Tablet Press
The prescribing newsletter for GPs, nurses and pharmacists in
Northamptonshire Primary Care Trust
Issue 54
March 2011
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Inhaled corticosteroids and the risk of diabetes
A Canadian cohort study identified that patients treated for respiratory disease using inhaled corticosteroids
(ICS) over a period of 5.5 years were, on average, at a 34% increased risk of both diabetes onset and
diabetes progression compared with patients not treated with ICS. The risk increased with increasing dose
of ICS. Patients treated with high doses of ICS, equivalent to fluticasone 1000microgram/day or more, had,
on average, a 64% increased risk of developing diabetes compared with patients not treated with ICS.
Prescribers are advised to follow the British guideline for the management of asthma with regard to the use
of ICS in patients with asthma. The dose of ICS should be titrated to the lowest dose at which effective
control is maintained. In COPD, ICS should only be used only in combination with a long-acting beta-
agonist and only in accordance with the NICE guideline for COPD.
A useful summary of the study and its implications can be found at http://www.npci.org.uk/blog/?p=2485
where the authors conclude, “The potential for ICS to increase risk of diabetes is another possible adverse
effect to consider when reviewing the risks and benefits of ICS with patients, particularly if high doses are
being considered for prolonged period. Based on an estimated baseline risk of 1.36%/year, and an
increased relative risk of 64%, we calculate that the number needed to harm (NNH) for patients taking high-
dose ICS is approximately 21 over 5.5 years. Or putting it another way, if 21 patients are treated with high-
dose corticosteroids for 5.5 years, one of them will develop diabetes requiring drug treatment who
otherwise would not have done if they had not been prescribed ICS”.
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Rosiglitazone and use of surrogate outcomes to show benefit
The Drug and Therapeutics Bulletin has featured an editorial discussing the rationale for the approval of
rosiglitazone, citing that following the publication of the UKPDS study in 1998 which claimed that the
greater the lowering of HbA1c in people with type 2 diabetes, the greater the benefit, thus rosiglitazone
appeared to provide benefit considering its effect on the marked reduction of HbA1c.
The editorial noted that in the UKPDS, the degree of HbA1c reduction was not related to measures that
matter most - reductions in the rate of macrovascular events, i.e. patient-orientated outcomes, although,
this surrogate number became the main outcome of interest and synonymous with ‘benefit‘.
The DTB concludes that “the problem comes when surrogate markers are used instead of patient-
orientated outcomes without sufficient evidence that the two are strongly linked. This seems to happen
often in early assessments of some new drugs: here surrogate marker evidence that can be accumulated
relatively easily and quickly dominates considerations of the treatment's worth. There needs to be greater
realisation that playing the numbers game doesn't automatically help patients (and, as with rosiglitazone,
might actually cause harm). In particular, blindly chasing a numerical surrogate target with multiple
unproven drug interventions may risk more than it achieves. It should go without saying that, ultimately, the
outcomes of choice are those that truly reflect patients living longer and living well”.
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Jext
Further to the NPAG bullets sent following the meeting on 16th February, we have now been advised by the
manufacturer that the launch of Jext has been delayed from April until September 2011. We advise that
Epipens are still prescribed until that time and we will send out further information when the launch of Jext
is imminent.
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NICE bites - Lipid Modification (update).
NICE bites have updated their bulletin on "lipid modification" so that the advice on Ezetimibe in
type 2 diabetes more accutrately represents the NICE guidance. Whilst the table in NICE bites is "user
friendly" the previous version had promoted the prescribing of Ezetimibe beyond that recommended in the
NICE guidance NICE bites - lipid
This edition is also available on HNN (Health Network Northants)
http://nww.northants.nhs.uk/Display/Dynamic.jsp?topid=14070&lhsid=514&oid=2854¤tid=2854
Disclaimer
Information in this newsletter is believed to be accurate and true. NHS Northamptonshire and its employees accept no liability for loss of any
nature, to persons, organisations or institutions that may arise as a result of any errors or omissions.
Contact No 01604 651360