Abstract
Objective: To determine long-term safety and effectiveness of repeat treatments with a high concentration capsaicin patch. Methods: In this 52-week, open-label, randomized controlled study, patients with painful diabetic peripheral neuropathy (PDPN) received either capsaicin patch: (30- or 60-min; 1–7 treatments to the feet) plus SOC or SOC alone. Effectiveness was assessed, by changes from baseline to end of study (EoS), in average and severity of pain, pain interference with daily function (Brief Pain Inventory-Diabetic Neuropathy version), responder rates, Patient Global Impression of Change (PGIC), and EuroQol 5-dimension (EQ-5D) questionnaire. Results: 468 patients were randomized (n=156 and n=157, 30 and 60-min respectively; SOC alone, n=155). Safety data have been reported previously. Changes in average pain from baseline to EoS (mean percentage (SD)) were: 30-min, −37.5% (32.9); 60-min, −40.8% (39.7); SOC alone, −13.9% (74.6). The difference between groups increased progressively from −17.7% and −18.6% at Month 1 for 30- and 60-min., respectively, to −21.9% and −24% at Month 12. More 30% responders occurred in the capsaicin groups (30-min, 67.3%; 60-min, 67.5%) and more felt: very much or much improved” (30-min, 24.2%; 60-min, 24.5%), compared with SOC alone (40.6% and 9.5% respectively). A greater mean improvement in EQ-5D utility index and EQ-5D visual analog scale score, from baseline to Month 12, was observed with the 30-min (0.12) and 60-min (0.15) versus SOC alone (0.07) and mean (SD), 30–min (10.4 [18.5]) and 60-min (11.2 [21.4]) versus SOC alone (5.5 [18.1]) respectively. Conclusion: Capsaicin 8% patch showed differential effectiveness over SOC alone, further increasing with repeat treatments.
Highlights
Painful diabetic peripheral neuropathy (PDPN) has a significant humanistic and economic impact [1] and has been shown to affect many dimensions of patient quality of life (QoL), including mood, sleep, work, self-esteem, and social relationships; it has a particular impact on individuals for whom pain is not well managed [2, 3]
Statistical methods: Since the primary objective of this study was the assessment of the long-term safety of repeat administration of 179mg capsaicin cutaneous patch, sample size was determined with reference to the primary safety outcome measure, namely the Norfolk Quality of Life - Diabetic Neuropathy (QOL-DN) scale (21)
A total of 468 patients were randomized to capsaicin 30-min plus standard of care (SOC) (n=156), capsaicin 60-min plus SOC (n=157), or SOC alone (n=155)
Summary
Painful diabetic peripheral neuropathy (PDPN) has a significant humanistic and economic impact [1] and has been shown to affect many dimensions of patient quality of life (QoL), including mood, sleep, work, self-esteem, and social relationships; it has a particular impact on individuals for whom pain is not well managed [2, 3]. A retrospective analysis of a United States claims database found that most newly diagnosed patients with PDPN are prescribed anticonvulsants at lower than recommended doses, which potentially results in poor treatment outcomes and low levels of satisfaction. These findings, combined with poor tolerability at adequate dose levels, lead to frequent discontinuations of these treatments [9] or suboptimal response due to either dosing or compliance [10]. Defunctionalization of hyperactive nociceptors in the skin induced by the rapid delivery of capsaicin provides fast, targeted, and sustained pain relief after a single treatment [12]. Local application of the capsaicin 8% patch provides minimal systemic absorption, without potential for drug–drug interactions or requirement for dose adjustment in elderly patients or patients with renal or hepatic impairment [13]
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