Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Genes alter LABA response

Clinical Science has published the results of a small randomised study that aimed to assess the efficacy of a tailored second-line asthma therapy in 62 children with poorly controlled asthma. This study has been reported in the wider media (BBC).

The 62 participants all had the homozygous Arginine-16 beta-receptor genotype which is already known to decrease response to LABA medication and thus increase susceptibility to exacerbations and poor control. They were randomly assigned to treatment with salmeterol at a dose of 50micrograms twice daily or montelukast at 5mg or 10mg daily (depending on age). Participants were followed up for 1 year.

The primary outcome was absence from school with secondary measures including salbutamol use, quality of life and FEV1. Absence from school was significantly lower in the montelukast group (−0.40, 95% CI −0.22 to −0.58, P=0.005). There were also a significant reduction in salbutamol use and improvements in quality of life measures, however FEV1 was unchanged.

The authors conclude that, "montelukast may be suitable as tailored second-line controller therapy instead of salmeterol in asthmatic children expressing the susceptible Arginine-16 genotype".

The authors note some limitations in the study. The individuals randomised to treatment with montelukast had received more courses of oral steroids in the year before the study so perhaps they had greater room for improvement in their symptoms, however it is also noted that in other scores of disease severity the two arms of the study were similar.

It is also worth noting that this study was exclusively in children, it is unknown if the effects seen replicate in adults. Finally, this study used a test that is currently not available to assess genotype.

The current Asthma Guideline from the British Thoracic Society and SIGN recommends trialling the addition of a LABA at step 3 with a recommendation to stop and try alternatives if there is a poor response.

Action: Clinicians should be aware of this study and the wider media reporting. This study highlights an interesting avenue of research into tailored treatments but this study alone should not change current practice.

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Meta-analysis of non-benzodiazepine hypnotics

The British Medical Journal has published the results of a meta-analysis that aimed to assess the effectiveness of non-benzodiazepine hypnotics (otherwise known as Z drugs) in treatment of adult insomnia.

The analysis included data from 13 studies submitted to the Food and Drugs Administration that involved 4,378 participants in 65 separate drug-placebo comparisons. The main outcomes assessed were polysomnographic and subjective sleep latency. Secondary outcomes including measures such as total sleep time, number of awakenings and sleep quality were also assessed but data for these were not available in all studies.

The study found a statistically significant but small reduction in polysomnographic sleep latency (−0.36, 95% CI −0.57 to −0.16) and subjective sleep latency (−0.33, 95% CI −0.62 to −0.04). Non-benzodiazepine hypnotics reduced sleep latency by 22 minutes (-11 to -33 minutes) compared to placebo. It was noted that the placebo response could account for approximately half of the drug response. No significant effects were found in any secondary outcomes but the population sizes were inadequate to allow conclusions to be drawn.

The authors note some limitations in their analysis including the omission of small studies from the analysis, variable entry criteria and primary outcomes in the studies and that all studies were industry sponsored. Industry sponsorship enhances outcomes but it is also noted that unpublished data were also included in this analysis.

The authors conclude that, "Z drugs improve objective and subjective sleep latency compared with placebo" but the "size of this effect is small and needs to be balanced with concerns about adverse effects, tolerance, and potential addiction".

Action: Clinicians should be aware of this analysis. A NICE Technology Appraisal from 2004 recommends consideration of non-medicine treatments with short term drug treatment for severe insomnia that is interfering with normal daily life.

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