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Efficacy and safety of pentosan polysulfate sodium in people with symptomatic knee osteoarthritis and dyslipidaemia: protocol of the MaRVeL trial.
Siddiq, Md Abu Bakar; Liu, Xiaoqian; Fedorova, Tatyana; Bracken, Karen; Virk, Sonika; Venkatesha, Venkatesha; Farivar, Abdolhay; Oo, Win Min; Linklater, James; Hill, David Cullis; Hunter, David J.
Afiliación
  • Siddiq MAB; Department of Rheumatology, Royal North Shore Hospital, Northern Clinical School, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia msid8426@uni.sydney.edu.au.
  • Liu X; Sydney Musculoskeletal Health, The University of Sydney, Sydney, New South Wales, Australia, Kolling Institute of Medical Research, St Leonards, New South Wales, Australia.
  • Fedorova T; Department of Rheumatology, Royal North Shore Hospital, Northern Clinical School, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.
  • Bracken K; Sydney Musculoskeletal Health, The University of Sydney, Sydney, New South Wales, Australia, Kolling Institute of Medical Research, St Leonards, New South Wales, Australia.
  • Virk S; The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.
  • Venkatesha V; Sydney Musculoskeletal Health, The University of Sydney, Sydney, New South Wales, Australia, Kolling Institute of Medical Research, St Leonards, New South Wales, Australia.
  • Farivar A; Musculoskeletal Health, Arabanoo Precinct, Kolling Institute, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.
  • Oo WM; Department of Rheumatology, Royal North Shore Hospital, Northern Clinical School, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.
  • Linklater J; Sydney Musculoskeletal Health, The University of Sydney, Sydney, New South Wales, Australia, Kolling Institute of Medical Research, St Leonards, New South Wales, Australia.
  • Hill DC; Rheumatology Department, Royal North Shore Hospital, St Leonards, New South Wales, Australia.
  • Hunter DJ; Department of Rheumatology, Royal North Shore Hospital, Northern Clinical School, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia.
BMJ Open ; 14(5): e083046, 2024 May 22.
Article en En | MEDLINE | ID: mdl-38777590
ABSTRACT

INTRODUCTION:

Knee osteoarthritis (OA) is the most prevalent arthritis type and a leading cause of chronic mobility disability. While pain medications provide only symptomatic pain relief; growing evidence suggests pentosan polysulfate sodium (PPS) is chondroprotective and could have anti-inflammatory effects in knee OA. This study aims to explore the efficacy and safety of oral PPS in symptomatic knee OA with dyslipidaemia. METHODS AND

ANALYSIS:

MaRVeL is a phase II, single-centre, parallel, superiority trial which will be conducted at Royal North Shore Hospital, Sydney, Australia. 92 participants (46 per arm) aged 40 and over with painful knee OA and mild to moderate structural change on X-ray (Kellgren and Lawrence grade 2 or 3) will be recruited from the community and randomly allocated to receive two cycles of either oral PPS or placebo for 5 weeks starting at baseline and week 11. Primary outcome will be the 16-week change in overall average knee pain severity measured using an 11-point Numeric Rating Scale. Main secondary outcomes include change in knee pain, patient global assessment, physical function, quality of life and other structural changes. A biostatistician blinded to allocation groups will perform the statistical analysis according to the intention-to-treat principle. ETHICS AND DISSEMINATION The protocol has been approved by the NSLHD Human Research Ethics Committee (HREC) (2021/ETH00315). All participants will provide written informed consent online. Study results will be disseminated through conferences, social media and academic publications. TRIAL REGISTRATION NUMBERS Australian New Zealand Clinical Trial Registry (ACTRN12621000654853); U1111-1265-3750.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Poliéster Pentosan Sulfúrico / Osteoartritis de la Rodilla / Dislipidemias Límite: Adult / Female / Humans / Male / Middle aged País/Región como asunto: Oceania Idioma: En Revista: BMJ Open Año: 2024 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Poliéster Pentosan Sulfúrico / Osteoartritis de la Rodilla / Dislipidemias Límite: Adult / Female / Humans / Male / Middle aged País/Región como asunto: Oceania Idioma: En Revista: BMJ Open Año: 2024 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Reino Unido