Cingal® (hyaluronic acid and triamcinolone hexacetonide) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g., acetaminophen). Cingal® includes an ancillary steroid to provide additional short-term pain relief.1
Most adverse events (AEs) (> 99%) were rated mild or moderate in severity and common for the general population
Triamcinolone hexacetonide has been marketed for over 45 years for use in short-term symptomatic management of human joint OA.
The visual analog scale VAS is a validated tool that helps objectively measure the intensity of certain sensations and feelings, such as pain.
WOMAC Pain Score differences between Cingal® and HA from baseline at Weeks 1 and 3¶,**,††
Cingal® delivered a 59% (-34.6 mm) and 68% (-40.1 mm) improvement relative to baseline at Weeks 1 and 3, respectively (ITT population; secondary endpoint).
Cingal® offered significant quick pain relief relative to HA at Weeks 1 and 3.
Cingal® was superior to saline in providing significant pain reduction through 12 weeks post treatment.
Cingal® demonstrated strong long-term pain and symptom relief similar to HA from Week 6 through Week 26.
Change in the global assessments as measured by the WOMAC Pain Subscale (100 mm VAS) from baseline through 26 weeks (ITT population)¶
Adverse events (AEs) were distributed proportionally to study randomization, with no statistical differences related to study arm.
Most common AEs (> 5% of total AEs) regardless of relatedness to treatment:
The majority of AEs were transitory and rated mild (71.7%) in severity.
Relevant warnings and precautions:
For more information:
Please consult the Cingal® Product Licence for important information relating to adverse reactions and dosing information that have not been discussed in this piece.
The Product Licence is also available upon request by calling 1-888-550-6060 or by emailing [email protected].
1. Cingal® Package Insert. Pendopharm. February 2016. 2. Data on file. Clinical study report: Cingal® 13-01. Anika Therapeutics Inc. January 2015. 3. The Arthritis Society. Arthritis medications: A reference guide. Accessed on September 9, 2019. Available from: https://arthritis.ca/treatment/medication/medications-to-treat-inflammatory-arthritis. 4. Monovisc® 0702 pivotal clinical trial. FDA Monovisc® Summary of Safety and Effectiveness Data. 2014. 5. Anika. Data on file. Study 0703. 6. Synvisc-One® Instructions for Use. Genzyme Corporation. December 16, 2014. 7. Durolane® website. Accessed November 13, 2015. Available from: www.durolane.com. 8. Electronic Compendium of Pharmaceuticals and Specialties. NeoVisc® Product Monograph. 9. Anika. Data on file. Study 0702.