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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Inhaled Insulin discontinued

According to an article on the PharmaTimes website, Inhaled Insulin marketed as Exubera® is being pulled from the market for commercial reasons.

Despite some heavy promotional activity the product has failed to make any impact in the diabetes market. According to PharmaTimes, this decision will cost the manufacturer $2.8 billion in terms of current inventory stock, fixed assets and exit costs in addition to the $1.3 billion already paid back in 2006 to ensure sole marketing rights to the drug.

Action: Patients who are currently being treated with inhaled insulin will need to be moved to an alternative treatment within the next three months.

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October MTRAC reviews

The Midlands Therapeutics Review and Advisory Committee has published reviews of sitagliptin and inhaled insulin.

The review of sitagliptin suggests that the drug is suitable for prescribing in primary care but only after metformin and sulphonylureas as recommended in guidance from the National Institute for Health and Clinical Excellence (NICE).

The review of inhaled insulin suggests that the drug is not suitable for prescribing in primary care. This recommendation is based on the limited numbers of patients who would meet the strict NICE criteria for eligibility and the long-term safety concerns, especially regarding changes in lung function.

Action: Clinicians who treat diabetes in primary or secondary care will find these product reviews to be a useful summary of the currently available evidence.

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Diagnosis and Treatment of Low Back Pain

The Annals of Internal Medicine has recently published a Joint Clinical Guideline for the diagnosis and treatment of low back pain.

The guideline was produced by the American College of Physicians and the American Pain Society and contains seven recommendations, each ranked for the strength of the recommendation and the quality of the supporting evidence.

The recommendations include:

  • Classification of the back pain depending whether it is non specific, associated with radiculopathy or spinal stenosis or associated with another specific spinal cause
  • Appropriate use of imaging or other diagnostic tests depending on the above classification
  • Provision of advice about remaining active and effective self-care

Action: Clinicians who see cases of low back pain may find these recommendations helpful when providing advice and making referrals for diagnostic tests.

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Annual infusion for osteoporosis

Zoledronic acid (Aclasta®) has been approved in Europe for the treatment of osteoporosis in post-menopausal women at increased risk of fracture. The summary of product characteristics has been updated to reflect this license extension.

The licence extension has been granted following publication earlier this year of the HORIZON-PFT study in the New England Journal of Medicine. This randomised controlled trial involved 7,765 women who were randomised to an annual infusion of zoledronic acid or placebo and followed up for 3 years.

The results of the study found a 70% relative risk reduction in vertebral fractures and a 41% relative risk reduction in hip fractures in the patients on active treatment. For hip fractures this is equivalent to a Number Needed to Treat (NNT) of 91 over 3 years to prevent one hip fracture. In monetary terms this means investing approximately £77,500 over 3 years to prevent one hip fracture.

There are data to show that compliance with bisphosphonate treatments is poor with some papers noting that half of patients stop taking treatment within the first year. This product may improve compliance by avoiding gastrointestinal side effects and simplifying the dosing regimen.

However, consideration needs to be given to the cost of treatment compared to existing strategies and also to delivery of the infusion. Based on the Drug Tariff price for alendronate 70mg, a year of treatment would cost £50.83 compared to £283.74 for zoledronic acid. A 15 minute infusion may also need to be undertaken in a secondary care setting which would invite an additional charge for service delivery.

Action: Clinicians should pro-actively check and encourage continued compliance in patients prescribed oral bisphosphonates. Zoledronic acid may be an option for patients who are unable to tolerate oral bisphosphonates due to intolerable side effects. Clinicians will need to investigate any local arrangements for administration of the infusion.

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AMD not prevented by antioxidant supplements

The British Medical Journal has published the results of a meta analysis that aimed to evaluate the effectiveness of dietary antioxidants in the primary prevention of age related macular degeneration (AMD).

Two reviewers independently searched for relevant papers using standardised search criteria and identified 4,192 abstracts. Nine cohort studies (involving 149,203 people) and three randomised controlled trials met the inclusion criteria for further analysis.

Different antioxidants were analysed separately, not all studies contributed to each analysis. Data from the cohort studies found that vitamin A, vitamin C, vitamin E, zinc, lutein, zeaxanthin, alpha carotene, beta carotene, beta cryptoxanthin and lycopene had little or no effect in prevention of early AMD. The randomised controlled trials also failed to show any benefit from antioxidant supplements in the prevention of early AMD.

The authors of the paper conclude that there is "insufficient evidence to support the role of dietary antioxidants, including the use of dietary antioxidant supplements, for the primary prevention of early AMD".

Action: Clinicians should ensure that antioxidant supplements are not prescribed at NHS expense for the primary prevention of AMD.

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