Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

CFC-Free Salmeterol

Salmeterol (Serevent) will be available as a CFC-Free inhaler from January 2006 according to a letter from the manufacturers.

The new device is dose equivalent to the existing metered dose inhaler in terms of efficacy, dose, safety and price; it is also the same size, shape and colour as the old device. Patients may notice a change in the taste, sound and feel of the new device.

Prescriptions for any of the following can be dispensed as the CFC-Free device:

  • Salemterol Xinafoate Inhaler
  • Salmeterol Xinafoate CFC-Free Inhaler
  • Salemterol Xinafoate Evohaler
  • Serevent Inhaler
  • Serevent CFC-Free Inhaler
  • Serevent Evohaler

Action: Clinicians need to be aware of the introduction of this new device as patients may notice a difference. Prescriptions will not need to be changed immediately although this should be done over time to avoid confusion.

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JBS guidelines on prevention of cardiovascular disease

The Joint British Societies (JBS) have published Guidelines on the prevention of cardiovascular disease in clinical practice. The publication has been reported by the BBC and is available in full online or as a PDF.

The guidelines suggest a consistent multidisciplinary approach to the management of people with established cardiovascular disease (CVD) and those at high risk of developing CVD. This statement is clarified to include people:

  • with established CVD
  • with a CVD risk of > 20% in 10 years
  • with diabetes (Type 1 or 2)

In addition, people with particularly elevated single risk factors are considered at high risk, specified as people:

  • with blood pressure above 160/100mmHg (or lower with target organ damage)
  • with total cholesterol to high density lipid ratio (TC:HDL) above 6
  • with familial dyslipidaemia

NOTE: The guidance seems to infer that patients in the above three categories should have interventions appropriate to their risk. A full CVD Risk assessment should be undertaken before initiating polypharmacy for CVD prevention.

The guideline goes on to recommend lifestyle advice and treatment targets in the key areas of blood pressure management, blood lipid management, blood glucose management and antiplatelet therapy. Drug choice in each of these areas has already been covered.

Action: Clinicians should receive a copy of the guidelines from the JBS. NICE are expected to publish Cardiovascular Disease - Statins guidance in January 2006 and to review the Hypertension guideline in May 2006. In the meantime continue to follow the formulary advice and the NICE Hypertension Guideline.

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Secondary Endpoints

All clinical trials are established to answer a clinical question; this is called the primary endpoint. It is to be hoped that the primary endpoint is demonstrated to be statistically significant at the end of the study but this is not always the case.

When a primary endpoint is not significant there is often a tendency to focus upon other endpoints that were investigated during the study or secondary endpoints as they are called. Consideration should be given to the fact hat the study may not have been designed to answer clinical questions based upon the secondary endpoints and therefore these results should be viewed more cautiously.

For example, in the PROactive study, recently covered here, the primary endpoint was not statistically significant while the secondary endpoint of death, non-fatal myocardial infarction and non-fatal stroke was significant. However, this study was designed to assess the efficacy of pioglitazone in secondary prevention based upon a composite of death, non-fatal MI, stroke, acute coronary syndrome, leg amputation, coronary revascularisation and revascularisation of the leg. Forming conclusions based on the secondary endpoint may not valid.

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Pioglitazone ineffective in secondary prevention

The PROactive study1 was designed to assess if pioglitazone could reduce macrovascular complications in patients with type 2 diabetes who were at high risk of fatal and non-fatal myocardial infarction (MI) and stroke.

The United Kingdom Prospective Diabetes Study2 has already demonstrated that, in obese patients, metformin reduces cardiovascular morbidity and mortality. This is the basis for placing metformin as the first line treatment of type 2 diabetes.

The PROactive study recruited over 5,000 patients, randomised them to pioglitazone or placebo and then followed them for an average duration of about 3 years. The primary endpoint was a composite of death, non-fatal MI, stroke, acute coronary syndrome, leg amputation, coronary revascularisation and revascularisation of the leg.

At the end of the study the difference between the two arms of the study for the primary endpoint was not statistically significant. Treatment with pioglitazone does not significantly reduce the likelihood of complications or death compared to placebo.

Action: Pioglitazone remains a second line treatment for diabetes. Metformin is still first-line for diabetes because it reduces cardiovascular morbidity and mortality above its blood glucose effects. Clinicians are encouraged to follow the existing prescribing formulary advice.

References

  1. Dormandy JA, Charbonnel B, Eckland DJ, et al, for the PROactive investigators. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet 2005;366:1279-89
  2. UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998;352:854-65

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Proton Pump Inhibitors

Proton Pump Inhibitors (PPI) are very common drugs that are used to treat gastrointestinal conditions associated with excess stomach acid production. Currently there are five PPIs available, omeprazole, lansoprazole, pantoprazole, rabeprazole and esomeprazole.

A meta-analysis1 of 19 studies that directly compared PPIs with each another has assessed if there are any differences between these PPIs in the treatment of gastro-oesophageal reflux disease (GORD).

The analysis concluded that, for equivalent doses, there is no difference between PPIs in the treatment of GORD and therefore choice should be based firstly on cost and secondly on individual patient response.

Action: On the basis of cost the first choice PPI is currently omeprazole. If individual patients fail to respond to an adequate dose of omeprazole, lansoprazole is likely to be a good second choice based on cost and clinician experience of using this drug.

References

  1. Klok RM et al. Meta-analysis: comparing the efficacy of proton pump inhibitors in short-term use. Alimentary Pharmacology and Therapeutics 2003;17:1237-45

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