Effectiveness and Safety of Diclofenac Epolamine Topical Patch 1.3% for the Treatment of Acute Pain Due to Back Strain: An Open-Label, Uncontrolled Study

Abstract

Background: The diclofenac epolamine topical patch 1.3% (DETP) is indicated for topical treatment of acute pain due to minor strains, sprains, and contusions. This exploratory, multicenter, open-label study evaluated effectiveness and safety of DETP in patients with acute pain due to back strain. Methods: Patients aged $ 18 years with acute pain due to nonradicular back strain with an average pain intensity of $ 4 (0 = no pain, 10 = pain as bad as you can imagine) entered a 3-day observation/washout period and completed daily diary modified Brief Pain Inventory assessments. At baseline, patients with an average pain intensity of $ 4 started DETP treatment (q12h). Patients were treated for 7 or 14 days, depending on investigator and patient assessment of pain resolution. Primary endpoint was mean change from baseline to end of treatment in average pain intensity. Key secondary endpoints included changes from baseline in least, worst, and current pain scores and Beck Depression Inventory ® II scores. Patients and investigators assessed patch satisfaction and global pain relief. Results: In 123 enrolled patients, baseline mean ± standard deviation average pain score was 6.5 ± 1.3, which decreased to 2.5 ± 2.4 (P , 0.0001) at end of treatment. Similarly, least, worst, and current pain scores were also reduced (P , 0.0001). Sixty-three percent of patients achieved $ 50% pain reduction from baseline. At the end of treatment, most patients (88%) were satisfied or very satisfied with DETP. For 85% of patients, investigators also reported being satisfied or very satisfied with DETP. Most patients (87%) and investigators (88%, rating the patient's response) rated global pain relief as moderate to complete. Fifteen patients experienced a total of 19 adverse events (AEs), 17 of which were mild to moderate, and 2 of which were severe. Three AEs were treatment related (application site rash, nausea, and tachycardia); 1 patient had a serious AE (noncardiac chest pain) considered unrelated to DETP. Conclusion: In this exploratory study, patients experienced well-tolerated relief for acute pain due to back strain, with $ 85% of patients and their investigators expressing satisfaction with DETP treatment.

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

“…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.…”

Effects of Topical Diclofenac Plus Heparin (Dhep+H Plaster) on Somatic Pain Sensitivity in Healthy Subjects With a Latent Algogenic Condition of the Lower Limb

“…Topical formulations of analgesics/anti‐inflammatory agents are being increasingly used clinically for the treatment of localized pain conditions of soft tissues, as they bear a number of positive aspects with respect to systemic drug administration . Firstly, thanks to the minimal systemic absorption of the compounds, the incidence of side effects is greatly reduced, and this is particularly important in the case of nonsteroidal anti‐inflammatory drugs (NSAIDs) which can cause serious gastrointestinal bleeding or impairment of renal function . Secondly, patients’ compliance to treatment is enhanced, due to both the absence of any trauma on application— differently from what happens with intramuscular or intravenous therapy—and the possibility of self‐administration .…”