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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

FDA reject rimonabant

The Food and Drugs Administration (FDA) is unlikely to licence rimonabant (Acomplia®) for the treatment of obesity after the advisory panel voted unanimously against recommending approval.

According to a report at PharmaTimes the panel were mainly concerned with psychiatric adverse effects, including suicide and seizures, seen in patients taking the drug. This led them to conclude that the benefits of treatment do not outweigh the risks.

As previously discussed, rimonobant occupies a last line option for treatment of obesity as an adjunct to diet and exercise. Additionally, MTRAC advised that use should be restricted and the DTB concluded that this drug was not a significant advance.

Action: In the light of this growing concern over safety and the lack of comparative efficacy data with existing treatment options it would seem prudent to make maximum use of existing therapies and to restrict use of rimonabant in existing patients only.

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GSK sued by investors

GlaxoSmithKline (GSK), the manufacturer of rosiglitazone (Avandia®), is facing a lawsuit in America claiming that it misled investors and withheld drug safety information.

PharmaTimes provides more details about the lawsuit. In particular this report notes that GSK performed their own meta-analysis that was submitted to the Food and Drugs Administration (FDA) in August 2006 that shows an increased risk of heart attacks. It is claimed that this information was "never adequately disclosed to the investing public". This claim may relate to the previously reported interim-analysis of the RECORD study.

Action: Media coverage of this lawsuit is likely to encourage patients taking rosiglitazone to consult about the risks and benefits of continued treatment.

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SMC accept Symbicort SMART

The Scottish Medicines Consortium (SMC) has accepted budesonide/formoterol dry powder inhalers (Symbicort SMART®) for use, in adults, for the regular treatment of asthma as maintenance and reliever therapy.

The Summary of Product Characteristics was recently updated to include two treatment approaches with the combination of budesonide and formoterol. The first approach is to use the combination inhaler as regular maintenance treatment with a separate rapid-acting bronchodilator as rescue therapy. The second approach is to use the combination inhaler as regular maintenance treatment and as needed in response to symptoms.

This new approach is possible, within the license, with the 100mcg budesonide/6mcg formoterol and the 200mcg budesonide/6mcg formoterol inhalers. It should be noted that this approach is not recommended for anyone under 18 years of age.

In the submission to the SMC evidence was submitted demonstrating a longer time to first severe exacerbation using this approach compared to alternative reliever therapies. Additionally, it was estimated that using this approach would generate an overall net saving to the NHS although this was only in comparison to alternative combination treatment approaches as used at Step 3 of the British Thoracic Society (BTS) Asthma Guidelines.

Action: Clinicians should be aware of this new approach. It may be of value in some patients who are at BTS Step 3 and have difficulty in understanding or remembering what their different inhalers are for and when they should be used.

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Varenicline SPC updated with MI data

The Summary of Product Characteristics (SPC) for varenicline (Champix®) has been updated to reflect some early yellow card data linking the drug to myocardial infarctions.

The SPC now states that, "post-marketing cases of myocardial infarction have been reported in patients taking varenicline".

It should be noted that post-marketing surveillance data such as this is observational and is therefore open to bias. For example, the observed myocardial infarctions may have been due to the existing smoking status of the patient, other cardiovascular factors that existed in the patient or this may be a genuine issue with varenicline.

Action: Despite this observational nature of this data it may still be prudent to exercise caution when considering using varenicline in patients who have already experienced or who are at risk of a myocardial infarction.

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Rosiglitazone defence unconvincing

The New England Journal of Medicine has published an interim analysis of the RECORD Study following publication 2 weeks ago of a meta-analysis that raised concerns about the cardiovascular safety of rosiglitazone (Avandia®).

The RECORD study (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes) is a randomised controlled trial expected to last for 6 years comparing the intervention of metformin and sulphonylurea with metformin and rosiglitazone with a primary outcome of hospital admission or death from cardiovascular causes.

This interim analysis has been conducted on data with a mean follow-up of 3.75 years. The only endpoint reaching statistical significance in this analysis is for congestive heart failure; this is already known to be more likely in patients taking rosiglitazone. [Hazard ratio 2.24; 95% confidence interval 1.27 - 3.97, p=0.006].

There is a trend towards more myocardial infarctions [Hazard ratio 1.16; 95% confidence interval 0.75 - 1.81, p=0.50] in the rosiglitazone arm although this was not statistically significant. The addition of events that are pending adjudication does move this trend towards greater significance [Hazard ratio 1.23; 95% confidence interval 0.81 - 1.86, p=0.34] although still not statistically significant.

It should be noted that the RECORD study is a non-inferiority study aiming to demonstrate that there is no difference between the two treatment alternatives in terms of the primary outcome. This interim analysis fails to demonstrate non-inferiority as explained in an editorial. This fact, combined with the trends towards more myocardial infarctions observed in the data, leads this editorial to conclude that, "there is continued uncertainty about the cardiovascular safety of rosiglitazone".

There are two further editorials, one by a diabetologist and one jointly authored by a cardiovascular epidemiologist and a drug-safety expert. Both editorials recommend assessment of risk and benefit and that more research needs to be done to fully understand the cardiovascular safety profile of rosiglitazone. The latter editorial also points out that rosiglitazone is associated with weight gain, adverse effects on low-density lipoprotein cholesterol, an increased risk of heart failure and an increased risk of fractures in women.

Action: This interim analysis fails to provide any reassurance with respect to the cardiovascular safety of rosiglitazone. MHRA advice recommends that patients currently taking rosiglitazone discuss the risks and benefits of continued treatment at their next routine appointment.

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