Effectiveness and Safety of Oral Dexketoprofen for Mild to Moderate Pain among Filipino Adults: A Post-marketing Surveillance Study

Abstract

Background: Studies abroad demonstrate the effectiveness and safety of dexketoprofen in various therapeutic indications. However, there has been no related study on our local population. Objectives: To evaluate the effectiveness and safety of oral dexketoprofen among Filipino adults in the treatment of mild to moderate acute pain due to musculoskeletal causes (such as osteoarthritis and low back pain), postoperative pain, headache, or dysmenorrhea in primary health care setting in the Philippines. Methods: This was a prospective observational study. Drug prescription by attending physicians was based on the drug’s Summary of Product Characteristics, which included its indications, contraindications, and precautions. Dosage prescriptions varied, depending on the nature and severity of pain on initial consultation, and physicians’ clinical judgment. Effectiveness was evaluated using Wong-Baker faces pain rating scale, clinical global impressions scale, and efficacy index; while safety was evaluated according to incidence and severity of adverse events. Results: Osteoarthritis and low back pain were the most common conditions seen by the physicians during the study period. Majority received the recommended dosage and duration of the medicine, which was 51-75 milligrams of dexketoprofen a day (56.2%) for at least 1 week (57.5%). On follow-up, there was statistically significant improvement (p<0.0001) in pain scores among patients, regardless of medical condition and dexketoprofen dosage and duration. There was low (2.8%) incidence of adverse events in the study population. Majority of side effects did not significantly interfere with daily functioning of patients. Conclusion: This study demonstrated the effectiveness and safety of oral dexketoprofen in various therapeutic indications. Majority experienced moderate or marked therapeutic effect with no to minimal side effect. No serious adverse event from intake of non-steroidal anti-inflammatory drug, particularly related to gastrointestinal and nervous system disorders was noted.