The National Institute of Health and Care Excellence (NICE) has published new guidance for the month of October 2013. This month there in one diagnostic guideline and one public health guideline that impact upon primary care.
The Faecal calprotectin diagnostic tests for inflammatory diseases of the bowel diagnostic guideline recommends that faecal calprotectin testing is made available as an option to help doctors distinguish between inflammatory bowel diseases, such as Crohn’s disease and ulcerative colitis, and non-inflammatory bowel diseases, such as irritable bowel syndrome. It is hoped that this test will help to reduce the number of people with irritable bowel syndrome having unnecessary invasive hospital investigations before their condition is diagnosed. Clinicians will need to check availability of this test with local pathology providers.
The Managing overweight and obesity among children and young people public health guideline makes recommendations on lifestyle weight management services for overweight and obese children and young people aged under 18. This guideline make several recommendations including raising awareness of lifestyle weight management programmes and formal referrals to such programmes.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
MTRAC issued two new Commissioning Support reviews in October 2013. The reviews cover perampanel and zonisamide.
The perampanel (Fycompa®) summary advises that this drug is not suitable for prescribing in primary care for adjunctive treatment of partial seizures in epilepsy. It is recommended that prescribing should occur in a tertiary care setting and notes that patients are likely to receive continued specialist supervision.
The zonisamide (Zonegran®) summary advises that this drug is suitable for restricted prescribing under defined conditions as monotherapy for partial seizures in epilepsy. It is recommended that the treatment is initiated and stabilised by a specialist after which maintenance therapy can be issued in primary care. It is expected that patients would continue to receive follow-up in secondary care.
Action: Clinicians should be aware of these reviews and use the recommendations to guide appropriate use of these medicines in current practice.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for October 2013 (PDF).
This issue contains drug safety advice informing clinicians of updated contraindications and warnings for the newer oral anticoagulants apixaban (Eliquis®), dabigatran (Pradaxa®) and rivaroxaban (Xarelto®). A common set of contraindications have been applied for all three of these agents to include range of clinical conditions where the patient is at significant risk of major bleeding, as well as in combination with other anticoagulant agents. The full contraindications are as follows:
- A lesion or condition, if considered a significant risk factor for major bleeding. This may include:
- Current or recent gastrointestinal ulceration
- Presence of malignant neoplasm at high risk of bleeding
- Recent brain or spinal injury
- Recent brain, spinal, or ophthalmic surgery
- Recent intracranial haemorrhage
- Known or suspected oesophageal varices
- Arteriovenous malformation
- Vascular aneurysms, or major intraspinal or intracerebral vascular abnormalities
- Concomitant treatment with any other anticoagulant agent for example: unfractionated heparin, low molecular weight heparin (such as enoxaparin or dalteparin), heparin derivatives (such as fondaparinux) or oral anticoagulants (such as warfarin). Exceptions are switching of therapy to or from the medicine, or when unfractionated heparin is given at doses necessary to maintain an open central venous or arterial catheter
Clinicians are also reminded to be aware of the contraindications, posology, and warnings and precautions for use specific to each medicine as well as the patient's individual risk factors for bleeding including their renal function (dose adjustment may be required).
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Bimatoprost / Timolol preservative-free eye-drops (Ganfort® Unit Dose) have been accepted for restricted use in the treatment of open-angle glaucoma or ocular hypertension. The restriction limits use to patients who have proven sensitivity to preservatives.
Nalmefene (Selincro®) has been accepted for use in the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level, without physical withdrawal symptoms and who do not require immediate detoxification. It is recommended that this medication only be prescribed in conjunction with continuous psychosocial support and if the drinking risk level remains high two weeks after initial assessment.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The New England Journal of Medicine has published the results of a study that aimed to assess the cardiovascular safety and efficacy of saxagliptin (Onglyza®).
The study recruited 16,492 patients with type 2 diabetes who had a history of or were at risk of cardiovascular event. The participants were randomly assigned saxagliptin or placebo and followed them for a median of 2.1 years. All other therapies for the management of the patient could be adjusted at the discretion of the physicians managing the patient; this included drugs for the treatment of diabetes. The primary outcome of the study was a composite cardiovascular outcome consisting of cardiovascular death, myocardial infarction or stroke.
7.3% (613/8280) of the patients who received saxagliptin experienced the primary outcome compared to 7.2% (609/8212) in those who received placebo. There was a statistically significant increase in the rate of hospital admission for heart failure in the saxagliptin group with a hazard ratio 1.27 (95% CI 1.07–1.51, p=0.007).
The authors propose several explanations for the apparent lack of benefit in terms of cardiovascular outcomes including a relatively short period of follow up (2 years), small differences in the levels of glycated haemoglobin in the treatment and placebo arms of the study (7.5% versus 7.8% at the end of the study), and large proportions of patient in the trial received statins, antiplatelet therapy and blood-pressure–lowering agents which may have mitigated any cardiovascular benefit.
The authors conclude that, "saxagliptin did not increase or decrease the rate of ischemic events" and they recommend that "other approaches are necessary to reduce cardiovascular risk in patients with diabetes".
Action: The absence of a cardiovascular benefit leaves no compelling reason to use saxagliptin ahead of other second line oral hypoglycaemic agents. Clinicians should continue to follow the existing NICE guideline for Type 2 Diabetes.