Real-world usage pattern, effectiveness and safety of oral tramadol/dexketoprofen trometamol fixed-dose combination in moderate-to-severe acute pain in Asia: a prospective, multicentre, observational study
Objectives This study aims to determine the usage pattern, effectiveness and safety of oral tramadol 75 mg and dexketoprofen trometamol 25 mg fixed-dose combination (TRAM/DKP FDC) in the short-term treatment of moderate-to-severe acute pain in real-world clinical practice in Asia.Design Real-world,...
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BMJ Publishing Group
2024-10-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/10/e090926.full |
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| author | Ankur Gupta Suwimon Tangwiwat Cesar Dimayuga Kok Yuen Ho Bibek Gyanwali Edgar Michael Eufemio Edwin Bernardo Gopinathan Raju Keen Wai Chong Kritsadakorn Waithayayothin Leonardo Ona Marc Anthony L Castro Passakorn Sawaddiruk Roehl C Salvador Sharifah Ahmad Roohi Vajara Wilairatana Zhi Hao Oon Dinesh Nagrale |
| author_facet | Ankur Gupta Suwimon Tangwiwat Cesar Dimayuga Kok Yuen Ho Bibek Gyanwali Edgar Michael Eufemio Edwin Bernardo Gopinathan Raju Keen Wai Chong Kritsadakorn Waithayayothin Leonardo Ona Marc Anthony L Castro Passakorn Sawaddiruk Roehl C Salvador Sharifah Ahmad Roohi Vajara Wilairatana Zhi Hao Oon Dinesh Nagrale |
| author_sort | Ankur Gupta |
| collection | DOAJ |
| description | Objectives This study aims to determine the usage pattern, effectiveness and safety of oral tramadol 75 mg and dexketoprofen trometamol 25 mg fixed-dose combination (TRAM/DKP FDC) in the short-term treatment of moderate-to-severe acute pain in real-world clinical practice in Asia.Design Real-world, prospective, multicentre, observational, phase IV study.Setting 13 tertiary-care hospital sites across the Philippines, Thailand, Malaysia and Singapore.Participants Adult patients aged 18–80 years prescribed TRAM/DKP FDC for the short-term (up to 5 days) treatment of moderate-to-severe acute pain.Main outcome measures Primary endpoints were the proportion of patients prescribed TRAM/DKP FDC with different types of postsurgical and non-surgical treatments, and the average dosing frequency and duration of TRAM/DKP FDC treatment. Secondary endpoints were the proportion of patients achieving ≥30% pain reduction at 8 hours post the first dose (pain severity was assessed using the 11-point Numeric Pain Rating Scale); patient satisfaction at the end of treatment (based on a 5-point Patient Global Evaluation Scale (PGE)) and safety including the incidence of adverse drug reactions (ADRs).Results Among 599 patients (median age 44 years, 61.3% female) enrolled in this study, 68.61% (n=411) were postsurgical and 31.39% (n=188) were non-surgical patients. TRAM/DKP FDC was prescribed in a diverse group of postsurgical patients (eg, orthopaedic, general and cancer surgery) as well as in non-surgical conditions (eg, lower back pain and musculoskeletal pain). In the majority of patients, TRAM/DKP FDC was prescribed every 8 hours (65.94%) and for 5 days (78.80%). There was a significant reduction in pain intensity throughout the study and 65% of patients achieved ≥30% pain reduction from baseline at 8 hours post the first dose of TRAM/DKP FDC on day 1. 95.69% of patients were satisfied with the treatment (rated good, very good and excellent on the PGE scale). Overall, 13.9% of patients reported ADRs; most were mild to moderate in severity. The most common ADRs were nausea, vomiting and dizziness.Conclusion This study showed that TRAM/DKP FDC was used in diverse types of postsurgical and non-surgical patients in the real-world setting in Asia. It effectively reduced pain and was well tolerated with a high level of patient satisfaction. |
| format | Article |
| id | doaj-art-a34b2b7088ab46bbb4e18bd53faec178 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-a34b2b7088ab46bbb4e18bd53faec1782025-08-20T03:48:31ZengBMJ Publishing GroupBMJ Open2044-60552024-10-01141010.1136/bmjopen-2024-090926Real-world usage pattern, effectiveness and safety of oral tramadol/dexketoprofen trometamol fixed-dose combination in moderate-to-severe acute pain in Asia: a prospective, multicentre, observational studyAnkur Gupta0Suwimon Tangwiwat1Cesar Dimayuga2Kok Yuen Ho3Bibek Gyanwali4Edgar Michael Eufemio5Edwin Bernardo6Gopinathan Raju7Keen Wai Chong8Kritsadakorn Waithayayothin9Leonardo Ona10Marc Anthony L Castro11Passakorn Sawaddiruk12Roehl C Salvador13Sharifah Ahmad Roohi14Vajara Wilairatana15Zhi Hao Oon16Dinesh Nagrale17Medical Affairs, A Menarini Asia Pacific Holdings Pte Ltd, SingaporeDepartment of Anesthesiology, Mahidol University Faculty of Medicine Siriraj Hospital, Bangkok, ThailandDepartment of Orthopedics, The Medical City, Pasig, PhilippinesThe Pain Clinic, Mount Alvernia Hospital, SingaporeMedical Affairs, A Menarini Asia Pacific Holdings Pte Ltd, SingaporeSports Medicine Institute, Cardinal Santos Medical Center, San Juan, PhilippinesDepartment of General Surgery, The Medical City, Pasig, PhilippinesPain Care Center, Pantai Hospital Kuala Lumpur, Kuala Lumpur, MalaysiaBJIOS Orthopaedics, SingaporeDepartment of Surgery, Ananda Mahidol Hospital, Bangkok, ThailandDepartment of Surgery, Adventist Medical Center, Manila, PhilippinesDepartment of Orthopedics, Philippine Orthopedics Institute, Quezon City, PhilippinesDepartment of Anesthesiology, Chiang Mai University Faculty of Medicine, Chiang Mai, ThailandDepartment of General Surgery, Manila Doctors Hospital, Manila, PhilippinesHand & Upper Limb Centre, Pantai Hospital Kuala Lumpur, Kuala Lumpur, MalaysiaDepartment of Orthopedics, King Chulalongkorn Memorial Hospital, Bangkok, ThailandDepartment of Anaesthesia, National University Hospital, SingaporeMedical Affairs, A Menarini Asia Pacific Holdings Pte Ltd, SingaporeObjectives This study aims to determine the usage pattern, effectiveness and safety of oral tramadol 75 mg and dexketoprofen trometamol 25 mg fixed-dose combination (TRAM/DKP FDC) in the short-term treatment of moderate-to-severe acute pain in real-world clinical practice in Asia.Design Real-world, prospective, multicentre, observational, phase IV study.Setting 13 tertiary-care hospital sites across the Philippines, Thailand, Malaysia and Singapore.Participants Adult patients aged 18–80 years prescribed TRAM/DKP FDC for the short-term (up to 5 days) treatment of moderate-to-severe acute pain.Main outcome measures Primary endpoints were the proportion of patients prescribed TRAM/DKP FDC with different types of postsurgical and non-surgical treatments, and the average dosing frequency and duration of TRAM/DKP FDC treatment. Secondary endpoints were the proportion of patients achieving ≥30% pain reduction at 8 hours post the first dose (pain severity was assessed using the 11-point Numeric Pain Rating Scale); patient satisfaction at the end of treatment (based on a 5-point Patient Global Evaluation Scale (PGE)) and safety including the incidence of adverse drug reactions (ADRs).Results Among 599 patients (median age 44 years, 61.3% female) enrolled in this study, 68.61% (n=411) were postsurgical and 31.39% (n=188) were non-surgical patients. TRAM/DKP FDC was prescribed in a diverse group of postsurgical patients (eg, orthopaedic, general and cancer surgery) as well as in non-surgical conditions (eg, lower back pain and musculoskeletal pain). In the majority of patients, TRAM/DKP FDC was prescribed every 8 hours (65.94%) and for 5 days (78.80%). There was a significant reduction in pain intensity throughout the study and 65% of patients achieved ≥30% pain reduction from baseline at 8 hours post the first dose of TRAM/DKP FDC on day 1. 95.69% of patients were satisfied with the treatment (rated good, very good and excellent on the PGE scale). Overall, 13.9% of patients reported ADRs; most were mild to moderate in severity. The most common ADRs were nausea, vomiting and dizziness.Conclusion This study showed that TRAM/DKP FDC was used in diverse types of postsurgical and non-surgical patients in the real-world setting in Asia. It effectively reduced pain and was well tolerated with a high level of patient satisfaction.https://bmjopen.bmj.com/content/14/10/e090926.full |
| spellingShingle | Ankur Gupta Suwimon Tangwiwat Cesar Dimayuga Kok Yuen Ho Bibek Gyanwali Edgar Michael Eufemio Edwin Bernardo Gopinathan Raju Keen Wai Chong Kritsadakorn Waithayayothin Leonardo Ona Marc Anthony L Castro Passakorn Sawaddiruk Roehl C Salvador Sharifah Ahmad Roohi Vajara Wilairatana Zhi Hao Oon Dinesh Nagrale Real-world usage pattern, effectiveness and safety of oral tramadol/dexketoprofen trometamol fixed-dose combination in moderate-to-severe acute pain in Asia: a prospective, multicentre, observational study BMJ Open |
| title | Real-world usage pattern, effectiveness and safety of oral tramadol/dexketoprofen trometamol fixed-dose combination in moderate-to-severe acute pain in Asia: a prospective, multicentre, observational study |
| title_full | Real-world usage pattern, effectiveness and safety of oral tramadol/dexketoprofen trometamol fixed-dose combination in moderate-to-severe acute pain in Asia: a prospective, multicentre, observational study |
| title_fullStr | Real-world usage pattern, effectiveness and safety of oral tramadol/dexketoprofen trometamol fixed-dose combination in moderate-to-severe acute pain in Asia: a prospective, multicentre, observational study |
| title_full_unstemmed | Real-world usage pattern, effectiveness and safety of oral tramadol/dexketoprofen trometamol fixed-dose combination in moderate-to-severe acute pain in Asia: a prospective, multicentre, observational study |
| title_short | Real-world usage pattern, effectiveness and safety of oral tramadol/dexketoprofen trometamol fixed-dose combination in moderate-to-severe acute pain in Asia: a prospective, multicentre, observational study |
| title_sort | real world usage pattern effectiveness and safety of oral tramadol dexketoprofen trometamol fixed dose combination in moderate to severe acute pain in asia a prospective multicentre observational study |
| url | https://bmjopen.bmj.com/content/14/10/e090926.full |
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