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Merec Monthly 46


No. 46 January 2012

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Diagnostic ambulatory blood pressure monitoring reduces misdiagnosis and costs
A comparison of the effectiveness of antimanic drugs in acute mania
Insulin analogues cost NHS millions
Inhaled corticosteroids and the risk of fractures in people with COPD

Diagnostic ambulatory blood pressure monitoring reduces misdiagnosis and costs

The cost-effectiveness modelling study1 underpinning the recommendations on blood pressure (BP) measurement in the updated NICE hypertension guidance, has been published. It concluded that, when used to confirm the diagnosis of hypertension after an initial raised reading in the clinic, ambulatory blood pressure monitoring (ABPM) reduces misdiagnosis and allows better targeted treatment. This reduces overall cost (saving between about £50 and £320 per patient over his or her lifetime).

Action
Healthcare professionals should follow NICE guidance on the management of hypertension. This advises that ABPM should be used to confirm a diagnosis of hypertension if the clinic-based BP measurement is 140/90 mmHg or higher on two or more readings. Home BP monitoring is an alternative for those who cannot tolerate ABPM.

Active plans need to be made locally to move practice towards the new NICE hypertension guidance. Use of ABPM in accordance with the new guideline should be introduced as soon as is practicable. For more details see MeReC Rapid Review No. 4624. MeReC Extra 51 discusses important changes in the NICE hypertension guidance from previous guidance. Further information on hypertension can be found on NHS Evidence and in the cardiovascular disease – hypertension e-learning section of the NPC website.

Reference

  1. Lovibond K, et al. Cost-effectiveness of options for the diagnosis of high blood pressure in primary care: a modelling study. The Lancet 2011;378:1219–30

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A comparison of the effectiveness of antimanic drugs in acute mania

A systematic review and multiple-treatment meta-analysis1 suggests that antipsychotic drugs are significantly more effective than mood stabilisers (e.g. valproate, lithium and carbamazepine) in the acute treatment of manic episodes in adults. Gabapentin, lamotrigine▼ and topiramate were not significantly more effective than placebo.

Action
While adding to the evidence base, this study should not by itself change practice. Health professionals should continue to follow the NICE clinical guideline on the management of bipolar disorder. If a patient develops acute mania when not taking antimanic medication, treatment options include starting an antipsychotic, valproate or lithium, taking into account patient preferences for future prophylactic use and the side-effect profile.

  • Antipsychotics (normally olanzapine, quetiapine▼* or risperidone▼* taking into account individual risk factors for side effects) are recommended if there are severe manic symptoms or marked behavioural disturbances as part of the syndrome of mania.
  • Valproate or lithium are recommended if symptoms have responded to these drugs before, and the person shows good adherence. However, valproate should be avoided in women of child-bearing potential and there are also concerns about the use of lithium in pregnancy (see Summaries of Product Characteristics for further detail). Lithium has a slower onset of action than valproate or antipsychotics, and NICE recommends lithium only if symptoms are not severe.

See the NICE guideline for additional recommendations for the treatment of acute mania, including the use of drugs for people who are already taking antimanic medication and suffer a manic episode. See MeReC Rapid Review No. 4707 for more detail. Further information on bipolar disorder can be found on NHS Evidence and in the bipolar disorder e-learning section of NPC.

* Notes re intensive monitoring (black triangle scheme)
Intensive monitoring is required only when:

  • quetiapine is used for the recently licensed indications of bipolar depression and preventing recurrence in bipolar disorder
  • risperidone is used for the recently licensed indications of short-term treatment of persistent aggression in Alzheimer's dementia and conduct disorder in children

Reference

  1. Cipriani A, et al. Comparative efficacy and acceptability of antimanic drugs in acute mania: a multiple-treatments meta-analysis. Lancet 2011;378:1306–15

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Insulin analogues cost NHS millions

A UK study1 found that if all insulin analogues dispensed in the UK between 2000 and 2009 had been for human insulin alternatives, the NHS would have saved an estimated £625 million in prescribing costs. The adjusted annual cost of insulin analogues increased from £18 million in 2000 (12% of total insulin cost) to £305 million in 2009 (85% of total insulin cost).

Action
Health professionals should continue to follow NICE guidance on the management of type 2 diabetes. If insulin therapy is considered appropriate, it should be initiated with human NPH insulin (isophane insulin) injected at bed-time or twice daily according to need. Insulin analogues should be considered only in specific circumstances, such as for patients who require assistance from a carer or healthcare professional to administer their insulin injections, for those with problematic hypoglycaemia, for those who would otherwise need twice daily NPH insulin in combination with oral glucose-lowering drugs and for those who are unable to use the device to inject NPH insulin.

The cost-effectiveness analysis conducted for the NICE type 2 diabetes guideline found the long-acting insulin analogues, insulin glargine or insulin detemir, were more effective than NPH insulin but they were also more costly. All the incremental cost-effectiveness ratios (ICERs) were outside conventional limits of cost effectiveness, with ICERs ranging from about £100,000 to £400,000 per quality-adjusted life year (QALY) depending on the scenario they are used in. These are substantially greater than the £20,000 to £30,000 per QALY threshold usually considered in NICE’s cost-effectiveness evaluation.

In type 2 diabetes in particular, the effect of NICE guidance ought to be that long-acting insulin analogues and biphasic insulins containing short-acting insulin analogues are not used routinely. However, prescribing data for England show that the uptake of insulin glargine, insulin detemir, biphasic insulin aspart, and to a lesser degree biphasic insulin lispro, is extensive.

The NPC Key Therapeutics Document, written in support of the Quality, Innovation, Productivity and Prevention (QIPP) workstream includes recommendations to review, and where appropriate, revise the prescribing of long-acting insulin analogues in type 2 diabetes to ensure that it is in line with NICE guidance.

For more detail see MeReC Rapid Review No. 4605. Further information can be found on NHS Evidence and in the type 2 diabetes e-learning sections of NPC.

Reference

  1. Holden SE, et al. Evaluation of the incremental cost to the National Health Service of prescribing analogue insulin. BMJ Open 2011;2:e000258

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Inhaled corticosteroids and the risk of fractures in people with COPD

A systematic review and meta-analysis1 of RCTs and observational studies found a statistically significant increase in the risk of fractures with prolonged use of the inhaled corticosteroids, budesonide and fluticasone, in people with COPD. However, there are some limitations to the data.

Action
Prescribers should continue to follow the NICE guideline on COPD, which recommends that inhaled corticosteroids (ICS) should only be used in specific circumstances and in a combination inhaler with a long-acting beta-agonist. The choice of drug(s) should take into account the person’s symptomatic response and preference, and the drug’s potential to reduce exacerbations, its side effects and cost.

Systemic side effects are important when considering the benefits and risks for individuals with COPD or asthma for whom ICS are being considered. The NICE guideline on COPD states that healthcare professionals should be aware of these potential risks and prepared to discuss these with patients. Whilst this study suggests that patients with COPD, who are taking ICS for prolonged periods, might be at increased risk of fracture, it would seem sensible to consider this in the context of patients’ overall risk of fracture, alongside the other risks of ICS, especially when high doses are used.

What are the details of this?
This systematic review and meta-analysis1 of 16 randomised controlled trials (RCTs) and 7 observational studies found a statistically significant increase in the risk of fractures with prolonged use of the ICS, budesonide and fluticasone, in people with COPD. The authors calculated a number needed to harm (NNH) of 83 (95% confidence interval [CI] 38 to 2107) over three years for fractures with ICS, but there are some limitations to these data. Data from six of the observational studies, suggested a dose-response relationship to fracture risk.

For more detail, including the limitations of the data see MeReC Rapid Review No. 4656. Further information on the use of ICS in COPD can be found on NHS Evidence and in section 2.3 of the COPD e-learning materials on NPC.

Reference

  1. Loke YK, Cavallazzi R, Singh S. Risk of fractures with inhaled corticosteroids in COPD: systematic review and meta-analysis of randomised controlled trials and observational studies. Thorax 2011;66:699–708

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