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Azmarda -Overview Indications Clinical Evidence amp Dosage

Azmarda is a brand name for the medication combination of sacubitril, a neprilysin inhibitor, and valsartan, an angiotensin II receptor blocker. It belongs to the group of medications known as angiotensin-neprilysin inhibitors (ARNI)

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Azmarda -Overview Indications Clinical Evidence amp Dosage

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  1. Overview, Indications, Clinical Evidence & Dosage medicaldialogues.in/partner/jbcpl/azmarda-sacubitril-valsartan Heart Failure - Overview Heart failure is a progressive chronic syndrome characterized by decrease in functional status and quality of life . The burden of heart failure has increased to an estimated 23 million people, worldwide. In India, the prevalence was estimated to be around 1.2/1000 people in the INDUS study.... 1 Indication Heart Failure To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. Important update 1/17

  2. Understanding ARNI in Hypertension Understanding Heart Failure in India Guidlines defined for the treatment of Heart Failure Quick Review- Role of ARNI in Heart Failure final Decoding the clinical Evidence for Sacubitril Valsartan in Heart Failure The Drug Review Sacubitril Valsartan John McMurray BHF Cardiovascular Research Centre, University of Glasgow & Queen Elizabeth University Hospital, Glasgow, Scotland, UK Dr. Partho P Chowdhury MD (DELHI UNIVERSITY), DM (IPGMER,KOL) Consultant Interventional Cardiologist Specialist in Radial Angioplasty, Complex Angioplasty, Pacemaker, ICD, CRT Implantation, Device Closure Meditrina Hospital, Jharkhand Professor Dr. J.C Mohan MBBS, MD (General Medicine) DM (Cardiology) M.NAMS FACC (Fellow American College of Cardiology) FASE (Honorary Fellow of American Society of Echocardiography) FESC (Fellow of European Society of Cardiology) Jaipur Golden Hospital, Delhi 2/17

  3. Dr. Armendra Kumar Pandey MBBS, DNB (Medicine) FNIC, DNB (Cardilogy) Consultant-Cardiology Dharamshila Narayana Superspeciality Hospital Watch Video At: https://youtu.be/sceEr6m2QnQ Dr. Dilip Kumar MBBS, MD, DM (Card) FRCP (GLASG), FHRS, FSCAI, FESC, IBHRE, CCDS Chief Academic Co-ordinator Medica Institute of Cardiac Sciences Kolkata 3/17

  4. Watch Video At: https://youtu.be/5rOxlgEIXaY Dr. Animesh Agarwal MD, DM (Cardiology), AFESC International Associate American College of Cardiology Senior Consultant & HOD Department of Cardiology Jindal Institute of Medical Sciences, Haryana Watch Video At: https://youtu.be/7x2WKKUV1rA 4/17

  5. Dr. Harpreet Singh Gilhotra DM, FESC Director Cardiology Sri Guru Harkrishan Sahib (C) Eye Hospital Trust, Sohan (Sohana Hospital) Watch Video At: https://youtu.be/ovMzlsB4o3M Dr. Amit Handa Consultant- Cardiologist MD (Med.), DM (Cardiology) Ivy Multi Speciality Hospital Punjab 5/17

  6. Watch Video At: https://youtu.be/YzWI1O20RCk Dr. Niroj Kumar Mishra M.D. (Medicine) Clinical Director (AN ISO:9001:2008 CERTIFIED HOSPITAL) KAR CLINIC & HOSPITAL PVT.LTD., Bhubaneswar Watch Video At: https://youtu.be/0xvq7sAwrUA 6/17

  7. Dr. Nitin Tiwari M.B.B.S (Gold Medallist) D.M.(Card), D.N.B.(Card), M.D. (Card), D.N.B (Med.), M.N.A.M.S., M.A.P.S.I.C., F.I.A.M.S. FIC (France), FIC (Germany), FESC (Europe), FACC (USA) Interventional Cardiologist WOCKHARDT HEART HOSPITAL, Nagpur Watch Video At: https://youtu.be/YbckiC1zSP8 Dr. Idris Ahmed Khan MD, DM (Card, PGI Chandigarh) Consultant Interventional Cardiologist BOMBAY HOSPITAL, INDORE 7/17

  8. Watch Video At: https://youtu.be/vc9lm8gWjbg Dr. Johann Christopher MD, DNB (Cardiology) Consultant Cardilogist Division of Cardiac Imaging CARE HOSPITALS, CARE OUTPATIENT CENTRE Hyderabad Watch Video At: https://youtu.be/Kx0B93PygOw 8/17

  9. Dr. C.K. Ponde Consultant Cardiologist M.D. (Gen.Med), D.M (Card), D.N.B. (Card) FACC (USA), FSCAI (USA) FCSI, FISE, FICC, FIAE Watch Video At: https://youtu.be/vTx4E4Y3tZs Prof Dr Satyanarayan Routray MBBS, MD (MEDICINE), DM (CARDIOLOGY), FICC,FCSI Professor and HOD SCB Medical College & Hospital Cuttack 9/17

  10. Watch Video At: https://youtu.be/lnBKczf--D0 Dr J.S Hiremath DM (Cardiology), DNB (Cardiology) Fellow of American College of Cardiology Director: Cath Lab, Ruby Hall Clinic Chief Cardiologist, Hearty Transplant Department, Ruby Hall Clinic, Pune About Azmarda Azmarda contains Sacubitril/Valsartan, the first agent to be approved in a new class of drugs called angiotensin receptor neprilysin inhibitor (ARNI) . 3 10/17

  11. How Azmarda Works? 11/17

  12. Sacubitril acts as a neprilysin inhibitor by preventing the breakdown of natriuretic peptides. This leads to a prolonged duration of the favorable effects of these peptides. Valsartan is an angiotensin receptor blocker, and it works by blocking the renin- angiotensin-aldosterone system . 3 Composition 4 Pharmacokinetics of Azmarda Absorption Following oral administration, Azmarda dissociates into sacubitril, which is further metabolized to sacubitrilat, and valsartan, which reach peak plasma concentrations in 0.5 hours, 2 hours, and 1.5 hours, respectively. The oral absolute bioavailability of sacubitril and valsartan is estimated to be ≥ 60% and 23%, respectively. Azmarda can be administered with or without food. Distribution Azmarda is highly bound to plasma proteins (94% - 97%). Based on the comparison of plasma and CSF exposures, sacubitrilat does cross the blood brain barrier to a limited extent (0.28%). Azmarda has an apparent volume of distribution ranging from 75L to 103L. 12/17

  13. Biotransformation Sacubitril is readily converted to sacubitrilat by esterases; sacubitrilat is not further metabolized to a significant extent. Valsartan is minimally metabolized, as only about 20% of the dose is recovered as metabolites. Elimination Following oral administration, 52 to 68% of sacubitril (primarily as sacubitrilat) and ~13% of valsartan and its metabolites are excreted in urine; 37 to 48% of sacubitril (primarily as sacubitrilat), and 86% of valsartan and its metabolites are excreted in feces. Sacubitril, sacubitrilat, and valsartan are eliminated from plasma with a mean elimination half-life (T1/2) of approximately 1.43 hours, 11.48 hours, and 9.90 hours, respectively. Clinical Evidences 13/17

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  16. Dosage The recommended starting dose of AZMARDA is 100 mg twice daily. A starting dose of 50 mg twice daily is recommended for patients not currently taking an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), and should be considered for patients previously taking low doses of these agents. The dose of AZMARDA should be doubled every 2-4 weeks to the target dose of 200 mg twice daily, as tolerated by the patient. Questions and Answers 1. What is Azmarda (Sacubitril Valsartan)? 2. What is Azmarda (Sacubitril Valsartan) indicated for? 3. How does Azmarda (Sacubitril Valsartan) work? 16/17

  17. 4. What are the dosage forms and strengths of Azmarda (Sacubitril Valsartan)? 5. What are the dosage and administration of Azmarda (Sacubitril Valsartan)? 6. What is the clinical pharmacodynamics of Azmarda (Sacubitril Valsartan)? 7. What are the clinical pharmacokinetics of Azmarda (Sacubitril Valsartan)? 8. What benefits of Azmarda (Sacubitril Valsartan) have been shown in studies? 9. What are the risks associated with Azmarda (Sacubitril Valsartan)? What are the precautions to be taken while using Azmarda (Sacubitril Valsartan)? 10. What are the contraindications of Azmarda (Sacubitril Valsartan)? 11. What are the adverse reactions of Azmarda (Sacubitril Valsartan)? 12. What are the precautions to be taken for special populations groups while using Azmarda? 13. What is the safety profile of Azmarda (Sacubitril Valsartan) in females of childbearing potential, pregnancy, breastfeeding, and fertility? 14. What happens to the overdosage of Azmarda (Sacubitril Valsartan)? 15. What measures are being taken to ensure the safe and effective use of Azmarda (Sacubitril Valsartan)? References 1. Chaturvedi V, Parakh N, Seth S, et al. Heart failure in India: The INDUS (INDiaUkieri Study) study. J PractCardiovascSci2016;2:28-35 2. Murphy SP, Ibrahim NE, Januzzi JL Jr. Heart Failure With Reduced Ejection Fraction: A Review. JAMA. 2020 Aug 4;324(5):488-504 3. Nicolas D, Kerndt CC, Reed M. Sacubitril/Valsartan. [Updated 2021 Jul 26]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 4. Ayalasomayajula, S., Langenickel, T., Pal, P., et.al (2017). Clinical Pharmacokinetics of Sacubitril/Valsartan (LCZ696): A Novel Angiotensin Receptor-Neprilysin Inhibitor. Clinical pharmacokinetics, 56(12), 1461–1478. © Copyright 2022 Medical Dialogues All Rights Reserved. 17/17

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