Angioedema in heart failure patients treated with sacubitril/valsartan (LCZ696) or enalapril in the PARADIGM-HF study

Shi, Victor; Senni, Michele; Streefkerk, Henk Johan; Modgill, Vikas; Zhou, Wenchun; Kaplan, Allen P.

doi:10.1016/j.ijcard.2018.03.121

Cited by 35 publications

(15 citation statements)

References 34 publications

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“…ACE inhibitors together with sacubitril increase the risk for angioedema which is a serious but rare adverse event. Sacubitril-valsartan alone has shown a frequency of angioedema of < 0.5% [15] and higher rates in black patients. We did not have any cases of angioedema.…”

Section: Discussionmentioning

confidence: 99%

Safety and Tolerability of Initiating Maximum-Dose Sacubitril-Valsartan in Patients on Target Dose Renin-Angiotensin System Inhibitors

Norberg

Bergdahl

Lindmark

2019

Cardiovascular Therapeutics

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Aim. Sacubitril-valsartan has proven beneficial in heart failure with reduced ejection fraction. Guidelines recommend initiating half-dose sacubitril-valsartan before up-titration even to patients already on target dose angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB). To reduce the number of titration steps needed in order to simplify for the patient as well as the clinic, we aimed to investigate the safety and tolerability of switching patients on target dose ACE inhibitors or ARBs directly to maximum-dose sacubitril-valsartan. Methods. This prospective cohort study was conducted between April 2016 and November 2017. A total of 66 patients with heart failure and reduced ejection fraction already on guideline-recommended target dose ACE inhibitors or ARBs (equivalent to enalapril 10 mg twice daily) were switched to maximum-dose sacubitril-valsartan (200 mg twice daily). The patients were followed for twelve months. Results. Patients had a mean age of 72 ± 10 years, mean systolic blood pressure of 121 ± 17 mmHg, and 92% were male. At 12-month follow-up, nine patients (14%) had discontinued sacubitril-valsartan, four patients (6%) had a dose reduction, and 17 patients (26%) had developed symptomatic hypotension. No angioedema occurred within the 12-month follow-up and there were no hospitalizations or emergency room visits within the first 14 days. Conclusions. Switching directly from target dose ACE inhibitors or ARBs to maximum-dose sacubitril-valsartan was safe and generally well tolerated.

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Section: Discussionmentioning

confidence: 99%

Safety and Tolerability of Initiating Maximum-Dose Sacubitril-Valsartan in Patients on Target Dose Renin-Angiotensin System Inhibitors

Norberg

Bergdahl

Lindmark

2019

Cardiovascular Therapeutics

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“…Existing trials repeatedly show no significant difference in the rate of angioedema between ARNI and ACE inhibitors. Angioedema incidence is rare overall, and more trials are needed to strengthen these results (24,54). In PARAGON-HF (33) angioedema was more common in the sacubitril/valsartan arm.…”

Section: Safety and Complicationsmentioning

confidence: 99%

Narrative review in the current role of angiotensin receptor-neprilysin inhibitors

Rodríguez¹,

Cu²,

Siddiqui³

2021

Ann Transl Med

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Heart failure (HF) accounts for a tremendous burden on health care systems and the society.Since the landmark PARADIGM-HF trial, sacubitril/valsartan, the first in the class of angiotensin receptor neprilysin inhibitor (ARNI) showed superiority to enalapril in patients with HF with reduced ejection fraction (HFrEF). We performed a narrative literature review, hand-searched the reference lists of included articles and relevant reviews. Inhibition of neprilysin increases bradykinin, natriuretic peptides and adrenomedullin levels counteract the neurohormal activation that leads to sodium retention, vasoconstriction, and cardiac remodeling. In PARADIGM-HF the primary outcome of CV death or HF hospitalization was reduced 20% in the ARNI group (HR 0.80, P<0.001) similar to mortality due to cardiovascular cause (HR 0.80, P<0.001) in patients with HFrEF, rendering a number needed to treat of 21 patients. This effect was consistent across subgroups. The safety of starting ARNI inpatient once the acute decompensation of HF is stabilized was demonstrated in PIONEER-HF trial. With willingness-topay thresholds commonly acceptable in the United States, sacubitril/valsartan is likely to be cost effective, which might not be in other health systems. Although its safety has been reassured in some clinical trials, common side effects are hypotension, worsening kidney function, hyperkalemia and angioedema. In HFpEF (PARAGON-HF), sacubitril/valsartan showed decrease in the level of the cardiac biomarkers, with improve functional NYHA and decrease in hospitalizations, predominately in women and patients with borderline ejection fraction. Some ongoing studies aim to demonstrate the effects of ARNI in acute coronary syndrome, stable ischemic heart disease, advanced HF, mitral regurgitation, aortic impedance and pulmonary hypertension. In conclusion, sacubitril/valsartan has proven to be an effective addition to the HFrEF arsenal, with safety comparable to current standard of care. In HFpEF, it improves quality of life, particularly in women and in patients with borderline ejection fraction, with no effect on mortality.

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“…В последние годы для лечения пациентов с ХСН и пониженной фракцией выброса (ФВ) используется новый препарат, который одновременно блокирует ренин-ангиотензиновую и систему натрийуретических пептидов. В серии клинических проспективных исследований было продемонстрировано его положительное влияние на прогноз жизни пациентов с ХСН [6][7][8][9].…”

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Comparative efficacy of medication and cardiac resynchronization therapy in patients with heart failure with reduced ejection fraction

Эюбова

2021

Russ J Cardiol

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Aim. To compare the effectiveness of standard conservative therapy for heart failure (HF) with the inclusion of sacubitril/valsartan combination and device therapy.Material and methods. The study included 64 patients from 38 to 73 years old (45 men and 19 women; mean age, 59,5±0,9 years) hospitalized in Baku (Azerbaijan) hospital due to NYHA class II-IV HF. The patients were divided into the experimental (group 1) and control (group 2) groups. The experimental group included 33 patients who took sacubitril/valsartan twice a day in combination with other drugs for standard HF therapy. The control group included 31 patients after cardiac resynchronization therapy. We compared clinical and hemodynamic parameters (including 6-minute walk test and echocardiography data) before and 6 months after treatment, as well as blood concentration of brain natriuretic peptide (BNP). In addition, Kaplan-Meier survival curves were analyzed.Results. As a result of 6-month therapy, clinical condition of patients in both groups was improved. In the experimental group, some parameters were significantly better than in the control one. So, the differences regarded distance in 6-minute walk test (pu=0,002), changes in HF class (pu=0,017), LV ESD (pu=0,006), LV EDD (pu=0,001) and blood BNP concentrations (pu<0,001).Conclusion. The use of sacubitril/valsartan combination as part of standard HF therapy was accompanied by a significant improvement in the clinical, hemodynamic and biochemical parameters of patients with HF compared with device therapy.

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Angioedema in heart failure patients treated with sacubitril/valsartan (LCZ696) or enalapril in the PARADIGM-HF study

Abstract: The number of confirmed angioedema events in PARADIGM-HF was low and there was no-marked excess risk of angioedema with sacubitril/valsartan versus enalapril.

Cited by 35 publications

References 34 publications

Safety and Tolerability of Initiating Maximum-Dose Sacubitril-Valsartan in Patients on Target Dose Renin-Angiotensin System Inhibitors

Safety and Tolerability of Initiating Maximum-Dose Sacubitril-Valsartan in Patients on Target Dose Renin-Angiotensin System Inhibitors

Narrative review in the current role of angiotensin receptor-neprilysin inhibitors

Comparative efficacy of medication and cardiac resynchronization therapy in patients with heart failure with reduced ejection fraction

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