Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Tiotropium safety analysis

Chest has published a analysis of several tiotropium (Spiriva®). The analysis examined various adverse event end points and compared the reported rates in the active and placebo arms of the included studies.

The analysis examined data for 4,435 tiotropium patients and 3,384 placebo patients. Statistical differences were identified for several reported adverse events, namely dyspnoea, exacerbation of COPD, urinary retention and dry mouth.

Comparing those patients who received tiotropium with those who received placebo:

  • Dry mouth was more likely, Relative Risk of 3.60 [95% CI, 2.56 to 5.05]
  • Urinary retention was more likely, Relative Risk of 10.93 [95% CI, 1.26 to 94.88]
  • Dyspnoea was less likely, Relative Risk of 0.64 [95% CI, 0.50 to 0.81]
  • Exacerbation of COPD was less likely, Relative Risk of 0.72 [95% CI, 0.64 to 0.82]

Mortality was not different between the two groups when analysed by cardiovascular, respiratory and all causes.

This analysis concludes that this pooled analysis "supports the present safety profile of tiotropium". It would appear that dyspnoea can be relieved and exacerbations made less likely at the risk of an increased likelihood of dry mouth and urinary retention. It should be noted that this analysis is only in comparison to placebo and not other active treatments. It remains unclear how tiotropium compares to ipratropium over long periods in terms of reducing hospital admissions and deaths from respiratory causes.

Action: This study adds to the safety data available for tiotropium but long-term efficacy data relating to hospital admissions and respiratory deaths are still needed.

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Flu vaccination for poultry workers

The Department of Health has announced that poultry workers in the UK are to be offered flu vaccinations.

Several documents have been made available containing further information about this precautionary measure.

The purpose of the campaign is to minimise the chance of poultry workers contracting human and avian forms of the influenza virus at the same time and therefore reduce the opportunity for the virus to mutate into a new form.

The covering letter encourages implementation to begin (at the latest) on the 22nd January 2007 with a proposed completion date of 31st March 2007. Primary Care Trusts will be issued with contact details for registered poultry premises so appropriate poultry workers can be contacted.

Action: The BBC has already reported the campaign and it may get wider coverage. Clinicians should be aware of the campaign and able to answer questions from patients.

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PPIs and increased hip fracture risk

The Journal of the American Medical Association has published a paper that has assessed the association between proton pump inhibitors and the risk of hip fracture.

It has been postulated the proton pump inhibitors (PPIs) may inhibit the absorption of calcium and that they may reduce bone resorption by inhibition of osteoclasts.

This study retrospectively examined the records of patients in the General Practice Research Database who were over the age of 50. Comparisons were made between those who experienced a hip fracture and control patients matched for certain variables including sex and age.

An analysis was performed for associations between hip fracture and use of PPIs and also histamine 2 receptor antagonists. The risk if hip fracture following at least one year of treatment with a PPI was 44% higher (odds ratio of 1.44) than in patients not taking a PPI. Long-term high-dose PPIs were associated with a greater risk having an odds ratio of 2.65. The association also grew in strength with time as follows:

  • Odds ratio of 1.22 at 1 year [95% CI, 1.15-1.30]
  • Odds ratio of 1.41 at 2 years [95% CI, 1.28-1.56]
  • Odds ratio of 1.54 at 3 years [95% CI, 1.37-1.73]
  • Odds ratio of 1.59 at 4 years [95% CI, 1.39-1.80]

The paper concludes that, "long-term PPI therapy, particularly at high doses, is associated with an increased risk of hip fracture". It would seem prudent to make patients aware of this long term risk of PPI treatment and make effective use of step-down, step-off and when required treatment strategies.

  • Step-Down: use the lowest effective dose where PPI treatment is necessary
  • Step-Off: stop PPI treatment if symptoms resolve, make use of other agents where symptoms are less severe
  • Use "when required" dosing: encourage patients not to take PPIs every day but instead, only when they experience symptoms

Action: Clinicians should make patients aware of the risk of hip fracture associated with long-term PPI treatment. Using the strategies above should contribute to a reduction in the risk of hip fractures.

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Suicide risk and antidepressants

The British Medical Journal has made a paper available through the Online First section of the website that examines the risk of suicide associated with several common antidepressants.

The study was a retrospective cohort study of the UK General Practice Research Database and examined suicide rates and attempted suicides associated with venlafaxine, citalopram, fluoxetine and dothiepin.

The study found higher rates of suicide in patients taking venlafaxine, however these patients were at higher risk of suicide at baseline and after accounting for confounders the differences observed should not be considered as causal.

The observe suicide rates were as follows:

  • venlafaxine - 0.64 per 1,000 person years
  • citalopram - 0.26 per 1,000 person years
  • fluoxetine - 0.23 per 1,000 person years
  • dothiepin - 0.27 per 1,000 person years

Background suicide rates are (calculated from National Office of Statistics data):

  • men - 0.181 per 1,000 person years
  • women - 0.063 per 1,000 person years

The risk of suicide is higher than baseline in patients treated common antidepressants. It remains unclear if this is a factor of depressive disease alone or if there is contribution from antidepressant therapy.

Action: Clinicians should assess suicide risk in all patients who exhibit symptoms of depression before commencing treatment.

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CMO Update

The Chief Medical Officer has issued a new CMO Update on the Department of Health website.

The update is sent to all doctors in England. This issue covers several topics including:

  • Making patient safety a priority
  • Raising the profile of stroke care
  • Chief Medical Officers' Annual Report 2005
  • Identifying alcohol misuse in healthcare settings
  • Guidance on using confidential patient information
  • Better management of controlled drugs

Action: This CMO Update provides useful information or reference to other documents that will be useful to primary and secondary care clinicians.

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