Effects of Estimated Glomerular Filtration Rate and Systolic Blood Pressure on the Discontinuation of Sacubitril/Valsartan Treatment for Heart Failure
This study aimed to evaluate the effect of systolic blood pressure (SBP) or estimated glomerulus filtration (eGFR) rate on sacubitril/valsartan (S/V) treatment discontinuation. A total of 148 Japanese patients who received S/V treatment for heart failure at Gifu General Medical Center between Septem...
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| Published in | Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences) Vol. 51; no. 3; pp. 130 - 138 |
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| Main Authors | , , , , , , |
| Format | Journal Article |
| Language | English Japanese |
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Japanese Society of Pharmaceutical Health Care and Sciences
10.03.2025
一般社団法人日本医療薬学会 |
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| ISSN | 1346-342X 1882-1499 |
| DOI | 10.5649/jjphcs.51.130 |
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| Abstract | This study aimed to evaluate the effect of systolic blood pressure (SBP) or estimated glomerulus filtration (eGFR) rate on sacubitril/valsartan (S/V) treatment discontinuation. A total of 148 Japanese patients who received S/V treatment for heart failure at Gifu General Medical Center between September 2020 and December 2022 were included. The treatment continuation rate considerably differed between the four groups for eGFR; no difference was observed for SBP. Furthermore, the eGFR and SBP for the risk of S/V treatment discontinuation calculated using the receiver operating characteristic curve were <31.24 mL/min/1.73m2 (specificity: 0.636; sensitivity: 0.748) and <117.5 mmHg (specificity: 0.545; sensitivity: 0.593), respectively, with 0.700 and 0.550 as the area under the curve. Thus, eGFR influenced treatment interruption more than SBP. The influence of eGFR on S/V treatment continuation was verified using the Kaplan–Meier curve because the number of patients with eGFR greater than this cutoff level was 8 of 22 patients who discontinued S/V. The eGFR of ≥45 and <45 groups were 398 (343 – 452) and 505 (465 – 545) days, respectively (P = 0.024). The hazard ratio of each risk factor for discontinuing S/V treatment was calculated using an eGFR of <45. Although only serum chlorine (Cl) levels were detected (hazard ratio: 3.053, P = 0.052), there was no significant difference. Reportedly, long-term S/V treatment for patients with eGFR of <45 mL/min/1.73m2 and Cl of <98 mmol/L should be performed under stricter inspection monitoring. |
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| AbstractList | This study aimed to evaluate the effect of systolic blood pressure (SBP) or estimated glomerulus filtration (eGFR) rate on sacubitril/valsartan (S/V) treatment discontinuation. A total of 148 Japanese patients who received S/V treatment for heart failure at Gifu General Medical Center between September 2020 and December 2022 were included. The treatment continuation rate considerably differed between the four groups for eGFR; no difference was observed for SBP. Furthermore, the eGFR and SBP for the risk of S/V treatment discontinuation calculated using the receiver operating characteristic curve were <31.24 mL/min/1.73m2 (specificity: 0.636; sensitivity: 0.748) and <117.5 mmHg (specificity: 0.545; sensitivity: 0.593), respectively, with 0.700 and 0.550 as the area under the curve. Thus, eGFR influenced treatment interruption more than SBP. The influence of eGFR on S/V treatment continuation was verified using the Kaplan–Meier curve because the number of patients with eGFR greater than this cutoff level was 8 of 22 patients who discontinued S/V. The eGFR of ≥45 and <45 groups were 398 (343 – 452) and 505 (465 – 545) days, respectively (P = 0.024). The hazard ratio of each risk factor for discontinuing S/V treatment was calculated using an eGFR of <45. Although only serum chlorine (Cl) levels were detected (hazard ratio: 3.053, P = 0.052), there was no significant difference. Reportedly, long-term S/V treatment for patients with eGFR of <45 mL/min/1.73m2 and Cl of <98 mmol/L should be performed under stricter inspection monitoring. |
| Author | Hayashi, Takahiro Nakao, Yuri Nishio, Yohei Bito, Rina Inoue, Kotoe Tsuchikawa, Takuya Hirashita, Tomoyuki |
| Author_FL | 林 高弘 平下 智之 西尾 洋平 土川 拓也 中尾 優里 尾藤 里奈 井上 壽江 |
| Author_FL_xml | – sequence: 1 fullname: 西尾 洋平 – sequence: 2 fullname: 中尾 優里 – sequence: 3 fullname: 尾藤 里奈 – sequence: 4 fullname: 土川 拓也 – sequence: 5 fullname: 井上 壽江 – sequence: 6 fullname: 平下 智之 – sequence: 7 fullname: 林 高弘 |
| Author_xml | – sequence: 1 fullname: Nishio, Yohei organization: Department of Pharmacy, Gifu Prefectural General Medical Center – sequence: 1 fullname: Tsuchikawa, Takuya organization: Department of Pharmacy, Gifu Prefectural General Medical Center – sequence: 1 fullname: Hayashi, Takahiro organization: College of Pharmacy, Kinjo Gakuin University – sequence: 1 fullname: Nakao, Yuri organization: College of Pharmacy, Kinjo Gakuin University – sequence: 1 fullname: Hirashita, Tomoyuki organization: Department of Pharmacy, Gifu Prefectural General Medical Center – sequence: 1 fullname: Inoue, Kotoe organization: Department of Pharmacy, Gifu Prefectural General Medical Center – sequence: 1 fullname: Bito, Rina organization: Department of Pharmacy, Gifu Prefectural General Medical Center |
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| Cites_doi | 10.1253/circj.CJ-16-0196 10.1056/NEJMoa1908655 10.1093/eurheartj/eht386 10.3390/jcm12196247 10.1056/NEJMoa1409077 10.1016/j.jchf.2022.04.013 10.1016/j.jacc.2005.11.084 10.1016/j.jchf.2018.02.004 10.1016/j.jjcc.2019.03.010 10.1253/circj.CJ-17-1424 10.1016/j.jjcc.2023.11.005 10.1007/s00228-016-2072-7 10.1159/000180580 10.1253/circj.CJ-20-0854 |
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| DocumentTitle_FL | 心不全に対するサクビトリルバルサルタンの治療中止に関する推算糸球体濾過量および収縮期血圧の影響 |
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| References | 5） Damman K, Valente MA, Voors AA, O'Connor CM, van Veldhuisen DJ, Hillege HL, Renal impairment, worsening renal function, and outcome in patients with heart failure: an updated meta-analysis, Eur Heart J, 2014, 35, 455-469. 12） Smith GL, Lichtman JH, Bracken MB, Shlipak MG, Phillips CO, DiCapua P, Krumholz HM, Renal impairment and outcomes in heart failure: systematic review and meta-analysis, J Am Coll Cardiol, 2006, 47, 1987-1996. 8） Vader JM, Givertz MM, Starling RC, McNulty SE, Anstrom KJ, Desvigne-Nickens P, Hernandez AF, Braunwald E, Mann DL, Tolerability of Sacubitril/Valsartan in Patients With Advanced Heart Failure: Analysis of the LIFE Trial Run-In, JACC Heart Fail, 2022, 10, 449-456. 4） Tsutsui H, Momomura SI, Saito Y, Ito H, Yamamoto K, Ohishi T, Okino N, Kitamura T, Guo W, Angiotensin Receptor Neprilysin Inhibitor in Japanese Patients With Heart Failure and Reduced Ejection Fraction - Baseline Characteristics and Treatment of PARALLEL-HF Trial, Circ J, 2018, 82, 2575-2583. 7） Dattilo G, Laterra G, Licordari R, Parisi F, Pistelli L, Colarusso L, Zappia L, Vaccaro V, Demurtas E, Allegra M, Crea P, Di Bella G, Signorelli SS, Aspromonte N, Imbalzano E, Correale M, The Long-Term Benefit of Sacubitril/Valsartan in Patients with HFrEF: A 5-Year Follow-Up Study in a Real World Population, J Clin Med, 2023, 12, 6247. doi: 10.3390/jcm12196247. 10） Ayalasomayajula SP, Langenickel TH, Jordaan P, Zhou W, Chandra P, Albrecht D, Pal P, Rajman I, Sunkara G, Effect of renal function on the pharmacokinetics of LCZ696 (sacubitril/valsartan), an angiotensin receptor neprilysin inhibitor, Eur J Clin Pharmacol, 2016, 72, 1065-1073. 9） Cockcroft DW, Gault MH, Prediction of creatinine clearance from serum creatinine, Nephron, 1976, 16, 31-41. 1） McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR, Angiotensin–Neprilysin Inhibition versus Enalapril in Heart Failure, N Engl J Med, 2014, 371, 993-1004. 3） Solomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Claggett B, Jhund PS, Boytsov SA, Comin-Colet J, Cleland J, Düngen HD, Goncalvesova E, Katova T, Kerr Saraiva JF, Lelonek M, Merkely B, Senni M, Shah SJ, Zhou J, Rizkala AR, Gong J, Shi VC, Lefkowitz MP, Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction, N Engl J Med, 2019, 381, 1609-1620. 14） Yasuda S, Nakao K, Nishimura K, Miyamoto Y, Sumita Y, Shishido T, Anzai T, Tsutsui H, Ito H, Komuro I, Saito Y, Ogawa H, The Current Status of Cardiovascular Medicine in Japan - Analysis of a Large Number of Health Records From a Nationwide Claim-Based Database, JROAD-DPC, Circ J, 2016, 80, 2327-2335. 6） Matsumoto S, McMurray JJV, Nasu T, Ishii S, Kagiyama N, Kida K, Fujimoto W, Kikuchi A, Ijichi T, Shibata T, Ikeda T, Kanaoka K, Relevant adverse events and drug discontinuation of sacubitril/valsartan in a real-world Japanese cohort: REVIEW-HF registry, J Cardiol, 2024, 84, 133-140. 2） Tsutsui H, Momomura SI, Saito Y, Ito H, Yamamoto K, Sakata Y, Desai AS, Ohishi T, Iimori T, Kitamura T, Guo W, Efficacy and Safety of Sacubitril/Valsartan in Japanese Patients With Chronic Heart Failure and Reduced Ejection Fraction - Results From the PARALLEL-HF Study, Circ J, 2021, 85, 584-594. 11） Chang HY, Feng AN, Fong MC, Hsueh CW, Lai WT, Huang KC, Chong E, Chen CN, Chang HC, Yin WH, Sacubitril/valsartan in heart failure with reduced ejection fraction patients: Real world experience on advanced chronic kidney disease, hypotension, and dose escalation, J Cardiol, 2019, 74, 372-380. 13） Damman K, Gori M, Claggett B, Jhund PS, Senni M, Lefkowitz MP, Prescott MF, Shi VC, Rouleau JL, Swedberg K, Zile MR, Packer M, Desai AS, Solomon SD, McMurray JJV, Renal Effects and Associated Outcomes During Angiotensin-Neprilysin Inhibition in Heart Failure, JACC Heart Fail, 2018, 6, 489-498. 11 12 13 14 1 2 3 4 5 6 7 8 9 10 |
| References_xml | – reference: 12） Smith GL, Lichtman JH, Bracken MB, Shlipak MG, Phillips CO, DiCapua P, Krumholz HM, Renal impairment and outcomes in heart failure: systematic review and meta-analysis, J Am Coll Cardiol, 2006, 47, 1987-1996. – reference: 3） Solomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Claggett B, Jhund PS, Boytsov SA, Comin-Colet J, Cleland J, Düngen HD, Goncalvesova E, Katova T, Kerr Saraiva JF, Lelonek M, Merkely B, Senni M, Shah SJ, Zhou J, Rizkala AR, Gong J, Shi VC, Lefkowitz MP, Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction, N Engl J Med, 2019, 381, 1609-1620. – reference: 5） Damman K, Valente MA, Voors AA, O'Connor CM, van Veldhuisen DJ, Hillege HL, Renal impairment, worsening renal function, and outcome in patients with heart failure: an updated meta-analysis, Eur Heart J, 2014, 35, 455-469. – reference: 9） Cockcroft DW, Gault MH, Prediction of creatinine clearance from serum creatinine, Nephron, 1976, 16, 31-41. – reference: 14） Yasuda S, Nakao K, Nishimura K, Miyamoto Y, Sumita Y, Shishido T, Anzai T, Tsutsui H, Ito H, Komuro I, Saito Y, Ogawa H, The Current Status of Cardiovascular Medicine in Japan - Analysis of a Large Number of Health Records From a Nationwide Claim-Based Database, JROAD-DPC, Circ J, 2016, 80, 2327-2335. – reference: 13） Damman K, Gori M, Claggett B, Jhund PS, Senni M, Lefkowitz MP, Prescott MF, Shi VC, Rouleau JL, Swedberg K, Zile MR, Packer M, Desai AS, Solomon SD, McMurray JJV, Renal Effects and Associated Outcomes During Angiotensin-Neprilysin Inhibition in Heart Failure, JACC Heart Fail, 2018, 6, 489-498. – reference: 2） Tsutsui H, Momomura SI, Saito Y, Ito H, Yamamoto K, Sakata Y, Desai AS, Ohishi T, Iimori T, Kitamura T, Guo W, Efficacy and Safety of Sacubitril/Valsartan in Japanese Patients With Chronic Heart Failure and Reduced Ejection Fraction - Results From the PARALLEL-HF Study, Circ J, 2021, 85, 584-594. – reference: 10） Ayalasomayajula SP, Langenickel TH, Jordaan P, Zhou W, Chandra P, Albrecht D, Pal P, Rajman I, Sunkara G, Effect of renal function on the pharmacokinetics of LCZ696 (sacubitril/valsartan), an angiotensin receptor neprilysin inhibitor, Eur J Clin Pharmacol, 2016, 72, 1065-1073. – reference: 4） Tsutsui H, Momomura SI, Saito Y, Ito H, Yamamoto K, Ohishi T, Okino N, Kitamura T, Guo W, Angiotensin Receptor Neprilysin Inhibitor in Japanese Patients With Heart Failure and Reduced Ejection Fraction - Baseline Characteristics and Treatment of PARALLEL-HF Trial, Circ J, 2018, 82, 2575-2583. – reference: 6） Matsumoto S, McMurray JJV, Nasu T, Ishii S, Kagiyama N, Kida K, Fujimoto W, Kikuchi A, Ijichi T, Shibata T, Ikeda T, Kanaoka K, Relevant adverse events and drug discontinuation of sacubitril/valsartan in a real-world Japanese cohort: REVIEW-HF registry, J Cardiol, 2024, 84, 133-140. – reference: 8） Vader JM, Givertz MM, Starling RC, McNulty SE, Anstrom KJ, Desvigne-Nickens P, Hernandez AF, Braunwald E, Mann DL, Tolerability of Sacubitril/Valsartan in Patients With Advanced Heart Failure: Analysis of the LIFE Trial Run-In, JACC Heart Fail, 2022, 10, 449-456. – reference: 1） McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR, Angiotensin–Neprilysin Inhibition versus Enalapril in Heart Failure, N Engl J Med, 2014, 371, 993-1004. – reference: 11） Chang HY, Feng AN, Fong MC, Hsueh CW, Lai WT, Huang KC, Chong E, Chen CN, Chang HC, Yin WH, Sacubitril/valsartan in heart failure with reduced ejection fraction patients: Real world experience on advanced chronic kidney disease, hypotension, and dose escalation, J Cardiol, 2019, 74, 372-380. – reference: 7） Dattilo G, Laterra G, Licordari R, Parisi F, Pistelli L, Colarusso L, Zappia L, Vaccaro V, Demurtas E, Allegra M, Crea P, Di Bella G, Signorelli SS, Aspromonte N, Imbalzano E, Correale M, The Long-Term Benefit of Sacubitril/Valsartan in Patients with HFrEF: A 5-Year Follow-Up Study in a Real World Population, J Clin Med, 2023, 12, 6247. doi: 10.3390/jcm12196247. – ident: 14 doi: 10.1253/circj.CJ-16-0196 – ident: 3 doi: 10.1056/NEJMoa1908655 – ident: 5 doi: 10.1093/eurheartj/eht386 – ident: 7 doi: 10.3390/jcm12196247 – ident: 1 doi: 10.1056/NEJMoa1409077 – ident: 8 doi: 10.1016/j.jchf.2022.04.013 – ident: 12 doi: 10.1016/j.jacc.2005.11.084 – ident: 13 doi: 10.1016/j.jchf.2018.02.004 – ident: 11 doi: 10.1016/j.jjcc.2019.03.010 – ident: 4 doi: 10.1253/circj.CJ-17-1424 – ident: 6 doi: 10.1016/j.jjcc.2023.11.005 – ident: 10 doi: 10.1007/s00228-016-2072-7 – ident: 9 doi: 10.1159/000180580 – ident: 2 doi: 10.1253/circj.CJ-20-0854 |
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| Title | Effects of Estimated Glomerular Filtration Rate and Systolic Blood Pressure on the Discontinuation of Sacubitril/Valsartan Treatment for Heart Failure |
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