Background Heart failure (HF) is a major public health concern, affecting 26 million people worldwide. The association sacubitril/valsartan was marketed for the treatment of chronic HF. In the PARADIGM-HF-trial, Entresto has shown a reduction of HF admissions and cardiovascular mortality significantly higher than standard recommended treatment.1 The most significant shortcoming of this study was the population included (younger and less severe).
Purpose The aim of our study was to compare characteristics of a patient cohort followed-up in a hospital centre with patients in the PARADIGM-HF trial. Other objectives were to estimate the incidence of HF hospitalisation of patients treated by Entresto and identify adverse events.
Material and methods A prospective study was conducted from January to December 2017. An extraction of Entresto ambulatory dispensations during this period was carried out. A selection of patients followed-up in our hospital was made. Data were collected in patient medical files. A statistical comparison between collected data and data from the PARADIGM-HF trial was done. Adverse events and the incidence of unexpected hospitalisations were listed.
Results Forty HF patients were retrospectively studied. Our patients were older and had a higher NYHA class than in the PARADIGM-HF trial (p<0.05), however fewer comorbidities have been identified (p<0.05) and fewer patients were pretreated by ACEI and beta-blockers (p<0.05 for both). Similar adverse events have been reported: arterial hypotension (17.5%), hyperkalaemia (22%), kidney failure (7.5%) and cough (2.5%). Other adverse events have been reported such as hypokalaemia (5.5%) and cardiac decompensation (35%). Thirteen patients were hospitalised in the cardiology care unit for at least one HF decompensation.
Conclusion Despite the low total headcount of patients in this study, the difference between baseline characteristics have been shown. Patients were older and had a higher NYHA class which may explain that 13 of 40 patients were hospitalised for at least one HF episodes. The occurrence of adverse effects can explain that patients were treated with a lower dosage of Entresto, only 22% reached maximal dosage (97/103 mg). An investigation needs to be done to compare hospitalisations of patients before and after the introduction of Entresto, to show its the real impact.
Reference and/or acknowledgements
McMurray, et al. NEJM 2014.
Reference and/or acknowledgementsNo conflict of interest.
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