Tags

Type your tag names separated by a space and hit enter

Efficacy and safety of diclofenac diethylamine 2.32% gel in acute ankle sprain.
Med Sci Sports Exerc 2012; 44(9):1629-36MS

Abstract

BACKGROUND

Topical diclofenac diethylamine (DDEA) 2.32% gel achieves lasting efficacy in localized pain with two applications per day, while maintaining the favorable safety profile of topical diclofenac and potentially improving convenience and patient compliance.

METHODS

This randomized double-blind controlled study enrolled patients with acute ankle sprain treated with DDEA 2.32% gel two times per day (bid) (n = 80) or three times per day (tid) (n = 80) or placebo (n = 82). Efficacy (including pain and swelling) and local tolerability were evaluated during 8 ± 1 d.

RESULTS

By day 5, the reduction in pain on movement (POM) (primary efficacy variable) with DDEA bid and tid (49.1 and 49.7 mm, respectively; 100-mm visual analog scale) was almost double that with placebo (25.4 mm) (P < 0.0001). In patients with severe baseline POM (≥ 80 mm), mean change in POM from baseline to day 5 with DDEA bid or tid was 30-40 mm greater than that with placebo, which was double the difference (15-20 mm) in patients with mild-moderate baseline POM (<80 mm). More than 70% of all DDEA patients experienced ≥ 50% reduction in POM between days 1 and 5 versus 21% of placebo patients (P < 0.0001). By study end (day 8), ankle swelling in patients treated with DDEA (0.3 cm) was one-third that in those treated with placebo (0.9 cm) (P < 0.0001), which had still not achieved the level of ankle joint function seen with DDEA on day 5 (P < 0.0001). At day 5, treatment satisfaction was "good" to "excellent" in almost 90% of DDEA patients but only "good" or "very good" in 23% of placebo patients (P < 0.0001). DDEA 2.32% gel was well tolerated.

CONCLUSIONS

DDEA 2.32% gel twice daily (applied in the morning and evening) was well tolerated and provided lasting relief from pain, improved function, and reduced symptomatic healing time in uncomplicated ankle sprain.

Authors+Show Affiliations

Institute of Cardiology and Sports Medicine, German Sport University Cologne, Köln, Germany. predel@dshs-koeln.de

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22525762

Citation

Predel, Hans-Georg, et al. "Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Acute Ankle Sprain." Medicine and Science in Sports and Exercise, vol. 44, no. 9, 2012, pp. 1629-36.
Predel HG, Hamelsky S, Gold M, et al. Efficacy and safety of diclofenac diethylamine 2.32% gel in acute ankle sprain. Med Sci Sports Exerc. 2012;44(9):1629-36.
Predel, H. G., Hamelsky, S., Gold, M., & Giannetti, B. (2012). Efficacy and safety of diclofenac diethylamine 2.32% gel in acute ankle sprain. Medicine and Science in Sports and Exercise, 44(9), pp. 1629-36. doi:10.1249/MSS.0b013e318257ed41.
Predel HG, et al. Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Acute Ankle Sprain. Med Sci Sports Exerc. 2012;44(9):1629-36. PubMed PMID: 22525762.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of diclofenac diethylamine 2.32% gel in acute ankle sprain. AU - Predel,Hans-Georg, AU - Hamelsky,Sandra, AU - Gold,Morris, AU - Giannetti,Bruno, PY - 2012/4/25/entrez PY - 2012/4/25/pubmed PY - 2013/6/12/medline SP - 1629 EP - 36 JF - Medicine and science in sports and exercise JO - Med Sci Sports Exerc VL - 44 IS - 9 N2 - BACKGROUND: Topical diclofenac diethylamine (DDEA) 2.32% gel achieves lasting efficacy in localized pain with two applications per day, while maintaining the favorable safety profile of topical diclofenac and potentially improving convenience and patient compliance. METHODS: This randomized double-blind controlled study enrolled patients with acute ankle sprain treated with DDEA 2.32% gel two times per day (bid) (n = 80) or three times per day (tid) (n = 80) or placebo (n = 82). Efficacy (including pain and swelling) and local tolerability were evaluated during 8 ± 1 d. RESULTS: By day 5, the reduction in pain on movement (POM) (primary efficacy variable) with DDEA bid and tid (49.1 and 49.7 mm, respectively; 100-mm visual analog scale) was almost double that with placebo (25.4 mm) (P < 0.0001). In patients with severe baseline POM (≥ 80 mm), mean change in POM from baseline to day 5 with DDEA bid or tid was 30-40 mm greater than that with placebo, which was double the difference (15-20 mm) in patients with mild-moderate baseline POM (<80 mm). More than 70% of all DDEA patients experienced ≥ 50% reduction in POM between days 1 and 5 versus 21% of placebo patients (P < 0.0001). By study end (day 8), ankle swelling in patients treated with DDEA (0.3 cm) was one-third that in those treated with placebo (0.9 cm) (P < 0.0001), which had still not achieved the level of ankle joint function seen with DDEA on day 5 (P < 0.0001). At day 5, treatment satisfaction was "good" to "excellent" in almost 90% of DDEA patients but only "good" or "very good" in 23% of placebo patients (P < 0.0001). DDEA 2.32% gel was well tolerated. CONCLUSIONS: DDEA 2.32% gel twice daily (applied in the morning and evening) was well tolerated and provided lasting relief from pain, improved function, and reduced symptomatic healing time in uncomplicated ankle sprain. SN - 1530-0315 UR - https://www.unboundmedicine.com/medline/citation/22525762/Efficacy_and_safety_of_diclofenac_diethylamine_2_32_gel_in_acute_ankle_sprain_ L2 - http://Insights.ovid.com/pubmed?pmid=22525762 DB - PRIME DP - Unbound Medicine ER -