Capsaicin 8% Patch in Painful Diabetic Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Study

Simpson, David M.; Robinson‐Papp, Jessica; Van, Joanna; Stoker, Malcolm; Jacobs, Hélène; Snijder, Robert; Schregardus, Diederik S.; Long, Sihui; Lambourg, Bruno; Katz, Nathaniel

doi:10.1016/j.jpain.2016.09.008

Cited by 118 publications

(88 citation statements)

References 24 publications

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“…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.…”

Section: Discussionmentioning

confidence: 99%

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

Perrot

Lantéri-Minet

2019

European Journal of Pain

106

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Background Patient‐Reported Outcome (PRO) instruments have been developed to evaluate pain management in daily practice; the Patients’ Global Impression of Change (PGIC) is particularly recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials. The prospective non‐interventional multicenter PRO‐QURE study aimed at assessing correlations between PGIC and pain measurements and treatment effects in patients followed in French pain centres. Methods Respectively, 495 and 379 patients with peripheral neuropathic pain initiating treatment with capsaicin 8% cutaneous patch(es) (female, 62.6%; mean age, 54.0 ± 14.8 years; post‐surgical or traumatic pain, 52.7%; mean pain duration, 42.2 ± 54.1 months; DN4 score >4, 92.9%) completed the PGIC and several other PRO instruments before (baseline) and 3 months (M3) after treatment application. Results At M3, improvement (“much improved” or “very much improved”) was observed in 23.0% of patients, associated with decreases of −3.0 ± 2.2, −2.5 ± 2.4, and −23.1 ± 19.7 in BPI pain intensity, BPI pain interference and NPSI total scores, respectively. The highest Spearman's rank correlation coefficients with PGIC were found for pain intensity (BPI: r = −0.479, p < 0.001), satisfaction with current state (Patient Acceptable Symptomatic State: r = 0.455, p < 0.001), and treatment effectiveness (TSQM: r = 0.431, p < 0.001); correlation coefficients were lower for all NPSI scores, BPI pain interference score, HAD scores and EQ‐5D‐3L index. Conclusions In daily clinical practice, significant improvement in peripheral neuropathic pain, as assessed by PGIC scores, significantly correlated with changes in well‐established measures of pain intensity, pain interference with activities of daily living, mood and quality of life, confirming its clinical interest as PRO measure in real‐world conditions. Significance Clinically important improvement in peripheral neuropathic pain, as assessed by PGIC scores, significantly correlated with well‐established measures of pain intensity, pain interference in daily life and treatment efficacy. This result, associated with the ease of administration and scoring, encourages the widespread use of the PGIC in daily practice.

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Section: Discussionmentioning

confidence: 99%

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

Perrot

Lantéri-Minet

2019

European Journal of Pain

106

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“…These findings are further supported by a randomised, open-label, non-inferiority study of the capsaicin 8% patch versus pregabalin (ELEVATE study) where non-diabetic patients with PHN, peripheral nerve injury or non-diabetic painful peripheral polyneuropathy had non-inferior pain relief versus pregabalin treatment, with a more rapid onset of action, fewer systemic effects and greater patient satisfaction with treatment [18]. In addition, studies performed in parallel to the ASCEND study have reported positive data for capsaicin 8% patch treatment in patients with painful diabetic peripheral neuropathy [29, 30]. A recent European label extension now allows for the use of the capsaicin 8% patch, either alone or in combination with other pain medications, in adults with diabetic PNP.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2017

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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.

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“…Since menthol cream has no noted side effects and is inexpensive, it could be worth investigating its use further, although randomized data are lacking. Non-CIPN studies showed benefit using 8% capsaicin-containing patches in patients with painful neuropathies [40] and attempts were made to try this also in patients with CIPN [38]. A topical 4% amitriptyline/2% ketamine preparation was studied in 462 patients in an RCT showing that neuropathic pain, numbness, or tingling could not be alleviated [41].…”

Section: Treatment Of Cipnmentioning

confidence: 99%

Prevention and Management of Chemotherapy-Induced Polyneuropathy

et al. 2019

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Chemotherapy-induced peripheral neurotoxicity (CIPN) is a severe and common side effect caused by a variety of antineoplastic agents. Approximately 30–40% of patients treated with agents such as taxanes, vinca alkaloids, or platinum derivatives will develop CIPN. CIPN presents predominantly as a sensory axonal neuro(no)pathy with occasional motor and autonomic dysfunction exhibiting considerable variability of clinical symptoms ranging from mild tingling sensation to severe neuropathic pain. Typical symptoms include numbness (“minus symptom”), weakness, and abnormal gait as well as paresthesia and pain (“positive symptoms”). As CIPN symptoms potentially lead to long-term morbidity and can even aggravate after cessation of therapy, patients’ quality of life can be tremendously affected. In view of improved breast cancer survival outcomes, the late effects of CIPN are an unmet need in these patients. Therefore, early detection and assessment of first symptoms is important to effectively prevent severe CIPN. Therapeutic options for patients with CIPN are still limited, and pharmacological treatment focuses primarily on reduction or relief of neuropathic pain. CIPN is usually acutely managed by dose reduction or discontinuation of causative chemotherapy, potentially compromising treatment outcome. Currently, there is no causative proven therapy for the prevention of CIPN.

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Capsaicin 8% Patch in Painful Diabetic Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Study

Cited by 118 publications

References 24 publications

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

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

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

Prevention and Management of Chemotherapy-Induced Polyneuropathy

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