1x OSTENIL® PLUS vs. 1x Synvisc-One®
SAME EFFICACY BUT AT SIGNIFICANTLY LOWER COST!
A variety of studies and scientific analyses have confirmed the efficacy of intra-articular (IA) injections of sodium hyaluronate for treating the symptoms of osteoarthritis (OA). In terms of pain reduction, as well as improved range-of-motion and functionality of synovial joints, the use of IA-HA has demonstrated significant utility. Multiple data sources suggest that pain reduction is noticeable from around two to five weeks after the first injection or course of injections, and that the maximum benefit is derived between weeks 5 and 13 post- injection, although the therapeutic effects can persist for 4 to 12 months.
The therapeutic and economic benefits of viscosupplementation using commercially available preparations of sodium hyaluronate vary depending on their molecular weight, their origin, the number of injections required per therapy cycle, and the cost. There is no consensus amongst musculoskeletal specialists on whether or not there is a connection between the molecular weight of differing sodium hyaluronate preparations and their respective efficacy.
For this reason it was considered useful to directly compare two different products in terms of the origin of the hyaluronate and their molecular weight. At the EULAR Congress in Rome in 2015, R L Dreiser et al.1 presented the results of a direct comparison between a high molecular weight, cross-linked sodium hyaluronate (Synvisc-One®) and a medium-weight, fermentative-source hyaluronate with Mannitol (OSTENIL® PLUS).
266 patients with symptomatic tibio-femoral osteoarthritis (Kellgren-Lawrence Ib-III, WOMAC pain ≥ 40 mm) were included in a randomised, double-blind, controlled multi-centre study. 134 patients received an intra-articular injection of OSTENIL® PLUS: 40 mg/2.0 ml. 132 patients received an intra-articular injection of Synvisc-One®: 48 mg/6.0 ml.
Efficacy was measured according to patient responder rate, WOMAC-Score (global, sub-scores pain (A), stiffness (B), function (C)), Lequesne Index, and Global Status as evaluated by the patient (VAS). Follow-up visits at day 30, 90 and 180 took place after the injection.
The results of the study show that both hyaluronan treatments led to significant pain reduction and increased functionality in OA patients, although neither product demonstrated statistically significant superiority. Both groups reported a noticeable improvement in the WOMAC A Score (pain) after just 30 days. The Pain score in the OSTENIL® PLUS cohort reduced from 58.2 mm to 28.5 mm, and in the Synvisc-One® cohort from 57.9 mm to 27.8 mm. After 180 days all patients reported a further pain reduction: down to 24.8 mm in the OSTENIL® PLUS group and 22 mm in the Synvisc-One® group.
Even 6 months after completion of treatment the patients benefited from a significant pain reduction compared with baseline, supporting the so-called carry-over-effect associated with infiltrating exogenous hyaluronan.
Reduction in pain over 180 days
Similarly, these impressive results for pain reduction were also observed in improvements on the joint stiffness sub-score. Again, after 30 days there was a significant improvement of joint stiffness. This improvement continued to the end of the 6 month observation period.
There were no statistically significant differences between the OSTENIL® PLUS and the Synvisc-One® cohorts. Patient responder rates after 180 days were 81.1 % in the OSTENIL® PLUS group and 86.3% in the Synvisc-One® group respectively.
Localised adverse events were observed in 8.4 % of patients in the OSTENIL® PLUS group, and in 13.0 % in the Synvisc-One® group, although no statistically significant differences were observable between the two cohorts.
Conclusion:
OSTENIL® PLUS is as effective as Synvisc-One® for the treatment of knee osteoarthritis when delivered via intra-articular injection. However, the acquisition cost of OSTENIL® PLUS is considerably lower!
MIMS: OSTENIL® PLUS: £80.00. Synvisc-One®: £205.00
• A single injection with OSTENIL® PLUS reduces pain and improves joint mobility in knee OA.
• This effect persists for a period of at least 6 months.
• OSTENIL® PLUS is a safe and effective therapeutic option for patients with osteoarthritis.
OSTENIL® PLUS: - Sodium Hyaluronate (40 mg/2 ml) of fermentative source - 10 mg Mannitol
For all synovial joints
R. L. Dreiser, B. Avouac, T. Bardin and the French study group. A 6-month trial evaluating the efficacy of one intra-articular injection of 2% sodium hyaluronate versus hylan G-F 20 in the treatment of painful tibiofemoral osteoarthritis. 16th Eular Congress, 10–13 June 2015, Rome.