Vandit Sardana1, Joanna Burzynski2, Paul Zalzal1. 1. Division of Orthopedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada. 2. School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada.
Abstract
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 aimed to determine the safety and efficacy of topical ketoprofen in Transfersome gel in knee osteoarthritis (OA). METHODS: A systematic literature review was performed. The electronic databases EMBASE, MEDLINE, HealthStar and PubMed were searched from 1946 to June 2016. A screen of the reference sections of the included studies was also performed. Two blinded reviewers searched, screened, abstracted and evaluated the data quality using the Jadad scale. Studies were included if they contained: at least 50% of participants with knee OA, topical ketoprofen, human subjects and participants from North America or Europe. Study outcomes had to include patient-reported functional outcome scores. RESULTS: Five studies were included, with a total of 3619 participants, and a mean Jadad score of 3.4/5. Western Ontario McMaster Universities (WOMAC) Osteoarthritis Index was the only outcome measure consistent across all of the randomized controlled trials included in the present review (four of the five included studies). 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. The average of all adverse events and gastrointestinal (GI) adverse events was highest in the oral celecoxib group (47.1% and 15.1%, respectively). The average frequency of GI adverse events in the topical ketoprofen groups was comparable with that in the topical placebo treatment arm. A meta-analysis was not feasible due to the heterogeneity among the studies. CONCLUSIONS: 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 aimed to determine the safety and efficacy of topical ketoprofen in Transfersome gel in knee osteoarthritis (OA). METHODS: A systematic literature review was performed. The electronic databases EMBASE, MEDLINE, HealthStar and PubMed were searched from 1946 to June 2016. A screen of the reference sections of the included studies was also performed. Two blinded reviewers searched, screened, abstracted and evaluated the data quality using the Jadad scale. Studies were included if they contained: at least 50% of participants with knee OA, topical ketoprofen, human subjects and participants from North America or Europe. Study outcomes had to include patient-reported functional outcome scores. RESULTS: Five studies were included, with a total of 3619 participants, and a mean Jadad score of 3.4/5. Western Ontario McMaster Universities (WOMAC) Osteoarthritis Index was the only outcome measure consistent across all of the randomized controlled trials included in the present review (four of the five included studies). 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. The average of all adverse events and gastrointestinal (GI) adverse events was highest in the oral celecoxib group (47.1% and 15.1%, respectively). The average frequency of GI adverse events in the topical ketoprofen groups was comparable with that in the topical placebo treatment arm. A meta-analysis was not feasible due to the heterogeneity among the studies. CONCLUSIONS: 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.
Authors: Amir Vahedian-Azimi; Sajad Shojaie; Maciej Banach; Farshad Heidari; Arrigo F G Cicero; Masoum Khoshfetrat; Tannaz Jamialahmadi; Amirhossein Sahebkar Journal: Ann Med Date: 2021-12 Impact factor: 4.709