Capsaicin 8% Patch in Painful Diabetic Peripheral Neuropathy: A Randomized,Double-Blind,Placebo-Controlled Study |
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Authors: | David M Simpson Jessica Robinson-Papp Joanna Van Malcolm Stoker Hélène Jacobs Robert J Snijder Diederik S Schregardus Stephen K Long Bruno Lambourg Nathaniel Katz |
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Institution: | 1. Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, New York;2. Diabetes Research Center, Tustin, California;3. Global Medical Science, Astellas Pharma Europe BV, Leiden, The Netherlands;4. Chiltern International, Leiden, The Netherlands;5. INC Research, Camberley, United Kingdom;6. Helix Biomedics LLC, Boynton Beach, Florida;7. Analgesic Solutions, Natick, Massachusetts;11. Department of Anesthesiology, Tufts University School of Medicine, Boston, Massachusetts |
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Abstract: | This 12-week study evaluated the efficacy and safety of capsaicin 8% patch versus placebo patch in painful diabetic peripheral neuropathy (PDPN). Patients aged 18 years or older with PDPN were randomized (1:1) to one 30-minute treatment (capsaicin 8% patch or placebo patch) to painful areas of the feet. Overall, 369 patients were randomized (capsaicin 8% patch, n = 186; placebo patch, n = 183). Percentage reduction in average daily pain score from baseline to between weeks 2 through 8 (the primary end point) was statistically significant for capsaicin 8% patch versus placebo (?27.4% vs ?20.9%; P = .025); improvements in pain were observed from week 2 onward. Versus placebo, patients treated with capsaicin 8% patch had a shorter median time to treatment response (19 vs 72 days) and modest improvements in sleep interference scores from baseline to between weeks 2 through 8 (P = .030) and weeks 2 through 12 (P = .020). Apart from application site reactions, treatment-emergent adverse events were similar between groups. No indications of deterioration in sensory perception of sharp, cold, warm, or vibration stimuli were observed. In patients with PDPN, capsaicin 8% patch treatment provided modest pain relief and sleep quality improvements versus a placebo patch, similar in magnitude to other treatments with known efficacy, but without systemic side effects or sensory deterioration.PerspectiveTo our knowledge, this is the first study of the capsaicin 8% patch versus placebo in patients with PDPN to show that one 30-minute capsaicin treatment provides modest improvements in pain and sleep quality. Results confirm the clinical utility of the capsaicin 8% patch in the diabetic population. |
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Keywords: | Capsaicin 8% patch painful diabetic peripheral neuropathy NPRS average daily pain score Brief Pain Inventory-Diabetic Neuropathy phase 3 study |
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