Print, 49/51 mg twice daily to start, increasing to 97/103 mg twice daily after two to four weeks if tolerated. STEPS: Sacubitril/Valsartan (Entresto) for Heart Failure. If switching from an ACE inhibitor to Entresto allow a washout period of 36 hours between administrations of the two drugs (1). / afp My doctor has decided to switch me from 20 mg per day of Lisinopril (ACE inhibitor) and 10 mg per day of Atenolol (Beta Blocker) to an ARB (Diovan). afpserv@aafp.org for copyright questions and/or permission requests. ENTRESTO is usually used with other heart failure therapies, in place of an angiotensin-converting enzyme (ACE) inhibitor or other angiotensin II receptor blocker (ARB) therapy. Copyright © 2020 American Academy of Family Physicians. ENTRESTO is contraindicated with concomitant use of an angiotensin-converting enzyme (ACE) inhibitor. 0000038120 00000 n Dosage range for ACE-Inhibitors3 Captopril 12.5 – 150mg daily (in 2 or 3 divided doses) Enalapril 2.5 – 40mg daily 0000020907 00000 n Drug Approximate Dose Equivalence Maximum Daily Dose (mg) Captopril (Capoten®) 12.5 mg tid: 150: Enalapril maleate (Vasotec®) 5 mg daily: 40: Enalapril sodium. Background Sacubitril/valsartan is an effective treatment for heart failure with reduced ejection fraction (HFrEF) based on clinical trial data. et al. Don't miss a single issue. Switching from an ACEI requires a 36-hour washout period to avoid angdioedema; no washout is needed for ARB switches. %%EOF If the initial dosage is tolerated, it should be doubled after two to four weeks to the target maintenance dosage of 97/103 mg twice daily. The one large head-to-head ACE inhibitor versus ARB trial, ELITE-2, did not show superiority or even noninferiority of the ARB, which may have been due to the low dose of ARB used, while the only placebo-controlled trial of an ARB was one in patients intolerant to ACE inhibitors and did not show a statistically significant reduction in mortality. endstream endobj 434 0 obj <>/Filter/FlateDecode/Index[24 370]/Length 35/Size 394/Type/XRef/W[1 1 1]>>stream Prescribe* and document ACE inhibitor or ARB therapy for patients ≥18 years with HF who have a current or prior LVEF < 40%. 0000043097 00000 n 394 42 0000029529 00000 n The average dose of enalapril used in this study was 18.9 mg, and the average dose of sacubitril/valsartan was 375 mg (the equivalent of approximately 300 mg of valsartan). Packer M, 8(October 15, 2016) 0000017053 00000 n The cases submitted to FDA describe patients who were taking an ACE inhibitor and were prescribed Entresto, and patients who started taking Entresto in the hospital and inadvertently restarted their ACE inhibitor after discharge. U.S. National Library of Medicine. 0000001157 00000 n It may be used in place of an ACE inhibitor in patients receiving optimal doses of guideline-directed medical therapy that includes ACE inhibitors, beta blockers, and aldosterone antagonists. McMurray JJ, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=000dc81d-ab91-450c-8eae-8eb74e72296f. However, little is known about its use or impact in real-world practice. Mortality rates from a cardiovascular cause over 3.5 years were 16.5% with enalapril vs. 13.3% with sacubitril/valsartan (number needed to treat [NNT] for 3.5 years = 31; 95% confidence interval [CI], 22 to 62). Eligibility requirements in the PARADIGM-HF trial at screening included an age of at least 18 Sacubitril/valsartan provides a small mortality benefit and decreases heart failure–related hospitalizations over and above an ACE inhibitor. Copyright © 2016 by the American Academy of Family Physicians. Dosage range for ACE-Inhibitors3 Captopril 12.5 – 150mg daily (in 2 or 3 divided doses) Enalapril 2.5 – 40mg daily If a consideration to switch is being driven by clinical deterioration or lack of clinical response, patients should first be stabilized by modulating their diuretic or ACE inhibitor. 0000017992 00000 n Sacubitril/valsartan therapy may increase serum lithium concentrations in patients taking lithium. Unless your patient is on a high ACEi/ARB dose, start ENTRESTO at 24/26 mg twice daily and double the dose every 2 to 4 weeks, as tolerated by the patient. If the initial dosage is tolerated, it should be doubled after two to four weeks to the target maintenance dosage of 97/103 mg twice daily. 0000009900 00000 n 0000041523 00000 n STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. This means you will need to stop taking all ACE inhibitors or ARBs for 36 hours prior to starting Entresto. Sacubitril/valsartan is generally well tolerated by most patients. Reprints are not available from the author. Sacubitril/valsartan (Entresto) is a combination of a neprilysin inhibitor and an angiotensin receptor blocker (ARB). / Vol. Closely monitor serum creatinine levels, and lower the dosage or stop therapy in patients who develop a clinically significant decrease in renal function. ; LCZ696 (sacubitril/valsartan) is taken twice daily without regard to food. It must be something with the sacubitril. 0000017281 00000 n Experience with them has been variable, with both success and failure reported for ACE inhibitors, angiotensin receptor blockers (ARBs), omega-3 fish oil, statins, and aldosterone antagonists and eplerinone. Monitoring requirements when switching ACE-inhibitors • Serum Potassium levels • Renal function (Creatinine clearance) • Blood pressure • Care should be taken in patients on diuretic therapy (monitor for hypotension). ARBs 1.25-20 mg daily in 1-2 divided doses 2-4 mg daily 2-32 mg daily in 1-2 divided doses 400-800 mg dialy in 1-2 divided doses 150-300 mg daily 25-100 mg daily in 1-2 divided doses 20-40 mg daily Drug Name Starting Dose3 Goal Dose in CKD3 Dosing in renal dysfunction 1,2,4 ACE-Inhibitors 2.5 mg daily 1 mg daily 16 mg as monotherapy 600 mg daily ; 0000003489 00000 n Eleven patients were hospitalized. 1. 394 0 obj <> endobj If switching from an ACE inhibitor to ENTRESTO allow a washout period of 36 hours between administration of the two drugs [see Contraindications (4) and … 0000012016 00000 n When switching from an ACE inhibitor, patients should wait 36 hours before starting sacubitril/valsartan. PARADIGM-HF Investigators and Committees. Entresto is contraindicated with concomitant use of an ACE inhibitor. Angioedema Avoid use in patients with a history of angioedema due to ACEI or ARB, hereditary or idiopathic angioedema Do not use combination of ACEI or ARB with Entresto Ensure 36 hours washout period when switching from an ACEI Hypotension Avoid use if systolic BP is less than 100mmHg Monitoring requirements when switching ACE-inhibitors • Serum Potassium levels • Renal function (Creatinine clearance) • Blood pressure • Care should be taken in patients on diuretic therapy (monitor for hypotension). Approximately 11% of patients will discontinue therapy because of adverse effects.1,2 It should not be used together with an ACE inhibitor because of the increased risk of angioedema, with another ARB, or with aliskiren (Tekturna) in patients with diabetes mellitus. ... washout period is not needed when switch- McMurray JJ, If switching from an ACE inhibitor to ENTRESTO allow a washout period of 36 hours between administration of the two drugs [see Contraindications (4) … Estimated retail price of one month's treatment based on information obtained at, Address correspondence to Judy Cheng, PharmD, MPH, FCCP, BCPS, at. https://www.aafp.org/afp/steps. Angiotensin-neprilysin inhibition versus enalapril in heart failure. To see the full article, log in or purchase access. trailer 2. 0000003338 00000 n Treatments aimed at reducing the effects of such circumstances have been termed "upstream therapies." Each independent review is provided by authors who have no financial association with the drug manufacturer. 2016 Oct 15;94(8):611-612. Approximately 3% of patients will develop an elevated creatinine level (greater than 2.5 mg per dL [221 μmol per L]), compared with 4.5% of patients receiving enalapril. 0000000016 00000 n 0000006018 00000 n This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, Contributing Editor. 0000011030 00000 n 0000017609 00000 n ACE Inhibitor and ARB Dose Equivalency Tables; About; ACE Inhibitor and ARB Dose Equivalency Tables. Eligibility requirements in the PARADIGM-HF trial at screening included an age of at least 18 Sacubitril and Valsartan (ENTRESTO) Drug Monograph September 2015 Updated version may be found at www.pbm.va.gov or PBM INTRAnet 2 Boxed Warning to discontinue sacubitril/valsartan as soon as pregnancy is detected, due to the risk for fetal injury and death. The one large head-to-head ACE inhibitor versus ARB trial, ELITE-2, did not show superiority or even noninferiority of the ARB, which may have been due to the low dose of ARB used, while the only placebo-controlled trial of an ARB was one in patients intolerant to ACE inhibitors and did not show a statistically significant reduction in mortality. Prescribe* and document ACE inhibitor or ARB therapy for patients ≥18 years with HF who have a current or prior LVEF < 40%. 0000014639 00000 n DailyMed. Finally, as a new drug, the cost will be high. Although these medication classes work in a similar fashion, ARBs do not inhibit kinase II which is thought to be responsible for the cough. Desai AS, Am Fam Physician. 3. Author disclosure: No relevant financial affiliations. 0000043008 00000 n 2014;371(11):993–1004. OR. These guidelines were published prior to the PARADIGM-HF trial. This material may not otherwise be downloaded, copied, printed, stored, transmitted or reproduced in any medium, whether now known or later invented, except as authorized in writing by the AAFP. 0000009686 00000 n ... Entresto is also contraindicated with concomitant use of an angiotensin-converting enzyme (ACE) inhibitor. However, the dose of enalapril used was not the maximum, whereas the dose of valsartan was. The recommended starting dose for LCZ696 (sacubitril/valsartan) is variable and depends on the dose of ACE inhibitor or ARB that the patient is taking and presence of severe renal dysfunction or moderate hepatic dysfunction (as defined below). Want to use this article elsewhere? 0000020301 00000 n If switching from an ACE inhibitor to Entresto allow a washout period of 36 hours between administrations of the two drugs (2). judy.cheng@mcphs.edu. When switching from an ACE inhibitor, a washout period of 36 hours between drugs is required due to the increased risk of angioedema. angiotensin-converting enzyme (ACE) inhibitor. Sacubitril/valsartan is much more expensive than other ACE inhibitor or ARB treatment options. The most common adverse events reported due to this drug interaction were angioedema, hyperkalemia, acute kidney injury, and hypotensi… Study design: Drug-utilization analysis using a large prescription database. My doctor has decided to switch me from 20 mg per day of Lisinopril (ACE inhibitor) and 10 mg per day of Atenolol (Beta Blocker) to an ARB (Diovan). 0000026879 00000 n This drug-utilization study in a prescription database of more than 50,000 patients analyzed compliance, persistence, and switching behavior for ACE inhibitors and ARBs. N Engl J Med. ENTRESTO is contraindicated with concomitant use of an angiotensin-converting enzyme (ACE) inhibitor. The cost of a one-month supply of sacubitril/valsartan is approximately $413. Monitor serum potassium levels periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high-potassium diet. If a patient develops an ACEI-induced cough, switch to an ARB. Study design: Drug-utilization analysis using a large prescription database. 0000020999 00000 n ENTRESTO is a prescription medicine used to reduce the risk of death and hospitalization in people with certain types of long-lasting (chronic) heart failure. treated with angiotensin-converting enzyme (ACE) inhibitors. The standard starting dose is 49/51 mg twice daily. It’s also new, so there doctors and patients alike have limited experience with it. Hyperkalemia (serum potassium concentration greater than 5.5 mEq per L [5.5 mmol per L]) will occur in approximately 16% of patients, a rate similar to that of enalapril,1,2 and it is more likely in patients treated with other potassium-sparing diuretics. Contact In comparison, an ACE inhibitor such as enalapril costs $20 ($770 for Vasotec), and an ARB such as valsartan (Diovan) costs $18 ($214). The most significant adverse effects of sacubitril/valsartan are symptomatic hypotension, renal dysfunction, and hyperkalemia. The recommended starting dosage of sacubitril/valsartan is 49/51 mg twice daily. �xtt4��N�����k�E�xg00�c`d�5?�_@��a���N�O�y�2��L��x$x��EM�R��g\�U{jfD-�f���x����+�ۄ�V i&��1ȧ��^X"��DC���gx��Y���4۪ K��LqF�L��- @t7� 0000003032 00000 n ACE inhibitors have long been the cornerstone of therapy for patients with HFrEF and ARBs are recommended as a substitution for patients who have intolerable side effects to ACE inhibitors. Document contraindication(s) to ACE/ARB. 'b��dK!��`���7��xo0[k7�;��}^�X��с�7��VU�xVm�]��6V ��bF��l_tq(֬��Ҷ�=nO|�r-��"V���p��S�ܯ�&X� ��6����j6{X�Dx%Xt�|�\����uhBQ�̋���:7 #��0�Q��+M�u�T9k\�^p�Q{� ;IY���,����5�3O8xa�{�xB$�x"ˉ&��`�l�j��С7�dP�'�p�E����v~��܆��#���r*z�� �2�a�� ,�6U��TL^"&�2�"�w�f2C��9Z�lM��(/tc�D,l�s�:Z:�Pxev`H%(t�q�@kݓ��t`O&�]z�6a��؎֙�fb#�ۄ�Tƫ)-ţs�⩐�B��8�c ���L38�m�J.���t_�.8]@k�C�6��^�=^-'�3 լ��>>ك��œ��g}Gz]�n�Z�e��Ϣ<7P�bj���O�/��l��o�qS<7n���M�e���w���v]�+�5��~ZTk�x�v8���[�R�ʮ֚��.^~�#4SjE&p�Ki>3Z`{\ n��/��R�6,�F�ũ;��r�C�8�����q��\y?^��`-QpE��Rǽ�(y>�I�j �"t�b�n�+�[�C$)�$�Q�^(t^����CS&0�U�|fvR�h��.\_ekdRZ. 0000001504 00000 n A collection of STEPS published in AFP is available at If switching from an ACE inhibitor to Entresto allow a washout period of 36 hours between administration of the two drugs [see Contraindications (4) and Drug Interactions (7.1)].The recommended starting dose of Entresto is 49/51 mg twice-daily.Double the dose of Entresto after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient. Angiotensin receptor blockers (ARB), like losartan (Cozaar), are less likely to cause this dry cough. 0000025004 00000 n When switching from ACEi, be sure to allow for a 36-hour washout period prior to initiating ENTRESTO. Issue Action Angioedema Avoid use in patients with a history of angioedema due to ACEI or ARB, hereditary or idiopathic angioedema Do not use combination of ACEI or ARB with Entresto Ensure 36 hours washout period when switching from an ACEI Hypotension DailyMed. D�=��@�E���G_�36@䈉�!��ŠV�ɧK��,R6AW�X V���4��r�8c� Z�,0��v@x��j9�(� PP�}��qƲ ��e�}���OH$G �G �%G|���@��� /�Ҧ)q3D��G���6M�^/ T���Q�z������z���0c�3W"�Z��rC#1�b�. 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