ENTRESTO is indicated in adult patients for the treatment of symptomatic chronic heart failure with reduced ejection fraction.1,2
For full safety information, please refer to the GB and NI Summary of Product Characteristics.1,2
Sacubitril/valsartan is recognised nationally by the CaReMe UK Partnership as a first-line treatment option for chronic HFrEF where ejection fraction is <35%. Sacubitril/valsartan is to be given in combination with a beta-blocker and MRA.3
ENTRESTO and the CaReMe UK Partnership
Watch Professor Iain Squire and Dr Jim Moore, board members of CaReMe UK, discuss the need for a ‘modern’ HF management algorithm, as well as the rationale for positioning sacubitril/valsartan as a first-line treatment option.3
Measure serum sodium, potassium and assess renal function before and after starting, and after each dose increment. If eGFR is 30 to 45 mL/min/1.73 m2, consider lower doses or slower titration of ACEi/ARBs/sacubitril valsartan or MRAs. Additionally, ENTRESTO contains valsartan, and therefore should not be co-administered with another ARB-containing product. Stop using an ACE inhibitor for 36 hours before starting ENTRESTO.1,2
Speaker Disclosures – Dr Jim Moore has received honoraria from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Novartis, Novo Nordisk and Roche for various activities including attending and participating in educational events and advisory boards, (National Cardiac Pathways Improvement Programme – Clinical Leadership Group, Observer on the British Society for Heart Failure Board, Member of the National Heart Failure Audit Domain Expert Group, NICE Guideline Committee member – Chronic Heart Failure 2018).
Professor Iain Squire has received honoraria for participating in educational activities and/or advisory boards for Novartis, Vifor Pharma and Boehringer Ingelheim. His employer has received funding for research from Novartis, Vifor Pharma, Boehringer Ingelheim, Merck and AstraZeneca.
Summary of the safety profile
The most commonly reported adverse events (AEs) during treatment with ENTRESTO were hypotension (17.6%), hyperkalaemia (11.6%) and renal impairment (10.1%). Angioedema was reported in patients treated with sacubitril/valsartan (0.5%).1,2
Common AE:
Anaemia, hypokalaemia, hypoglycaemia, dizziness, headache, syncope, vertigo, orthostatic hypotension, cough, diarrhoea, nausea, gastritis, renal failure (renal failure, acute renal failure), fatigue, asthenia.1,2
Very common AE:
Hyperkalaemia, hypotension, renal impairment.1,2
Adverse reactions are ranked by System organ class and then by frequency with the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
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*CaReMe UK Partnership is a collaboration between the British Cardiovascular Society, the Renal Association, the Association of British Clinical Diabetologists, the Primary Care Cardiovascular Society and the Primary Care Diabetes Society.
ACE, angiotensin-converting enzyme; ACEi, angiotensin converting enzyme inhibitor; AE, adverse event; ARB, angiotensin receptor blocker; HF, heart failure; HFrEF, heart failure with reduced ejection fraction; MRA, mineralocorticoid receptor antagonist.
References:
- ENTRESTO Summary of Product Characteristics. Electronic medicines compendium website, GB. Available at: https://www.medicines.org.uk/emc/product/7751/smpc. (Accessed May 2023).
- ENTRESTO Summary of Product Characteristics. Electronic medicines compendium website, NI. Available at: https://www.emcmedicines.com/en-gb/northernireland/medicine?id=a1393009-... (Accessed May 2023).
- CaReMe UK Partnership. HF Algorithm. Available at: https://www.britishcardiovascularsociety.org/__data/assets/powerpoint_do... (Accessed May 2023).
- Enalapril Summary of Product Characteristics. Electronic medicines compendium website, UK. Available at: https://www.medicines.org.uk/emc/product/561/smpc. (Accessed May 2023).