Effectiveness of the capsaicin 8% patch in the management of peripheral neuropathic pain in European clinical practice: the ASCEND study

Abstract

BackgroundIn randomised studies, the capsaicin 8% patch has demonstrated effective pain relief in patients with peripheral neuropathic pain (PNP) arising from different aetiologies.MethodsASCEND 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. 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. The primary analysis was intended to assess analgesic equivalence between post-herpetic neuralgia (PHN) and other PNP aetiologies. Health-related quality of life (HRQoL, using EQ-5D), Patient Global Impression of Change (PGIC) and tolerability were also assessed.ResultsFollowing 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. Equivalence was demonstrated between PHN and the neuropathic back pain, post-operative and post-traumatic neuropathic pain and ‘other’ PNP aetiology subgroups. The median time from first to second treatment was 191 days (95% CI: 147, 235; n = 181). 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. 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. Patients with the shortest duration of pain (0–0.72 years) experienced the highest pain response from baseline to Weeks 2 and 8. 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. Most patients reported improvements in PGIC at Week 2 and at all follow-up assessments regardless of number of treatments received. Adverse events were primarily mild or moderate reversible application site reactions.ConclusionIn 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.Trial registration NCT01737294 Date of registration - October 22, 2012.

Patients’ Global Impression of Change in the management of peripheral neuropathic pain: Clinical relevance and correlations in daily practice

“…We chose to perform this analysis in patients treated with capsaicin 8% cutaneous patch because the application is performed in specialized facilities by trained health professionals, which guaranteed that all patients would correctly receive the correct dose of the product. In addition, the effectiveness of the patch has been proven in several randomized clinical trials and non‐interventional studies (Backonja et al, ; Clifford et al, ; Hansson, Jensen, Kvarstein, & Strömberg, ; Irving et al, ; Maihofner & Heskamp, ; Mankowski et al, ; Simpson et al, ). Finally, thanks to its low systemic exposure and rapid elimination following application (Pickering, Martin, Tiberghien, Delorme, & Mick, ), few side effects, and in particular cognitive side effects that could interfere with mood or quality of life or lead to premature treatment discontinuation, were expected.…”

Pain‐relieving effectiveness, quality of life and tolerability of repeated capsaicin 8% patch treatment of peripheral neuropathic pain in Scandinavian clinical practice

“…Also, the heterogeneous patient population from a diagnostic perspective may have included subgroups of patients less susceptible to respond to this type of treatment. For example, in another real‐world study of the capsaicin 8% patch that included seven European countries, patients with post‐operative and post‐traumatic neuropathic pain had less improvement in pain over 8 weeks compared with patients with other aetiologies including postherpetic neuralgia and neuropathic back pain (Mankowski et al., ). Direct comparisons to other studies are not possible due to differences in trial design (i.e.…”

“…A recent study showed that the number needed to treat to achieve a 50% reduction in pain was 10.6 (Finnerup et al., ). The outcomes of single applications of the capsaicin 8% patch for the treatment of PNP have been documented in clinical practice (Maihofner and Heskamp, , ; Haanpaa et al., ), and recently, repeat applications were found to be effective and well tolerated in a 52‐week real‐world European study (Mankowski et al., ).…”

Predictors of Treatment Response to Capsaicin Patch

“…This desensitization allows the use of capsaicin as an analgesic [19]. Long term treatment have been studied along several prospective cohort studies [20][21][22] CP8% treatment have been studied up to 52 weeks of follow-up, with repeated patch application. In these studies no sensory changes in the skin was found after repeated treatment.…”