The National Prescribing Centre (NPC) has published MeReC Extra 32 (PDF). It summarises the NICE guidance for ezetimibe in hypercholesterolaemia, the recent safety concerns with rimonabant and an update on the safety and efficacy of paediatric cough medicines.
The discussion of the guidance from the National Institute for Health and Clinical Excellence (NICE) regarding the use of ezetimibe (Ezetrol®) in hypercholesterolaemia summarises the guidance and defines intolerance to statins. It is also noted that it is currently less expensive to prescribe simvastatin and ezetimibe as separate components than in the combined product, Inegy®.
The section detailing the safety concerns with rimonabant provides details of a recent meta-analysis of four studies that found a 40% increased risk of adverse events and also serious adverse events with rimonabant compared to placebo. Recent advice has indicated that this drug must not be used in patients who are taking antidepressants and who have a personal history of depression.
Finally, this MeReC provides details of a recent American study of paediatric cough and cold medicines that prompted the evaluation of the risk-benefit profile of these medicines leading to some products being withdrawn from sale.
Action: Clinicians will find this MeReC Extra to be useful and informative. It is of the usual high standard expected from the NPC.
The Medicines and Healthcare products Regulatory Agency (MHRA) has reached an agreement with the pharmaceutical industry to voluntarily withdraw six cough medicines for children under 2 and to change the labels on other products to remove the dosage instructions for children under 2. The MHRA has issued a press release and this story has reached the general media (BBC).
This action has been taken after a number of serious reports led to a safety review in the United States. There have been far fewer reports in the UK but because children under the age of two are more susceptible to the effects of overdose this action has been taken as a precautionary measure.
Coughs and colds are generally self limiting and symptom management should aim to control fever with ibuprofen or paracetamol and alleviate with simple cough mixtures, for example paediatric simple linctus or those containing glycerol or honey and lemon.
Action: Clinicians should be aware of this withdrawal and the changes to advised management of coughs and colds in children under 2. Parents may seek advice and reassurance in the coming days.
The National Institute of Health and Clinical Excellence has published new guidance for the month of March.
The published guidance includes Clinical Guidelines that cover Antenatal Care, Diabetes in Pregnancy and Prophylaxis against Infective Endocarditis. There are also two technology appraisals that cover Asthma (in adults) - corticosteroids and Sleep apnoea - continuous positive airways pressure.
Perhaps the most controversial recommendation (PDF) made is that antibiotic prophylaxis is no longer recommended for prevention of infective endocarditis in patients undergoing interventional procedures. This has been routine however there is little evidence of efficacy and no clear link between infective endocarditis and procedures. The guidance has prompted a letter (PDF) from the Chief Dental Officer at the Department of Health that supports the recommendations.
Action: Clinicians who diagnose and treat patients with any of the above conditions will find these guidelines are a useful aid to management of these conditions.
The New England Journal of Medicine has published a letter detailing some case reports of atypical low-trauma fractures in patients who have had prolonged treatment with alendronate.
The authors of the letter have identified 15 cases of unusual fractures in post menopausal women who had been treated with alendronate for an average of 5.4 years (SD 2.7 years). All fractures were subtrochanteric or proximal diaphyseal fractures and occurred following a fall from standing height or less.
Vitamin D and parathyroid hormone measurements were not taken as part of fracture care and bone mineral density was not assessed. Additionally, no data are presented to indicate rates of treatment compliance in these patients. The authors propose that a subgroup of the population may be more susceptible to the effects of prolonged suppression of bone turnover. They also suggest that, "additional studies are needed to characterise this subgroup and to establish a clear association between atypical fractures of the femur and prolonged bisphosphonate treatment".
Action: Clinicians should continue to follow the current NICE Guideline for secondary prevention of fractures in osteoporosis. Further investigation is required to understand this observed effect before clinical recommendations can be made. It would seem prudent to stop therapy in patients who sustain an atypical fracture while on treatment and submit a yellowcard report.
Vildagliptin (Galvus®), the second in a new class of hypoglycaemics has been launched.
Vildagliptin is available as a 50mg tablet with a dosage recommendation of 50mg daily when in combination with a sulphonylurea and 50mg twice daily when used in combination with other oral antidiabetic drugs.
In addition, this new drug is also available in a combination formulation with metformin. Marketed as Eucreas®, each tablet contains 50mg of vildagliptin and either 850mg or 1000mg of metformin hydrochloride.
Comparing the two gliptins, vildagliptin has the disadvantage of being a twice daily medicine and being contraindication in hepatic impairment (including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 3x the upper limit of normal) with the small benefit of a combination product.
Action: The launch of this drug was delayed by safety concerns. Current recommendations still apply; if a gliptin is an appropriate therapeutic option then sitagliptin would appear to be the agent to choose.