1 / 13

Design: A randomized, prospective, double-blind cohort followed for 16 weeks

RenehaVis Original Study. Design: A randomized, prospective, double-blind cohort followed for 16 weeks. 50 DMW. 50 HMW. 50 LMW. 50 Placebo. RenehaVis Original Study. RenehaVis Original Study. RenehaVis Original Study. Summary:

lixue
Télécharger la présentation

Design: A randomized, prospective, double-blind cohort followed for 16 weeks

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. RenehaVis Original Study Design: • A randomized, prospective, double-blind cohort followed for 16 weeks 50 DMW 50 HMW 50 LMW 50 Placebo

  2. RenehaVis Original Study

  3. RenehaVis Original Study

  4. RenehaVis Original Study Summary: • Therapeutic effects of RenehaVis can be seen after second injection • These effects are maintained following the third injection up to the follow up at 16 weeks • RenehaVis is able to work quickly and efficiently in relieving the OA patients of their symptoms

  5. RenehaVis Long Term Follow Up Design: • The primary objective was efficacy as evaluated through the self-paced 40m walking pain visual analog scale (VAS) at week 16, 52 and 104. • The secondary endpoints were as follows: • Efficacy through assessment of the following: • Pain at rest. A 10cm visual analog scale (VAS) was used prior to first treatment and again at weeks 16, 52, 104 • Patient global satisfaction using a 5-point numerical scale • Consumption of concomitant medications • Patients with <45mm pain at follow-up 52 and 104 weeks • Safety through the number of recorded adverse events

  6. RenehaVis Long Term Follow Up Results: • Performance: At 16, 52 and 104 weeks respectively, walking VAS pain was significantly improved in all treatment groups vs. placebo: DMW (89.3%, p<0.001; 87.4%, p<0.001; 88.1%, p<0.001); LMW (81.3%, p<0.001; 78.2%, p<0.001; 77.0%, p<0.001) and HMW (78.1%, p<0.001; 81.1%, p<0.001; 79.4%, p<0.001) • At 52 weeks, 8 patients in DMW group had resting VAS <45mm. No patient in the LMW or HMW groups had VAS<45mm. • DMW had lower (62mm, p<0.001) compared to LMW (76mm) and HMW (88mm) VAS at rest. • Similar differences were observed for walking VAS  (77mm vs 89mm vs 91mm respectively). 39, 41 and 43 (DMW, LMW, HMW) received repeat injections. • At 104 weeks, these differences were similar. DMW and LMW had no reported adverse events; HMW had 2 local reactions at 52 weeks and 1 at 104 weeks. Safety: There were no serious adverse events. Non- serious adverse events included pain and local swelling at the injection site (21%), erythema at the injection site (12%) and stiffness in the index knee (7%).

  7. Long Term Results

  8. Long Term Results

  9. Long Term Results

  10. Long Term Results

  11. Long Term Results

  12. RenehaVis Long Term Follow Up Summary: • Intra-articular Hyaluronic Acid injections using any of low, high or combined MW were highly effective in improving resting and more so, walking pain in patients with osteoarthritis of the knee. • Greater improvement in both rest and activity outcomes in patients who received the DMW product • DMW group had concomitantly greater patient satisfaction and fewer use of concomitant therapeutic modalities at 16, 52 and 104 weeks • Greater patient satisfaction in DMW groups

  13. Summary • RenehaVis provides better and fastertherapeutic effects because of the 2 HAs comprising of different characteristics • RenehaVis provides shortened treatment regimen (2 injection per treatment) • 1 treatment course of RenehaVis lasts up to 1 year • RenehaVis has international patent coverage

More Related