To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Diclofenac Epolamine Topical Patch Efficacious and Safe in Elderly Patients With Acute Periarthritis: Presented at AGS URL: http://www.pslgroup.com/dg/220EC2.htm Doctor's Guide May 9, 2008
By Crina Frincu-Mallos, PhD WASHINGTON, DC -- May 9, 2008 -- Diclofenac epolamine topical patch 1.3% (DETP) appears to provide suitable analgesia for older patients with localised pain due to inflammation, the investigators concluded. In older adults, musculoskeletal pain represents a major cause of disability. Approximately 65% of patients aged 65 and older take at least 1 medication daily, while elderly in nursing homes are on 5 to 8 medications daily (Schmucker DL, Vessell ES. J Clin Pharmacol. 1999;39:1103-1108). DETP provides transdermal delivery of the nonsteroidal anti-inflammatory drug diclofenac, which significantly reduces pain on movement in patients with painful periarticular pathologies. Lead author Jesus F. Arroyo, MD, Geriatrician, Hôpital de la Gériatrie, Institutions Universitaires de Gériatrie, Geneva, Switzerland, discussed the findings of a study of DTEP on behalf of his colleagues in a poster presentation here at the 2008 Annual Scientific Meeting of the American Geriatrics Society (AGS). Dr. Arroyo and colleagues looked at the efficacy and tolerability of DETP in elderly patients with periarticular pathologies of the shoulder (scapulohumeral periarthritis) or knee (peripatellar tendonitis and pes anserinus). Eighty patients with either shoulder (n = 55) or knee (n = 25) pain were enrolled in this double-blind, randomised, crossover, placebo-controlled study. To be eligible, the patients had to experience acute pain for at least 10 consecutive days, said the researchers. The patients had a mean age of 84 years and 84% of them were women. They were randomised to receive twice daily treatment with either DETP followed by placebo patch for 6 days each (n = 42) or placebo patch followed by DETP for 6 days each (n = 38). A vast majority of the patients had prior treatments: infiltrations, NSAIDs, analgesics, physiotherapy. All were required to discontinue any analgesic/anti-inflammatory agent 10 days before they were included in the current study, noted Dr. Arroyo. Pain on movement was assessed both by the patient and by a clinician, using a visual analog scale (VAS), while the evaluations of functional impact were performed using a 5-point verbal scale, Dr. Arroyo explained. From baseline to day 6 of the first treatment period, noteworthy improvements were seen in pain on movement and on function, according to the researchers. Clinicians' assessments at day 6 showed a statistically significant difference from baseline in percent change in VAS pain on movement for DTEP of -52% (P < .0001) and -48% for placebo (P < .0001). It also showed a statistically significant difference from baseline in percent change in functional impact for DTEP (-29%, P < .0001) and for placebo (-25%, P < .0001). The reductions were also significant for DTEP versus placebo (P < .01, analysis of variance for crossover). Analysis of the crossover period (days 6 to 12) revealed that the effect of treatment continued to be felt during this time, possibly due to a lack of a washout period, Dr. Arroyo acknowledged. Two patients -- 1 in the DETP group and 1 in the placebo group -- had to discontinue treatment due to allergic dermatitis and pruritus. Three patients experienced mild adverse events (AEs) -- 2 cases of local pruritus and 1 unspecified, said the investigators. "Since topical NSAIDs yield lower systemic levels compared to oral formulations, systemic AEs and drug-drug interactions are less likely [to occur]," Dr. Arroyo explained. Indeed, "no systemic AEs were observed [with DETP]," he added. Laboratory tests performed at baseline and at study completion do not indicate any clinically relevant laboratory changes. There were, however, small changes in creatinine levels (mean, -3.0 mcmol/L) and creatinine clearance (mean, +2.1 mL/min). DETP may provide a suitable option for administration of NSAIDs in older patients with localised pain due to inflammation, the investigators concluded. Funding for this study was provided by the Institut Biochimique SA and Alpharma Pharmaceuticals LLC. [Presentation title: Efficacy and Tolerability of Diclofenac Epolamine Topical Patch for Pain of Inflammation of Shoulder and Knee in Patients >=64 Years Old. Abstract A45] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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