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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

NICE guidance on Inhaled Insulin

The National Institute of Health and Clinical Excellence (NICE) has published a Technology Appraisal on Inhaled Insulin for the treatment of diabetes (type 1 and 2).

As previously reported, NICE were not expected to widely endorse this product. Additionally, the Scottish Medicines Consortium (SMC) has rejected Inhaled Insulin for use on the NHS in Scotland.

The guidance recommends that inhaled insulin (Exubera®) is not routinely used. It suggests there may be a place where glycaemic control is poor despite maximal therapy with alternative hypoglycaemics AND initiation or titration of injectable insulin is not possible because of:

  • marked and persistent fear of needles diagnosed by a diabetes or mental health specialist
  • severe and persistent problems with injection sites despite support with injection site rotation

If these criteria are met it is recommended that initiation and monitoring of treatment is carried out in a specialist centre and that treatment is only continued if there is evidence of clinically relevant improvements in glyclosylated haemaglobin (HbA1c).

Action: Inhaled insulin is not appropriate for initiation in primary care. Responsibility for prescribing may pass from specialist centres to primary care but this should be accompanied by advice regarding criteria for monitoring, continuation and cessation of treatment.

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NELM reviews ADOPT Study

The National Electronic Library for Medicines has published an 'In-Focus' review of ADOPT (A Diabetes Outcome Progression Trial).

As previously reported, this study does not provide compelling evidence to change current practice away from using metformin first-line.

This review provides a thorough evaluation of the trial and highlights many issues raised by this trial that need further work, including those previously covered here. Additionally, this review highlighted weight gain as an adverse effect observed in the rosiglitazone group. At four years follow-up there was a difference of almost 7kg between patients taking rosiglitazone compared to those taking metformin. Some of this weight gain may be due to fluid retention but in already obese individuals this is still a cause for concern.

This review also concludes that metformin remains first-line based especially after consideration of cost. At the maximum doses used in the trial rosiglitazone would cost £49.48 per month compared to metformin at £3.60.

Action: Metformin continues to be the first-line hypoglycaemic for type 2 diabetes.

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MeReC Bulletin - Common Infections

The National Prescribing Centre has published a MeReC Bulletin examining the management of common infections in primary care.

The bulletin covers several common infections in separate documents and has an accompanying introduction and key points section. The infections covered are as follows:

For each infection type the documents provide a background to the condition under discussion and a consideration of the management options, including the place of antibiotics. Some tactics for managing demand for antibiotic prescriptions are also covered, for example, explaining the benefits and risks of antibiotics treatment and delayed prescriptions.

Action: Primary care clinicians who manage the common infections listed above will find these documents useful. For each condition there is a clear definition of the place in therapy of antibiotics. Information is also provided on how to manage patient demand for antibiotics when they are unlikely to be of benefit.

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Lancet reports on stopped cholesterol trial

The Lancet has reported the early termination of a trial involving a new class of medicines that modify cholesterol levels.

Cholesterol ester transfer protein (CETP) inhibitors lead to increased levels of high-density lipoprotein cholesterol (HDL-C) however the development of torcetrapib has been stopped after increased numbers of deaths in trial patients taking this new drug.

The reason for the increased deaths is not fully understood but may be due to increased blood pressure in those taking the study drug. According to the Lancet, there are currently two other CETP inhibitors being developed. No data are available on these drugs as yet so it is unclear if the effects seen with torcetrapib are indicative of a class effect.

Action: Patients may have heard about the cessation of development of this drug in the media. Clinicians can reassure concerned individuals that this does not involve any currently available cholesterol medications, including statins.

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Comparison of hypoglycaemics

The New England Journal of Medicine has published the results of a study comparing rosiglitazone, metformin and glyburide in maintaining long-term glycaemic control in patients with type 2 diabetes.

The study was a double-blind, randomised controlled trial involving over 4,000 treatment naive patients who were followed up for a median of 4 years. Patients were randomly assigned to one of the three study drugs (rosiglitazone, metformin or glyburide). A dose increase was required if fasting plasma glucose was above 7.8mmol/L at any visit. Initiation and maximum doses were defined as follows:

  • Rosiglitazone, initially 4mg daily increased to a maximum of 8mg daily in divided doses
  • Metformin, initially 500mg daily increased to a maximum of 2,000mg daily in divided doses
  • Glyburide, initially 2.5mg daily increased to a maximum of 15mg daily in divided doses

The primary outcome of the study was monotherapy failure defined by fasting plasma glucose levels or more than 10mmol/L.

A higher than expected drop out rate (~40%) and a lower than expected event rate contributed to the decision to extend the follow-up period and increase the number of patients enrolled in the study. These changes reduced the statistical power of the study from 90% to 83%. The impact of this reduction in power upon the findings will be the topic of debate among statisticians.

Over the course of the study, Kaplan-Meier estimates of monotherapy treatment failure were 15% in the rosiglitazone group, 21% in the metformin group and 34% in the glyburide group. An analysis of the difference between the rosiglitazone and metformin groups could not exclude the effect of bias introduced by the high withdrawal rates.

Rosiglitazone was associated increases in presentation with oedema and use of loop diuretics than either of the other two study drugs but had fewer gastrointestinal side effects than metformin and fewer episodes of hypoglycaemia than glyburide. All of these differences were statistically significant.

There were no differences between groups in all cause death. Heart failure data were also collected showing no statistical difference between rosiglitazone and metformin but this diagnosis was investigator reported and the study was not designed to evaluate cardiovascular disease outcomes.

The authors conclude that additional studies are required to investigate whether the differences found in this study translate into longer-term benefits on disease progression and cardiovascular outcomes. They also state that, "the potential risks and benefits, the profile of adverse events, and the costs of these three drugs should all be considered" when selecting an appropriate treatment.

Action: The cardiovascular benefits of metformin are well proven. This study highlights the need for further investigation into the potential long-term benefits of treatment with rosiglitazone. In the meantime, metformin remains the first-line choice among hypoglycaemic agents.

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