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
Issued Date
2024-10-17
Resource Type
eISSN
20446055
Scopus ID
2-s2.0-85206851031
Pubmed ID
39419619
Journal Title
BMJ Open
Volume
14
Issue
10
Rights Holder(s)
SCOPUS
Bibliographic Citation
BMJ Open Vol.14 No.10 (2024)
Suggested Citation
Ho K.Y., Gyanwali B., Dimayuga C., Eufemio E.M., Bernardo E., Raju G., Chong K.W., Waithayayothin K., Ona L., Castro M.A.L., Sawaddiruk P., Salvador R.C., Roohi S.A., Tangwiwat S., Wilairatana V., Oon Z.H., Gupta A., Nagrale D. 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 Vol.14 No.10 (2024). doi:10.1136/bmjopen-2024-090926 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/109359
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
Author's Affiliation
Siriraj Hospital
Manila Doctors Hospital
Faculty of Medicine, Chiang Mai University
National University Hospital
Mount Alvernia Hospital
King Chulalongkorn Memorial Hospital
Pantai Holdings Sdn Bhd
Ananda Mahidol Hospital
BJIOS Orthopaedics
A Menarini Asia Pacific Holdings Pte Ltd
The Medical City
Medical Center
Philippine Orthopedic Center
Cardinal Santos Medical Center
Manila Doctors Hospital
Faculty of Medicine, Chiang Mai University
National University Hospital
Mount Alvernia Hospital
King Chulalongkorn Memorial Hospital
Pantai Holdings Sdn Bhd
Ananda Mahidol Hospital
BJIOS Orthopaedics
A Menarini Asia Pacific Holdings Pte Ltd
The Medical City
Medical Center
Philippine Orthopedic Center
Cardinal Santos Medical Center
Corresponding Author(s)
Other Contributor(s)
Abstract
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.