In European clinical practice, the capsaicin 8% patch provided effective and sustained pain relief, substantially improved HRQoL, improved overall health status and was generally well tolerated in a heterogeneous PNP population. Adverse events were primarily mild or moderate reversible application site reactions. Most patients reported improvements in PGIC at Week 2 and at all follow-up assessments regardless of number of treatments received. Mean EQ-5D index score improved by 0.199 utils (responders: 0.292 utils) from baseline to Week 2 and was maintained until Week 52. Patients with the shortest duration of pain (0–0.72 years) experienced the highest pain response from baseline to Weeks 2 and 8. A sustained pain response was observed until Week 52, with a 37.0% (95% CI: 31.3, 42.7 n = 176) reduction in mean NPRS score from baseline. Forty-four percent of all patients were responders (≥30% reduction in NPRS score from baseline to Weeks 2 and 8) following first treatment, and 86.9% ( n = 159/183) remained so at Week 12. The median time from first to second treatment was 191 days (95% CI: 147, 235 n = 181). Equivalence was demonstrated between PHN and the neuropathic back pain, post-operative and post-traumatic neuropathic pain and ‘other’ PNP aetiology subgroups. Resultsįollowing first application, patients experienced a 26.6% (95% CI: 23.6, 29.62 n = 412) reduction in mean NPRS score from baseline to Weeks 2 and 8. Health-related quality of life (HRQoL, using EQ-5D), Patient Global Impression of Change (PGIC) and tolerability were also assessed. The primary analysis was intended to assess analgesic equivalence between post-herpetic neuralgia (PHN) and other PNP aetiologies. Co-primary endpoints were percentage change in the mean numeric pain rating scale (NPRS) ‘average daily pain’ score from baseline to the average of Weeks 2 and 8 following first treatment and median time from first to second treatment. MethodsĪSCEND was an open-label, non-interventional study of patients with non-diabetes-related PNP who received capsaicin 8% patch treatment, according to usual clinical practice, and were followed for ≤52 weeks. In randomised studies, the capsaicin 8% patch has demonstrated effective pain relief in patients with peripheral neuropathic pain (PNP) arising from different aetiologies.
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