Prescribing Advice for GPs

Lancet Letters Question PROactive Findings

January 6, 2006 on 4:21 pm | In Prescribing Extra - Drugs |  Print | No Comments

This weeks Lancet contains no less than four letter that question the validity of the conclusions of the PROactive Study¹.

All four letters² raise concerns about several aspects of the study including the non-significance of the primary end-point, basing conclusions on a secondary end-point, potential harms and differences in other established markers of cardiovascular risk.

The first two letters (Gaede et al and Guillausseau) question whether the conclusion that pioglitazone reduces cardiovascular events is valid or accurate. The last (Holman et al) of these letters concludes “Metformin is the only antidiabetic agent that has been shown definitively to reduce macrovascular risk in overweight type 2 diabetic patients”.

Action: The recommendations made earlier are still valid. Metformin is still the first line choice for diabetes.

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. Correspondence. Lancet 2006;367:23-26 [Registration may be required]

Return of Volumatic

January 5, 2006 on 12:47 pm | In Prescribing Extra - Drugs |  Print | No Comments

In August it was announced that the Volumatic^® spacer device was to be discontinued and replaced by the Aerochamber Plus^®.

The Committee on Safety of Medicines (CSM) have raised concerns about changes in drug delivery through the new spacer. This has led to the reintroduction of the Volumatic spacer. Regular supplies are expected to be available from mid February although limited amounts of imported stock are available immediately.

The CSM recommend that:

• patients who are prescribed a spacer for the first time should be prescribed a Volumatic with Aerochamber Plus being used only if Volumatic spacers are unavailable.
• patients currently using either a Volumatic or an Aerochamber Plus should continue using this spacer device unless they are experiencing difficulties.
• children using high dose inhaled steroids or long acting beta-agonists through the Aerochamber Plus should be given priority to changing back to Volumatic when product availability allows.

A question and answer document concerning the reintroduction of the Volumatic Spacer is available at the Medicines and Healthcare products Regulatory Agency.

Action: All Clinicians who prescribe for patients with asthma should be aware of the reintroduction of the Volumatic. The impact of the reintroduction is likely to be small because relatively few patients will have been changed to the Aerochamber Plus spacer device.

Modified Release Mesalazine

January 4, 2006 on 4:45 pm | In Prescribing Extra - Drugs |  Print | No Comments

Mesalazine is a commonly prescribed drug that provides a modified release (MR) delivery of a topical anti-inflammatory for the treatment of Crohn’s Disease and Ulcerative Colitis.

Concerns have been raised that there are differences in the release characteristics of the different products. These concerns are based upon in vitro studies of Asacol^® and Ipocol^®. These differences are the basis of recommendations to prescribed MR mesalazine by brand. However, in vitro differences may not mean that there are clinically noticeable differences.

Both UK Medicines Information and the East Anglian Medicines Information Service have looked at the evidence used to support claims of a difference. They have both concluded that while there is evidence of in vitro differences there is also evidence of clinical similarity based on the available clinical data.

Action: Many MR products should be prescribed by brand but there is currently insufficient clinical data to support brand name prescribing of mesalazine. Generic prescribing should be used in the majority of cases unless individual patients show demonstrable benefit on one product in preference to another.

New advice on NRT

January 3, 2006 on 1:36 pm | In Prescribing Extra - Drugs |  Print | No Comments

The Committee on Safety of Medicines has recommended that use of nicotine replacement therapy (NRT) could be extended for the following patient categories:

• Pregnant and breast-feeding women
• Patients with heart disease
• Patients with kidney / liver disease
• Patients with diabetes
• 12-18 year olds

An Expert Working Group considered the current evidence on the safety and efficacy of NRT and made recommendations to maximise the benefits and ensure that any risks there may be with NRT are balanced against the well-established dangers of continued smoking.

An information letter to healthcare professionals details the recommendations in full. There is also a question and answer document that provides additional information.

Manufacturers of NRT products are updating their patient information leaflets to contain the new recommendations however this will take some time. In the meantime supplies of the patient leaflet are to be made available online and from doctors, pharmacists and smoking cessation clinics.

Action: Clinicians should be aware of the new recommendations and the implications it will have on current practice in the provision of NRT. Access to the patient information leaflet may also prove useful until NRT product information is updated.

New Year - New Look

January 1, 2006 on 9:42 am | In Admin Information |  Print | No Comments

New for 2006 the site has been given a new look!

This site has been available for just over 6 months now and has posted over 100 articles. It gets visited over 4000 times each month from over 1000 different places and this is still growing.

Mainly, users in the United Kingdom visit us, but also America, Australia, Canada and New Zealand.

Our European visitors come from Austria, Denmark, Germany, Poland, Sweden, Belgium, Estonia, Hungary, Ireland, Italy and Cyprus.

Internationally, we also get visits from Singapore, Japan, China, Mexico, Argentina and Saudi Arabia.

What started as a personal and very local project just to see if this type of site was possible has grown into something I never imagined.

So, as a thank you to all the visitors who use this site I have given it an overhaul. I hope you like it during the coming year.

Happy New Year!