CLINICAL EFFICIENCY AND SAFETY OF FENOFIBRATE, A PPARα AGONIST, IN THE PATIENTS WITH DIABETESASSOCIATED OSTEOARTHRITIS: A CROSS-OVER PILOT STUDY

Sixteen female patients with diabetes-associated osteoarthritis (DAOA) participated in an openlabel, randomized, cross-over study. The mean patients’ age was 65.5 (±5.4) years, the patients were obese (mean body mass index, 35.8±5.7 kg/m2 ). They suffered from durable osteoarthritis (14.5±7.6 years)...

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Autores principales:	V. S. Shirinsky, E. V. Kazygasheva, N. Yu. Kalynovskaya, I. V. Shirinsky
Formato:	article
Lenguaje:	RU
Publicado:	SPb RAACI 2017
Materias:	osteoarthritis comorbidity type 2 diabetes peroxisome proliferator-activated receptors α lipids cytokines inflammation Immunologic diseases. Allergy RC581-607
Acceso en línea:	https://doaj.org/article/9100c7cc1e40494ca866e45e63e639ba
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spelling	oai:doaj.org-article:9100c7cc1e40494ca866e45e63e639ba2021-11-18T08:03:46ZCLINICAL EFFICIENCY AND SAFETY OF FENOFIBRATE, A PPARα AGONIST, IN THE PATIENTS WITH DIABETESASSOCIATED OSTEOARTHRITIS: A CROSS-OVER PILOT STUDY1563-06252313-741X10.15789/1563-0625-2017-2-165-174https://doaj.org/article/9100c7cc1e40494ca866e45e63e639ba2017-05-01T00:00:00Zhttps://www.mimmun.ru/mimmun/article/view/1219https://doaj.org/toc/1563-0625https://doaj.org/toc/2313-741XSixteen female patients with diabetes-associated osteoarthritis (DAOA) participated in an openlabel, randomized, cross-over study. The mean patients’ age was 65.5 (±5.4) years, the patients were obese (mean body mass index, 35.8±5.7 kg/m2 ). They suffered from durable osteoarthritis (14.5±7.6 years) associated with diabetes mellitus (13.08±3.43 years). Clinical and radiographic signs of knee OA were observed in 100% of the cases, all the patients had Kellgren–Lawrence grade III radiographic changes. First group of patients (n = 9) was randomized to Fenofibrate (145 mg/day for 12 weeks), the second group (n = 7) received chondroitine sulfate (1000 mg/day for 12 weeks). Then, following a two-week washout period, the first group was switched to chondroitine sulfate and the second group, to fenofibrate. Clinical examination was performed monthly, and laboratory evaluation was performed at the baseline and by the end of each treatment course. pain level according to VAS scale was used as the primary endpoint, whereas KOOS, WOMAC, ICOAP and other scores served as secondary endpoints. We have also assessed effects of Fenofibrate upon serum biomarkers (IL-6, IL-18, IL-10, lipid profiles, and CRP concentrations). Comparative effect of Fenofibrate was evaluated by means of generalized estimating equation (GEE) models adjusted for the treatment sequence. It was shown that clinical effects of Fenofibrate in patients with DAOA did not significantly differ from those of chondroitine sulfate. However, fenofibrate had broader spectrum of effects including improvement of lipid profiles. E.g., Fenofibrate treatment was associated with increased HDL levels (β coefficient, -0.19; р = 0.02), a decrease in total cholesterol (β coefficient, -0.78; р = 0.01), and triglycerides (β coefficient,0.85; р = 0.002). In addition, Fenofibrate therapy was associated with a decrease in ESR, a laboratory biomarker of systemic inflammation (β coefficient, -7.76; р = 0.01). Cytokine changes following the Fenofibrate treatment did not differ from those registered after chondroitine sulfate therapy. In conclusion, the results of this pilot study provide a rationale for further studies of PPARα agonists and their pleiotropic effects in large-scale controlled clinical trials.V. S. ShirinskyE. V. KazygashevaN. Yu. KalynovskayaI. V. ShirinskySPb RAACIarticleosteoarthritiscomorbiditytype 2 diabetesperoxisome proliferator-activated receptors αlipidscytokinesinflammationImmunologic diseases. AllergyRC581-607RUMedicinskaâ Immunologiâ, Vol 19, Iss 2, Pp 165-174 (2017)
institution	DOAJ
collection	DOAJ
language	RU
topic	osteoarthritis comorbidity type 2 diabetes peroxisome proliferator-activated receptors α lipids cytokines inflammation Immunologic diseases. Allergy RC581-607
spellingShingle	osteoarthritis comorbidity type 2 diabetes peroxisome proliferator-activated receptors α lipids cytokines inflammation Immunologic diseases. Allergy RC581-607 V. S. Shirinsky E. V. Kazygasheva N. Yu. Kalynovskaya I. V. Shirinsky CLINICAL EFFICIENCY AND SAFETY OF FENOFIBRATE, A PPARα AGONIST, IN THE PATIENTS WITH DIABETESASSOCIATED OSTEOARTHRITIS: A CROSS-OVER PILOT STUDY
description	Sixteen female patients with diabetes-associated osteoarthritis (DAOA) participated in an openlabel, randomized, cross-over study. The mean patients’ age was 65.5 (±5.4) years, the patients were obese (mean body mass index, 35.8±5.7 kg/m2 ). They suffered from durable osteoarthritis (14.5±7.6 years) associated with diabetes mellitus (13.08±3.43 years). Clinical and radiographic signs of knee OA were observed in 100% of the cases, all the patients had Kellgren–Lawrence grade III radiographic changes. First group of patients (n = 9) was randomized to Fenofibrate (145 mg/day for 12 weeks), the second group (n = 7) received chondroitine sulfate (1000 mg/day for 12 weeks). Then, following a two-week washout period, the first group was switched to chondroitine sulfate and the second group, to fenofibrate. Clinical examination was performed monthly, and laboratory evaluation was performed at the baseline and by the end of each treatment course. pain level according to VAS scale was used as the primary endpoint, whereas KOOS, WOMAC, ICOAP and other scores served as secondary endpoints. We have also assessed effects of Fenofibrate upon serum biomarkers (IL-6, IL-18, IL-10, lipid profiles, and CRP concentrations). Comparative effect of Fenofibrate was evaluated by means of generalized estimating equation (GEE) models adjusted for the treatment sequence. It was shown that clinical effects of Fenofibrate in patients with DAOA did not significantly differ from those of chondroitine sulfate. However, fenofibrate had broader spectrum of effects including improvement of lipid profiles. E.g., Fenofibrate treatment was associated with increased HDL levels (β coefficient, -0.19; р = 0.02), a decrease in total cholesterol (β coefficient, -0.78; р = 0.01), and triglycerides (β coefficient,0.85; р = 0.002). In addition, Fenofibrate therapy was associated with a decrease in ESR, a laboratory biomarker of systemic inflammation (β coefficient, -7.76; р = 0.01). Cytokine changes following the Fenofibrate treatment did not differ from those registered after chondroitine sulfate therapy. In conclusion, the results of this pilot study provide a rationale for further studies of PPARα agonists and their pleiotropic effects in large-scale controlled clinical trials.
format	article
author	V. S. Shirinsky E. V. Kazygasheva N. Yu. Kalynovskaya I. V. Shirinsky
author_facet	V. S. Shirinsky E. V. Kazygasheva N. Yu. Kalynovskaya I. V. Shirinsky
author_sort	V. S. Shirinsky
title	CLINICAL EFFICIENCY AND SAFETY OF FENOFIBRATE, A PPARα AGONIST, IN THE PATIENTS WITH DIABETESASSOCIATED OSTEOARTHRITIS: A CROSS-OVER PILOT STUDY
title_short	CLINICAL EFFICIENCY AND SAFETY OF FENOFIBRATE, A PPARα AGONIST, IN THE PATIENTS WITH DIABETESASSOCIATED OSTEOARTHRITIS: A CROSS-OVER PILOT STUDY
title_full	CLINICAL EFFICIENCY AND SAFETY OF FENOFIBRATE, A PPARα AGONIST, IN THE PATIENTS WITH DIABETESASSOCIATED OSTEOARTHRITIS: A CROSS-OVER PILOT STUDY
title_fullStr	CLINICAL EFFICIENCY AND SAFETY OF FENOFIBRATE, A PPARα AGONIST, IN THE PATIENTS WITH DIABETESASSOCIATED OSTEOARTHRITIS: A CROSS-OVER PILOT STUDY
title_full_unstemmed	CLINICAL EFFICIENCY AND SAFETY OF FENOFIBRATE, A PPARα AGONIST, IN THE PATIENTS WITH DIABETESASSOCIATED OSTEOARTHRITIS: A CROSS-OVER PILOT STUDY
title_sort	clinical efficiency and safety of fenofibrate, a pparα agonist, in the patients with diabetesassociated osteoarthritis: a cross-over pilot study
publisher	SPb RAACI
publishDate	2017
url	https://doaj.org/article/9100c7cc1e40494ca866e45e63e639ba
work_keys_str_mv	AT vsshirinsky clinicalefficiencyandsafetyoffenofibrateapparaagonistinthepatientswithdiabetesassociatedosteoarthritisacrossoverpilotstudy AT evkazygasheva clinicalefficiencyandsafetyoffenofibrateapparaagonistinthepatientswithdiabetesassociatedosteoarthritisacrossoverpilotstudy AT nyukalynovskaya clinicalefficiencyandsafetyoffenofibrateapparaagonistinthepatientswithdiabetesassociatedosteoarthritisacrossoverpilotstudy AT ivshirinsky clinicalefficiencyandsafetyoffenofibrateapparaagonistinthepatientswithdiabetesassociatedosteoarthritisacrossoverpilotstudy
_version_	1718422365812031488

CLINICAL EFFICIENCY AND SAFETY OF FENOFIBRATE, A PPARα AGONIST, IN THE PATIENTS WITH DIABETESASSOCIATED OSTEOARTHRITIS: A CROSS-OVER PILOT STUDY

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