Multimodal Analgesia Approach in Acute Low Back Pain Management: A Phase III Study of a Novel Analgesic Combination of Etoricoxib/Tramadol
Abstract Introduction Pain and disability management are crucial for a speedy recovery. Combining analgesics with different mechanisms of action provides greater pain relief with lower doses, promoting efficient multimodal analgesia. This study evaluated the efficacy and safety between two fixed-dos...
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Adis, Springer Healthcare
2024-09-01
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| Series: | Pain and Therapy |
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| Online Access: | https://doi.org/10.1007/s40122-024-00653-y |
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| author | Miguel A. Zuqui-Ramírez Victor M. Belalcazar-López Adelfia Urenda-Quezada Alejandro González-Rebatu y González José G. Sander-Padilla Laura A. Lugo-Sánchez Ileana C. Rodríguez-Vázquez Kevin F. Rios-Brito María M. Arguedas-Núñez Emmanuel Canales-Vázquez Jorge González-Canudas |
| author_facet | Miguel A. Zuqui-Ramírez Victor M. Belalcazar-López Adelfia Urenda-Quezada Alejandro González-Rebatu y González José G. Sander-Padilla Laura A. Lugo-Sánchez Ileana C. Rodríguez-Vázquez Kevin F. Rios-Brito María M. Arguedas-Núñez Emmanuel Canales-Vázquez Jorge González-Canudas |
| author_sort | Miguel A. Zuqui-Ramírez |
| collection | DOAJ |
| description | Abstract Introduction Pain and disability management are crucial for a speedy recovery. Combining analgesics with different mechanisms of action provides greater pain relief with lower doses, promoting efficient multimodal analgesia. This study evaluated the efficacy and safety between two fixed-dose combinations (FDC): etoricoxib/tramadol compared to paracetamol/tramadol for the management of acute low back pain (LBP) in a 7-day treatment. Methods We conducted a phase IIIb, prospective, randomized, and multicenter study in patients with acute LBP treated with etoricoxib 90 mg/tramadol 50 mg (one packet of granules diluted in 100 ml of water, once a day [QD], for 7 days) or paracetamol 975 mg/tramadol 112.5 mg (one tablet of 325 mg/37.5 mg, three times a day [TID], for 7 days) to assess the efficacy (in terms of pain and disability improvement) and safety. Results One hundred and twenty-four patients were randomized to receive either etoricoxib/tramadol QD (n = 61) or paracetamol/tramadol TID (n = 63). From the magnitude of change in pain evaluations, differences were observed between the treatment groups at 3 [p = 0.054, CI 95% − 0.648 (− 0.010 to 1.306)] and 5 days (p = 0.041). The proportion of patients with a 30% reduction in Visual Analogue Scale (VAS) score was statistically significant when comparing the treatment groups on the third day of follow-up [p = 0.008, CI 95% 0.241 (0.061–0.421)]. An improvement in LBP’s disability to perform activities of daily routine (Oswestry and Roland–Morris questionnaires) was observed in both treatment groups. A total of 79 adverse events (AEs) (38 [48.1%] with etoricoxib/tramadol and 41 [51.9%] with paracetamol/tramadol) were reported. The most frequent AEs were nausea (17.7%) and dizziness (16.4%). Conclusions The results show the clinical benefits of etoricoxib/tramadol FDC, such as the sparing effect of tramadol dose per day, early therapeutic response rate compared with paracetamol/tramadol; which translates into faster pain relief, better adherence, less tramadol drug dependency, and a reduction of related AEs incidence. Trial registration ClinicalTrials.gov identifier, NCT04968158. |
| format | Article |
| id | doaj-art-fd8fd8ea89274e0290d6d8636bd6acc8 |
| institution | DOAJ |
| issn | 2193-8237 2193-651X |
| language | English |
| publishDate | 2024-09-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Pain and Therapy |
| spelling | doaj-art-fd8fd8ea89274e0290d6d8636bd6acc82025-08-20T02:49:56ZengAdis, Springer HealthcarePain and Therapy2193-82372193-651X2024-09-011361511152810.1007/s40122-024-00653-yMultimodal Analgesia Approach in Acute Low Back Pain Management: A Phase III Study of a Novel Analgesic Combination of Etoricoxib/TramadolMiguel A. Zuqui-Ramírez0Victor M. Belalcazar-López1Adelfia Urenda-Quezada2Alejandro González-Rebatu y González3José G. Sander-Padilla4Laura A. Lugo-Sánchez5Ileana C. Rodríguez-Vázquez6Kevin F. Rios-Brito7María M. Arguedas-Núñez8Emmanuel Canales-Vázquez9Jorge González-Canudas10Ícaro Investigaciones en Medicina S.A. de C.V.Ícaro Investigaciones en Medicina S.A. de C.V.Mediadvance Clinical S.A.P.I. de C.V.Clinical Research Institute S.C.Laboratorios Silanes S.A. de C.V.Laboratorios Silanes S.A. de C.V.Laboratorios Silanes S.A. de C.V.Laboratorios Silanes S.A. de C.V.Laboratorios Silanes S.A. de C.V.Laboratorios Silanes S.A. de C.V.Laboratorios Silanes S.A. de C.V.Abstract Introduction Pain and disability management are crucial for a speedy recovery. Combining analgesics with different mechanisms of action provides greater pain relief with lower doses, promoting efficient multimodal analgesia. This study evaluated the efficacy and safety between two fixed-dose combinations (FDC): etoricoxib/tramadol compared to paracetamol/tramadol for the management of acute low back pain (LBP) in a 7-day treatment. Methods We conducted a phase IIIb, prospective, randomized, and multicenter study in patients with acute LBP treated with etoricoxib 90 mg/tramadol 50 mg (one packet of granules diluted in 100 ml of water, once a day [QD], for 7 days) or paracetamol 975 mg/tramadol 112.5 mg (one tablet of 325 mg/37.5 mg, three times a day [TID], for 7 days) to assess the efficacy (in terms of pain and disability improvement) and safety. Results One hundred and twenty-four patients were randomized to receive either etoricoxib/tramadol QD (n = 61) or paracetamol/tramadol TID (n = 63). From the magnitude of change in pain evaluations, differences were observed between the treatment groups at 3 [p = 0.054, CI 95% − 0.648 (− 0.010 to 1.306)] and 5 days (p = 0.041). The proportion of patients with a 30% reduction in Visual Analogue Scale (VAS) score was statistically significant when comparing the treatment groups on the third day of follow-up [p = 0.008, CI 95% 0.241 (0.061–0.421)]. An improvement in LBP’s disability to perform activities of daily routine (Oswestry and Roland–Morris questionnaires) was observed in both treatment groups. A total of 79 adverse events (AEs) (38 [48.1%] with etoricoxib/tramadol and 41 [51.9%] with paracetamol/tramadol) were reported. The most frequent AEs were nausea (17.7%) and dizziness (16.4%). Conclusions The results show the clinical benefits of etoricoxib/tramadol FDC, such as the sparing effect of tramadol dose per day, early therapeutic response rate compared with paracetamol/tramadol; which translates into faster pain relief, better adherence, less tramadol drug dependency, and a reduction of related AEs incidence. Trial registration ClinicalTrials.gov identifier, NCT04968158.https://doi.org/10.1007/s40122-024-00653-yAcute painCoxibsDrug safetyEfficacyEtoricoxibMultimodal analgesia |
| spellingShingle | Miguel A. Zuqui-Ramírez Victor M. Belalcazar-López Adelfia Urenda-Quezada Alejandro González-Rebatu y González José G. Sander-Padilla Laura A. Lugo-Sánchez Ileana C. Rodríguez-Vázquez Kevin F. Rios-Brito María M. Arguedas-Núñez Emmanuel Canales-Vázquez Jorge González-Canudas Multimodal Analgesia Approach in Acute Low Back Pain Management: A Phase III Study of a Novel Analgesic Combination of Etoricoxib/Tramadol Pain and Therapy Acute pain Coxibs Drug safety Efficacy Etoricoxib Multimodal analgesia |
| title | Multimodal Analgesia Approach in Acute Low Back Pain Management: A Phase III Study of a Novel Analgesic Combination of Etoricoxib/Tramadol |
| title_full | Multimodal Analgesia Approach in Acute Low Back Pain Management: A Phase III Study of a Novel Analgesic Combination of Etoricoxib/Tramadol |
| title_fullStr | Multimodal Analgesia Approach in Acute Low Back Pain Management: A Phase III Study of a Novel Analgesic Combination of Etoricoxib/Tramadol |
| title_full_unstemmed | Multimodal Analgesia Approach in Acute Low Back Pain Management: A Phase III Study of a Novel Analgesic Combination of Etoricoxib/Tramadol |
| title_short | Multimodal Analgesia Approach in Acute Low Back Pain Management: A Phase III Study of a Novel Analgesic Combination of Etoricoxib/Tramadol |
| title_sort | multimodal analgesia approach in acute low back pain management a phase iii study of a novel analgesic combination of etoricoxib tramadol |
| topic | Acute pain Coxibs Drug safety Efficacy Etoricoxib Multimodal analgesia |
| url | https://doi.org/10.1007/s40122-024-00653-y |
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