espinoza
- Instituto de Investigación en Ciencias Médicas, Cuerpo Académico Terapéutica y Biología Molecular (UDG-CA-973), Departamento de Clínicas, División de Ciencias Biomédicas, Centro Universitario de los Altos, Universidad de Guadalajara, Tepatitlán de Morelos 47620, Mexico; (L.F.-d.l.T.); (A.H.-G.); (D.L.F.-G.)
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Chen HY, Wang ZN, Zhang WY, Zhu T. Advances in the clinical application of oxycodone in the perioperative period. World J Clin Cases 2022; 10:5156-5164. [PMID: 35812649 PMCID: PMC9210879 DOI: 10.12998/wjcc.v10.i16.5156] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/22/2021] [Revised: 01/29/2022] [Accepted: 04/03/2022] [Indexed: 02/06/2023] Open
Abstract
To review the research progress of pure opioid receptor agonist oxycodone. The research progress of oxycodone in terms of pharmacokinetics, pharmacodynamics, adverse reactions, clinical application, combined medication and new progress in clinical application was summarized by referring to the literature. Oxycodone is a semi-synthetic thebaine derivative of opioid alkaloids, and is a pure opioid μ and κ receptor agonist. The main action sites are the central nervous system and visceral smooth muscle. Due to its advantages of low adverse reactions, good analgesic effects, and a wide range of safe doses, the drug has been widely used in the control of acute and chronic postoperative pain, as well as malignant and non-malignant pain. Since the end of the 20th century, researchers have begun to formulate antipyretic analgesics, opioid receptor agonists, opioid receptor antagonists, dopamine receptor antagonists and other drugs with oxycodone in different proportions to enhance the analgesic effect. At the same time, it can reduce the dosage of oxycodone and reduce its adverse reactions, so as to achieve the purpose of limiting opioid abuse. With the continuous research on the efficacy and safety of oxycodone in the perioperative period at home and abroad, oxycodone has become the only dual-opioid potent analgesic that can be used in clinical work.
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Affiliation(s)
- Hong-Yang Chen
- Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
- The Research Units of West China(2018RU012)-Chinese Academy of Medical Sciences, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
| | - Zi-Ning Wang
- Department of Anesthesiology, West China School of Clinical Medicine, Sichuan University, Chengdu 610041, Sichuan Province, China
| | - Wei-Yi Zhang
- Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
- The Research Units of West China(2018RU012)-Chinese Academy of Medical Sciences, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
| | - Tao Zhu
- Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
- The Research Units of West China(2018RU012)-Chinese Academy of Medical Sciences, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
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Hot topics in opioid pharmacology: mixed and biased opioids. Br J Anaesth 2019; 122:e136-e145. [DOI: 10.1016/j.bja.2019.03.006] [Citation(s) in RCA: 78] [Impact Index Per Article: 13.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/31/2018] [Revised: 03/03/2019] [Accepted: 03/07/2019] [Indexed: 01/14/2023] Open
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Singla NK, Meske DS, Desjardins PJ. Exploring the Interplay between Rescue Drugs, Data Imputation, and Study Outcomes: Conceptual Review and Qualitative Analysis of an Acute Pain Data Set. Pain Ther 2017; 6:165-175. [PMID: 28676997 PMCID: PMC5693805 DOI: 10.1007/s40122-017-0074-5] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/06/2017] [Indexed: 11/01/2022] Open
Abstract
In placebo-controlled acute surgical pain studies, provisions must be made for study subjects to receive adequate analgesic therapy. As such, most protocols allow study subjects to receive a pre-specified regimen of open-label analgesic drugs (rescue drugs) as needed. The selection of an appropriate rescue regimen is a critical experimental design choice. We hypothesized that a rescue regimen that is too liberal could lead to all study arms receiving similar levels of pain relief (thereby confounding experimental results), while a regimen that is too stringent could lead to a high subject dropout rate (giving rise to a preponderance of missing data). Despite the importance of rescue regimen as a study design feature, there exist no published review articles or meta-analysis focusing on the impact of rescue therapy on experimental outcomes. Therefore, when selecting a rescue regimen, researchers must rely on clinical factors (what analgesics do patients usually receive in similar surgical scenarios) and/or anecdotal evidence. In the following article, we attempt to bridge this gap by reviewing and discussing the experimental impacts of rescue therapy on a common acute surgical pain population: first metatarsal bunionectomy. The function of this analysis is to (1) create a framework for discussion and future exploration of rescue as a methodological study design feature, (2) discuss the interplay between data imputation techniques and rescue drugs, and (3) inform the readership regarding the impact of data imputation techniques on the validity of study conclusions. Our findings indicate that liberal rescue may degrade assay sensitivity, while stringent rescue may lead to unacceptably high dropout rates.
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Affiliation(s)
- Neil K Singla
- Lotus Clinical Research, Huntington Hospital, Department of Anesthesiology, Pasadena, CA, USA.
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A randomized, phase 2 study investigating TRV130, a biased ligand of the μ-opioid receptor, for the intravenous treatment of acute pain. Pain 2016; 157:264-272. [DOI: 10.1097/j.pain.0000000000000363] [Citation(s) in RCA: 151] [Impact Index Per Article: 16.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
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Singla N, Hunsinger M, Chang PD, McDermott MP, Chowdhry AK, Desjardins PJ, Turk DC, Dworkin RH. Assay sensitivity of pain intensity versus pain relief in acute pain clinical trials: ACTTION systematic review and meta-analysis. THE JOURNAL OF PAIN 2015; 16:683-91. [PMID: 25892656 DOI: 10.1016/j.jpain.2015.03.015] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/02/2014] [Revised: 03/20/2015] [Accepted: 03/31/2015] [Indexed: 01/05/2023]
Abstract
UNLABELLED The magnitude of the effect size of an analgesic intervention can be influenced by several factors, including research design. A key design component is the choice of the primary endpoint. The purpose of this meta-analysis was to compare the assay sensitivity of 2 efficacy paradigms: pain intensity (calculated using summed pain intensity difference [SPID]) and pain relief (calculated using total pain relief [TOTPAR]). A systematic review of the literature was performed to identify acute pain studies that calculated both SPIDs and TOTPARs within the same study. Studies were included in this review if they were randomized, double-blind, placebo-controlled investigations involving medications for postsurgical acute pain and if enough data were provided to calculate TOTPAR and SPID standardized effect sizes. Based on a meta-analysis of 45 studies, the mean standardized effect size for TOTPAR (1.13) was .11 higher than that for SPID (1.02; P = .01). Mixed-effects meta-regression analyses found no significant associations between the TOTPAR - SPID difference in standardized effect size and trial design characteristics. Results from this review suggest that for acute pain studies, utilizing TOTPAR to assess pain relief may be more sensitive to treatment effects than utilizing SPID to assess pain intensity. PERSPECTIVE The results of this meta-analysis suggest that TOTPAR may be more sensitive to treatment effects than SPIDs are in analgesic trials examining acute pain. We found that standardized effect sizes were higher for TOTPAR compared to SPIDs.
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Affiliation(s)
- Neil Singla
- Lotus Clinical Research, Huntington Hospital, Department of Anesthesiology, Pasadena, California.
| | - Matthew Hunsinger
- School of Professional Psychology, Pacific University, Hillsboro, Oregon
| | - Phoebe D Chang
- Lotus Clinical Research, Huntington Hospital, Department of Anesthesiology, Pasadena, California
| | - Michael P McDermott
- Department of Biostatistics and Computational Biology, University of Rochester, Rochester, New York
| | - Amit K Chowdhry
- Department of Biostatistics and Computational Biology, University of Rochester, Rochester, New York
| | | | - Dennis C Turk
- Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington
| | - Robert H Dworkin
- Department of Anesthesiology, University of Rochester, Rochester, New York
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Singla N, Barrett T, Sisk L, Kostenbader K, Young J. Assessment of the safety and efficacy of extended-release oxycodone/acetaminophen, for 14 days postsurgery. Curr Med Res Opin 2014; 30:2571-8. [PMID: 25157951 DOI: 10.1185/03007995.2014.957824] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
OBJECTIVE To investigate the safety and satisfaction of patients treated ≤ 14 days after unilateral bunionectomy with extended-release oxycodone/acetaminophen (ER OC/APAP), a biphasic (ER and immediate release) fixed-dose combination analgesic being developed for moderate to severe acute pain. RESEARCH DESIGN AND METHODS This was an open-label extension (OLE) of a randomized, double-blind, placebo-controlled trial (DBRCT) of patients undergoing bunionectomy. Patients who consented to the OLE before entering the 48 hour DBRCT entered the OLE upon completing the DBRCT and during the OLE received two tablets of ER OC/APAP (15/650 mg total dose) every 12 hours for ≤ 14 days. ClinicalTrials identifier: NCT01484652. MAIN OUTCOME MEASURES Treatment-emergent adverse events, physical examinations, vital sign measurements, and clinical laboratory testing were assessed throughout the study. Global assessments of treatment satisfaction were made at the end of the DBRCT and at each clinic visit during the OLE. RESULTS A total of 146 patients consented to the OLE before entering the DBRCT and 129 completed the OLE. Tolerability of ER OC/APAP during the OLE was consistent with that of an opioid product. Adverse events occurred during the OLE in 64 patients (43.8%); the most common were gastrointestinal events including nausea (17.8%), vomiting (7.5%), and constipation (6.2%). No changes in vital signs or clinical laboratory tests were considered by the investigator to be clinically significant. At all visits during the OLE, the majority of patients were satisfied or very satisfied with their medication. Limitations include a 14 day postprocedure study duration that may be confounded with natural healing time, and lack of a placebo arm. CONCLUSIONS These results show that ER OC/APAP demonstrated an expected safety and tolerability profile and good patient satisfaction in a postsurgical model of acute pain.
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Affiliation(s)
- Neil Singla
- Lotus Clinical Research LLC, Huntington Hospital, Department of Anesthesia , Pasadena, CA , USA
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Abstract
There is some evidence for a partial opioid switching or an 'add on' approach to opioid dosing strategies. Preclinical and clinical findings suggest different activation profiles for the stimulation of the mu subtypes, raising the questions about what might occur with combinations of these substances. In the postoperative setting, it seems that the analgesic effect of the combination at equivalent doses is similar to that produced by the individual components, not adding particular advantages. However, adverse effects seem to be reduced with the combination of morphine/oxycodone, when given in doses equianalgesic to individual opioids. The reduction of opioid-induced postoperative adverse effects may have important clinical implications, given that adverse effects may prolong length of stay and hospitalization costs. Thus, in the acute postoperative setting, a reduction of adverse effects may be expected. In chronic pain, information is still in the infancy, but opioid combination therapy may have greater advantages in improving the opioid response. The possibility to clinically translate opioid combinations into practice, as demonstrated in some animal models, depends on a broad number of factors implicated in the pain process. More research is needed to better elucidate these issues in the near future.
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Affiliation(s)
- Sebastiano Mercadante
- Anesthesia and Intensive Care and Pain Relief and Palliative Care La Maddalena Cancer Center , Via san Lorenzo 312, 90145 Palermo , Italy +39 0916806521 ; +39 0916806110 ;
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Singla N, Barrett T, Sisk L, Kostenbader K, Young J, Giuliani M. A randomized, double-blind, placebo-controlled study of the efficacy and safety of MNK-795, a dual-layer, biphasic, immediate-release and extended-release combination analgesic for acute pain. Curr Med Res Opin 2014; 30:349-59. [PMID: 24351079 DOI: 10.1185/03007995.2013.876979] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
OBJECTIVE To investigate the efficacy and safety of a bilayer combination oxycodone (OC) and acetaminophen (APAP) analgesic with both immediate-release and extended-release (ER) components (OC/APAP ER) in patients with moderate to severe pain using an established acute pain model. RESEARCH DESIGN AND METHODS This was a randomized, double-blind, placebo-controlled trial. Adult patients were included in the study if they had a pain intensity score≥4 on a 0-10 numerical rating scale after bunionectomy surgery, and were randomized (1:1) to receive four doses (two tablets q12h) of OC/APAP ER or placebo. CLINICAL TRIAL REGISTRATION NCT01484652. MAIN OUTCOME MEASURES The primary efficacy endpoint was the summed pain intensity difference over the first 48 hours (SPID48). Secondary endpoints included SPIDs and total pain relief (TOTPAR) over the dosing intervals; time to perceptible, meaningful, and confirmed pain relief; and the proportion of patients with ≥30% reduction in pain intensity scores. RESULTS A total of 329 patients were enrolled, of whom 266 (OC/APAP ER, n=135; placebo, n=131) completed the study. The mean (SE) SPID48 was 114.9 (7.6) in the OC/APAP ER group and 66.9 (7.6) in the placebo group (P<0.0001). SPID and TOTPAR values were significantly greater with OC/APAP ER than with placebo over all time periods analyzed, and the median times to perceptible, meaningful, and confirmed pain relief were significantly shorter. More patients showed ≥30% reduction in pain intensity scores with OC/APAP ER than with placebo at all times after 0.5 hours. OC/APAP ER was generally well tolerated. A limitation of this study was the lack of an active comparator. CONCLUSIONS OC/APAP ER was efficacious and generally well tolerated in an established model of moderate to severe acute pain, providing an onset of analgesia in approximately 30 minutes and sustained pain relief over the 12 hour dosing period.
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Affiliation(s)
- Neil Singla
- Lotus Clinical Research LLC, Huntington Hospital , Pasadena, CA , USA
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Argoff CE. Recent management advances in acute postoperative pain. Pain Pract 2013; 14:477-87. [PMID: 23945010 DOI: 10.1111/papr.12108] [Citation(s) in RCA: 52] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/06/2013] [Accepted: 07/09/2013] [Indexed: 12/16/2022]
Abstract
INTRODUCTION Acute postoperative pain remains a major problem, with both undertreatment and overtreatment leading to serious consequences, including increased risk of persistent postoperative pain, impaired rehabilitation, increased length of stay and/or hospital readmission, and adverse events related to excessive analgesic use, such as oversedation. New analgesic medications and techniques have been introduced that target the preoperative, intraoperative, and postoperative periods to better manage acute postoperative pain, with improvements in analgesic efficacy and safety over more traditional pain management approaches. This review provides an overview of these new analgesic medications and techniques. Specific topics that are discussed include the use of preoperative nonsteroidal anti-inflammatory drugs, anxiolytics, and anticonvulsants; intraoperative approaches such as neuraxial analgesia, continuous local anesthetic wound infusion, transversus abdominis plane block, extended-release epidural morphine, intravenous acetaminophen, and intravenous ketamine; and postoperative use of intravenous ibuprofen, new opioids (eg, tapentadol) or opioid formulations (morphine-oxycodone), and patient-controlled analgesia. CONCLUSION New, targeted, analgesic medications and techniques may provide a safer and more effective approach to the management of acute postoperative pain than traditional approaches such as postoperative oral analgesics.
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Richards P, Riff D, Kelen R, Stern W. A phase 3, randomized, double-blind comparison of analgesic efficacy and tolerability of Q8003 vs oxycodone or morphine for moderate-to-severe postoperative pain following bunionectomy surgery. PAIN MEDICINE 2013; 14:1230-8. [PMID: 23802706 PMCID: PMC3817521 DOI: 10.1111/pme.12167] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
Abstract
Objective Compare the efficacy and tolerability of the dual-opioid, Q8003® (morphine/oxycodone combination) 12 mg/8 mg to morphine 12 mg or oxycodone 8 mg in subjects following bunionectomy surgery. Design This was a randomized, double-blind study. Setting Hospitalized patients. Patients Healthy men or women aged ≥18 years with moderate or severe pain (score ≥2 on a 4-point Likert scale) and ≥4 on the 11-point numerical pain rating scale following surgery. Interventions Study medication was initiated after surgery and was given for 48 hours. Outcomes The primary efficacy variable was mean sum of the pain intensity difference (SPID) scores from the postsurgical baseline. Results Five hundred twenty-two subjects were randomized; 31 (5.9%) discontinued, including 19 (3.6%) for adverse events. The mean total morphine equivalent dose (MED) was 182.7 mg from Q8003 12 mg/8 mg, 92.4 mg for morphine 12 mg, and 92.1 mg for oxycodone 8 mg. SPID from baseline over 24 hours and SPID from baseline over 48 hours were significantly (P < 0.02) higher for Q8003 12 mg/8 mg vs morphine 12 mg or oxycodone 8 mg. Significantly (P < 0.015) fewer subjects in the Q8003 group required ibuprofen rescue medication, used lower doses of rescue medication, and had a longer median time to first use of rescue medication. Oxygen desaturation <90% occurred in 5.3% with Q8003, 2.8% with morphine 12 mg, and 2.3% with oxycodone 8 mg, and the cumulative median dose at first desaturation was twofold greater with Q8003. Conclusion Q8003 provided superior efficacy to its individual components at twice the MED with only a modest increase in the incidence of adverse events.
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Richards P, Gimbel JS, Minkowitz HS, Kelen R, Stern W. Comparison of the Efficacy and Safety of Dual-Opioid Treatment With Morphine Plus Oxycodone Versus Oxycodone/Acetaminophen for Moderate to Severe Acute Pain After Total Knee Arthroplasty. Clin Ther 2013; 35:498-511. [DOI: 10.1016/j.clinthera.2013.03.002] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/26/2012] [Revised: 12/17/2012] [Accepted: 03/11/2013] [Indexed: 11/26/2022]
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Abstract
INTRODUCTION Morphine sulfate and oxycodone hydrochloride are commonly used for pain management because of their pharmacologic profile, pharmacokinetics, and analgesic potency. However, opioids are associated with a significant adverse event (AE) burden that limits their use in both the acute and the chronic pain settings. SUMMARY Co-administration of opioids demonstrated synergistic analgesia and reduced side effects. Thus, dual-opioid therapy has the potential to enhance the positive analgesic benefits of opioids, while limiting the burden of opioid-related AEs. This symposium proceedings was based on presentations at the 13th World Congress on Pain in August 2010. CONCLUSIONS This program will review the rationale for dual-opioid therapy based on preclinical findings and data from clinical studies showing the efficacy and tolerability profile of a dual-opioid formulation when used to treat acute postoperative pain.
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MESH Headings
- Analgesics, Opioid/chemistry
- Analgesics, Opioid/metabolism
- Analgesics, Opioid/pharmacology
- Drug Therapy, Combination/methods
- Drug Therapy, Combination/standards
- Drug Therapy, Combination/trends
- Humans
- Pain/drug therapy
- Pain/metabolism
- Pain/physiopathology
- Receptors, Opioid, mu/agonists
- Receptors, Opioid, mu/chemistry
- Receptors, Opioid, mu/genetics
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Analgesic Efficacy and Tolerability of Intravenous Morphine Versus Combined Intravenous Morphine and Oxycodone in a 2-Center, Randomized, Double-Blind, Pilot Trial of Patients With Moderate to Severe Pain After Total Hip Replacement. Clin Ther 2012; 34:1751-60. [DOI: 10.1016/j.clinthera.2012.06.023] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/27/2012] [Revised: 06/19/2012] [Accepted: 06/22/2012] [Indexed: 11/21/2022]
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Webster L. Efficacy and Safety of Dual-Opioid Therapy in Acute Pain. PAIN MEDICINE 2012; 13 Suppl 1:S12-20. [DOI: 10.1111/j.1526-4637.2012.01330.x] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
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A phase 3, randomized, placebo-controlled trial of DepoFoam® bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy. Adv Ther 2011; 28:776-88. [PMID: 21842428 DOI: 10.1007/s12325-011-0052-y] [Citation(s) in RCA: 189] [Impact Index Per Article: 13.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/23/2011] [Indexed: 10/17/2022]
Abstract
BACKGROUND DepoFoam® bupivacaine (Pacira Pharmaceuticals, Inc., San Diego, CA, USA), an extended-release liposomal bupivacaine-based analgesic, was compared with placebo for the prevention of pain after bunionectomy in a randomized, multicenter, double-blind phase 3 clinical study. METHODS Patients received placebo (n = 96) or DepoFoam bupivacaine 120 mg (n = 97) via wound infiltration prior to closure. Pain intensity was assessed using a numeric rating scale (NRS) from time 0 through to 72 hours postsurgically. The primary efficacy measure was area under the curve (AUC) of NRS scores through 24 hours. Other efficacy measures included AUC of NRS at other time points, proportion of patients who were pain-free, time to first opioid use, and total postsurgical consumption of supplemental opioid medication. Adverse events were also assessed. RESULTS The AUC for NRS scores was significantly less in patients treated with DepoFoam bupivacaine versus patients receiving placebo at 24 hours (P = 0.0005) and 36 hours (P < 0.0229). More patients treated with DepoFoam bupivacaine avoided use of opioid rescue medication during the first 24 hours (7.2% vs. 1%; P < 0.0404) and were pain-free (NRS ≤ 1) at 2, 4, 8, and 48 hours. Median time-to-first-opioid use was delayed in favor of DepoFoam bupivacaine (4.3 vs. 7.2 hours; P < 0.0001). Fewer adverse events were reported by patients treated with DepoFoam bupivacaine (59.8%) versus placebo (67.7%). CONCLUSIONS DepoFoam bupivacaine, a long-acting local analgesic, provided extended pain relief and decreased opioid use after bunionectomy, compared with placebo.
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Rothwell M, Pearson D, Hunter J, Mitchell P, Graham-Woollard T, Goodwin L, Dunn G. Oral oxycodone offers equivalent analgesia to intravenous patient-controlled analgesia after total hip replacement: a randomized, single-centre, non-blinded, non-inferiority study. Br J Anaesth 2011; 106:865-72. [DOI: 10.1093/bja/aer084] [Citation(s) in RCA: 36] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/24/2022] Open
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Hartrick CT, Rozek RJ. Tapentadol in pain management: a μ-opioid receptor agonist and noradrenaline reuptake inhibitor. CNS Drugs 2011; 25:359-70. [PMID: 21476608 DOI: 10.2165/11589080-000000000-00000] [Citation(s) in RCA: 80] [Impact Index Per Article: 5.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/03/2023]
Abstract
Several mechanisms can be proposed to explain an apparent synergistic analgesic action between μ-opioid and α(2)-adrenergic receptor agonists. Combining both effects in a single molecule eliminates the potential for drug-drug interactions inherent in multiple drug therapy. Tapentadol is the first US FDA-approved centrally acting analgesic having both μ-opioid receptor agonist and noradrenaline (norepinephrine) reuptake inhibition activity with minimal serotonin reuptake inhibition. This dual mode of action may make tapentadol particularly useful in the treatment of neuropathic pain. Having limited protein binding, no active metabolites and no significant microsomal enzyme induction or inhibition, tapentadol has a limited potential for drug-drug interactions. Clinical trial evidence in acute and chronic non-cancer pain and neuropathic pain supports an opioid-sparing effect that reduces some of the typical opioid-related adverse effects. Specifically, the reduction in treatment-emergent gastrointestinal adverse effects for tapentadol compared with equianalgesic pure μ-opioid receptor agonists results in improved tolerability and adherence to therapy for both the immediate- and extended-release formulations of tapentadol.
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Affiliation(s)
- Craig T Hartrick
- Department of Health Sciences, Oakland University, Rochester, Michigan, USA.
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