Sodium Pentosan Polysulfate Resulted in Cartilage Improvement in Knee Osteoarthritis - An Open Clinical Trial

Kenji Kumagai; Susumu Shirabe; Noriaki Miyata; Masakazu Murata; Atsushi Yamauchi; Yasuhumi Kataoka; Masami Niwa

Disclosures

BMC Clin Pharmacol. 2010;10:1-24. 

In This Article

Results

The trial began enrolling patients in November 2005 and finished in August 2007. All twenty patients were followed up for one year.

1. Primary Outcome Measurements

The hydrarthroses were reduced quickly in all cases. The ROM of the knee joint improved significantly (Figure 1, Table 1 ). The clinical assessments, i.e., knee flexion, pain while walking, pain after climbing up and down stairs (Figure 2, Table 1 ), and pain just after ROM exercise improved significantly ( Table 1 ). The concentration of C2C in the blood decreased significantly (Figure 3, Table 1 ). The clinical benefits of this study continued for almost one year. In the X-ray findings, neither improvement nor degeneration were detected.

Figure 1.

Flexion angle of knee joint
The hydrarthroses were reduced quickly in all cases.
The ROM of knee joint was improved significantly.
Clinical improvements were maintained at the one-year follow-up.

Figure 2.

Pain scores after climbing up and down stairs
Pain scores after climbing up and down stairs, measured by VAS, was improved significantly. This improvement was maintained for almost one year.

Figure 3.

Concentration of C2C in Blood
The concentration of C2C in the blood decreased significantly at 8 and 24 weeks.
To check the change of type II collagen metabolism, we measured C2C as a degradation marker of type II collagen, as C2C is said to be the only reliable marker of cartilage metabolism. The significant decreasing tendency of C2C is thought to be more objective than those parameters measured with VAS and ROM findings in this study.

2. Secondary Outcomes Measurements

There was no statistical improvement in the total score of the WOMAC compared to the baseline measurements (Table 2). Both the WOMAC and the clinical assessments showed the same tendencies in time course curve (Figure 4). Walking pain and pain while at rest, as initial checks of each visit at our clinic, showed statistical improvement compared to the baseline measurements (Table 2).

Figure 4.

WOMAC scores
There were significant differences in the values between individual follow-up points in the WOMAC scores, but there was no significant difference in the data comparing the baseline and each follow-up. This may have been due to a problem with the baseline evaluation or the techniques of the score system

3. Adverse Events

The dose of pentosan affected the blood coagulation tests, but the values were within a safe range. For aPPT, the highest value was 61.7. For PT (INR), the highest value was 1.47, which was weaker than the prophylactic administration of cardiovascular event. The value of ACT had the same tendency (Figure 5). Slightly abnormal findings were noted in serum chemistry: i.e., serum triglycerides at one hour after injection, but these were reduced quickly in the follow-up period (Figure 6).

Figure 5.

Activated Clotting Time (ACT) and Prothrombin Time (INR) 1 hour after injection
a: ACT, b: PT (INR)
Activated clotting time (ACT) is a measure of the anticoagulation affects of heparin. So we checked the level of ACT, as well as usual blood coagulation test one hour after every injection. The dose of pentosan affected the ACT value, but the values were within a safe range. For PT (INR), the highest value was 1.47, which was weaker than the prophylactic administration of cardiovascular event.

Figure 6.

Serum triglycerides 1 hour after injection
Slightly abnormal findings were noted in serum triglycerides at one hour after injection, but this was reduced quickly in the follow-up period.

Six patients had a small amount of subcutaneous bleeding at the injection site. Four patients claimed severe pain at injection, but the pain decreased rapidly. No patient suffered any major AE occurrence.

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