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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Systematic Review of Antileukotrienes

A systematic review of antileukotriene therapy in seasonal allergic rhinitis has been published in the Annals of Allergy, Asthma and Immunology and reported by the British Medical Journal in BMJUpdates.

As previously suggested, in patients with asthma and seasonal allergic rhinitis, the asthma symptoms should be the prime concern. Clinical Evidence has also rated this class of drugs as likely to be beneficial.

This systematic review found that antileukotriene therapy was superior to placebo, equivalent to antihistamines and inferior to intranasal corticosteroids. It also found that the combination of antileukotriene therapy with antihistamines was superior to antihistamines alone but still inferior to intranasal corticosteroids.

Action: Antileukotriene therapy is equivalent or inferior to current treatment options for seasonal allergic rhinitis. These drugs also have a higher acquisition cost and are the least cost-effective option. They should be reserved for when all current treatment strategies have failed.

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Statins Update

Earlier this year the Summaries of Product Characteristics (SPC) for Atorvastatin (Lipitor®) and Ezetimibe/Simvastatin (Inegy®) were updated. These new documents list details of the expected reductions in total cholesterol from untreated baseline results.

A previous article has suggested a stepped approach to lipid management however the information in the updated SPCs has changed this advice.

Simvastatin 40mg is still the first line choice. Based upon an expected additional cholesterol reduction, atorvastatin 40mg is second line. Third line is atorvastatin 80mg.

Reversion to simvastatin 40mg with the addition of ezetimibe is no longer recommended as a third line option as the additional reduction in cholesterol is very small. The expected reduction in total cholesterol is 39% compared to a 38% expected reduction with the second line choice.

Action: The revised stepwise approach to lipid management is as suggested below:

  • Simvastatin 40mg tablets - expected total cholesterol reduction of 30%
  • Atorvastatin 40mg tablets - expected total cholesterol reduction of 38%
  • Atorvastatin 80mg tablets - expected total cholesterol reduction of 46%

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Health Act 2006

The Health Bill has received Royal Assent making it the Health Act 2006.

This Act contains legislative changes that will "deliver a wide range of improvements to help people lead healthier lives and enjoy better health services", according to Public Health Minister Caroline Flint MP.

The Act contains sections on:

  • restriction of the harmful effects of smoking in enclosed public spaces and workplaces
  • raising hygiene standards by introducing a code of practice on healthcare associated infections
  • new powers around the safe, appropriate and effective management and use of controlled drugs in response to the Shipman Inquiry
  • delivery of better and more convenient community pharmacy and ophthalmic services

Action: The changes detailed in this act will be implemented over time and are likely to have wide ranging effects. More information is expected to be available immediately before each change.

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Skip the Abstract

Clinical Papers are written up in a standard scientific style with an introduction of the paper topic, details of the method used in the study, the study results and a discussion of these results. Often clinical papers will also have a summary at the beginning called an abstract.

The British Medical Journal has added a study to Online First ahead of publication in the paper journal that examined the content of the abstract compared to the main paper.

This study found that the p-values quoted in abstracts are not evenly distributed but are skewed towards values representing statistical significance. The study went on to check the accuracy of the p-values where the data was available. Of the 27 studies that were checked 5 studies were found to be quoting incorrect p-values with an additional 9 studies that used the wrong statistical test or altered the data before performing the test. A table summarises these results.

The conclusion of the paper is "Significant results in abstracts are common but should generally be disbelieved". So, when reading a clinical paper, skip the abstract!

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Prevention of Fractures

The National Institute of health and Clinical Excellence (NICE) published a technology appraisal on the secondary prevention of osteoporotic fractures in postmenopausal women in January 2005.

NICE are also working on a similar appraisal aimed at primary prevention but until this is published it will be difficult to assess who to treat as primary prevention should be based upon a risk assessment.

The Secondary Prevention appraisal recommends that unless patients have an adequate dietary calcium intake and are vitamin D replete that they be provided with supplementation. Continual monitoring and assessment of diet would be required in order to assure adequate levels of calcium and vitamin D are maintained and therefore provision of supplementation may be sensible in most cases. Suitable supplements (which should be prescribed by brand to avoid confusion) are as follows:

  • Adcal-D3® tablets
  • Calcichew-D3® Forte tablets
  • Calceos® tablets
  • Calfovit D3® granules

The NICE appraisal recommends that Bisphosphonates should be prescribed to women who have already had an osteoporotic fragility (low impact) fracture providing they are:

  • Aged over 75 years old
  • Aged 65 to 74 years old and T-Score from a DEXA scan is at least -2.5 SD
  • Aged below 65 years old and T Score from a DEXA scan is at least -3 SD or -2.5 SD and the patient has at least one additional risk factor

The appraisal also recommends that choice of bisphosphonate is based upon an assessment of efficacy against tolerability and adverse effects in individual patients.

There are currently four bisphosphonates available on the NHS in the UK that are licensed for use in osteoporosis, these are:

  • Alendronate
  • Etidronate
  • Ibandronate
  • Risedronate

The main aim of treatment is to prevent hip fractures due the impact these have on morbidity, mortality and quality of life. Studies of the bisphosphonates have looked the drugs beneficial effects on the rate of vertebral and non-vertebral fractures.

All of these drugs reduce the rate of vertebral fractures, but hip fractures are included in the non-vertebral data. Currently, only alendronate and risedronate have shown reductions in the rates of non-vertebral fractures. Clinical evidence ranks both of these drugs as beneficial. Choosing between alendronate and risedronate as a first line treatment option therefore must involve an assessment of acquisition cost. Alendronate is now off patent and therefore has a lower acquisition cost making it the first line choice where a bisphosphonate is indicated.

Action: Clinicians who encounter postmenopausal women with fragility fractures should be aware of the NICE Technology Appraisal. Adequate calcium and vitamin D supplementation should be provided where appropriate and alendronate is the first-line evidence-based bisphosphonate.

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