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Attachment 9.Pdf Kyowa Hakko U.S.A., Inc. Dated: February 14, 2003 N-Acetyl-L-Hydroxyproline New Dietary Ingredient Notification Reference No. 9 ? Clin Rheumatol (2000) 19:99-104 0 2000 Clinical Rheulnatology Clinical Rheumatology Original Article Oxaceprol is a Well-Tolerated Therapy for Osteoarthritis with Efficacy Equivalent to Diclofenac G. Herrmann’, D. Steeger’, M. Klasser*, J. Wirbitzky’, M. Fiirst4, R. Venbrocks’, H. Rohde6, D. Jungmiche17, H. D. Hildebrandt’, M. J. Parnham9, W. Gimbell’ and H. Dirschedl’ ‘BayerischesRotes Kreuz, Orthop&discheKlinik Lindenlohe,Schwandorf; ‘Gesellschaft fur wissenschaftlicheDatenverarbeitung + Didaktik mbH, MiihlheimiMain; 3Kurpark-Klinik,Bad Schussenried;4Schlo13park-Kliniken, Bad Waldsee;‘ Orthopgdische Uniklinik am Rudolf-Elle-Krankenhaus,Eisenberg; 6Fachklinikfiir Orthopadieund Rheumatologie,Oberstdorf; 7Fachklinik fir Orthopadie,Bad Dfiben; ‘Klinik am Homberg,Bad Wildungen;“ PamhamAdvisory Services,Bonn; and “ChephasaarGmbH, St Ingbert, Germany Abstract: The therapeutic equivalence and safety of was statistically significant (p = 0.04106) for the number treatment for 21 days with 400 mg t.i.d. oxaceprol (n = of these adverse events. Oxaceprol is therapeutically 132) and 50 mg t.i.d. diclofenac (n = 131) were assessed equivalent to diclofenac, but better tolerated than in a multicentre, randomised, double-blind study of a diclofenac in the treatment of osteoarthritis. mixed population of patients with osteoarthritis of the knee and/or hip. In a per-protocol analysis of efficacy, Keywords: Diclofenac; Lequesne index; Osteoarthritis; the mean Lequesne index decreasedby 2.5 points in the Oxaceprol; Pain oxaceprol group (n = 109) and by 2.8 points in the diclofenac group (n = 109). The 95% confidence interval for the end-point difference revealed therapeutic equivalence. This was confirmed by assessments (visual analogue scale) of pain at rest, weight-bearing pain, pain on standing and pain on movement, all of Introduction which decreased to a similar extent under both treatments. The pain-free walking time increased in There is a clearly perceived need for drugs for both groups from 10 min to 25 min by the end of the osteoarthritis which act to preserve articular cartilage treatment period. Mobility was also increased to a function rather than just act to inhibit inflammatory similar extent by both drugs. The physicians assessed mediator production [ 11. treatment as good or very good in 45-46% .of patients in Oxaceprol is a drug that has been in use for several both groups. In all patients who received treatment, 28 years for the therapy of degenerative joint disease. It and 37 adverse events were reported by 25 out of 132 exhibits experimental anti-inflammatory activity but, (18.9%) and 33 out of 131 (25.2%) patients treated with unlike non-steroidal anti-inflammatory drugs @&AIDS), oxaceprol and diclofenac, respectively. In 15 patients is not an inhibitor of prostaglandin synthesis [2]. In (11.4%) with 15 adverse events in the oxaceprol group animal models, oxaceprol reduces the adherence of and 25 patients (19.1%) with 27 adverse events in the leucocytes to the blood vessel endothelium [3] and the diclofenac group, a relation to the medication was granulocyte infiltration of arthritic joints [2]. considered probable. The difference between the groups In several, controlled, double-blind studies in osteo- arthritis of the knee and hip, 1200 mglday oxaceprol has been shown to provide similar improvement in joint Correspondence and oflprint requests to: Dr Gerhard Henmann, Bayerisches Rotes Kreuz Orthopldische Klinik, Lindenlohe, D-92421 mobility and pain to 1200 mg/day ibuprofen [4,5] or 150 Schwandorf, Germany. Tel: +49-9431-888-O; Fax: +49-9431-888- mg/day diclofenac [6]. In all these studies, the incidence 685. of adverse events to oxaceprol was very low. The present 100 G. Henmann et al. study was carried out to confirm whether 1200 mg/day joint circumference, immediately before (day 1) and at oxaceprol exhibits a therapeutic equivalence to 150 mgl the end of the treatment period (day 21). An intragroup day diclofenac, a widely used NSAID, in the treatment change by day 21 of 2-3 points in the Lequesne index of osteoarthritis of the knee or hip. was to be considered as clinically relevant and a difference between treatment groups of ~2 points not clinically relevant. On days 1, 5, 10, 15 and 21, Patients and Methods subjective pain was assessedon the basis of the change in pain-free walking time, together with pain at rest, Study Design initial pain on movement, pain on active and passive movement, and pain in weight-bearing and weight- This study was a double-blind, randomised, multicentre relieving positions, all of which were assessedusing a 10 (seven centres in Germany) clinical trial comparing two cm VAS (0 = no pain, 10 = severe pain) [IO]. Both the parallel groups and was conducted in accordance with the Guidelines for Good Clinical Practice and with the physician and the patient made a global assessmentof Declaration of Helsinki. efficacy (unsatisfactory, poor, satisfactory, good, very good) at the end of the treatment. Patients Adult inpatients of both sexes were included in the Safety Variables study who were suffering from radiologically and clinically confirmed osteoarthritis of the knee or hip at a painful stage, at least one variable for pain at rest Spontaneously reported adverse events that occurred or in a weight-bearing position registering 5 points on a during the course of treatment were recorded at each 10 cm visual analogue scale (VAS), according to visit (days 5, 10, 15 and 21) and their severity and EULAR criteria [7]. Patients with rheumatoid arthritis, possible relation to the medication were assessed gout, asthma, haemolytic, gastrointestinal, cardiovascu- following coding of individual adverse events. Labora- lar, renal or other systemic disorders and any having tory variables (haematology, clinical chemistry and urine undergone a gastrointestinal operation were excluded, status) were measured at the beginning (day 1) and end together with pregnant women, subjects exhibiting of the treatment (day 21). hypersensitivity to the test medication, those treated with intra-articular corticosteroids in the previous 2 months or undergoing treatment with anticoagulants. All patients gave their written, informed consent to St@istical Analyses . inclusion in the study. Efficacy variables were evaluated on the basis of a per- Treatment protocol analysis that is more conservative than the intention-to-treat analysis in equivalence trials. All Following a washout period of 2 days or at least five patients who received treatment entered the safety times the plasma half-life of the previously administered analysis. For the primary variable, the Lequesne index, medication, patients were randomly assigned to treat- the null hypothesis that a difference of at least 2 points ment for 21 days with daily oral doses of 400 mg t.i.d. existed between the changesin the index within the two oxaceprol or 50 mg t.i.d. diclofenac, as visually identical treatment groups could be rejected when the 95% white tablets, taken during meals. If the patient had not confidence interval for the pre-/post-treatment difference received treatment for 14 days, a washout was not required. To ensure compliance, tablets were handed out between the groups was less than 2 score points. The by nursing staff. If necessary,escape medication with up confirmatory analysis was assessedusing the one-way t- to 3000 mg/day paracetamol was permitted. All patients test. In addition to the per-protocol analysis, the data received comparable daily physical therapy. were also analysed on the basis of the intention-to-treat sample. The results of the intention-to-treat analysis were tested for biometrically significant differences from Efficacy Variables the results of the per-protocol analysis. Exploratory analysis of the remaining efficacy and A full medical examination with assessmentof efficacy safety data was carried out on an end-point basis using and laboratory variables and vital signs was carried out the Mann-Whitney U-test for interval and ranked data on entry into the study. Joint pain and mobility were and the Kruskal-Wallis x2 test for categorical data. assessedusing standard validated methods [8,9]. The Differences from baseline in pain variables were primary variable was the Lequesne joint function index assessedusing the t-test. All data analysis was carried [8], which was assessed,together with the mobility of out using the programme SPSS for Windows, version the joint, by the neutral zero method and the change in 6.1. Oxaceprol as a Well-Tolerated Osteoarthritis Therapy 101 Results Table 3. Lequesne index Oxaceprol Diclofenac Putient Characten’stics Mean total score Day 1 14.0+3.5 (109) 14.Ok4.1 (109) A total of 263 patients were recruited and received Day 21 ll.Srt3.8 (110) 11.2+3.9 (109) treatment, 2 19 of whom were available for per-protocol Difference from baseline -2.5+_2.8 (109) -2.8f2.8 (109) analysis. Of the other 44 patients, 20 withdrew from the at end-point 95% confidence interval -0.377 to 1.120 study before day 14 (eight in the oxaceprol group, 12‘in for end-point difference the diclofenac group). These patients were only included in the safety analysis. Six patients among the remaining Values are means f SD of the number of patients in parentheses. 24 patients who were included in the intention-to-treat analysis (243 patients in total) withdrew from the study patients were overweight (oxaceprol: 55, diclofenac 53) between day 14 and the study end (four in the oxaceprol and 54 patients were excessively overweight (oxaceprol: group, two in the diclofenac group). In a further five 24, diclofenac: 30). patients the diagnosis was not clinically confirmed (one in the oxaceprol group, four in the diclofenac group). Ten patients were excluded from the per-protocol Lequesne index analysis because the final examination differed by more than 3 days Gem the planned date (seven in the No differences were observed between the two groups at oxaceprol group, three in the diclofenac group).
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