Real-world experience and clinical data with sacubitril/valsartan: a Northern Ireland perspective

Br J Cardiol 2019;26(suppl 1):S22–S23doi:10.5837/bjc.2019.s06 Leave a comment
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Sponsorship Statement:

This sponsored supplement was initiated and funded by Novartis Pharmaceuticals UK Ltd. Editorial control, however, was retained by the authors and editors but Novartis reviewed the supplement for technical accuracy and compliance with relevant regulatory requirements before publication.

Prescribing information for Entresto® (sacubitril/valsartan) in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction is available here.

Date of preparation: July 2019
Job bag number: ENT19-C029

Advances in the treatment of chronic heart failure in real-world settingsThis article will contribute to a ‘Learning with reflection’ CPD activity

Guidance from the UK National Institute for Health and Care Excellence changed in 2016 to support the therapeutic use of sacubitril/valsartan in adult patients with symptomatic chronic heart failure with reduced ejection fraction. We review the way the drug has since been initiated by heart failure nurse specialists in Northern Ireland, the management of its side effects and its positive effect on patient outcomes.

Real-world experience and clinical data with sacubitril/valsartan: a Northern Ireland perspective

Background

The Southern Health and Social Care Trust (SHSCT) in Northern Ireland has a nurse-led heart failure (HF) service, with seven band 7 heart failure nurse specialists (HFNS) serving a total of about 1,500 patients. All but two of the nurses are non-medical prescribers. The service is community-based with hospital in-reach, with each nurse managing a geographically defined caseload. This model allows patients with HF to be reviewed by a HFNS in either a domiciliary, clinic or acute setting. The nurses have access to, and support from, consultant cardiologists, renal consultants, GPs and a cardiology pharmacist, and also have access to cardiac investigations.

Prescribing sacubitril/valsartan

HFNS in the SHSCT began to initiate patients with chronic HF with reduced left ventricular ejection fraction (LVEF) on sacubitril/valsartan in September 2016, following the publication in that year of the National Institute for Health and Care Excellence (NICE) guidance on its use.1 Patients received sacubitril/valsartan if they met the following criteria from the NICE guidance:1

  • New York Heart Association (NYHA) class II or above
  • LVEF ≤35%
  • Already established on an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).

The past medical history of these patients, aged from 25–91 years, included ischaemic heart disease, chronic obstructive pulmonary disease, diabetes mellitus, atrial fibrillation and chronic kidney disease.

The HFNS worked within their existing clinical capacity: no extra clinics were run and no additional resources were allocated. Each nurse was responsible for the identification of potentially appropriate patients as they presented, whether this be at home, at clinic or on an inpatient ward. The majority of patients were initiated on sacubitril/valsartan at the nurse-led heart failure clinics.

Regardless of the setting, before commencing sacubitril/valsartan, appropriately selected patients underwent a full clinical assessment by the HFNS, including a drug history and review of renal and hepatic function. Dose at initiation was guided by the prescribing advice in the sacubitril/valsartan Summary of Product Characteristics,2 taking into account blood pressure and renal function. Patients were advised of the need for a 48-hour washout period between stopping their ACE inhibitor and commencing sacubitril/valsartan, and were educated about potential side effects. Each patient was given the contact number for their HFNS to allow them to contact their nurse directly should they have any problems. Bloods for follow-up urinalysis and electrolytes monitoring were reserved at their general practice surgery and reviewed and actioned by the HFNS.

Real-world experience and clinical data with sacubitril/valsartan: a Northern Ireland perspective

Experience with sacubitril/valsartan

To date, 463 patients have been initiated on sacubitril/valsartan. The drug was discontinued in 31 (7%), mostly due to significant renal decline, significant symptomatic hypotension and significant diarrhoea. A small number of patients reported feeling generally less well following the change to sacubitril/valsartan, and were unwilling to continue treatment, but we have found side effects to be largely manageable.

Hypotension and a decline in renal function were the most commonly reported side effects for all patients within our patient cohort. We realised quickly that sacubitril/valsartan is less well tolerated in patients who were ‘dry’ at initiation, and that careful assessment of volume status and diuretic dose pre-initiation is essential. Patients now commonly have their diuretic dose reduced prior to initiation where possible. When hypotension and or decline in renal function proves to be problematic, then further medication review is undertaken with a view to identifying medications that could be stopped, reduced in dose or have a change in administration time. Hyperkalaemia is managed within our local Trust protocols.

The HFNS have also established an excellent link to the renal consultants within the Trust, and they have been happy to give advice on a case-by-case basis regarding patients with significant renal impairment. This has proved invaluable, and has allowed us to continue therapy in patients who may otherwise have had the drug discontinued. For a number of the patients who experience diarrhoea with the initiation of sacubitril/valsartan, a short course of loperamide (taken as required) was sufficient to manage this symptom.

In terms of patient outcomes, we have noted an improvement in NYHA class in our patients treated with sacubitril/valsartan. This has been most obvious in those patients who have moved from NYHA class III to class II. For some patients, this has meant that they no longer needed referral for cardiac resynchronisation therapy, and one patient was removed from the transplant list.

Conclusion

From the perspective of the nurse-led HF service within the SHSCT in Northern Ireland, the experience of commencing patients on sacubitril/valsartan has been largely positive and we hope that we have demonstrated that sacubitril/valsartan can be appropriately initiated, titrated and managed in this setting. We have found that sacubitril/valsartan is generally well tolerated within our patient population, across a broad age spectrum and in patients with various comorbidities. We have also found that side effects are, on the whole, manageable, with the need to discontinue treatment occurring in only a small minority. Careful patient assessment is vital prior to initiation and titration, and it is useful for patients to be able to contact their HFNS directly should there be any concerns regarding side effects, facilitating further review and potentially avoiding withdrawal of therapy.

Key messages

  • Heart failure nurse specialists (HFNS) routinely initiate sacubitril/valsartan in Northern Ireland, according to current National Institute for Health and Care Excellence guidance
  • Of 463 patients initiated, only 31 (7%) discontinued treatment (mostly for renal decline, symptomatic hypotension, diarrhoea)
  • Regular contact with the HFNS, supported by other healthcare practitioners, often helped to avoid the need for withdrawal of therapy
  • Improvements in heart failure symptoms were common
  • Our experience shows that sacubitril/valsartan can be appropriately initiated and titrated in a HFNS-led setting

Conflicts of interest

None declared.

Edith Donnelly
Heart Failure Nurse Specialist
Email: Edith.Donnelly@southerntrust.hscni.net

Carol Patton
Heart Failure Nurse Specialist

Social Health and Social Care Trust, Northern Ireland

References

1. National Institute for Health and Care Excellence. Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction. TA388. London: NICE, April 2016. Available from: https://www.nice.org.uk/guidance/ta388

2. European Medicines Agency. Entresto. Summary of product characteristics. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004062/WC500197536.pdf [accessed 10 July 2018]

Articles in this supplement

Introduction
1. Applying PARADIGM-HF to the use of sacubitril/valsartan in clinical practice
2. Early clinical experience with sacubitril/valsartan from a large UK tertiary centre
3. Initial experience of introducing sacubitril/valsartan in a UK heart failure service
4. Sacubitril/valsartan prescribing and community experience in Medway

Advances in the treatment of chronic heart failure in real-world settingsOnce you have read all these articles, you can take the ‘Learning with reflection’ CPD activity on this supplement.

Dosing of sacubitril/valsartan: Throughout this supplement, the dosing of sacubitril/ valsartan (Entresto™, Novartis Pharmaceuticals) has been split to show the constituent doses. 

In clinical trials, sacubitril/ valsartan – initially known as the investigational agent LCZ696 – was used in 100 mg and 200 mg doses. These translate to the licensed doses of 49 mg sacubitril/51 mg valsartan and 97 mg sacubitril/103 mg of valsartan, respectively.

A smaller 50 mg dose, which equates to 24 mg sacubitril/26 mg valsartan, is also available.

Disclaimer: Medinews Cardiology Limited advises healthcare professionals to consult up-to-date Prescribing Information and the full Summary of Product Characteristics available from the manufacturers before prescribing any product. Medinews Cardiology Limited cannot accept responsibility for any errors in prescribing which may occur.

Use for revalidation – BJC Learning with reflection activity

This article can be used towards revalidation. If you would like to reflect on what you have learned, please log in or register to record your thoughts on how this article has influenced your practice.

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