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Keele’s ‘Important News and Evidence’ Service KINES Monthly News Update February 2016 Welcome to the KINES Monthly News Update for February 2016. During February, we also published KINES Rapid Updates on: a new observational study that found proton pump inhibitor use was associated with a higher risk of incident chronic kidney disease a systematic review of blood pressure lowering trials, the findings of which support the perspective that the lower the blood pressure, the better a randomised study of different prescription strategies for acute uncomplicated respiratory infections, providing further evidence that delayed antibiotic strategies can reduce antibiotic use All KINES outputs are available via login at our website (www.centreformedicinesoptimisation.co.uk). Update from NICE: The guidelines on bipolar disorder and epilepsies have been updated to promote use of a new toolkit, developed by the MHRA, to support better understanding by female patients of the risks of taking valproate in pregnancy. Final guidance on ezetimibe for the treatment of primary hypercholesterolaemia has now been published. Recommendations are essentially unchanged from the previous guidance. In a reversal of earlier draft guidance, NICE has issued a revised appraisal consultation document recommending Amgen's lipid-lowering proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor Repatha (evolocumab) for use in various scenarios, but only at a dose of 140 mg every 2 weeks and where the company provides evolocumab with the discount agreed in the patient access scheme. Final guidance on evolocumab is expected to be published in April 2016. Draft guidance has also been published for Sanofi’s PCSK9 inhibitor Praluent (alirocumab), in which NICE does not recommend use of this treatment. Final guidance for alirocumab is due to be available in June 2016. NICE has updated recommendations on dietary advice in the clinical guideline on attention deficit hyperactivity disorder (ADHD). A new recommendation for 2016 is that families and carers should be advised there is no evidence about the long-term effectiveness or potential harms of a 'few food' diet (a type of restriction/elimination diet) for children with ADHD, and only limited evidence of short-term benefits. Regulatory agency safety update: An alert has been issued regarding the recall of various nebulisers and nebulisations kits from Unomedical Inc and Convatec Ltd, which, due to a manufacturing fault, may fail to deliver treatment to the patient. The list of affected devices can be downloaded from the manufacturer’s safety notice. A deadline of the 22nd March has been given in the alert for organisations to identify and quarantine affected devices. A drug safety update from the MHRA reiterates the importance of monitoring blood electrolytes in patients coprescribed spironolactone and an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) for heart failure. Concomitant use of spironolactone with an ACEi or ARB is not routinely recommended because of the risks of severe hyperkalaemia, particularly in patients with marked renal impairment. If co-administration is essential, the lowest effective doses should be used, with regular monitoring of serum potassium and renal function. The update also notes there have been several fatal cases of abnormal blood potassium in patients where these treatments have been co-prescribed and that reports of adverse drug reactions (ADRs) to the MHRA have recently risen. This has coincided with the publication of advice from the European Medicines Agency (EMA) that dual blockade therapy with an ACEi and an ARB is not recommended. The recent increase in ADR reports could therefore possibly reflect increased co-administration of spironolactone and ACEi or ARBs, or stimulated reporting due to increased awareness of the risks. The EMA has started a review of metformin-containing medicines in renal conditions. This was at the request of the Dutch medicines agency following identification that advice on use of metformin in patients with reduced kidney function varies between countries. Last September Bayer notified the EMA that use of a defective INR device had been identified in the ROCKET trial – the pivotal study investigating the efficacy and safety of the oral anticoagulant rivaroxaban (Xarelto) in patients with atrial fibrillation. The EMA’s Committee for Human Medicinal Product (CHMP) has now concluded that the defective device would have had only a marginal effect on the study results, and the safety of rivaroxaban remains unchanged. The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has made recommendations to minimise the risk of diabetic ketoacidosis with sodium glucose transporter 2 (SGLT2) inhibitors (canagliflozin, dapagliflozin, empagliflozin) in type 2 diabetes. Rare cases, some of which were life-threatening, have occurred in patients taking these medicines, including a number of atypical cases in patients not having blood sugar levels as high as expected. The PRAC is therefore recommending that healthcare professionals should consider the possibility of ketoacidosis, even if blood sugar levels are not high. The PRAC has also recommended temporarily stopping SGLT2-inhibitor treatment in patients in hospital for major surgical procedures or due to serious illness. These recommendations will now be considered by the CHMP. (The MHRA has also previously issued a drug safety update on the risk of diabetic ketoacidosis and late last year, the US FDA revised the labels of SGLT-2 inhibitors to include additional warnings about ketoacidosis, as well as the risk of urinary tract infections.) NHS England/Department of Health/Public Health England: Following a drop in uptake, Public Health England (PHE) is encouraging eligible older people to have their shingles vaccination. As a reminder, the shingles vaccine is currently being offered to groups aged 70 or 78 years on the 1st September 2015. Those who were eligible for immunisation during the first two years of the programme but who have not yet been vaccinated also remain eligible until their 80 th birthday. These are people who were aged 71, 72 or 79 on the 1st September 2015. There have been several publications on the Zika virus, including travel advice for pregnant women, guidance for primary care, and an update for clinicians. The BMJ has also published a feature “Questions your patients may have about Zika virus”. There has been a refresh to some of the data included in the Medicines Optimisation dashboard published by NHS England. More information can be found on the dashboard webpage, where Keele’s evaluation of the prototype dashboard is also available. An evaluation of the updated dashboard is also in preparation by Keele. Other news: London Medicines Information Service has published a briefing on antidotes to the new oral anticoagulants (NOACs). On a related note, Praxbind (idarucizumab), a reversal agent for dabigatran, is now available in the UK. NICE is due to publish an evidence summary for this treatment in May 2016. A new toolkit has been launched by Pfizer to support community pharmacy teams in the delivery of Medicines Use Reviews (MURs) and the New Medicine Service (NMS) for people who are taking anticoagulants. Drug update: Launched: Benepali (manufactured by Biogen Idec), the first biosimilar version of etanercept, has now been launched in the UK. An in-use product safety assessment has been published by UK Medicines Information, which provides a useful summary of the similarities and differences between Benepali and the originator product Enbrel.