Dexketoprofen Trometamol versus Diclofenac for Arthritis
Dexketoprofen Trometamol versus Diclofenac for Arthritis
Background: Dexketoprofen trometamol (DKP.TRIS) is the tromethamine salt of dexketoprofen, the S-enantiomer responsible for the pharmacological activity of ketoprofen. DKP.TRIS has rapid absorption and onset of action in pain relief. Objective: To compare the efficacy and tolerability of DKP.TRIS and diclofenac, a nonsteroidal anti-inflammatory drug widely accepted as reference therapy for symptomatic treatment of osteoarthritis, in patients with chronic pain due to knee osteoarthritis.
Design: This was a multicentre, randomised, comparative, double-blind study.
Methods: Radiological evidence of osteoarthritis, shown by the presence of Kellgren grade 2 to 4 changes, was required. Patients were evaluated before and after a washout period of 7 to 14 days and after 1 and 2 weeks of treatment with DKP.TRIS 25mg three times daily orally or diclofenac 50mg three times daily orally. Primary end-points were reduction of pain measured on a visual analogue scale (VAS, 0 to 100mm) and disability measured by the Lequesne index of severity for knee osteoarthritis (ISK). Tolerability was evaluated by laboratory parameters and frequency and nature of adverse events. Results: Of 117 patients recruited to the study, 115 were treated (61 with DKP.TRIS, 54 with diclofenac) and 99 (54/45) completed the 2-week treatment period. Patient characteristics were homogenous between groups. Pain measured on the VAS decreased by 43% from 61.7 ±18.5mm (mean ±SD) at baseline to 34.7 ±22.3mm at the end of treatment with DKP.TRIS compared with a 29% decrease from 62.1 ±22.7mm to 40.6 ±22.2mm for diclofenac [p = 0.027; 95% confidence interval (CI) for the difference between treatments: 1.7, 27.9]. Median ISK scores improved from 11 (range 9 to 12) to 8 (6 to 10) in the DKP.TRIS group versus 10.75 (9 to 12.5) to 8.5 (6 to 10.5) in the diclofenac group. There were no group differences for secondary end-points. Adverse events were comparable overall between groups.
Conclusion: Oral DKP.TRIS 25mg three times daily is at least as effective as diclofenac 50mg three times daily for the short term treatment of pain in patients with osteoarthritis of the knee.
Osteoarthritis is a common form of arthritis seen in weight-bearing and frequently used joints such as the knee, hand and hip. It affects both men and women and has an increasing prevalence with age, being nearly universal beyond the age of 75 years. Pain is the predominant symptom, which is aggravated by motion. Stiffness occurs after periods of inactivity. The main current therapeutic goals for osteoarthritis are management of pain and improvement of functional capacity, the latter usually being achieved only when a certain degree of pain relief has been established.
Dexketoprofen trometamol (DKP.TRIS) is the water-soluble tromethamine salt formulation of dexketoprofen, a nonsteroidal anti-inflammatory drug (NSAID). Several clinical trials have been conducted with DKP.TRIS using different models of acute and chronic pain. A previous randomised study established the suitability of knee osteoarthritis as a pain model for assessing the analgesic efficacy of DKP.TRIS 25mg three times daily orally compared with racemic ketoprofen 50mg three times daily orally, which is the regimen of racemic ketoprofen currently in use for this indication.
In line with recommendations for the assessment of analgesic drugs, the present study was performed in patients with knee osteoarthritis comparing the efficacy and tolerability of DKP.TRIS and diclofenac, an NSAID widely accepted as reference therapy for symptomatic treatment of osteoarthritis. The study design conformed to the Guidelines for the Clinical Investigation of Drugs used in Rheumatic Diseases (European League Against Rheumatism) and to the Guidelines for the Clinical Evaluation of Antiinflammatory and Antirheumatic Drugs (FDA). The primary objective of this study was to compare the effects of DKP.TRIS 25mg three times daily orally versus diclofenac 50mg three times daily orally on pain, as measured on a visual analogue scale (VAS), and on functional ability, as measured by the Lequesne index of severity of knee osteoarthritis (ISK), at weeks 1 and 2 of treatment. Other objectives were to compare the overall assessment of efficacy made by the physician and patient, the daily assessment by the patient of pain intensity during the first week of treatment, use of rescue medication and the tolerability of the study treatments.
Background: Dexketoprofen trometamol (DKP.TRIS) is the tromethamine salt of dexketoprofen, the S-enantiomer responsible for the pharmacological activity of ketoprofen. DKP.TRIS has rapid absorption and onset of action in pain relief. Objective: To compare the efficacy and tolerability of DKP.TRIS and diclofenac, a nonsteroidal anti-inflammatory drug widely accepted as reference therapy for symptomatic treatment of osteoarthritis, in patients with chronic pain due to knee osteoarthritis.
Design: This was a multicentre, randomised, comparative, double-blind study.
Methods: Radiological evidence of osteoarthritis, shown by the presence of Kellgren grade 2 to 4 changes, was required. Patients were evaluated before and after a washout period of 7 to 14 days and after 1 and 2 weeks of treatment with DKP.TRIS 25mg three times daily orally or diclofenac 50mg three times daily orally. Primary end-points were reduction of pain measured on a visual analogue scale (VAS, 0 to 100mm) and disability measured by the Lequesne index of severity for knee osteoarthritis (ISK). Tolerability was evaluated by laboratory parameters and frequency and nature of adverse events. Results: Of 117 patients recruited to the study, 115 were treated (61 with DKP.TRIS, 54 with diclofenac) and 99 (54/45) completed the 2-week treatment period. Patient characteristics were homogenous between groups. Pain measured on the VAS decreased by 43% from 61.7 ±18.5mm (mean ±SD) at baseline to 34.7 ±22.3mm at the end of treatment with DKP.TRIS compared with a 29% decrease from 62.1 ±22.7mm to 40.6 ±22.2mm for diclofenac [p = 0.027; 95% confidence interval (CI) for the difference between treatments: 1.7, 27.9]. Median ISK scores improved from 11 (range 9 to 12) to 8 (6 to 10) in the DKP.TRIS group versus 10.75 (9 to 12.5) to 8.5 (6 to 10.5) in the diclofenac group. There were no group differences for secondary end-points. Adverse events were comparable overall between groups.
Conclusion: Oral DKP.TRIS 25mg three times daily is at least as effective as diclofenac 50mg three times daily for the short term treatment of pain in patients with osteoarthritis of the knee.
Osteoarthritis is a common form of arthritis seen in weight-bearing and frequently used joints such as the knee, hand and hip. It affects both men and women and has an increasing prevalence with age, being nearly universal beyond the age of 75 years. Pain is the predominant symptom, which is aggravated by motion. Stiffness occurs after periods of inactivity. The main current therapeutic goals for osteoarthritis are management of pain and improvement of functional capacity, the latter usually being achieved only when a certain degree of pain relief has been established.
Dexketoprofen trometamol (DKP.TRIS) is the water-soluble tromethamine salt formulation of dexketoprofen, a nonsteroidal anti-inflammatory drug (NSAID). Several clinical trials have been conducted with DKP.TRIS using different models of acute and chronic pain. A previous randomised study established the suitability of knee osteoarthritis as a pain model for assessing the analgesic efficacy of DKP.TRIS 25mg three times daily orally compared with racemic ketoprofen 50mg three times daily orally, which is the regimen of racemic ketoprofen currently in use for this indication.
In line with recommendations for the assessment of analgesic drugs, the present study was performed in patients with knee osteoarthritis comparing the efficacy and tolerability of DKP.TRIS and diclofenac, an NSAID widely accepted as reference therapy for symptomatic treatment of osteoarthritis. The study design conformed to the Guidelines for the Clinical Investigation of Drugs used in Rheumatic Diseases (European League Against Rheumatism) and to the Guidelines for the Clinical Evaluation of Antiinflammatory and Antirheumatic Drugs (FDA). The primary objective of this study was to compare the effects of DKP.TRIS 25mg three times daily orally versus diclofenac 50mg three times daily orally on pain, as measured on a visual analogue scale (VAS), and on functional ability, as measured by the Lequesne index of severity of knee osteoarthritis (ISK), at weeks 1 and 2 of treatment. Other objectives were to compare the overall assessment of efficacy made by the physician and patient, the daily assessment by the patient of pain intensity during the first week of treatment, use of rescue medication and the tolerability of the study treatments.
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