Safety and tolerability of sacubitril-valsartan: a systematic review and meta-analysis

References

• Solomon SD, Zile M, Pieske B, et al. The angiotensin receptor neprilysin inhibitor LCZ696 in heart failure with preserved ejection fraction: a phase 2 double-blind randomised controlled trial. Lancet. 2012;380(9851):1387–1395.
   PubMed Web of Science ®Google Scholar
• McMurray JJV, Packer M, Desai AS, et al., Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 371(11):993–1004. 2014.
   PubMed Web of Science ®Google Scholar
• Ruilope LM, Dukat A, Böhm M, et al., Blood-pressure reduction with LCZ696, a novel dual-acting inhibitor of the angiotensin II receptor and neprilysin: a randomised, double-blind, placebo-controlled, active comparator study. Lancet. 375(9722):1255–1266. 2010.
   PubMed Web of Science ®Google Scholar
• Huo Y, Li W, Webb R, et al. Efficacy and safety of sacubitril/valsartan compared with olmesartan in Asian patients with essential hypertension: a randomized, double-blind, 8-week study. J Clin Hypertens. 2019;21:67–76.
   PubMed Web of Science ®Google Scholar
• Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2016;37(27):2129–2200.
   PubMed Web of Science ®Google Scholar
• Yancy CW, Jessup M, Bozkurt B, et al. ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. 2017;2017(136):e137–e161.
   Google Scholar
• Packer M, McMurray JJV. Importance of endogenous compensatory vasoactive peptides in broadening the effects of inhibitors of the renin-angiotensin system for the treatment of heart failure. Internet Lancet. 2017;38910081:1831–1840.
   PubMed Web of Science ®Google Scholar
• Braunwald E. The path to an angiotensin receptor antagonist-neprilysin inhibitor in the treatment of heart failure. J Am Coll Cardiol. 2015;65(10):1029–1041. [Internet].
   PubMed Web of Science ®Google Scholar
• Kang DH, Park SJ, Shin SH, et al. Angiotensin receptor neprilysin inhibitor for functional mitral regurgitation: PRIME study. Circulation. 2019;139(11):1354–1365.
   PubMed Web of Science ®Google Scholar
• Solomon SD, McMurray JJV, Anand IS, et al. Angiotensin–neprilysin inhibition in heart failure with preserved ejection fraction. N Engl J Med. 2019;381(17):1609–1620.
   PubMed Web of Science ®Google Scholar
• Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ. 2009;339:b2700.
   PubMedGoogle Scholar
• Sterne JAC, Savović J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:1–8.
   Google Scholar
• Deeks JJ. Issues in the selection of a summary statistic for meta-analysis of clinical trials with binary outcomes. Stat Med. 2002;21(11):1575–1600.
   PubMed Web of Science ®Google Scholar
• Higgins JPT, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21(11):1539–1558.
   PubMed Web of Science ®Google Scholar
• Page MJ, Higgins JPT, Sterne JAC. Chapter 13: assessing risk of bias due to missing results in a synthesis. In: Higgins JPT, Thomas J, Chandler J, et al. editors. Cochrane Handb Syst Rev Interv version 60 (updated July 2019) [Internet]. Cochrane; 2019. Available from. www.training.cochrane.org/handbook
   Google Scholar
• Balshem H, Helfand M, Schünemann HJ, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol. 2011;64(4):401–406.
   PubMed Web of Science ®Google Scholar
• Supasyndh O, Wang J, Hafeez K, et al. Efficacy and safety of sacubitril/valsartan (LCZ696) compared with olmesartan in elderly asian patients (≥65 years) with systolic hypertension. Am J Hypertens. 2017;30(12):1163–1169.
   PubMed Web of Science ®Google Scholar
• Izzo JL, Zappe DH, Jia Y, et al. Efficacy and safety of crystalline valsartan/sacubitril (LCZ696) compared with placebo and combinations of free valsartan and sacubitril in patients with systolic hypertension: the RATIO study. J Cardiovasc Pharmacol. 2017;69(6):374–381.
   PubMed Web of Science ®Google Scholar
• Williams B, Cockcroft JR, Kario K, et al. Effects of sacubitril/valsartan versus olmesartan on central hemodynamics in the elderly with systolic hypertension. Hypertension. 2017;69(3):411–420.
   PubMed Web of Science ®Google Scholar
• Engeli S, Stinkens R, Heise T, et al. Effect of sacubitril/valsartan on exercise-induced lipid metabolism in patients with obesity and hypertension. Hypertension. 2018;71(1):70–77.
   PubMed Web of Science ®Google Scholar
• Cheung DG, Aizenberg D, Gorbunov V, et al. Efficacy and safety of sacubitril/valsartan in patients with essential hypertension uncontrolled by olmesartan: a randomized, double-blind, 8-week study. J Clin Hypertens. 2018;20(1):150–158.
   PubMed Web of Science ®Google Scholar
• Haynes R, Judge PK, Staplin N, et al., Effects of sacubitril/valsartan versus irbesartan in patients with chronic kidney disease: a randomized double-blind trial. Circulation. 138(15):1505–1514. 2018. .
   PubMed Web of Science ®Google Scholar
• NCT. A multi-center, prospective, randomized, double-blind study to assess the impact of sacubitril/valsartan vs. enalapril on daily physical activity using a wrist worn actigraphy device in adult chronic heart failure patients [Internet]. 2019 [cited 2019 Dec 20]. Available from: https://clinicaltrials.gov/ct2/show/NCT02900378.
   Google Scholar
• NCT. Multicenter, randomized, double-blind, double dummy, parallel group, active-controlled 8-week study and 8-week open label extension to evaluate the effect of initiation of sacubitril/valsartan on objective measures of waking activity and sleep, as health- [Internet]. 2019 [cited 2019 Dec 20]. Available from: https://clinicaltrials.gov/ct2/show/NCT02970669.
   Google Scholar
• Velazquez EJ, Morrow DA, DeVore AD, et al. Angiotensin-neprilysin inhibition in acute decompensated heart failure. N Engl J Med. 2019;380(6):539–548.
   PubMed Web of Science ®Google Scholar
• Desai AS, Solomon SD, Shah AM, et al. Effect of sacubitril-valsartan vs enalapril on aortic stiffness in patients with heart failure and reduced ejection fraction: a randomized clinical trial. J Am Med Assoc. 2019;322(11):1077–1084.
   PubMed Web of Science ®Google Scholar
• Kario K, Sun N, Chiang FT, et al. Efficacy and safety of LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor, in Asian patients with hypertension: a randomized, double-blind, placebo-controlled study. Hypertension. 2014;63(4):698–705. .
   PubMed Web of Science ®Google Scholar
• NCT. Efficacy and safety of LCZ696 in comparison to olmesartan in Japanese patients with essential hypertension [Internet]. 2015 [cited 2019 Dec 20]. Available from: https://clinicaltrials.gov/ct2/show/study/NCT01599104.
   Google Scholar
• Wang JG, Yukisada K, Sibulo A, et al. Efficacy and safety of sacubitril/valsartan (LCZ696) add-on to amlodipine in Asian patients with systolic hypertension uncontrolled with amlodipine monotherapy. J Hypertens. 2016;35:877–885.
   Web of Science ®Google Scholar
• Schmieder RE, Wagner F, Mayr M, et al. The effect of sacubitril/valsartan compared to olmesartan on cardiovascular remodelling in subjects with essential hypertension: the results of a randomized, double-blind, active-controlled study. Eur Heart J. 2017;38(44):3308–3317.
   PubMed Web of Science ®Google Scholar
• Packer M, McMurray JJV, Desai AS, et al. Angiotensin receptor neprilysin inhibition compared with enalapril on the risk of clinical progression in surviving patients with heart failure. Circulation. 2015;131(1):54–61.
   PubMed Web of Science ®Google Scholar
• Bettencourt P, Azevedo A, Pimenta J, et al. N-terminal-pro-brain natriuretic peptide predicts outcome after hospital discharge in heart failure patients. Circulation. 2004;110(15):2168–2174.
   PubMed Web of Science ®Google Scholar
• Chrysant SG. Benefits and pitfalls of sacubitril/valsartan treatment in patients with hypertension. J Clin Hypertens. 2018;20(2):351–355.
   PubMed Web of Science ®Google Scholar
• Israili ZH, Dallas Hall W. Cough and angioneurotic edema associated with angiotensin-converting enzyme inhibitor therapy: a review of the literature and pathophysiology. Ann Intern Med. 1992;117(3):234–242.
   PubMed Web of Science ®Google Scholar
• Caldeira D, David C, Sampaio C. Tolerability of angiotensin-receptor blockers in patients with intolerance to angiotensin-converting enzyme inhibitors: a systematic review and meta-analysis. Am J Cardiovasc Drugs. 2012;12(4):263–277.
   PubMed Web of Science ®Google Scholar
• Campbell DJ. Long-term neprilysin inhibition-implications for ARNIs. Nat Rev Cardiol. 2017;14:171–186.
   PubMed Web of Science ®Google Scholar
• Ettehad D, Emdin CA, Kiran A, et al. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. Lancet. 2016;387(10022):957–967. Internet.
   PubMed Web of Science ®Google Scholar
• Uijl E, Roksnoer LCW, Hoorn EJ, et al. From ARB to ARNI in cardiovascular control. Curr Hypertens Rep. 2016;18(12). Internet. doi:10.1007/s11906-016-0694-x
   PubMed Web of Science ®Google Scholar
• Pharithi RB, Ferre-Vallverdu M, Maisel AS, et al. Sacubitril-valsartan in a routine community population: attention to volume status critical to achieving target dose. ESC Hear Fail. 2020;7:158–166.
   PubMed Web of Science ®Google Scholar
• Langenickel TH, Tsubouchi C, Ayalasomayajula S, et al. The effect of LCZ696 (sacubitril/valsartan) on amyloid-β concentrations in cerebrospinal fluid in healthy subjects. Br J Clin Pharmacol. 2016;81(5):878–890.
   PubMed Web of Science ®Google Scholar
• Epstein M, Lifschitz MD. Potassium homeostasis and dyskinesias: the respective roles of renal, extrarenal, and gut sensors in potassium handling. Internet Kidney Int Suppl. 2016;61:7–15.
   Web of Science ®Google Scholar
• Bender R, Bunce C, Clarke M, et al. Attention should be given to multiplicity issues in systematic reviews. J Clin Epidemiol. 2008;61(9):857–865.
   PubMed Web of Science ®Google Scholar
• Desai AS, Solomon S, Claggett B, et al. Factors associated with noncompletion during the run-in period before randomization and influence on the estimated benefit of LCZ696 in the PARADIGM-HF trial. Circ Hear Fail. 2016;9:1–6.
   Web of Science ®Google Scholar