Different Diclofenac diethylamine formulations have similar pain relief and tolerability in acute ankle sprain

Written By : Dr. Shravani Dali |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2023-02-09T10:00:14+05:30 | Updated On 9 Feb 2023 2:37 PM IST

Diclofenac diethylamine (DDEA) 2.32% gel BID and Diclofenac diethylamine (DDEA) 1.16% gel QID is equally efficient for acute ankle sprain suggests a new study published in the BMC Musculoskeletal Disorders

Diclofenac diethylamine (DDEA) gel has demonstrated efficacy for treatment of ankle sprains in both the 1.16% four-times-daily (QID) and 2.32% twice-daily (BID) formulations. The objective of this study was to compare, for the first time, the efficacy of DDEA 2.32% gel BID and DDEA 1.16% gel QID.

This was a phase 3, randomized, double-blind, multicenter, active-controlled, parallel-group study conducted in China from October 2019 to November 2020, designed to determine the noninferiority of DDEA 2.32% gel BID relative to DDEA 1.16% gel QID for treatment of grade I–II ankle sprain. At study entry, patients must have had pain on movement (POM) ≥50 mm on a 100-mm visual analogue scale (VAS), and not received any pain medication. The primary efficacy endpoint was the noninferiority of DDEA 2.32% gel BID vs DDEA 1.16% gel QID for POM as assessed by the patient using the 100-mm VAS, conducted on day 5. Secondary endpoints included measures of ankle tenderness, joint function, swelling, and patient-reported pain intensity and pain relief.

Results

• A total of 302 patients were randomized and 95.4% completed the study.

• The mean (SD) change in POM from baseline to day 5 using the 100-mm VAS was − 42.8 mm (19.7 mm) with DDEA 2.32% gel BID and − 43.1 mm (18.1 mm) with DDEA 1.16% gel QID for the per-protocol population.

• The least squares mean difference (DDEA gel 2.32% – DDEA gel 1.16%) at this timepoint was 1.11 mm (95% CI − 3.00, 5.22; P = 0.595), and the upper limit (5.22 mm) of the 95% CI was less than the noninferiority margin of 13 mm, demonstrating that DDEA 2.32% gel BID was noninferior to DDEA 1.16% gel QID.

• Similar trends were seen for the secondary efficacy endpoints.

• There was no significant difference in the incidence of treatment-emergent adverse events or adverse events adjudicated as being treatment related.

• All treatment-related adverse events were dermatological; one patient discontinued from the DDEA 2.32% gel BID arm due to application-site inflammation.

DDEA 2.32% gel BID offers a convenient alternative to DDEA 1.16% gel QID, with similar pain reduction and relief, anti-inflammatory effects, and tolerability.

Reference:

Yin, F., Ma, J., Xiao, H. et al. Randomized, double-blind, noninferiority study of diclofenac diethylamine 2.32% gel applied twice daily versus diclofenac diethylamine 1.16% gel applied four times daily in patients with acute ankle sprain. BMC Musculoskelet Disord 23, 1125 (2022). https://doi.org/10.1186/s12891-022-06077-z

BMC Musculoskeletal Disordersacute ankle sprainDiclofenac diethylamine gelAnkle injurySprainAnalogue pain scale

Source : BMC Musculoskeletal Disorders

Dr. Shravani Dali

Dr. Shravani Dali has completed her BDS from Pravara institute of medical sciences, loni. Following which she extensively worked in the healthcare sector for 2+ years. She has been actively involved in writing blogs in field of health and wellness. Currently she is pursuing her Masters of public health-health administration from Tata institute of social sciences. She can be contacted at editorial@medicaldialogues.in.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751