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Open Access Highly Accessed Research article

Sodium pentosan polysulfate resulted in cartilage improvement in knee osteoarthritis - An open clinical trial-

Kenji Kumagai1*, Susumu Shirabe2, Noriaki Miyata1, Masakazu Murata1, Atsushi Yamauchi3, Yasuhumi Kataoka3 and Masami Niwa4

Author Affiliations

1 Department of Orthopaedic Surgery, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture, 852-8501, Japan

2 Regent and Vice President, Center for Health and Community Medicine, Nagasaki University, 1-14 Bunkyou, Nagasaki city, Nagasaki prefecture, 852-8521, Japan

3 Department of Pharmaceutical Care and Health Sciences, Faculty of Pharmaceutical Sciences, Fukuoka University, 8-19-1, Nanakuma, Jonan-ku, Fukuoka city, 814-0180, Fukuoka prefecture, JAPAN

4 Department of Pharmacology, Graduate School of Biomedical Sciences, Nagasaki University, 1-12-4, Sakamoto, Nagasaki city, Nagasaki prefecture, 852-8523, Japan

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BMC Clinical Pharmacology 2010, 10:7  doi:10.1186/1472-6904-10-7

Published: 28 March 2010

Abstract

Background

Pentosan polysulfate sodium (pentosan) is a semi-synthetic drug manufactured from beech-wood hemicellulose by sulfate esterification of the xylopyranose hydroxyl groups. From in vitro and animal model studies, pentosan has been proposed as a disease modifying osteoarthritis drug (DMOAD). The objective of this study was to assess the efficacy, safety, and patient satisfaction in patients with mild radiographic knee osteoarthritis (OA) findings and OA-associated symptoms and signs.

Methods

Twenty patients were assessed clinically at Nagasaki University Hospital. The radiographic indications of OA were grade 1 to 3 using the Kellgren-Lawrence Grading System (K/L grade). Pentosan used in this study was manufactured and supplied in sterile injectable vials (100 mg/ml) by bene GmbH, Munich, Germany. The study was a single-center, open-label trial. Treatment consisted of 6 weekly subcutaneous injections (sc) of pentosan (2 mg/kg). Patients were clinically assessed at entry and 1 to 8, 11, 15, 24 & 52 weeks post treatment. The results were analyzed using one way ANOVA and Dunnett's method.

Results

Hydrarthroses were reduced quickly in all cases. The clinical assessments, i.e., knee flexion, pain while walking, pain after climbing up and down stairs, etc, were improved significantly and these clinical improvements continued for almost one year. The dose used in this study affected the blood coagulation test, but was within safe levels. Slightly abnormal findings were noted in serum triglycerides.

Conclusions

Pentosan treatment in twenty patients with mild knee OA seemed to provide improvements in clinical assessments and C2C level of cartilage metabolism.

Trial Registration

UMIN Clinical Trials Registry (UMIN-CTR) UMIN000002790