‘Biological bypass’ shows promise in coronary artery disease
A new gene therapy that targets the heart and requires only one treatment session, has been found safe for patients with coronary artery disease, according to a successful trial carried out in Finland (doi: 10.1093/eurheartj/ehx352). The treatment enhances circulation in ischaemic heart muscle and the effects were still visible one year after treatment.
The randomised, blinded, placebo-controlled phase 1/2a trial was carried out in collaboration between the University of Eastern Finland, Kuopio University Hospital and Turku PET Centre. The biological bypass is based on gene transfer in which a natural human growth factor, AdVEGF-DΔNΔC, a new member of the vascular endothelial graft family (VEGF) that stimulates both angiogenesis and lymphangiogenesis, is injected into the heart muscle to enhance vascular growth.
The trial was the first in the world to use a novel vascular growth factor that has several beneficial effects on circulation in the heart muscle. The trial also developed a novel and precise method for injecting the gene into the ischaemic heart muscle area. A customised catheter is inserted via the groin to the left ventricle, after which the gene solution can be injected directly into the cardiac muscle. The method is as easy to perform as coronary angioplasty, which means that it is also suitable for older patients and patients who are beyond a bypass surgery or other demanding surgical or arterial operations.
The biological bypass constitutes a significant step forward in the development of novel biological treatments for patients with severe coronary artery disease. It was also discovered that the biomarker lipoprotein (a) (Lp[a]) makes it possible to identify patients who are most likely to benefit from the new treatment.
Latest drug news
Patiromer (Veltassa®, Vifor) has been received European Commission marketing authorisation for the treatment of elevated serum potassium levels (hyperkalaemia) in adults. Patiromer, a potassium binder, is the first new drug developed for the treatment of hyperkalaemia for nearly 60 years.
It is thought that in the UK, around half of the 2.6 million people suffering with late-stage chronic kidney disease and a further 2– 3% of the one million people with heart failure are affected by hyperkalaemia. Vifor expects to be make patiromer available in the UK later this year.
Edoxaban (Lixiana®, Daiichi Sankyo) has been recommended for a label update to provide guidance on its use in transoesophageal echocardiography-guided and delayed cardioversion by Europe’s Committee for Medicinal Products for Human Use. This is based on results from the ENSURE-AF study, the largest, prospective, randomized, clinical trial of an anticoagulant for cardioversion in patients with non-valvular atrial fibrillation, with a total of 2,199 patients enrolled.
Ticagrelor 90 mg (Brilique®, AstraZeneca) has been made available as an orodispersible tablet formulation for the prevention of atherthrombotic events in adult paients with acute coronary syndromes. The new formulation is designed for patients requiring antiplatelet therapy, who are either intubated and have a nasogastric tube inserted, or who have difficulty swallowing the film-coated tablets.
Type 2 diabetes increasing in young people
More than 600 children and teenagers are now being treated for type 2 diabetes, an increase of 14% in a year, according to the Local Government Association. It calls this continuing increase, “a hugely disturbing trend”.
It highlights that figures for 2015–16 from the Royal College of Paediatrics and Child Health show that 621 children and young people under the age of 25, of whom 78.5% were also obese, received care for type 2 diabetes from Paediatric Diabetes Units in England and Wales. Fifteen children with type 2 diabetes were aged between five and nine. As these figures do not include those treated in primary care, for example, the actual number of young people with type 2 diabetes is likely to be even higher.
The Local Government Association is calling for urgent action to tackle childhood obesity. Data from the National Child Measurement Programme, carried out in schools and funded by councils, shows 9.3% of reception children and 19.8% of those in year 6 were obese in 2015–16.
Long-term aspirin use linked to higher bleeding in elderly
In people aged 75 or over, long-term daily aspirin use is linked to a higher than expected risk of disabling or fatal bleeding, according to a new study in The Lancet (doi: 10.1016/S0140-6736(17)30770-5).
While short-term aspirin use after a stroke or heart attack has clear benefits, the authors say that patients over 75 who take aspirin on a daily basis should be prescribed a proton-pump inhibitor to reduce the risk of bleeding.
The Oxford Vascular Study followed 3,166 patients who had previously had a stroke or heart attack and were prescribed antiplatelet drugs (mostly aspirin). Half the patients were aged 75 or over at the start of the study. Over 10 years of the study, a total of 314 patients were admitted to hospital for bleeding. The risk of bleeding, in particular the risk of fatal or disabling bleeding, increased with age.
For patients under 65 taking daily aspirin, the annual rate of bleeds requiring hospital admission was approximately 1.5%. For patients aged 75-84, the annual rate rose to approximately 3.5% and to 5% for patients aged over 85.
Similarly the risk of disabling or fatal bleeding increased with age, and the outcome of non-fatal bleeds was also worse at older ages.