Comparative Benefit–Risk Assessment for Lidocaine 700 mg Medicated Plaster and Pregabalin in Peripheral Neuropathic Pain Following a Structured Framework Approach

Abstract

Introduction Peripheral neuropathic pain (PNP) is difficult to treat. Several oral drugs are recommended as first-line treatments. Nevertheless, many patients cannot obtain sufficient pain relief or do not tolerate systemically active treatments. Topical treatments, with a lower risk of systemic side effects such as lidocaine 700 mg medicated plaster, are also recommended in treatment guidelines. This analysis compares the benefit–risk balance of topical 700 mg lidocaine medicated plaster with the benefit–risk balance of oral pregabalin administration for the treatment of PNP following current recommendations on benefit–risk assessment (BRA) methodology. Methods The Benefit–Risk Action Team (BRAT) framework was used as structured approach. Selection of key benefits and risks was supported by a patient survey. Published randomized controlled clinical trials were the main source to identify data related to key benefits and risks. The outcome of randomized clinical trials was compared with real-world evidence (RWE) data for consistency. Results Identified key benefits were pain reduction and improvement in quality of life. Key risks identified were application site reactions, dizziness, confusion, weight gain, peripheral edema, and blurred vision. Overall, there was similarity in key benefits between the comparators; however, a clear advantage regarding key risks in favor of lidocaine 700 mg medicated plaster was observed. This observation was consistent across data from a direct comparison trial, randomized placebo-controlled trials, as well as data from RWE studies. The low number of randomized controlled trials for lidocaine 700 mg medicated plaster was the main limitation. Conclusion Guided by the opinion of patients regarding key benefits and risks deemed important for treatments of peripheral neuropathic pain, our analysis showed that lidocaine 700 mg medicated plaster has a more favorable benefit–risk balance compared to pregabalin (300 and 600 mg daily). Supplementary Information The online version contains supplementary material available at 10.1007/s40122-021-00340-2.

Painful diabetic peripheral neuropathy: real-world comparison between topical treatment with lidocaine 700 mg medicated plaster and oral treatments

“…Our findings support the previously reported good short-term and long-term tolerability of the plaster32 and the generally better adverse event profile compared with oral medications 33 34. A recent benefit/risk analysis showed that LMP had a more favorable benefit/risk balance compared with pregabalin (300 and 600 mg/day) for the treatment of peripheral neuropathic pain 35…”

“… 33 34 A recent benefit/risk analysis showed that LMP had a more favorable benefit/risk balance compared with pregabalin (300 and 600 mg/day) for the treatment of peripheral neuropathic pain. 35 …”

“…33 34 A recent benefit/risk analysis showed that LMP had a more favorable benefit/risk balance compared with pregabalin (300 and 600 mg/day) for the treatment of peripheral neuropathic pain. 35 The focus of the current study was to compare LMP with oral treatments used as first-line treatments in PDPN. There are other topical treatments indicated for PDPN, such as the capsaicin 179 mg cutaneous patch.…”

Modeling of Microneedle Arrays in Transdermal Drug Delivery Applications

“…Lidocaine, depending on its form of administration, can have different problems, ranging from systemic side effects in its intravenous administration [ 19 ], to discomfort in the oral intake of pills, especially in the geriatric and pediatric population [ 20 ]. This tends to be a major challenge in medical issues and the topical alternative can present an unacceptable response time in many cases [ 9 , 21 ].…”

Atualização no manejo da dor musculoesquelética

“…Outros efeitos nos queratinócitos e células imunes, ou ativação de receptores (TRPV1 e TRPA1), podem contribuir para o efeito analgésico da lidocaína. 45 É medicação de primeira linha da DN localizada, como neuralgia pós-herpética e lesão traumática de nervo periférico, onde a falta de efeitos colaterais sistêmicos a torna uma ótima opção (►Tabela 3). 12 O adesivo, emplastro de lidocaína 5%, deve ser utilizado por 12 horas, por dia, no máximo 3 unidades concomitantes, e por um período entre 2 a 4 semanas para que a resposta seja avaliada.…”