2 June 2010
NICE has published a new clinical guideline on the pharmacological management of neuropathic pain in adults in non-specialist settings (CG96). This updates and replaces recommendations on the drug treatment of painful diabetic neuropathy in previous NICE clinical guidelines on type 1 (CG15) and type 2 diabetes (CG87).
The guideline outlines ‘key principles of care’ with which all non-specialist clinicians involved in the care of patients with neuropathic pain should familiarise themselves. After starting or changing a treatment, early and regular clinical reviews should be performed to assess the suitability of treatment. More information on neuropathic pain can currently be found on the pain overview section of NPC. Part 5 of the e-learning event specifically discusses the evidence-base for the pharmacological treatment of neuropathic pain. A brand new NPCi floor on neuropathic pain is currently under development to take in account this new NICE guidance and will be available later in 2010.
What does the guideline say?
The recommendations are only applicable in non-specialist settings — i.e. primary and secondary care services that do not provide specialist pain services. NICE make the following ‘key principles of care’ recommendations:
- Consider referral to a specialist pain service and/or a condition-specific service at any stage if pain is severe or significantly limits daily activities and participation, or underlying health has deteriorated
- Continue existing treatments for people whose neuropathic pain is already effectively managed
- Address the person’s concerns and expectations when agreeing which treatments to use by discussing benefits and adverse effects, why a particular treatment is chosen, coping strategies, and non-pharmacological treatments
- When selecting pharmacological agents consider:
– the person’s vulnerability to adverse effects
– contraindications and warnings (as in the treatment’s summary of product characteristics)
– the person’s preferences
– lifestyle factors including the person’s occupation
– mental health problems
– other medication the person is taking
- Explain the importance of dosage titration and the titration process
- When withdrawing or switching treatment, taper the withdrawal regimen
- When introducing a new treatment, consider overlap with the old treatments
- Perform early clinical review after starting or changing treatment
- Perform regular clinical reviews to assess and monitor treatment effectiveness. Assess:
– pain reduction
– adverse effects
– daily activities and participation (involvement in life situations, such as ability to work)
– mood (in particular, whether the person may have depression and/or anxiety)
– quality of sleep
– overall improvement as reported by the person
- If there is satisfactory improvement — continue the treatment; if the improvement is sustained — consider reducing the dose
The guideline treats neuropathic pain as a ‘blanket condition’, but makes specific recommendations for painful diabetic neuropathy. NICE recommends amitriptyline or pregabalin▼ as equal first-line treatments for most people. Duloxetine▼ (or amitriptyline if duloxetine is contra-indicated) is recommended first-line in painful diabetic neuropathy. If satisfactory pain relief is obtained with amitriptyline, but it cannot be tolerated, imipramine or nortriptyline can be considered as alternatives. If pain reduction is unsatisfactory at the maximum tolerated dose of first-line treatment, another drug can be used instead, or in combination with the original drug, after informed discussion with the patient. For example, if first-line treatment was with amitriptyline, NICE recommends switching or combining with pregabalin. See CG96 for full details of the recommendations.
What’s the evidence behind the guidance?
There is a lack of high-quality evidence for neuropathic pain treatments — i.e. most studies are small, short-term, placebo-controlled trials. There have been no high-quality direct head-to-head comparisons of individual drug treatments or drug classes, and no good evidence regarding which combination of drugs may be most effective. Overall, currently available evidence suggests that tricyclic antidepressants and anticonvulsants are similarly effective at reducing pain, and have similar rates of adverse events. Currently, there is no direct evidence to distinguish between the clinical effectiveness and safety profiles of pregabalin and amitriptyline in neuropathic pain conditions. As the NICE recommendations do not state a preference between these two treatments, prescribers may base their decision on clinical judgement of the patient’s condition and cost of the treatment. The costing statement issued by NICE gives the estimated 28-day prescribing costs of amitriptyline as £0.84 and pregabalin as £64.40.
Pregabalin▼ and duloxetine▼are under intensive surveillance by the CHM and MHRA, and all suspected adverse drug reactions should be reported via the Yellow Card Scheme. Amitriptyline, imipramine and nortriptyline are not licensed for neuropathic pain and so would be used ‘off label’ (as are a number of drugs in routine clinical practice) — however there is a responsible body of medical opinion to support their use in this setting, not least the NICE guideline.
More information on neuropathic pain can currently be found on the pain overview section of NPC. Part 5 of the e-learning event specifically discusses the evidence-base for the pharmacological treatment of neuropathic pain. A brand new NPC section on neuropathic pain is currently under development and will be available later in 2010. This will contain a suite of educational materials including a quiz, case study, data-focused commentary and key slides with accompanying educational notes.
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