Objective: To compare epicutaneous ketoprofen in Transfersome (ultra-deformable vesicles, IDEA-033) versus oral celecoxib and placebo for relief of signs and symptoms in knee osteoarthritis. Methods: This was a multicentre, randomised, double-blind, controlled trial; 397 patients with knee osteoarthritis participated and 324 completed the trial. They were randomly assigned 110 mg epicutaneous ketoprofen in 4.8 g Transfersome plus oral placebo (n = 138), 100 mg oral celecoxib plus placebo gel (n = 132), or both placebo formulations (n = 127) twice daily for 6 weeks. Primary efficacy outcome measures were the changes from baseline to end of the study on the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index pain subscale, physical function subscale and patient global assessment (PGA) of response. Results: The mean WOMAC pain subscale scores in the intent to treat population were reduced by 18.2 (95% confidence interval 222
Zusammenfassung Dieses gemeinsame Positionspapier der 3 Fachgesellschaften Bundesarbeitsgemeinschaft der Akutkrankenh?user mit Abteilungen f?r fach?bergreifende Fr?hrehabilitation (BAG Fr?hrehabilitation), Berufsverband der Rehabilitations?rzte Deutschlands (BVPRM) und Deutsche Gesellschaft f?r Physikalische Medizin und Rehabilitation (DGPMR) stellt den aktuellen Stand, die Perspektiven und notwendige Ma?nahmen zur Weiterentwicklung der fach?bergreifenden Fr?hrehabilitation dar. Fr?hrehabilitation ist die fr?hestm?glich einsetzende Therapie in Kombination aus akutmedizinischer und rehabilitationsmedizinischer Behandlung. Fr?hrehabilitation ist dabei als erstes Glied einer nahtlosen Rehabilitationskette zu verstehen, gleichzeitig integraler und gesetzlich geforderter Bestandteil der Krankenhausbehandlung. Die Notwendigkeit und die Bedeutung der Fr?hrehabilitation steigen durch die demografische und die medizinisch-technische Entwicklung. Internationale Richtlinien (WHO, EU) und die nationale Gesetzgebung begr?nden ein Recht auf Fr?hrehabilitation. Das Positionspapier grenzt die fach?bergreifende Fr?hrehabilitation von der Fr?hmobilisation und der postakuten Rehabilitation ab. Ferner erfolgt die Einordnung in den Kontext weiterer Formen der Fr?hrehabilitation. Die verschiedenen Arten der Leistungserbringung, im Besonderen die bettenf?hrenden Fr?hrehabilitationsstationen (Acute Rehabilitation Units) und die Behandlung durch ein dezentrales Fr?hrehabilitationsteam (Acute Rehabilitation Team), werden dargestellt. Ziele und Aufgaben sowie strukturelle und prozessuale Voraussetzungen werden definiert. Typische Indikationen werden synoptisch dargestellt und sowohl Indikationskriterien als auch Ausschlusskriterien f?r die Indikationsstellung zur Fr?hrehabilitation daraus abgeleitet. Die Versorgungsstruktur in Deutschland und regionale Unterschiede werden analysiert und Bedarfssch?tzungen gegen?bergestellt. Aus ?konomischer Sicht wird das Finanzierungssystem der Fr?hrehabilitation im DRG-System diskutiert, das den Ressourcenaufwand derzeit nur inad?quat abbildet. Auf der Grundlage dieser Analysen werden grunds?tzliche Forderungen abgeleitet und ein Katalog konkreter Ma?nahmen zur Weiterentwicklung der Fr?hrehabilitation vorgelegt. Bereits vorhandene Ans?tze der Fr?hrehabilitation im Akutkrankenhaus sollen gest?rkt werden. Gesetzliche Vorgaben sollen umgesetzt und eine fach?bergreifende, bedarfsgerechte Versorgung mit Leistungen der Fr?hrehabilitation sichergestellt werden.
The temporary and sometimes dramatic elevations and fluctuations in IOP observed in this study, coupled with daily exposure to instrument play, puts professional wind instrument players at increased risk of developing glaucoma. Consequently, these musicians should be monitored for signs of glaucoma, especially those with co-existing risk factors.
ObjectiveTo evaluate the safety and efficacy of ketoprofen in Transfersome® gel (IDEA-033) in comparison with a ketoprofen-free vehicle (TDT 064) for the treatment of osteoarthritis (OA) of the knee.MethodsPatients with knee OA (N = 866) were randomly assigned to receive topical IDEA-033 containing 100, 50, or 25 mg ketoprofen, or TDT 064 twice daily for 12 weeks, in a double-blind trial. The primary efficacy endpoint was the change in the Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index pain subscale score. The coprimary efficacy endpoints were the WOMAC function subscale score and the patient global assessment of response to therapy. The secondary endpoints included the numeric pain rating for the first 14 days of treatment and the Outcome Measures in Rheumatology (OMERACT)-Osteoarthritis Research Society International (OARSI) responder rates.ResultsThe WOMAC pain scores were reduced by approximately 50% or more in all four groups. The 100 and 50 mg ketoprofen groups, but not the 25 mg group, showed a superior reduction in the WOMAC pain score versus the TDT 064 group (100 mg: −57.4% [P = 0.0383]; 50 mg: −57.1% [P = 0.0204]; and 25 mg: −53.4% [P = 0.3616] versus TDT 064: −49.5%). The superiority of the ketoprofen-containing formulations was not demonstrated for the WOMAC function subscale score, whereas the patient global assessment of 50 mg ketoprofen group, but not the 100 or 25 mg group, was superior to that of the TDT 064 group (P = 0.0283). Responder rates were significantly higher for all the IDEA-033 groups versus the TDT 064 group, but were high in all groups (100 mg: 88.6%; 50 mg: 86.8%; 25 mg: 88.6%; and TDT 064: 77.5%). Dermal reactions were the only relevant drug-related adverse events in all four groups.ConclusionThe 50 and 100 mg ketoprofen doses of IDEA-033 were only marginally superior to TDT 064 for reducing pain associated with knee OA. The study indicates a high treatment response to the topical ketoprofen-free vehicle TDT 064.
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, standard 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).
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