Our regular review of pharmacotherapy
New antidiabetic shows promise in patients with renal disease
Renal impairment is one of the more common and challenging long-term complications of diabetes and limits the use of available antidiabetic treatment options. In the UK, the risk of developing chronic kidney disease stages 3b-5 among people with diabetes is around eight times higher in women and over 12 times higher in men, compared with those who do not have diabetes.
“About a third of people with diabetes also have chronic kidney disease. It can be a particular problem, especially in the over 65s, limiting diabetes treatment options and increasing the risk of hypoglycaemia,” said Steve Bain, Professor of Medicine at Swansea University and Clinical Lead for the Diabetes Research Network, Wales
Liraglutide is a human glucagon-like peptide-1 (GLP-1) analogue which works by stimulating the beta cells to release insulin and suppressing glucagon secretion from the alpha cells only when blood sugar levels are high.
The 26-week, double-blind, randomised, controlled LIRA-RENAL study investigated the efficacy and safety of liraglutide compared with placebo when added to pre-existing oral antidiabetic treatment, insulin or a combination thereof. The study showed that adults with type 2 diabetes and moderate renal impairment treated with liraglutide had significantly greater improvements in mean HbA1c, were more likely to achieve target HbA1c, and experienced significantly greater weight loss from baseline versus placebo.
A lower incidence of hypoglycaemia, with no worsening of renal function, was also observed in patients treated with liraglutide compared with those on placebo.
The most common adverse events seen in this study were nausea, vomiting, diarrhoea and constipation.
Novel anti-gout agent demostrates positive trial results
Promising data have emerged from three pivotal Phase 3 clinical trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor (SURI), as a combination therapy for the treatment of patients with symptomatic gout. Lesinurad is an investigational agent that inhibits the URAT1 transporter, increasing uric acid excretion and thereby lowering serum uric acid (sUA).
In the CRYSTAL trial, lesinurad 400mg in combination with febuxostat met the primary endpoint, with a statistically significant higher proportion of patients reaching the target sUA goal of <5.0mg/dL at month 6 compared to febuxostat alone (p<0.0001).
The most commonly reported adverse events in the lesinurad-treated patients across the three trials were upper respiratory tract infection, nasopharyngitis, arthralgia and back pain. A full assessment of the safety and tolerability findings of all three studies is ongoing.
The trial findings suggest that lesinurad may help address a significant unmet need, with 40 to 70% of gout patients not reaching target levels of serum uric acid with the current standard of care.
Authorisation and appraisal
EC approves drug for treatment of DVT and PE
The European Commission has approved apixaban (Eliquis) for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
The approval broadens the clinical use for apixaban, which is also approved for use in the EU for the prevention of venous thromboembolism (VTE) in adults who have undergone elective total hip or knee replacement surgery, and the prevention of stroke and systemic embolism in adult patients with non- valvular atrial fibrillation.
The EC approval is based on the results of two trials. One of these, AMPLIFY (Apixaban for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapY) found apixaban to be non-inferior for the primary efficacy endpoint of recurrent VTE/ VTE-related death, and superior in the primary safety endpoint of major bleeding, compared with enoxaparin/warfarin.
VTE accounts for approximately 60,000 deaths each year, costing the NHS between £340 and £640 million. Dr Alexander T. Cohen, a consultant vascular physician at Guy’s and St Thomas’ Hospitals, London, said: “In the AMPLIFY trial apixaban was shown to be effective in the treatment of venous thromboembolism, with the additional benefit of having a significantly lower risk of bleeds compared to current standard therapies, which is positive news for patients and healthcare professionals.
“This improved risk benefit profile will provide clinicians with confidence when considering prescribing this treatment and provide greater reassurance for patients. The fact it is an oral treatment that does not require INR monitoring has additional advantages in terms of convenience for patients with the additional potential to reduce hospitalisations.”
NICE issues guidelines for treatment of CIC
Scotland expands treatment options for RA patients
People suffering with rheumatoid arthritis (RA) in Scotland will soon have the ability to select how they receive their medication, bringing improved quality of life to thousands of patients, the Scottish Medicines Consortium (SMC) has said.
NICE calls for more information on Empagliflozin
NICE has requested further evidence from Boehringer Ingelheim on its new anti- diabetic drug empagliflozin.
Linezolid linked with possible risk of Hypoglycaemia
The US Food and Drugs Administration (FDA) has updated its warnings and precautions relating to linezolid after an inquiry into the effects of people with diabetes who received the drug from April 2000 to March 2012.