Efficacy of Pregabalin and High-Concentration (179 mg) Capsaicin Patch in Peripheral Neuropathic Pain: A Review of Studies ? 26 Weeks' Duration
Author(s)
Diane BLAYRAC, PharmD, Miranda AGER, PhD, Charlotte BOTH, PhD, Rita Freitas, PharmD.
Grünenthal GmbH or its affiliates, AACHEN, Germany.
Grünenthal GmbH or its affiliates, AACHEN, Germany.
OBJECTIVES: Peripheral neuropathic pain (PNP) is a chronic condition impacting quality of life that often requires long-term treatment. The recent update to the European summary of product characteristics for high concentration (179mg) capsaicin patch (HCCP) (2023) recommends treating for sufficiently long and to reassess effectiveness after three applications. This targeted analysis aimed to assess the efficacy of HCCP and the standard of care pregabalin, in patients with PNP based on published studies of ≥26 weeks duration.
METHODS: A systematic literature review was performed to identify relevant studies on PNP treatments (Embase, PubMed: Dec 2024). Studies including PNP patients (≥18 years) treated with pregabalin and/or HCCP, duration ≥26 weeks, were included in the analysis. Reduction in pain scores (any reported) and responder rates were analysed, and the feasibility of indirect comparisons was explored.
RESULTS: Eight studies for HCCP and five for pregabalin met the inclusion criteria, both drugs were studied across a mixture of PNP aetiologies, including diabetic peripheral neuropathy, post herpetic neuralgia (both products) post-surgical pain (HCCP). The majority were real-world observational studies or open-label extensions of phase 3 studies. The only randomized controlled study in PNP >26 weeks found was for HCCP. Due to differences in study design, patient populations, and use of background treatments, a formal indirect comparison was not feasible. However, extracted data suggest that while with pregabalin analgesic effect is maintained in PNP over 26-52 weeks, with HCCP effectiveness seems to increase with repeated treatment over similar periods.
CONCLUSIONS: Although limited by study heterogeneity and the absence of a common comparator, available data suggest distinct efficacy trajectories: pregabalin shows stable analgesic effects, whereas HCCP may offer progressive benefit with repeated treatment. Long-term head-to-head trials are warranted to validate these findings and better inform treatment decisions in PNP management.
METHODS: A systematic literature review was performed to identify relevant studies on PNP treatments (Embase, PubMed: Dec 2024). Studies including PNP patients (≥18 years) treated with pregabalin and/or HCCP, duration ≥26 weeks, were included in the analysis. Reduction in pain scores (any reported) and responder rates were analysed, and the feasibility of indirect comparisons was explored.
RESULTS: Eight studies for HCCP and five for pregabalin met the inclusion criteria, both drugs were studied across a mixture of PNP aetiologies, including diabetic peripheral neuropathy, post herpetic neuralgia (both products) post-surgical pain (HCCP). The majority were real-world observational studies or open-label extensions of phase 3 studies. The only randomized controlled study in PNP >26 weeks found was for HCCP. Due to differences in study design, patient populations, and use of background treatments, a formal indirect comparison was not feasible. However, extracted data suggest that while with pregabalin analgesic effect is maintained in PNP over 26-52 weeks, with HCCP effectiveness seems to increase with repeated treatment over similar periods.
CONCLUSIONS: Although limited by study heterogeneity and the absence of a common comparator, available data suggest distinct efficacy trajectories: pregabalin shows stable analgesic effects, whereas HCCP may offer progressive benefit with repeated treatment. Long-term head-to-head trials are warranted to validate these findings and better inform treatment decisions in PNP management.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO96
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy, Relating Intermediate to Long-term Outcomes