Entresto (sacubitril, valsartan)
Entresto is the first medicine in the class of combined angiotensin receptor neprilysin inhibitors (ARNI) containing valsartan and sacubitril. It is indicated for the treatment of heart failure as an alternative to angiotensin converting enzyme (ACE) inhibitors/angiotensin II receptor blockers (ARB). The active ingredient has proven to have a convincing effect on both survival and readmission rates in patients with heart failure who remain symptomatic despite treatment with ACE inhibitors/ARBs at the maximum dose. Treatment should primarily be started by cardiologists experienced in the treatment of patients with heart failure. It is expected that the monitoring of patients up-titrated to the maintenance dose of Entresto are transferred to their GPs.
The profile of adverse reactions is similar to the existing treatment with ACE inhibitors/ARBs, although Entresto has an increased rate of symptomatic hypotension. It is therefore important to pay attention to renal dysfunction, hyperkalaemia and symptomatic hypotension, especially in elderly patients, just as NSAID treatment should be avoided. If any of these adverse reactions occur, adjustment of concomitant medicines, temporary down-titration or discontinuation of Entresto is recommended (3). The treatment price of Entresto is nearly DKK 50/day, and doctors may currently apply for single reimbursement on behalf of patients starting treatment (see the criteria below).
It is IRF's overall assessment that a switch to Entresto can be considered in patients with heart failure who remain symptomatic despite being treated with ACE inhibitors/ARBs at the maximum dose, whereas there is not sufficient evidence to recommend the treatment to patients who cannot be up-titrated to maximum treatment with ACE inhibitors/ARBs or to newly-diagnosed patients as first-line treatment. The recommendation is in line with the announcement by NICE (1).
1. NICE gives green light to new drug set to benefit 100,000 people with common heart condition | Press and media | News | NICE [Internet]. [cited 2016 May 3]. Available from: https://www.nice.org.uk/news/press-and-media/nice-gives-green-light-to-new-drug-set-to-benefit-100-000-people-with-common-heart-condition
3. EMA. PRODUKTRESUMÉ - ENTRESTO [Internet]. [cited 2016 May 1]. Available from: http://www.ema.europa.eu/docs/da_DK/document_library/EPAR_-_Product_Information/human/004062/WC500197536.pdf