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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Additional glitazone fracture data

The Archives of Internal Medicine has published the results of an analysis that examined the association between the use of glitazones or other oral anti-diabetic drugs and the risk of fracture.

The analysis queried the UK General Practice Research Database for patients aged 30 to 89 years who had a fracture between January 1994 and December 2005. Control patients were matched for age, gender and general practice attended.

The study identified 1,020 case patients with a low trauma fracture and 3,728 controls. After correction for several factors including age, body mass index and co-morbidities users of glitazones were at statistically higher risk of fractures; odds ratio 2.43 (95% confidence interval [CI], 1.49-3.95). The risk also appeared to be dose related. There were no detectable differences associated with the other oral anti-diabetic drugs.

The authors conclude that, "this analysis provides further evidence of a possible association between long-term use of thiazolidinediones [glitazones] and fractures".

Action: Clinicians should reserve glitazone use for patients who are contraindicated to or cannot tolerate metformin and/or a sulphonylurea.

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Medicines Zone on NHS Direct

The NHS Direct website has launched a new area containing a wealth of information for patients about medicines.

The new Medicines Zone is an in-depth guide to medicines, prescriptions, immunisation, contraception and more. The zone is arranged into sections covering topics such as pregnancy, side effects, travel and immunisations.

Commonly asked questions about taking medicines are answered and detailed information about commonly prescribed medicines and side effects is available.

Action: Clinicians may be able to direct patients to this web site if they have simple medication related queries. Practices may also want to consider linking from their own website.

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Enoxaparin contamination

The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a press release (PDF) warning clinicians about potential contamination of enoxaparin (Clexane®) injections.

Enoxaparin is a low molecular weight heparin injection. Some batches contain low levels of an impurity called over-sulphated chondroitin sulphate (OSCS). New product entering the supply chain is unaffected.

Existing stocks are not being recalled because there is currently no evidence of risk to patients. Clinicians are advised to be extra vigilant to possible adverse drug reactions (ADRs). Patients are advised to seek advice from a healthcare professional if they have concerns.

Action: Clinicians should be aware of this issue. Patients may seek reassurance about continued treatment. Any suspected ADRs must be reported through the yellow card scheme.

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More information required for HPV vaccination

The British Medical Journal has published the results of a prospective cohort study that aimed to assess the feasibility and acceptability of delivering a human papillomavirus (HPV) vaccine to adolescent girls. The BBC has reported the results of this study.

The study collected vaccination data for 2,817 girls aged 12 and 13 years old who attended 36 secondary schools in two primary care trusts in Greater Manchester. The vaccine should be administered on three occasions at 0, 1 and 6 months over one school year.

Vaccine uptake was 70.6% for the first dose and 68.5% for the second dose. The main reasons given for parents' refusal of vaccination were insufficient information about the vaccine and its long term safety.

The Department of Health has made a training slide set available on the NHS Immunisation website. This information can be used to reassure teenage girls and their parents about the benefits of this vaccination and current safety data.

Action: The national vaccination programme is due to start this autumn. Clinicians should support this programme by giving information when asked about the vaccination.

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Drug Evaluations for the gliptins

The Regional Drug and Therapeutics Centre has produced New Drug Evaluations for sitagliptin (Januvia®) and vildagliptin (Galvus®).

The evaluation of sitagliptin recommends that this drug "may be considered as an option for patients who fail to achieve glycaemic control despite an adequate trial of established first and second-line regimens". It also notes that long term safety and efficacy data are lacking.

The evaluation for vildagliptin makes the same recommendations and qualifies that an "appropriate place in treatment protocols is presently undetermined".

The gliptins are a new drug class with data to support statistically significant improvements in HbA1c. However, long term efficacy and safety are unknown and there are no data to demonstrate improvements in morbidity and mortality.

Action: The limitations above currently place these drugs as a last line option before moving to insulin in patients who have poor glycaemic control on established treatments or who are intolerant to established agents.

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