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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

More PPI fracture data

The Canadian Medical Association Journal has published the results of a retrospective analysis of the Population Health Research Data Repository that aimed to further explore the relation between duration of exposure to proton pump inhibitors (PPIs) and osteoporosis-related fractures.

The study matched 15,792 cases of fracture for age, gender and co-morbidities with 47,289 controls. The study did not appear to correct for different doses of PPIs but analysed the data in terms of duration of exposure.

A statistically significant increase in hip fractures was detected as 5 years exposure (adjusted OR 1.62, 95% CI 1.02–2.58) and for all osteoporosis-related fractures (hip, vertebra or wrist) after 7 years exposure (adjusted OR 1.92, 95% CI 1.16–3.18).

These results are consistent with other similar analyses. An editorial accompanying this paper notes that this is the third large studies of administrative databases that has found an association between hip fractures and usage of PPIs. It also calls for further prospective research to be conducted to confirm these findings.

Action: As previously suggested, clinicians should ensure patients are made aware of the potential risks and make effective use of step-down, step-off and when required treatment strategies to minimise drug exposure.

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Tibolone for fracture prevention?

The New England Journal of Medicine has published the results of a study that aimed to assess the effects of tibolone therapy on fractures, breast cancer and cardiovascular disease.

This study recruited 4,538 women aged 60 to 85 years old. Inclusion criteria were a T-score bone mineral density (BMD) of -2.5 at the hip or -2.0 at the spine with radiological evidence of a spinal fracture.

Patients were randomised to treatment with placebo or 1.25mg of tibolone daily (Note the usual dose is 2.5mg daily). Data were collected for fractures, radiological fractures, cardiovascular events and cancers.

The study was stopped early due to an increased risk of stroke being detected in the active treatment arm. The median treatment period was 34 months, in this time other outcomes were as follows:

  • Reduced risk of vertebral fracture (Relative risk reduction 0.55; 95% CI 0.41-0.74; P<0.001)
  • Reduced risk of non-vertebral fracture (RRR 0.74; 95% CI 0.58-0.93; P=0.01)
  • Reduced risk of invasive breast cancer (RRR 0.32; 95% CI 0.13-0.80; P=0.02)
  • Reduced risk of colon cancer (RRR 0.31; 95% CI 0.10-0.96; P=0.04)
  • Increased risk of stroke (RRI 2.19; 95% CI 1.14-4.23; P=0.02)

Despite the apparent benefits in terms of reduced fractures and cancers the additional risk of stroke appears to be the over-riding concern. The current licence for tibolone includes second-line prophylaxis of osteoporosis in patients who are intolerant of, or contraindicated for, other treatments for osteoporosis.

Action: Tibolone should not be used as a treatment of choice for osteoporosis or fracture prevention. Patients intolerant or contraindicated to other other treatment options should have the stroke risk explained if considering this treatment.

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Triglyceride Factfile

The British Heart Foundation has published a Factfile focussing on Triglycerides.

This document discusses the relationship between triglyceride levels (TG levels) and cardiovascular disease (CVD). Although there is a positive correlation between TG levels and cardiovascular risk the relationship is weakened after correcting for other factors including total cholesterol, low-density lipoprotein, glucose and obesity.

Additionally, trials investigating TG lowering and CVD prevention are not conclusive; the only clear benefit is for gemfibrozil yet this benefit does not appear to relate to TG lowering!

It is suggested that secondary causes of high triglycerides should be identified and altered first, for example reducing alcohol intake and consuming a low fat diet. Statins remain the first line treatment for primary and secondary prevention of cardiovascular disease in combination with intensive diet and lifestyle measures.

Treatment combinations to achieve lower TG levels are supported by surrogate evidence only (e.g. carotid intima-medial thickness) and require careful safety monitoring for rhabdomyolysis. Isolated cases of elevated TG levels can be treated with fibrates and omega-3 fatty acids in severe cases.

Action: Clinicians who see patients with elevated levels of triglycerides will find this Factfile useful in guiding treatment decisions.

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BNF for Children 2008

The British National Formulary for Children has been updated, published and made available online.

Hard copies can be ordered from the publishers however many NHS staff will already have received a free hard copy through usual channels and can also access the online version at http://www.bnfc.nhs.uk.

Updates in this revision include:

  • Details of a new immunisation schedule for vaccination against the human papilloma virus
  • Revised guidance on the treatment and prevention of urinary-tract infections
  • New advice on the use of all forms of contraception, including emergency contraception
  • A new section on the treatment of pelvic inflammatory disease to further expand the guidance on management of sexually transmitted infections
  • More information on the administration of continuous IV infusions in neonatal intensive care to reduce medication errors when calculating infusion rates

Action: BNFC is the primary source of prescribing information when prescribing to all children up to the age of 18 years.

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