RESUMEN

OBJECTIVE: The purpose of this investigation was to evaluate the gastrointestinal (GI) tolerability profile of diclofenac epolamine topical patch 1.3% (DETP) during short-term treatment in patients with mild-to-moderate pain. DESIGN: Fourteen clinical trials of DETP were examined; 10 placebo-controlled studies were further integrated for analyses. All adverse event (AE) data were coded to the Medical Dictionary for Regulatory Activities. OUTCOME MEASURES: Frequency of GI AEs was summarized by treatment, preferred term, sex, and age group. RESULTS: The percentage of patients reporting GI AEs were similar between patients treated with the DETP and placebo, with only 3 of the 10 placebo-controlled trials reporting events in >2% of patients; there was no significant difference between DETP and placebo for any preferred GI term. The most common GI AE reported for both treatment groups was nausea (1.5% DETP, 1.1% placebo). There was no significant difference between treatment groups and sex in the number of reported events and no noted difference between age groups. CONCLUSION: This study provides evidence that DETP is a topical nonsteroidal anti-inflammatory drug that is a well-tolerated treatment option, demonstrating a low incidence of GI AEs across 14 clinical trials, making it a possible alternative to short-term oral NSAIDs, which are commonly associated with GI complications.

Asunto(s)

Antiinflamatorios no Esteroideos/efectos adversos , Diclofenaco/análogos & derivados , Tracto Gastrointestinal/efectos de los fármacos , Adulto , Factores de Edad , Anciano , Antiinflamatorios no Esteroideos/administración & dosificación , Diclofenaco/administración & dosificación , Diclofenaco/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dolor/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores Sexuales , Parche Transdérmico

RESUMEN

BACKGROUND: Sports-related injuries, such as sprains and strains, commonly occur during exercise and athletic events. Current therapy includes nonsteroidal anti-inflammatory drugs (NSAIDs), which have a high incidence of upper gastrointestinal side effects. The present study assessed the efficacy and safety of the diclofenac epolamine topical patch (DETP, 1.3%), a topical NSAID for the treatment of acute minor sprains and strains. METHODS: This multicenter, randomized, placebo-controlled clinical study enrolled adult patients (n = 134) with acute ankle pain (due to a minor sprain) occurring less than 48 hours prior to entering the study. Patients were treated with either the DETP or a placebo topical patch daily for seven days. Pain intensity was evaluated during the first six hours after application of the patch, and on treatment days 1, 2, 3, and 7. RESULTS: Patients treated with the DETP experienced a significantly greater reduction in pain associated with their ankle injury compared with placebo, beginning four hours after the first patch application (P = 0.02). The DETP was well tolerated and was comparable with placebo in terms of safety. CONCLUSION: Overall, the results of this study demonstrate that the DETP is an effective analgesic for local treatment of pain in mild acute ankle sprain.

RESUMEN

This pooled analysis assessed the efficacy and safety of the diclofenac epolamine topical patch 1.3% (DETP) for the treatment of acute mild-to-moderate ankle sprain. Data from 2 randomized, double-blind, placebo-controlled studies enrolling 274 male and female patients aged 18 to 65 years with acute ankle sprain were pooled and evaluated. The primary end point was pain reduction on movement assessed using a 100 mm visual analog scale (VAS). Safety and tolerability were also assessed. Beginning approximately 3 hours after initial treatment, DETP-treated patients experienced statistically significant and sustained lower mean VAS scores in pain intensity on movement (mean ± SD, 54.1 ± 20.0 mm versus 60.3 ± 16.8 mm) compared with placebo-treated patients, representing a 20% versus 13% reduction in VA S pain scores from baseline (P = 0.012). This statistically significant difference in mean VAS score was maintained through day 7 (9.4 ± 14.4 mm versus 18.4 ± 18.2 mm, P < 0.0001). The DETP and placebo patches were well tolerated. These results further confirm the efficacy and safety of DETP for the treatment of acute pain from ankle sprains.