Key result
Sacubitril/valsartan was well tolerated in patients with HFrEF and a history of cancer, significantly improving left ventricular ejection fraction by a mean of 12% (p=0.0004).
Why the study?
Data on sacubitril/valsartan in patients with a history of cancer are scarce because they were excluded from the pivotal PARADIGM-HF trial.
Does sacubitril/valsartan improve ventricular function and is it well tolerated in patients with HFrEF and a history of cancer?
Observational (n=21)
No
Does sacubitril/valsartan improve ventricular function and is it well tolerated in patients with HFrEF and a history of cancer?
Mean Difference: 12 (95% CI 8.4–16.4)
Absolute Event Rate: 39.2% vs 26.8%
p-value: p=0.0004
Sacubitril/valsartan is well tolerated and significantly improves left and right ventricular function in patients with HFrEF and a history of cancer, a population previously excluded from pivotal trials.
May warrant consideration in cardio-oncology but should not change practice; leaves open randomized confirmation of outcomes.
BACKGROUND: Sacubitril/valsartan has been shown to significantly reduce cardiovascular mortality and hospitalizations due to heart failure in patients with reduced ejection fraction (HFrEF) when compared to enalapril. Data about sacubitril/valsartan in patients with a history of cancer are scarce, as these patients were excluded from the pivotal trial, PARADIGM-HF. The aim of the current study was to assess tolerability of sacubitril/valsartan in patients with a history of cancer. METHODS: We identified 225 patients at our heart failure out-patient unit who fulfilled the indication criteria to receive sacubitril/valsartan. Out of these, 9.3% (n = 21) had a history of histologically confirmed cancer. Oncologic surgery was performed in 16 (76.2%) patients, 11 (52.4%) patients received previous antineoplastic therapy and 9 patients (42.9%) radiation. RESULTS: Sacubitril/valsartan was withdrawn in 3 of 21 patients (14.3%) because of dizziness (n = 2) or pruritus (n = 1). After a median follow-up of 12 months (range 1-34 months), NYHA functional class improved significantly from NYHA 3 to NYHA 2 (mean -0.6, p = 0.006) and left ventricular ejection fraction as assessed by echocardiography increased significantly from 26.8 ± 5.4% to 39.2 ± 10% (mean + 12%, CI 95% [8.4-16.4], p = 0.0004). NT-proBNP was significantly reduced (baseline median 2774 pg/ml, range 1441 - 12,982 vs follow-up 1266 pg/ml, range 199-6324, p = 0.009). There was no significant change in creatinine levels (1.18 ± 0.4 vs 1.22 ± 0.4 mg/dl; mean + 0.005 mg/dl, CI 95% [-0.21- 0.12], p = 0.566). CONCLUSIONS: In our pilot study we show that sacubitril/valsartan is generally well tolerated in patients with HFrEF and history of cancer. Importantly, even patients with long-standing cardiotoxicity induced heart failure can be treated and up-titrated with sacubitril/valsartan to usual target dosages, leading to improvement in LV function and biomarkers. Larger studies are needed to confirm these findings in cancer patients with cardiotoxicity.
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Frey et al. (2021) conducted an observational in Heart failure with reduced ejection fraction and history of cancer (n=21). Sacubitril/valsartan vs. Baseline (pre-treatment) was evaluated on Left ventricular ejection fraction (MD 12%, 95% CI 8.4-16.4, p=0.0004). Sacubitril/valsartan was well tolerated in patients with HFrEF and a history of cancer, significantly improving left ventricular ejection fraction by a mean of 12% (p=0.0004).
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