NICE has published guidance for the use of sodium zirconium cyclosilicate for the treatment of hyperkalaemia
Hyperkalaemia is a high level of potassium in the blood, classified in three levels: mild (serum potassium level of 5.5 mmol/litre to 5.9 mmol/litre), moderate (6.0 mmol/litre to 6.4 mmol/litre) or severe (6.5 mmol/litre and above). NICE has made detailed recommendations available as to when sodium zirconium cyclosilicate is an appropriate treatment. It is noted that it may also benefit adults with chronic kidney disease or heart failure in emergency and outpatient care.
Clinical evidence has shown that sodium zirconium cyclosilicate decreased serum potassium when used in outpatient care. However, there is no clinical evidence that it extends or improves quality of life. It may allow patients to stay on RAAS inhibitors for longer periods.
NICE has said that on the benefit of being able to stay on RAAS inhibitors, sodium zirconium cyclosilicate proves to be a cost-effective resource for the NHS. They recommend the drug for the treatment of confirmed persistent hyperkalaemia in outpatient care and for those who are not taking an optimised dose of RAAS inhibitors because of hyperkalaemia.
EMA guidance to be supplied on avoiding nitrosamines in medicationThe European Medicines Agency (EMA) has asked its Committee for Medicinal Products for Human Use (CHMP) to provide guidance for avoiding nitrosamine presence in medication containing chemically synthesised active substances.Nitrosamines have been classified as possible human carcinogens. Human carcinogens were previously found in a number of blood pressure medications known as ‘sartans', which led to a recall of several products and an EU review.
Ibsrela approved for treating irritable bowel syndromeThe US Food and Drug Administration has approved the drug Ibsrela for the use of treating irritable bowel syndrome (IBS)-C in adults.IBS-C is categorised as an abdominal discomfort normally caused by bloating and constipation.Ibsrela, a small, minimally absorbed molecule, which acts locally in the gastrointestinal track by inhibiting the sodium-hydrogen exchanger NHE3.The approval of Ibsrela is based on data from two phase-3, randomised, double-blind, placebo-controlled trials. A patient was considered to have responded well to the drug if their symptoms had improved by more than 30% during the trial.
NICE recommends risankizumab for the treatment of moderate to severe plaque psoriasis
Considered an autoimmune disease, plaque psoriasis, the most common form of psoriasis, presents as raised red patches of skin with a build-up of dead skin cells of a whitish colour.
The treatment of risankizumab is only recommended by NICE if the plaque psoriasis is deemed severe, when the Psoriasis Area and Severity Index (PASI) is >10 and a Dermatology Life Quality Index (DLQI) is also >10. NICE recommends that before prescribing risankizumab, treatments such as ciclosporin, methotrexate and phototherapy should be tried.
NICE has chosen to recommend this treatment due to clinical trials showing that risankizumab is more effective than adalimumab and ustekinumab and has generated better PASI results compared with many other biologicals.
The treatment can be allowed to run for 16 weeks. If at that point there is a little or no response in the patient, the medication must be stopped. An adequate response is defined as follows:
- A 75% reduction in the PASI score (PASI 75) from when treatment started
- A 50% reduction in the PASI score (PASI 50) and a 5 point reduction in DLQI from when treatment started.
Healthcare professionals are advised to consider skin colour when assessing the patient's PASI score; to ensure that they make the appropriate clinical adjustments. Considerations must also be made when assessing the DLQI index upon using the treatment, considering physical, psychological, sensory or learning disabilities, or communication difficulties.
NICE recommends dapagliflozin for diabetes treatmentNICE has approved the routine NHS use of dapagliflozin in certain adults with type I diabetes, when insulin proves to be insufficient alone.NICE considered the benefits of dapagliflozin used with insulin to be modest. Clinical trials showed small improvements in HbA1c levels and weight loss, as well as small improvements to quality of life. The appraisal committee, however, recognised the unmet need for interventions that help people with type I diabetes achieve good glycaemic control without complications.For a patient to be eligible for treatment with the SGLT2 inhibitor, they must have an insulin dose of more than 0.5 units/kg per day and complete a structured educational programme that is quality assured and delivered by trained educators, including information about diabetic ketoacidosis, for example:
- Recognising risk factors, signs and symptoms
- Monitoring blood ketone levels
- Actions to take for elevated blood ketones.
Fingolimod increases risk of congenital malformations in pregnancy
Research has found that pregnant women exposed to fingolimod have an increased risk of developing congenital malformations.
Fingolimod is a sphingosine 1-phospatre receptor modulator, which is authorised for the treatment of active-remitting multiple sclerosis in patients aged 10 years or older, whose disease hasn't responded to at least one disease-modifying therapy.
It is estimated that an additional 2–3 major congenital cases per 100 live births occurred, compared to that of the general population. Medical practitioners have therefore been advised that women must be made aware of the increased the risk of congenital abnormalities and provide them with the new pregnancy-specific patient reminder card.
Suggestions for the management of fingolimod include excluding pregnancy before starting the drug and repeating pregnancy tests at suitable staged in the treatment process. It is also suggested that an effective method of contraception is in place during treatment and up to two months after treatment. If pregnancy is planned, ensure a two-month gap before starting and look for alternative treatments. Should a patient on fingolimod become pregnant, treatment should be stopped immediately and refer to an obstetrician for close monitoring during pregnancy, including ultrasound assessments.
Epidyolex approved by EMA for seizue managment in childrenEpidyolex, a cannabidiol-based medication, has been approved by the EMA for the management of seizures in children with severe epilepsy.The product is aimed at patients with Lennox-Gastaut syndrome or Dravet syndrome. Epidyolex has been approved for use in the UK and other European countries, however, the NHS does not currently recommend this medication under the advisement of NICE who have has stated that the drug is not cost effective, and its long-term effects remains unclear.
Suliqua launched in UK
After being approved by the EMA in 2017, Sanofi has launched Suliqua in the UK, for the treatment of type II diabetes. It is recommended for use when blood glucose levels are not controlled satisfactorily by metformin alone or by metformin and another medication.
This once-daily injection is combines two active ingredients, lixisenatide and insulin glargine. It is available as a pre-filled disposable pen in two different strengths.
There were two phase III studies, LixiLan-O and LixiLan-L, into Suliqua, enrolling over 1900 patients. Both found the treatment to be statistically superior in reducing blood sugar levels when compared to lixisenatide or insulin glargine alone. One study tested this treatment in comparison to both individual active ingredients when taken in combination with metformin, a standard treatment for diabetes, and the other tested the drug against only insulin glargine in combination with metformin.
Dr Thomas Barber, Associate Clinical Professor in Endocrinology and Diabetes, University of Warwick, and Honorary Consultant Endocrinologist at University Hospitals Coventry and Warwickshire NHS Trust, said: ‘Diabetes can have a huge impact on the people it affects, so finding treatments that are convenient and easy to use is extremely important. The simple administration of an insulin glargine/lixisenatide fixed ratio combination in a single daily injection may help to reduce the daily complexity of diabetes management’.