SYNVISC vs. Other Viscosupplements
|
Hyalgan® (sodium hyaluronate)1 |
Supartz® (sodium hyaluronate)2 |
Orthovisc® (high molecular weight hyaluronan)3 |
EuflexxaTM (1% sodium hyaluronate)4 |
|
|
6,000,000 |
500,000 - 730,000 |
620,000 - 1,700,000 |
1,000,000 - 2,900,000 |
2,400,000 - 3,600,000 |
|
|
3 injections:
1 week apart |
3-5 injections:
1 week apart |
3-5 injections:
1 week apart |
3-4 injections:
1 week apart |
3 injections:
1 week apart |
|
|
26 weeks |
60 days |
90 days |
22 weeks
(3 or 4 injections) |
12 weeks |
|
(all cause, % of patients) |
Knee pain and/or swelling: 7.2% (2.2% of injections) |
Injection site pain: 23%
Local joint pain and swelling: 13%* |
Arthralgia: 17.8%
Injection site reaction: 5.7%*
Injections site pain: 4.2% |
Arthralgia: 12.6%
Injection site pain: 2.5%*
Joint effusion: 0.4%*
Joint swelling: 0.7%*
Injection site edema: 0.9%* |
Multicenter study:†
Arthralgia: 8.8%
Joint effusion: 0.6%
Joint swelling: 1.9% |
|
|
511 patients |
164 patients |
619 patients |
562 patients |
Multicenter study:† 160 patients |
From a head-to-head trial of SYNVISC® (hylan G-F 20) vs. Hyalgan® (sodium hyaluronate)
SYNVISC provided superior improvement in pain and function than Hyalgan6*
Prospective, observer-blinded, active-controlled trial of 392 patients with OA knee pain who were randomized to receive either 3 weekly injections of SYNVISC or 5 weekly injections of Hyalgan. Follow-up visits occurred at 6 weeks, 3 months, 6 months and 1 year. Mean age of patients was 66.7 years. Most had radiographically confirmed Kellgren-Lawrence grade III OA at baseline (SYNVISC 61%; Hyalgan 59%). Pain was measured on a 10-cm visual analog scale (VAS). Functional outcomes were assessed using Oxford, Tegner and UCLA knee scores.6
* Well-controlled clinical trials demonstrate that reducing pain can help improve function as measured by WOMAC pain and function domains.7,8
Supartz®: Less than optimal results
Consider the facts about Supartz:
- Failed to separate from placebo in 3 of the 5 trials included in product labeling9
- Efficacy has not been established with fewer than 5 injections9
- No evidence in product labeling to support efficacy and safety in repeat treatment9
- Patients experienced: arthralgia or joint pain (17.8%), injection site reactions (5.7%) and injection site pain (4.2%), regardless of cause
- Supartz is a non-cross-linked HA product9
Supartz approved labeling is based only on a pooled analysis of 5 trials9:
|
Study |
Duration |
Number of Patients |
Efficacy Results (Based on Lequesne Score) |
| |
|
(5 injections unless noted) |
|
superior to control |
superior to control |
|
|
18 weeks |
108 |
115 |
X |
|
|
|
90 days |
87 (5 inj)
87 (3 inj) |
80 |
|
X |
|
|
14 weeks |
102 |
106 |
|
X |
|
|
20 weeks |
119 |
120 |
|
X |
|
|
26 weeks |
116 |
115 |
X |
|
Orthovisc®: Minimal efficacy demonstrated
Consider the facts about Orthovisc:
- Only 2 clinical trials evaluate its efficacy and safety10
- Failed to separate from placebo with 3 or 4 weekly injections10
- Studies demonstrated efficacy up to only 22 weeks with 3 or 4 injections10
- Orthovisc is a non-cross-linked HA product10
Orthovisc approved labeling is based only on a pooled analysis of 2 trials10:
|
Study |
Method |
Reported Efficacy Results |
|
|
- Orthovisc 3 injections (n=114) vs saline 3 injections (n=112)
- 27-week follow-up
|
- Primary analysis showed no significant differences between the Orthovisc and saline groups for any efficacy measures at any time point
- A post hoc analysis of a patient subgroup (50% of all studied patients) showed significant differences in favor of Orthovisc for some efficacy measures
|
|
|
- Orthovisc 4 injections (n=128) vs Orthovisc 3 injections + 1 arthrocentesis (n=119) vs 4 arthrocenteses (n=123)
- 22-week follow-up
|
- Primary analysis showed no significant differences between the Orthovisc and control groups in primary efficacy measures and WOMAC pain scores at any time point
- One post hoc analysis (≥ 40% WOMAC improvement) of a patient subgroup (88% of all patients) demonstrated that 4 Orthovisc injections were better than 4 arthrocenteses
|
EuflexxaTM: The evidence falls short
Consider the facts about Euflexxa:
- Only 3 clinical trials that evaluate its efficacy and safety
- Euflexxa is only indicated for up to 12 weeks of pain relief13
- Unlike SYNVISC, Euflexxa has never been proven superior to Steroids, NSAIDS, or Appropriate Care alone13
- Euflexxa is the only viscosupplement that contains a precaution that patients with repeated exposure to Euflexxa have the potential for an immune response13
- Euflexxa is a non-cross-linked HA product13
Euflexxa approved labeling is based on only 2 published studies13:
|
Study |
Method |
Reported Results |
|
|
- Euflexxa 5 injections (n=25) vs saline 5 injections (n=24)
- 20 weeks
|
- Euflexxa did not seperate from placebo in terms of efficacy at any time point in the study
- 72% of Euflexxa patients reported knee pain, 4% reported knee swelling
|
|
|
- Euflexxa 3 injections (n=160) vs SYNVISC 3 injections (n=161)
- 12 weeks
|
- Euflexxa was shown to be noninferior to SYNVISC at 12 weeks
- 8x8% of patients in Euflexxa group had joint pain; 0.6% had a joint effusion, and 1.9% had joint swelling
|
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