References of "Pavelka, K"
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See detailPharmaceutical-grade Chondroitin sulfate is as effective as celecoxib and superior to placebo in symptomatic knee osteoarthritis: the Chondroitin versus Celecoxib versus placebo trial (CONCEPT)
Reginster, Jean-Yves ULiege; Dudler, J; Blicharski, T et al

in Annals of the Rheumatic Diseases (2017), 0n line

Objectives : Chondroitin sulfate 800 mg/day (CS) pharmaceutical-grade in the management of symptomatic knee osteoarthritis consistent with the European Medicines Agency guideline. Methods: A prospective ... [more ▼]

Objectives : Chondroitin sulfate 800 mg/day (CS) pharmaceutical-grade in the management of symptomatic knee osteoarthritis consistent with the European Medicines Agency guideline. Methods: A prospective, randomised, 6-month, 3-arm, double-blind, double-dummy, placebo and celecoxib (200 mg/day)-controlled trial assessing changes in pain on a Visual Analogue Scale (VAS) and in the Lequesne Index (LI) as coprimary endpoints. Minimal-Clinically Important Improvement (MCII), Patient-Acceptable Symptoms State (PASS) were used as secondary endpoints. Results: 604 patients (knee osteoarthritis) diagnosed according to American College of Rheumalogy (ACR) criteria, recruited in five European countries and followed for 182 days. CS and celecoxib showed a greater significant reduction in pain and LI than placebo. In the intention-to-treat (ITT) population, pain reduction in VAS at day 182 in the CS group (−42.6 mm) and in celecoxib group (−39.5 mm) was significantly greater than the placebo group (−33.3 mm) (p=0.001 for CS and p=0.009 for celecoxib), while no difference observed between CS and celecoxib. Similar trend for the LI, as reduction in this metric in the CS group (−4.7) and celecoxib group (−4.6) was significantly greater than the placebo group (−3.7) (p=0.023 for CS and p=0.015 for celecoxib), no difference was observed between CS and celecoxib. Both secondary endpoints (MCII and PASS) at day 182 improved significantly in the CS and celecoxib groups. All treatments demonstrated excellent safety profiles. Conclusion: A 800 mg/day pharmaceutical-grade CS is superior to placebo and similar to celecoxib in reducing pain and improving function over 6 months in symptomatic knee osteoarthritis (OA) patients. This formulation of CS should be considered a first-line treatment in the medical management of knee OA. [less ▲]

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See detailStrontium ranelate improves osteoarthritis symptoms compared to placebo in patients with knee OA: The SEKOIA study
Bruyère, Olivier ULiege; Richette, P; Bellamy, N et al

in Osteoporosis International (2013, April), 24(Suppl.1), 49-51

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See detailEffects of Strontium ranelate on knee osteoarthritis pain : a responder analysis
Reginster, Jean-Yves ULiege; Chapurlat, R; Bellamy, N et al

in Arthritis and Rheumatism (2012), 64(S10), 110

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See detailEffect of glucosamine sulfate on health utility data in patients with knee osteoarthritis : reanalysis of two 3-year prospective studies.
Scholtissen, S.; Bruyère, Olivier ULiege; Hiligsmann, Mickaël ULiege et al

in Osteoporosis International (2009, March), 20(Suppl.1), 18

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See detailTotal Joint Replacement after Glucosamine Sulphate Treatment in Knee Osteoarthritis: Results of a Mean 8-Year Observation of Patients from Two Previous 3-Year, Randomised, Placebo-Controlled Trials
Bruyère, Olivier ULiege; Pavelka, K.; Rovati, L. C. et al

in Osteoarthritis and Cartilage (2008), 16(2), 254-60

OBJECTIVE: To assess the incidence of Total Joint Replacement (TJR) during the long-term follow-up of patients with knee osteoarthritis (OA) formerly receiving treatment with glucosamine sulphate or ... [more ▼]

OBJECTIVE: To assess the incidence of Total Joint Replacement (TJR) during the long-term follow-up of patients with knee osteoarthritis (OA) formerly receiving treatment with glucosamine sulphate or placebo. METHODS: Knee OA patients participating in two previous randomised, placebo-controlled, double-blind, 3-year trials of glucosamine sulphate and receiving treatment for at least 12 months, were systematically contacted to participate in a long-term follow-up retrospective assessment of the incidence of total knee replacement. RESULTS: Out of 340 patients with at least 12 months of treatment, 275 (i.e., 81%) could be retrieved and interviewed for the present evaluation: 131 formerly on placebo and 144 on glucosamine sulphate. There were no differences in baseline disease characteristics between groups or with the patients lost to follow-up. The mean duration of follow-up was approximately 5 years after trial termination and treatment discontinuation, making up a total of 2178 patient-years of observation (including treatment and follow-up). Total knee replacement had occurred in over twice as many patients from the placebo group, 19/131 (14.5%), than in those formerly receiving glucosamine sulphate, 9/144 (6.3%) (P=0.024, chi-square test), with a Relative Risk that was therefore 0.43 (95% confidence interval (CI): 0.20-0.92), i.e., a 57% decrease compared with placebo. The Kaplan Meier/Log-Rank test survival analysis confirmed a significantly decreased (P=0.026) cumulative incidence of total knee replacements in patients who had received glucosamine sulphate. A pharmacoeconomic analysis in a subgroup of subjects suggested that patients formerly on glucosamine sulphate had recurred to less symptomatic medications and use of other health resources than those from the placebo group during the last year of follow-up. CONCLUSIONS: Treatment of knee OA with glucosamine sulphate for at least 12 months and up to 3 years may prevent TJR in an average follow-up of 5 years after drug discontinuation. [less ▲]

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See detailTotal joint replacement after glucosamine sulfate treatment of knee osteoarthritis: results from a 8-year prospective cohort
Bruyère, Olivier ULiege; Pavelka, K.; Rovati, Lucio C et al

in Osteoporosis International (2007, March), 18(Suppl.1), 81

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See detailCommentary: osteoarthritis of the knee and glucosamine
Altman, R. D.; Abramson, S.; Bruyère, Olivier ULiege et al

in Osteoarthritis and Cartilage (2006), 14(10), 963-966

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See detailClinical significance of the long-term symptom-modifying effects of glucosamine sulfate: comment on the article by Brandt and Mazzuca
Bruyère, Olivier ULiege; Reginster, Jean-Yves ULiege; Giacovelli, Giampaolo et al

in Arthritis and Rheumatism (2006), 54(7), 2339-2341

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See detailEffect of glucosamine sulfate on newly proposed/recommended clinical trial end-points in patients with knee osteoarthritis
Bruyère, Olivier ULiege; Giacovelli, G.; Pavelka, K. et al

in Osteoporosis International (2006, March), 17(Suppl.1), 13

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See detailAssessment of joint space narrowing with conventional standing antero-posterior radiographs: relief in mild-to-moderate pain is not a confounder in recent osteoarthritis structure-modifying drug trials
Rovati, L. C.; Pavelka, K.; Giacovelli, G. et al

in Osteoarthritis and Cartilage (2006), 14(Suppl. A), 14-18

Objective: Knee pain relief has been suggested to potentially alter radioanatomic positioning in conventional standing antero-posterior knee radiographs. This study was performed to determine whether this ... [more ▼]

Objective: Knee pain relief has been suggested to potentially alter radioanatomic positioning in conventional standing antero-posterior knee radiographs. This study was performed to determine whether this is always the case and in particular if it applied to two recent randomised, placebo-controlled trials showing both symptom- and structure-modification with glucosamine sulfate in knee osteoarthritis. Design: Patients in the two studies were selected if they completed the 3-year evaluations and, irrespectively of treatment, (1) were pain-improvers in that they underwent Western Ontario and McMaster Universities (WOMAC) osteoarthritis index (WOMAC) pain decrease at least equal to the mean improvement observed with glucosamine sulfate, or (2) if their baseline standing knee pain (item #5 of the WOMAC pain scale) was "severe" or "extreme" and improved by any degree at the end of the trials. Changes in minimum joint space width were then compared between treatments. Results: Knee pain was of mild-to-moderate severity in the two original studies and in all patient subsets identified here. Obviously, there were more pain-improvers in the glucosamine sulfate than in the placebo subsets (N 76 vs 57 in pooling the two studies), but WOMAC pain scores improved to the same extent (over 50% relative to baseline). Notwithstanding such a major pain relief, patients in the placebo subsets of both studies suffered a definite mean (SE) joint space narrowing, that was of -0.22 (0.15) mm in the pooled analysis, and that was not observed with glucosamine sulfate: +0.15 (0.07) mm; P= 0.003. Similar evidence was found in the smaller subsets with at least severe baseline standing knee pain improving after 3 years. Conclusions: Knee pain relief did not bias the report of a structure-modifying effect of glucosamine sulfate in two recent long-term trials, possibly due to the mild-to-moderate patient characteristics. Consensus deliverables should acknowledge that the potential limitations of conventional standing antero-posterior radiographs should not be overestimated since they may not apply to all patient populations and to all studies using this gold standard technique. (C) 2006 OsteoArthritis Research Society International. Published by Elsevier Ltd. All rights reserved. [less ▲]

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See detailTotal joint replacement of hip or knee as an outcome measure for structure modifying trials in osteoarthritis
Altman, R. D.; Abadie, Eric ULiege; Avouac, B. et al

in Osteoporosis International (2005, March), 16(Suppl.3), 10

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See detailResponders to glucosamine sulfate in knee osteoarthritis
Bruyère, Olivier ULiege; Pavelka, K.; Richy, Florent et al

in Osteoporosis International (2005, March), 16(Suppl.3), 77

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See detailTotal joint replacement of hip or knee as an outcome measure for structure modifying trials in osteoarthritis
Altman, R. D.; Abadie, Eric ULiege; Avouac, B. et al

in Osteoarthritis and Cartilage (2005), 13(1), 13-19

Objective: The Group for the Respect of Ethics and Excellence in Science (GREES) organized a working group to assess the value of time to joint surgery as a potential therapeutic failure outcome criterion ... [more ▼]

Objective: The Group for the Respect of Ethics and Excellence in Science (GREES) organized a working group to assess the value of time to joint surgery as a potential therapeutic failure outcome criterion for osteoarthritis (OA) of the hip or knee in the assessment of potential structure modifying agents. Methods: PubMed was searched for manuscripts from 1976 to 2004. Relevant studies were discussed at a 1-day meeting. Results: There are no accepted guidelines for 'time to' and 'indications for' joint replacement surgery. A limited number of trials have examined joint replacement surgery within the study population. Several parameters, particularly joint space narrowing (interbone distance), correlate with surgical intervention. However, at the level of the knee, none of the parameters have positive predictive value for joint replacement surgery better than 30%. In contrast, lack of significant joint space narrowing has a strong negative predictive value for joint replacement surgery (> 90%), that remains after controlling for OA pain severity. Conclusion: At this time, GREES cannot recommend time to joint surgery as a primary endpoint of failure for structure modifying trials of hip or knee OA-as the parameter has sensitivity but lacks specificity. In contrast, in existing trials, a lack of progression of joint space narrowing has predictive value of > 90% for not having surgery. GREES suggests utilizing joint space narrowing (e.g., > 0.3-0.7 mm) combined with a lack of clinically relevant improvement in symptoms (e.g., greater than or equal to 20-25%) for 'failure' of a secondary outcome in structure modifying trials of the hip and knee. (C) 2004 OsteoArthritis Research Society International. Published by Elsevier Ltd. All rights reserved. [less ▲]

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See detailClinical relevance of pain and function outcomes in glucosamine sulfate long-term trials
Giacovelli, G.; Bruyère, Olivier ULiege; Barbetta, B. et al

in Osteoarthritis and Cartilage (2005), 13(A), 69

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See detailTherapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial
Klareskog, L.; van der Heijde, D.; de Jager, J. P. et al

in Lancet (2004), 363(9410), 675-681

Background Etanercept and methotrexate are effective in the treatment of rheumatoid arthritis but no data exist on concurrent initiation or use of the combination compared with either drug alone. We aimed ... [more ▼]

Background Etanercept and methotrexate are effective in the treatment of rheumatoid arthritis but no data exist on concurrent initiation or use of the combination compared with either drug alone. We aimed to assess combination treatment with etanercept and methotrexate versus the monotherapies in patients with rheumatoid arthritis. Methods In a double-blind, randomised, clinical efficacy, safety, and radiographic study, 686 patients with active rheumatoid arthritis were randomly allocated to treatment with etanercept 25 mg (subcutaneously twice a week), oral methotrexate (up to 20 mg every week), or the combination. Clinical response was assessed by criteria of the American College of Rheumatology (ACR). The primary efficacy endpoint was the numeric index of the ACR response (ACR-N) area under the curve (AUC) over the first 24 weeks. The primary radiographic endpoint was change from baseline to week 52 in total joint damage and was assessed with the modified Sharp score. Analysis was by intention to treat. Findings Four patients did not receive any drug; thus 682 were studied. ACR-N AUC at 24 weeks was greater for the combination group compared with etanercept alone and methotrexate alone (18.3% years [95% CI 17.1-19.6] vs 14.7%-years [13.5-16.0], p<0.0001, and 12.2%-years [11.0-13.4], p<0.0001; respectively). The mean difference in ACR-N AUC between combination and methotrexate alone was 6.1 (95% CI 4.5-7.8, p<0.0001) and between etanercept and methotrexate was 2.5 (0.8-4.2, p=0.0034). The combination was more efficacious than methotrexate or etanercept alone in retardation of joint damage (mean total Sharp score -0.54 [95% CI -1.00 to -0.07] vs 2.80 [1.08 to 4.51], p<0.0001, and 0.52 [-0.10 to 1.15], p=0.0006; respectively). The mean difference in total Sharp score between combination and methotrexate alone was -3.34 (95% CI -4.86 to -1.81, p<0.0001) and between etanercept and methotrexate was -2.27 (-3.81 to -0.74, p=0.0469). The number of patients reporting infections or adverse events was similar in all groups. Interpretation The combination of etanercept and methotrexate was significantly better in reduction of disease activity, improvement of functional disability, and retardation of radiographic progression compared with methotrexate or etanercept alone. These findings bring us closer to achievement of remission and repair of structural damage in rheumatoid arthritis. [less ▲]

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See detailResponders to glucosamine sulfate in knee osteoarthritis
Bruyère, Olivier ULiege; Pavelka, K.; Richy, F. et al

in Osteoporosis International (2004), 12(SB), 76

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See detailGlucosamine sulfate reduces osteoarthritis progression in postmenopausal women with knee osteoarthritis: evidence from two 3-year studies
Bruyère, Olivier ULiege; Pavelka, K.; Rovati, Lucio C et al

in Menopause (2004), 11(2), 138-143

OBJECTIVE: To investigate the effect of glucosamine sulfate on long-term symptoms and structure progression in postmenopausal women with knee osteoarthritis (OA). DESIGN: This study consisted of a ... [more ▼]

OBJECTIVE: To investigate the effect of glucosamine sulfate on long-term symptoms and structure progression in postmenopausal women with knee osteoarthritis (OA). DESIGN: This study consisted of a preplanned combination of two three-year, randomized, placebo-controlled, prospective, independent studies evaluating the effect of glucosamine sulfate on symptoms and structure modification in OA and post-hoc analysis of the results obtained in postmenopausal women with knee OA. Minimal joint space width was assessed at baseline and after 3 years from standing anteroposterior knee radiographs. Symptoms were scored by the algo-functional WOMAC index at baseline and after 3 years. All primary statistical analyses were performed in intention-to-treat, comparing joint space width and WOMAC changes between groups by ANOVA. RESULTS: Of 414 participants randomized in the two studies, 319 were postmenopausal women. At baseline, glucosamine sulfate and placebo groups were comparable for demographic and disease characteristics, both in the general population and in the postmenopausal women subset. After 3 years, postmenopausal participants in the glucosamine sulfate group showed no joint space narrowing [joint space change of +0.003 mm (95% CI, -0.09 to 0.11)], whereas participants in the placebo group experienced a narrowing of -0.33 mm (95% CI, -0.44 to -0.22; P < 0.0001 between the two groups). Percent changes after 3 years in the WOMAC index showed an improvement in the glucosamine sulfate group [-14.1% (95%, -22.2 to -5.9)] and a trend for worsening in the placebo group (5.4% (95% CI, -4.9 to 15.7) (P = 0.003 between the two groups). CONCLUSION: This analysis, focusing on a large cohort of postmenopausal women, demonstrated for the first time that a pharmacological intervention for OA has a disease-modifying effect in this particular population, the most frequently affected by knee OA. [less ▲]

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See detailGlucosamine sulfate reduces osteoarthritis progression in postmenopausal women with knee osteoarthritis: evidence from two large, randomised, placebo-controlled, double-blind, 3-year studies
Bruyère, Olivier ULiege; Pavelka, K.; Rovati, Lucio C et al

in Osteoporosis International (2003, November), 14(Suppl. 7), 62

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See detailRelief in mild-to-moderate pain is not a confounder in joint space narrowing assessment of full extension knee radiographs in recent osteoarthritis structure modifying drug trials
Pavelka, K.; Bruyère, Olivier ULiege; Rovati, Lucio C et al

in Osteoporosis International (2003, November), 14(Suppl. 7), 62-63

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