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Clinical news round-up

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Clinical news round-up

We bring you this month's latest clinical news...

 

 

 

Autism – a gut reaction?

Many studies have reported abnormal gut microbiota in individuals with autism spectrum disorders (ASD), suggesting a link between gut microbiome and autism-like behaviour. Further evidence has been provided recently by research carried out at Arizona State University.

Previous work by one of the research team had sequenced the DNA of the gut bacteria of 20 children from 20 autistic children and found that they were missing hundreds of the 1,000 or more species of bacteria that colonise a typical health intestine.

This led to the idea that restoring the absent bacteria might alleviate the symptoms seen in the children. An open-label trial of microbiota transfer therapy (MTT) that combined antibiotics, a bowel cleanse, a stomach-acid suppressant, and faecal microbiota transplant was performed in 18 autistic children aged between seven and 16. Significant improvements in GI symptoms, autism-related symptoms, and gut microbiota were observed.

Now the team has reported on a follow-up with the same 18 participants two years after treatment was completed. Most improvements in GI symptoms were maintained, the researchers report, and autism-related symptoms improved even more after the end of the MTT treatment.

Important changes in gut microbiota at the end of MTT treatment remained at follow-up, including significant increases in bacterial diversity and relative abundances of Bifidobacteria and Prevotella.

The team says its observations demonstrate the long-term safety and efficacy of MTT as a potential therapy to treat children with ASD who have GI problems, and warrant a double-blind, placebo-controlled trial in the future.

ASD is an umbrella term which includes autism, Asperger syndrome and other pervasive developmental disorders. All of these disorders have an onset before the age of three. The cause is still unknown, although in some cases they can be passed down genetically.

Approximately 1% of the UK population has an autistic spectrum condition, and around 60-70% of these people will also have a learning disability. The prevalence rate of autistic spectrum conditions is higher in men than it is in women (1.8% vs. 0.2%).

Individuals with ASDs, Parkinson’s disease and Alzheimer’s disease have been known to experience chronic gastrointestinal (GI) symptoms as a common co-occurring medical condition, suggesting the presence of a gut-brain axis.

 

Long-term benefit of Microbiota Transfer Therapy on autism symptoms and gut microbiota. Dae-Wook Kang et al. Scientific Reports volume 9, Article number:5821(2019)

 

 

Flours to be fortified with folic acid

Health departments in England, Northern Ireland, Scotland and Wales are consulting on a proposal to require flour millers to add folic acid to flour.

The public consultation, which closes on September 9, will explore what kinds of products should be included.

Folate (vitamin B9) is a water-soluble vitamin found naturally in many foods such as green leafy vegetables and brown rice. Folic acid is the synthetic form of folate. It is already used in the fortification of some foods such as breakfast cereals, and in vitamin supplements.

Folate cannot be made, or stored, by the body and must therefore be provided daily from the diet. While folate deficiency is not a major problem for those eating a balanced diet, many people do not achieve recommended intakes.

Folate deficiency can put pregnant women at greater risk of giving birth to infants with neural tube defects (NTD). An estimated 90% of women aged 16-49 have a folate status below the level recommended to reduce the risk of an NTD-affected pregnancy.

There is strong evidence that many NTDs can be prevented by increasing women’s intake of folic acid. However, in the UK, it is estimated that around half of pregnancies are unplanned, and NTDs occur in the first 4 weeks of pregnancy, before many women know that they are pregnant.

Women who are trying to become pregnant are advised to take a daily supplement of 400 micrograms of folic acid before they conceive and during the first 12 weeks of pregnancy.

Even in those pregnancies that are planned, many mothers do not take folic acid supplements or modify their diet to increase folate intake before conception and up until the 12th week of pregnancy. It is estimated that only one-fifth of women report taking folic acid before pregnancy, which rises to three-fifths of women once their pregnancy is confirmed.

Around 1,000 pregnancies are diagnosed with neural tube defects each year in the UK. Of these:

·       over 40% of cases are fatal.

·       spina bifida accounts for about half.

Additionally, an estimated 28% of girls aged 11-18 years, 15% of boys aged 11-18 years and 7% of adults have low blood folate levels, putting them at risk of megaloblastic anaemia, with underdeveloped red blood cells that are larger than normal.

More than 60 countries worldwide now add folic acid to their flour, including Australia, Canada and the US. In the UK wheat flour millers already have to add thiamine, niacin and iron to restore what is lost in the milling process and calcium for health benefits.

Being obese before conception triples odds of overweight offspring
Women who are obese before becoming pregnant have more than three times the odds of having obese or overweight offspring when compared with women of a healthy weight, a systematic review and meta-analysis has found.

The study, by researchers at Newcastle University, analysed data from 79 studies looking at the association between maternal pre-pregnancy body mass index (BMI) and childhood weight status.

The results showed that maternal obesity before pregnancy was significantly more associated with child obesity (odds ratio 3.64) than the recommended maternal BMI of 18.5 to 24.9. It was also associated with child overweight/obesity combined (odds ratio 2.69) and child overweight (1.80).

 

The association between maternal body mass index and child obesity: A systematic review and meta-analysis. PLoS Med2019;16:e1002817. doi:10.1371/journal.pmed.1002817. pmid:31185012

 

Rivaroxaban a risk in patients with antiphospholipid syndrome

A clinical trial has shown an increased risk of recurrent thrombotic events associated with rivaroxaban compared with warfarin, in patients with antiphospholipid syndrome and a history of thrombosis.

The TRAPS study compared rivaroxaban with warfarin in patients with antiphospholipid syndrome and a history of thrombosis, and at high risk for thromboembolic events. The trial was terminated prematurely after the enrolment of 120 patients due to an excess of thromboembolic events among patients in the rivaroxaban arm.

Mean follow-up was 569 days. In the study, 59 patients were randomly assigned to rivaroxaban 20 mg (15 mg dose for patients with creatinine clearance <50 ml/min) and 61 to warfarin (INR 2.0–3.0).

Thromboembolic events occurred in 12% of patients assigned to receive rivaroxaban, while no such events were reported in patients assigned to receive warfarin. Major bleeding events occurred in 4 patients (7%) in the rivaroxaban group and 2 patients (3%) in the warfarin group. Other direct-acting oral anticoagulants (DOACs) may be associated with a similarly increased risk, says the MHRA.

 

Pengo V, et al.Rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome. Blood 2018; 132: 1365–71.

 

 

In brief …

Retinoid PPP materials updated

New pharmacy and prescriber checklists, and patient reminder cards, are available to support the pregnancy prevention programme in women taking acitretin, alitretinoin, and isotretinoin. Due to a high risk of serious congenital malformations, these medicines must not be used in pregnancy. Advice about the risk of neuropsychiatric reactions has been made consistent for all oral retinoid medicines.

 

Diabetic ketoacidosis risk

The MHRA is warning that serious and life-threatening cases of diabetic ketoacidosis have been reported in association with exenatide, liraglutide, and dulaglutide, particularly after discontinuation or reduction of concomitant insulin. GLP-1 receptor agonists are not substitutes for insulin, and any reduction of insulin should be done in a stepwise manner with careful glucose self-monitoring. Abrupt discontinuation or reduction in insulin doses can lead to poor glycaemic control, with a risk of diabetic ketoacidosis.

 

Disopyramide stock issues

Disopyramide 100mg capsules manufactured by Sanofi and Mylan will be out of until late July. Mylan disopyramide 150mg capsules will be out of stock from approximately mid-August until mid-September 2019. If a patient does not have sufficient supplies, they should be switched to an unlicensed import – supplies are available from specialist importers on an ‘unlicensed’ basis.

 

Epanutin oral suspension

Epanutin (phenytoin) 30mg/5ml oral suspension will be out of stock until the end of July. The Canadian brand Dilantin-30 is equivalent to Epanutin 30mg/5ml oral suspension and supplies are available on an ‘unlicensed’ basis. Different formulations of phenytoin (other than Dilantin) are not interchangeable.

 

Paracetamol 500mg recall

M & A Pharmachem is recalling Paracetamol 500mg Tablets, 1 x 1000 PL 04077/0001 (MDR 13-04/19) because a small number of pots from each batch have been found to contain discoloured tablets due to fungal contamination.

 

 

 

 

Picture: Antonio Carlos Bezerra (iStock)

 

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