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Capsaicin 8% Patch Repeat Treatment in Nondiabetic Peripheral Neuropathic Pain: A 52-Week, Open-Label, Single-Arm,
Rafael Gálvez1, Marie-Louise Navez, Graeme Moyle
1*Pain and Palliative Care Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain †Center for Pain Evaluation and Treatment, Saint Etienne Hospital, Saint Etienne, France #Center for the Treatment and Evaluation of Pain and INSERM U 987, Hôpital Ambroise Paré, Boulogne-Billancourt, France ‡Chelsea & Westminster NHS Foundation Trust, London ¶The Walton Centre NHS Foundation Trust, University of Liverpool, Clinical Sciences Centre, Liverpool, UK §Department of Neurology, General Hospital Fürth, Fürth, Germany ∥Astellas Pharma Europe B.V., Leiden, The Netherlands.
Objectives:
To investigate the long-term safety and tolerability of capsaicin 8% patch repeat treatment in nondiabetic patients with peripheral neuropathic pain.
Methods:
A prospective, open-label, observational study in patients with postherpetic neuralgia, posttraumatic or postsurgical nerve injury, HIV-associated distal sensory polyneuropathy, or other peripheral neuropathic pain, and average daily pain score ≥4, who received ≤6 capsaicin 8% patch treatments over 52 weeks according to clinical need (retreatment at 9 to 12 wk intervals). Sensory testing and analgesic effectiveness were assessed using "bedside tests" and Brief Pain Inventory (question 5).
Results:
Overall, 306 patients received treatment. Treatment-emergent adverse events (TEAEs) and drug-related TEAEs were reported by 252 (82.4%) and 207 (67.6%) patients. Application site pain was the most common drug-related TEAE (n=112, 36.6%); no drug-related serious TEAEs were reported. Sensory category shift analyses from baseline to end of study (EoS) in patients attending at least 2 sensory visits (n=278 for all tests except warm, n=277) found sensory deterioration/loss in at least 1 modality in 50.4% (n=140); deterioration/loss in 1, 2, 3, 4, or 5 modalities occurred in 26.6% (n=74), 14.0% (n=39), 5.8% (n=16), 2.5% (n=7), and 1.4% (n=4) cases. Newly emergent hyperesthesia or allodynia was apparent in 1.1% to 3.6% of the cases (depending on modality) by EoS. Between 25.2% and 32.0% of patients reported improvement in a sensory modality by EoS. Average daily pain was 6.6 and 4.7 at baseline and month 12.
Conclusions:
Generally, capsaicin 8% patch repeat treatment over 52 weeks was well tolerated, with variable alteration in sensory function and minimal chance of complete sensory loss.