Abstract| Volume 22, SUPPLEMENT , S407, April 2014

Pain relief, functional recovery and associated medical treatments reduction in large-scale population with osteoarthritis receiving injections of viscosupplement incorporating high concentration of sorbitol

      Purpose: Synolis V-A is a visco-antalgic composed of highly concentrated non-crosslinked hyaluronic acid (2%) from biofermentation origin combined with a high concentration of Sorbitol (4%). Sorbitol is an endogenous molecule which functions as an oxygen free radical (OFR) scavenger. We hypothesize that anti-oxidant effect of sorbitol may play an active role in rapid and strong pain reduction in patients with osteoarthritis, and therefore influence function recovery and medication intake reduction.
      Methods: 1147 patients with a majority suffering from knee Osteoarthritis (92.9%), were enrolled in a Non-Interventional Study conducted in 398 centres in Germany. Studied population had an average age of 63.3 years, including 499 males and 614 females, and was distributed into the following grades according to Kellgren–Lawrence scale: Grade I – 6.7%, Grade II – 31.4%, Grade III – 48.0% and Grade IV – 13.9%. Patients were assessed for pain level and functional impairment using 5 points Likert scale (scoring from 0 = None to 4 = Very Severe). Patients received between 1 and 3 intraarticular (IA) injections of 2 ml of Synolis V-A. Selected primary criteria were variations of pain and function impairment scores, between baseline and following the time points: week1, week 12 and week 24. Selected secondary criterion was the evaluation of concomitant medical treatments (topical, NSAID, corticosteroids and analgesics) prior to treatment initiation and at week 24.
      Results: Selected Histological Measures from Best Subset Regression Modeling: Average pain level (pooled data) scored at 2.61 (n = 1125) at baseline, 1.68 (n = 832) at week 1, 1.14 (n = 1085) at week 12 and 1.07 (n = 1030) at week 24. Average functional impairment level (pooled data) scored at 1.99 (n = 1103) at baseline, 1.47 (n = 819) at week 1, 1.07 (n = 1074) at week 12 and 1.02 (n = 1031) at week 24. Patients with no reported medical treatment increased by 120%, from 354 patients before treatment initiation to 780 at week 24. Average daily medication per patient decreased by 72% from 1.30 before treatment initiation to 0.37 at week 24. Out of 1147 patients only 24 adverse events (AEs) were reported for 22 patients (1.9%), the most common Adverse Event being “Injection site joint pain”.
      Conclusions: This study suggests that a strong pain relief occurs immediately after the first injection of Synolis V-A, with a relief that amplifies until week 24.Functional improvement had been observed to follow a similar trend than pain relief. With a baseline score slightly lower, the amplitude of the observed improvement was also slightly inferior to that of pain relief. Never-the-less, both average scores ended up around 1 (Mild) at week 24. The trend similarities between pain relief and functional improvement suggest a direct link between both factors; link that can be explained by the impact of pain on loss of function. Not surprisingly, pain reduction and function recovery were associated with an important drop in medication intake.