Pooled analysis of clinical trial data evaluating the safety and effectiveness of diclofenac epolamine topical patch 1.3% for the treatment of acute ankle sprain

Lionberger, David R.; Joussellin, E; Yanchick, Jillmarie K.; Magelli, Merrell; Lanzarotti, Arturo

doi:10.2147/oajsm.s17048

Cited by 7 publications

(5 citation statements)

References 22 publications

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“…Thus, withdrawing the cadet from sport matches for a few term of time seems to be the choice. The excellent results achieved by physiotherapy in cadets receiving conservative treatment of ankle sprains have been described by Lionberger et al [15]. This study con irms the ankle sprain as a common injury in cadets.…”

Section: Resultssupporting

confidence: 76%

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The Risk Factors for Ankle Sprain in Cadets at a Male Military School in Iran: A Retrospective Case-control Study

Najafipour¹

2017

J Clin Med Exp Images

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Introduction: Ankle sprain is a widespread impairment in sport groups; this impairment leads to an absence from the workplace. The ankle sprains incidence rates are induced by height, weight, BMI, physical fi tness, level of match, classifi cation of sport, and personal exposure to sport. Methods:A longitudinal case-control study was executed to verify the outcome of risk factors for ankle sprain at a Military Male School between 2012 and 2013 of 4987 people at risk for ankle sprain, a total of 234 cadets sustained new ankle sprains during the study, 432 non-injured cadets randomly selected as the control group.Results: Regarding to the total people at risk in our study the incidence rate was approximately 5/1000 ankle sprain-years. Cadets with ankle sprains had higher weight, BMI and higher scores in Army Physical Fitness test than the control group. Ankle sprain occurred most commonly during athletics (51.4%). Ankle sprain incidence rate did not signifi cantly vary from different athletic competitions after controlling for athlete-exposure. Soccer and Ball Games had the highest ankle sprain incidence rate. Conclusion:Higher weight, increased BMI, greater physical conditioning and athlete exposure to selected sports were all risk factors for ankle sprain.

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Section: Resultssupporting

confidence: 76%

“…Many studies on sports injuries have indicated the high incidence of recurrence of ankle sprain [13][14][15][16]; although, investigations on the outcomes of ankle injuries and their in luences on the sports performance level are rare. Ankle sprain is considered to be a very common type of cadets training injury [17,18].…”

Section: Introductionmentioning

confidence: 99%

The Risk Factors for Ankle Sprain in Cadets at a Male Military School in Iran: A Retrospective Case-control Study

Najafipour¹

2017

J Clin Med Exp Images

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“…Compared with diclofenac sodium and potassium salts, the epolamine salt of diclofenac demonstrates detergent-like properties with improved solubility in both water and organic solvents, facilitating enhanced epidermal penetration [ 47 , 175 ]. Clinical studies in patients experiencing acute pain from minor soft tissue injuries or ankle sprains reported that diclofenac epolamine topical patches provided rapid and effective local analgesia compared with placebo and were generally safe and well tolerated [ 176 – 178 ]. Diclofenac epolamine (FLECTOR ® IBSA Institut Biochimique SA, Lugano, Switzerland) 1.3 % patches (10 × 14 cm) containing 180 mg of diclofenac were approved by the FDA in 2007.…”

Section: Topical Formulations Of Diclofenac Sodium or Epolamine Salt mentioning

confidence: 99%

Advances in NSAID Development: Evolution of Diclofenac Products Using Pharmaceutical Technology

Altman¹,

Bosch

Brune

et al. 2015

Drugs

377

193

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Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) of the phenylacetic acid class with anti-inflammatory, analgesic, and antipyretic properties. Contrary to the action of many traditional NSAIDs, diclofenac inhibits cyclooxygenase (COX)-2 enzyme with greater potency than it does COX-1. Similar to other NSAIDs, diclofenac is associated with serious dose-dependent gastrointestinal, cardiovascular, and renal adverse effects. Since its introduction in 1973, a number of different diclofenac-containing drug products have been developed with the goal of improving efficacy, tolerability, and patient convenience. Delayed- and extended-release forms of diclofenac sodium were initially developed with the goal of improving the safety profile of diclofenac and providing convenient, once-daily dosing for the treatment of patients with chronic pain. New drug products consisting of diclofenac potassium salt were associated with faster absorption and rapid onset of pain relief. These include diclofenac potassium immediate-release tablets, diclofenac potassium liquid-filled soft gel capsules, and diclofenac potassium powder for oral solution. The advent of topical formulations of diclofenac enabled local treatment of pain and inflammation while minimizing systemic absorption of diclofenac. SoluMatrix diclofenac, consisting of submicron particles of diclofenac free acid and a proprietary combination of excipients, was developed to provide analgesic efficacy at reduced doses associated with lower systemic absorption. This review illustrates how pharmaceutical technology has been used to modify the pharmacokinetic properties of diclofenac, leading to the creation of novel drug products with improved clinical utility.

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“…The safety and efficacy of the marketed DHEP medicated plaster have been demonstrated by data from clinical studies and postmarketing experience of the treatment of acute musculoskeletal pain associated with soft tissue injuries and inflammatory pathologies, including osteoarthritis and A c c e p t e d M a n u s c r i p t other rheumatological conditions 5,8,9,[21][22][23][24][25][26] . Results from a skin permeability and pharmacokinetic study 10 and a pharmacokinetic study in healthy volunteers 27 show that the systemic exposure of diclofenac is very low compared with oral administration when applied as the DHEP medicated plaster.…”

Section: Introductionmentioning

confidence: 99%

Rationale and evidence for the incorporation of heparin into the diclofenac epolamine medicated plaster

Rainsford

Roberts

Nencioni

et al. 2018

Current Medical Research and Opinion

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The nonsteroidal anti-inflammatory drug (NSAID) diclofenac epolamine (DHEP) formulated as a topical patch has demonstrated efficacy and safety in the localized treatment of acute pain from minor strains, sprains, and contusions, and for epicondylitis and knee osteoarthritis. The glycosaminoglycan heparin enhances the activity of topical NSAIDs formulated as a medicated plaster, even in the absence of any significant release of heparin. Therefore, DHEP Plus, a new formulation of the DHEP medicated plaster containing a small amount of heparin sodium as excipient has been developed. Methods: We reviewed the pivotal and supportive studies of the clinical development program of the new patch and evaluated the role of heparin as an enhancer in the treatment of localized pain/inflammation of musculoskeletal structures, associated with post-traumatic and/or rheumatic conditions. Results: The data were consistent with the concept that heparin increased the clinical activity of the DHEP Plus medicated plaster versus the reference DHEP medicated plaster through improved bioavailability due to enhanced movement of diclofenac from the plaster. Both DHEP formulations have the same dissolution profile, indicating that heparin does not change the physical and chemical characteristics of the plaster. Permeation testing showed that heparin is not released from the DHEP Plus medicated plaster. Efficacy studies showed that the DHEP Plus medicated plaster was significantly more effective in reducing pain than the reference marketed DHEP medicated plaster. A c c e p t e d M a n u s c r i p t Conclusions: The benefit/risk assessment of DHEP Plus 180 mg medicated plaster is favorable, with a safety profile equal to placebo and improved efficacy over the reference marketed DHEP medicated plaster.

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Pooled analysis of clinical trial data evaluating the safety and effectiveness of diclofenac epolamine topical patch 1.3% for the treatment of acute ankle sprain

Cited by 7 publications

References 22 publications

The Risk Factors for Ankle Sprain in Cadets at a Male Military School in Iran: A Retrospective Case-control Study

The Risk Factors for Ankle Sprain in Cadets at a Male Military School in Iran: A Retrospective Case-control Study

Advances in NSAID Development: Evolution of Diclofenac Products Using Pharmaceutical Technology

Rationale and evidence for the incorporation of heparin into the diclofenac epolamine medicated plaster

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