A randomized, triple-blinded controlled clinical study with a novel disease-modifying drug combination in equine lameness-associated osteoarthritis.
Abstract: This study aimed to test a novel treatment combination (TC) (equivalent to sildenafil, mepivacaine, and glucose) with disease-modifying properties compared to Celestone® bifas® (CB) in a randomized triple-blinded phase III clinical study in horses with mild osteoarthritis (OA). Joint biomarkers (reflecting the articular cartilage and subchondral bone remodelling) and clinical lameness were used as readouts to evaluate the treatment efficacy. Unassigned: Twenty horses with OA-associated lameness in the carpal joint were included in the study and received either TC (n = 10) or CB (n = 10) drug intra-articularly-twice in the middle carpal joint with an interval of 2 weeks (visit 1 & 2). Clinical lameness was assessed both objectively (Lameness locator) and subjectively (visually). Synovial fluid and serum were sampled for quantification of the extracellular matrix (ECM) neo-epitope joint biomarkers represented by biglycan (BGN262) and cartilage oligomeric matrix protein (COMP156). Another two weeks later clinical lameness was recorded, and serum was collected for biomarkers analysis. The overall health status was compared pre and post-intervention by interviewing the trainer. Unassigned: Post-intervention, SF BGN262 levels significantly declined in TC (P = 0.002) and COMP156 levels significantly increased in CB (P = 0.002). The flexion test scores improved in the TC compared to CB (P =0.033) and also had an improved trotting gait quality (P =0.044). No adverse events were reported. Unassigned: This is the first clinical study presenting companion diagnostics assisting in identifying OA phenotype and evaluating the efficacy and safety of a novel disease-modifying osteoarthritic drug.
© 2023 The Author(s).
Publication Date: 2023-06-16 PubMed ID: 37416846PubMed Central: PMC10320210DOI: 10.1016/j.ocarto.2023.100381Google Scholar: Lookup
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- Journal Article
Summary
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The research article outlines a clinical study on a new drug combination to treat osteoarthritis in horses, compared to an existing treatment. Biomarkers for joint health and clinical lameness were used to evaluate the effectiveness of the two treatments.
Objective and Methodology
- The main aim of this research was to evaluate the impacts of a novel treatment combination (called TC in the paper, and comprised of sildenafil, mepivacaine, and glucose), against Celestone® bifas® (referred to as CB), an existing treatment. The study was randomized and triple-blinded to ensure impartial results.
- The research involved 20 horses diagnosed with osteoarthritis (OA) related lameness. These horses were randomly assigned to either the TC or the CB treatment groups. Each horse received two doses of the assigned treatment in their middle carpal joint, with a two-week gap between doses.
- The health of the horses was assessed using joint biomarkers which provide information about the health and integrity of the cartilage and bone in the joint. The researchers focused specifically on biglycan (BGN) and cartilage oligomeric matrix protein (COMP) biomarkers. Assessments were also made based on clinical lameness, using both visual and objective measures (via a device known as a Lameness Locator).
Results
- After the interventions, the researchers found that the levels of BGN significantly declined in the TC group and COMP levels significantly increased in the CB group.
- In addition to these biomarker changes, they also found the TC treatment led to improved scores in a joint flexion test (which assesses the flexibility and range of motion in the joint) and an improved trotting gait quality, compared to the CB treatment.
- No adverse events were reported in the study, suggesting both treatments were safe to use in the studied population.
Significance
- This study is the first of its kind to use companion diagnostics, a method of evaluating disease and effectiveness of treatment, in understanding the OA phenotype (characteristic) in horses and evaluating the treatment efficacy.
- The results of the study suggest that the novel drug combination tested (TC) could lead to improved outcomes in treating OA in horses.
Cite This Article
APA
Skiöldebrand E, Adepu S, Lützelschwab C, Nyström S, Lindahl A, Abrahamsson-Aurell K, Hansson E.
(2023).
A randomized, triple-blinded controlled clinical study with a novel disease-modifying drug combination in equine lameness-associated osteoarthritis.
Osteoarthr Cartil Open, 5(3), 100381.
https://doi.org/10.1016/j.ocarto.2023.100381 Publication
Researcher Affiliations
- Department of Biomedical Sciences and Veterinary Public Health, Swedish University of Agricultural Sciences, Uppsala, Sweden.
- Department of Biomedical Sciences and Veterinary Public Health, Swedish University of Agricultural Sciences, Uppsala, Sweden.
- Department of Biomedical Sciences and Veterinary Public Health, Swedish University of Agricultural Sciences, Uppsala, Sweden.
- Department of Clinical Chemistry and Transfusion Medicine, Institute of Biomedicine, Sahlgrenska University Hospital, Gothenburg University, Gothenburg, Sweden.
- Department of Clinical Chemistry and Transfusion Medicine, Institute of Biomedicine, Sahlgrenska University Hospital, Gothenburg University, Gothenburg, Sweden.
- Hallands Djursjukhus Kungsbacka Hästklinik, Älvsåkers Byväg 20, 434 95 Kungsbacka, Sweden.
- Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
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Citations
This article has been cited 1 times.- Auer U, Kelemen Z, Vogl C, von Ritgen S, Haddad R, Torres Borda L, Gabmaier C, Breteler J, Jenner F. Development, refinement, and validation of an equine musculoskeletal pain scale. Front Pain Res (Lausanne) 2023;4:1292299.
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