All topical ketoprofen in Transfersome gel groups ( 25 mg , 50 mg and 100 mg ) had improvements in pain that were superior to all other treatment arms , and the 50 mg topical ketoprofen in Transfersome gel group had functional gains that were superior to all other treatment arms .
The majority of the adverse events were non-serious and related to skin and subcutaneous tissue disorders , with erythema being the most common .
Topical ketoprofen in Transfersome gel is an effective means of treating symptoms of knee OA , and is superior to oral celecoxib , oral placebo and topical placebo .
The most commonly reported adverse events associated with the use of topical ketoprofen in Transfersome gel were non-severe skin and subcutaneous tissue disorders .
Furthermore , as topical ketoprofen in Transfersome gel was associated with fewer adverse events when compared with oral celecoxib , and had rates of GI adverse events comparable with those of topical placebo , it may be ideal for those who are unable to take oral NSAIDs
PURPOSE Topical ketoprofen in Transfersome gel has been used for the alleviation of symptoms in osteoarthritis .
Non-steroidal anti-inflammatory drugs ( NSAIDs ) are associated with various side effects .
Topical NSAIDs are known to have a lower side-effect profile when compared with systemic administration .
The present systematic review aim ed to determine the safety and efficacy of topical ketoprofen in Transfersome gel in knee osteoarthritis ( OA ) .
A multiple-dose, open-label, safety, compliance, and usage evaluation study of epicutaneously applied Diractin (ketoprofen in Transfersome) in joint/musculoskeletal pain or soft tissue inflammation.
The risk of oral NSAID including Cox-2 inhibitors to cause gastrointestinal , renal or cardiovascular adverse events related to systemic drug exposure could be reduced by local application . But only few long-term studies have been published to show safety and efficacy for long-term use of topical NSAID s. Diractin ( formerly IDEA-033 ) is a viscous , aqueous formulation for epicutaneous application of ketoprofen based on ultra-deformable , self-regulating carrier ( Transfersome ) . This multiple-dose , open label study with treatment periods up to 18 months included 402 patients with joint pain , musculoskeletal pain , stiffness or soft tissue inflammation ( age of 61.4+/-11.5 years ) . Most of the patients suffered from osteoarthritis ( OA ) of the knee ( 68.9 % ) .  Diractin was applied epicutaneously up to twice daily with a maximum dose of 220 mg ketoprofen per a maximum of 2 application sites . The mean pain score at baseline was 5.4+/-.4 on a 10 point categorical scale . During the study the pain score progressively improved up to week 36 ( 3.5+/-1.9 ) without a substantial further change during the rest of observation period of up to 18 months . The reduction of pain scores between week 0 ( baseline ) and at all later visits was statistically significant ( P<0.0001 ) . Patients also reported an improvement of quality of life on the EUROQoL. The majority of treatment related adverse events were skin and subcutaneous tissue disorders with the highest frequency reported for erythema ( 16.7 % ) and pruritus ( 2.0 % ) . Systemic ketoprofen exposure remained low throughout the study period with plasma concentrations of less than 1 % of what was reported for a single , st and ard oral dose of 200 mg ketoprofen . There were no occurrences of treatment related serious adverse events and no remarkable changes in laboratory values or vital signs . In summary , Diractin provided adequate pain relief with a good safety and tolerability profile when used for up to 18 months ( 72 weeks )
All topical ketoprofen in Transfersome gel groups ( 25 mg , 50 mg and 100 mg ) had improvements in pain that were superior to all other treatment arms , and the 50 mg topical ketoprofen in Transfersome gel group had functional gains that were superior to all other treatment arms .
The majority of the adverse events were non-serious and related to skin and subcutaneous tissue disorders , with erythema being the most common .
Topical ketoprofen in Transfersome gel is an effective means of treating symptoms of knee OA , and is superior to oral celecoxib , oral placebo and topical placebo .
The most commonly reported adverse events associated with the use of topical ketoprofen in Transfersome gel were non-severe skin and subcutaneous tissue disorders .
Furthermore , as topical ketoprofen in Transfersome gel was associated with fewer adverse events when compared with oral celecoxib , and had rates of GI adverse events comparable with those of topical placebo , it may be ideal for those who are unable to take oral NSAIDs
PURPOSE Topical ketoprofen in Transfersome gel has been used for the alleviation of symptoms in osteoarthritis .
Non-steroidal anti-inflammatory drugs ( NSAIDs ) are associated with various side effects .
Topical NSAIDs are known to have a lower side-effect profile when compared with systemic administration .
The present systematic review aim ed to determine the safety and efficacy of topical ketoprofen in Transfersome gel in knee osteoarthritis ( OA ) .