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5% Lidocaine Medicated Plaster for the Treatment of Postherpetic Neuralgia: A Review of the Clinical Safety and Tolerability.

Navez ML, Monella C, Bösl I, Sommer D, Delorme C - Pain Ther (2015)

Bottom Line: An efficacious and safe treatment with a low interaction potential is therefore of high importance.This review focuses on the safety and tolerability of the 5% lidocaine medicated plaster, a topical analgesic indicated for the treatment of PHN.The available literature (up to June 2014) was searched for publications containing safety data regarding the use of the 5% lidocaine medicated plaster in PHN treatment; unpublished clinical safety data were also included in this review.

View Article: PubMed Central - PubMed

Affiliation: Center for Pain Evaluation and Treatment, Saint Etienne Hospital, Saint Etienne, France, malou.navez@chu-st-etienne.fr.

ABSTRACT
Postherpetic neuralgia (PHN) is a common, very painful, and often long-lasting complication of herpes zoster which is frequently underdiagnosed and undertreated. It mainly affects the elderly, many of whom are already treated for comorbidities with a variety of systemic medications and are thus at high risk of drug-drug interactions. An efficacious and safe treatment with a low interaction potential is therefore of high importance. This review focuses on the safety and tolerability of the 5% lidocaine medicated plaster, a topical analgesic indicated for the treatment of PHN. The available literature (up to June 2014) was searched for publications containing safety data regarding the use of the 5% lidocaine medicated plaster in PHN treatment; unpublished clinical safety data were also included in this review. The 5% lidocaine medicated plaster demonstrated good short- and long-term tolerability with low systemic uptake (3 ± 2%) and minimal risk for systemic adverse drug reactions (ADRs). ADRs related to topical lidocaine treatment were mainly application site reactions of mild to moderate intensity. The treatment discontinuation rate was generally below 5% of patients. In one trial, the 5% lidocaine medicated plaster was better tolerated than systemic treatment with pregabalin. The 5% lidocaine medicated plaster provides a safe alternative to systemic medications for PHN treatment, including long-term pain treatment.

No MeSH data available.


Related in: MedlinePlus

Comparison of lidocaine plasma/serum concentrations after topical application of the 5% lidocaine medicated plaster (open/white bars) in healthy volunteers and patients with AHZ or PHN to plasma concentrations associated with the therapeutic systemic administration (grey bar) and toxic range for cardiac arrhythmias (black bar). Trials with various 5% lidocaine medicated plaster treatment regimes and populations: a 4 plasters administered every 12 h (twice daily) or 24 h for 3 consecutive days to healthy volunteers [28]; b 4 plasters administered for 18 h/day for 3 consecutive days to healthy volunteers [34]; c 3 plasters administered for 12 h/day for 3 consecutive days to healthy volunteers (Grünenthal, data on file); c 3 plasters administered for 12 h for 1 day to patients with AHZ and to patients with PHN (Grünenthal, data on file); d 3 plasters administered for 12 h/day for 5 consecutive days to healthy volunteers (Grünenthal, data on file); e 3 plasters administered for up to 12 h/day for 1 year to patients with PHN (mean maximum serum concentration value; Grünenthal, data on file). AHZ acute herpes zoster, PHN postherpetic neuralgia
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Fig1: Comparison of lidocaine plasma/serum concentrations after topical application of the 5% lidocaine medicated plaster (open/white bars) in healthy volunteers and patients with AHZ or PHN to plasma concentrations associated with the therapeutic systemic administration (grey bar) and toxic range for cardiac arrhythmias (black bar). Trials with various 5% lidocaine medicated plaster treatment regimes and populations: a 4 plasters administered every 12 h (twice daily) or 24 h for 3 consecutive days to healthy volunteers [28]; b 4 plasters administered for 18 h/day for 3 consecutive days to healthy volunteers [34]; c 3 plasters administered for 12 h/day for 3 consecutive days to healthy volunteers (Grünenthal, data on file); c 3 plasters administered for 12 h for 1 day to patients with AHZ and to patients with PHN (Grünenthal, data on file); d 3 plasters administered for 12 h/day for 5 consecutive days to healthy volunteers (Grünenthal, data on file); e 3 plasters administered for up to 12 h/day for 1 year to patients with PHN (mean maximum serum concentration value; Grünenthal, data on file). AHZ acute herpes zoster, PHN postherpetic neuralgia

Mentions: Following plaster application lidocaine is continuously released at the application site; only approximately 3 ± 2% of the applied lidocaine enters systemic circulation [33]. Steady-state plasma concentrations are reached within 4 days with no tendency for lidocaine accumulation [25]. Pharmacokinetic studies and a population kinetics analysis of clinical efficacy studies observed that mean maximum lidocaine plasma concentrations were below 0.3 µg/ml using up to four plasters in healthy volunteers and up to three plasters in patients with acute herpes zoster or PHN (Fig. 1) including extended dosing regimens (four plasters simultaneously, application for 18 h, continuous 72 h application with plaster changes every 24 h [28, 34]). When more than three plasters were applied and an extended application time was used, increases in area under the curve and maximum serum concentration relative to the investigations using three plasters were documented [28, 34]. However, the observed absorption remained low, that is, well below the minimum effective plasma concentrations during therapy of cardiac arrhythmias and well below the toxic range for lidocaine (Fig. 1). Lidocaine plasma concentrations even remained below 0.5 µg/ml after 4 months of treatment with ten 5% lidocaine medicated plasters daily to ease neuropathic pain in one cancer patient [37].Fig. 1


5% Lidocaine Medicated Plaster for the Treatment of Postherpetic Neuralgia: A Review of the Clinical Safety and Tolerability.

Navez ML, Monella C, Bösl I, Sommer D, Delorme C - Pain Ther (2015)

Comparison of lidocaine plasma/serum concentrations after topical application of the 5% lidocaine medicated plaster (open/white bars) in healthy volunteers and patients with AHZ or PHN to plasma concentrations associated with the therapeutic systemic administration (grey bar) and toxic range for cardiac arrhythmias (black bar). Trials with various 5% lidocaine medicated plaster treatment regimes and populations: a 4 plasters administered every 12 h (twice daily) or 24 h for 3 consecutive days to healthy volunteers [28]; b 4 plasters administered for 18 h/day for 3 consecutive days to healthy volunteers [34]; c 3 plasters administered for 12 h/day for 3 consecutive days to healthy volunteers (Grünenthal, data on file); c 3 plasters administered for 12 h for 1 day to patients with AHZ and to patients with PHN (Grünenthal, data on file); d 3 plasters administered for 12 h/day for 5 consecutive days to healthy volunteers (Grünenthal, data on file); e 3 plasters administered for up to 12 h/day for 1 year to patients with PHN (mean maximum serum concentration value; Grünenthal, data on file). AHZ acute herpes zoster, PHN postherpetic neuralgia
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Related In: Results  -  Collection

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Fig1: Comparison of lidocaine plasma/serum concentrations after topical application of the 5% lidocaine medicated plaster (open/white bars) in healthy volunteers and patients with AHZ or PHN to plasma concentrations associated with the therapeutic systemic administration (grey bar) and toxic range for cardiac arrhythmias (black bar). Trials with various 5% lidocaine medicated plaster treatment regimes and populations: a 4 plasters administered every 12 h (twice daily) or 24 h for 3 consecutive days to healthy volunteers [28]; b 4 plasters administered for 18 h/day for 3 consecutive days to healthy volunteers [34]; c 3 plasters administered for 12 h/day for 3 consecutive days to healthy volunteers (Grünenthal, data on file); c 3 plasters administered for 12 h for 1 day to patients with AHZ and to patients with PHN (Grünenthal, data on file); d 3 plasters administered for 12 h/day for 5 consecutive days to healthy volunteers (Grünenthal, data on file); e 3 plasters administered for up to 12 h/day for 1 year to patients with PHN (mean maximum serum concentration value; Grünenthal, data on file). AHZ acute herpes zoster, PHN postherpetic neuralgia
Mentions: Following plaster application lidocaine is continuously released at the application site; only approximately 3 ± 2% of the applied lidocaine enters systemic circulation [33]. Steady-state plasma concentrations are reached within 4 days with no tendency for lidocaine accumulation [25]. Pharmacokinetic studies and a population kinetics analysis of clinical efficacy studies observed that mean maximum lidocaine plasma concentrations were below 0.3 µg/ml using up to four plasters in healthy volunteers and up to three plasters in patients with acute herpes zoster or PHN (Fig. 1) including extended dosing regimens (four plasters simultaneously, application for 18 h, continuous 72 h application with plaster changes every 24 h [28, 34]). When more than three plasters were applied and an extended application time was used, increases in area under the curve and maximum serum concentration relative to the investigations using three plasters were documented [28, 34]. However, the observed absorption remained low, that is, well below the minimum effective plasma concentrations during therapy of cardiac arrhythmias and well below the toxic range for lidocaine (Fig. 1). Lidocaine plasma concentrations even remained below 0.5 µg/ml after 4 months of treatment with ten 5% lidocaine medicated plasters daily to ease neuropathic pain in one cancer patient [37].Fig. 1

Bottom Line: An efficacious and safe treatment with a low interaction potential is therefore of high importance.This review focuses on the safety and tolerability of the 5% lidocaine medicated plaster, a topical analgesic indicated for the treatment of PHN.The available literature (up to June 2014) was searched for publications containing safety data regarding the use of the 5% lidocaine medicated plaster in PHN treatment; unpublished clinical safety data were also included in this review.

View Article: PubMed Central - PubMed

Affiliation: Center for Pain Evaluation and Treatment, Saint Etienne Hospital, Saint Etienne, France, malou.navez@chu-st-etienne.fr.

ABSTRACT
Postherpetic neuralgia (PHN) is a common, very painful, and often long-lasting complication of herpes zoster which is frequently underdiagnosed and undertreated. It mainly affects the elderly, many of whom are already treated for comorbidities with a variety of systemic medications and are thus at high risk of drug-drug interactions. An efficacious and safe treatment with a low interaction potential is therefore of high importance. This review focuses on the safety and tolerability of the 5% lidocaine medicated plaster, a topical analgesic indicated for the treatment of PHN. The available literature (up to June 2014) was searched for publications containing safety data regarding the use of the 5% lidocaine medicated plaster in PHN treatment; unpublished clinical safety data were also included in this review. The 5% lidocaine medicated plaster demonstrated good short- and long-term tolerability with low systemic uptake (3 ± 2%) and minimal risk for systemic adverse drug reactions (ADRs). ADRs related to topical lidocaine treatment were mainly application site reactions of mild to moderate intensity. The treatment discontinuation rate was generally below 5% of patients. In one trial, the 5% lidocaine medicated plaster was better tolerated than systemic treatment with pregabalin. The 5% lidocaine medicated plaster provides a safe alternative to systemic medications for PHN treatment, including long-term pain treatment.

No MeSH data available.


Related in: MedlinePlus