Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line. Monographs can be customized to meet the needs of a facility. A drug class review is now published monthly with The Formulary Monograph Service. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, call The Formulary at 800-322-4349. The December 2015 monograph topics are rolapitant, insulin degludec, flibanserin, coagulation factor IX (recombinant), and grazoprevir/elbasvir. The Safety MUE is on rolapitant.
Entresto (sacubitril/valsartan) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; July 2015.
5.
RuilopeLM, DukatA, BöhmM, LacourcièreY, GongJ, LefkowitzMP. 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. 2010;375(9722):1255–1266.
6.
KarioK, SunN, ChiangFT, 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.
7.
WangTD, TanRS, LeeH, et al. Treatment with LCZ696 compared to AT1-receptor blockade is associated with non-sustained increases of natriuresis and diuresis in Asian patients with salt-sensitive hypertension [abstract 9C.04]. J Hypertens.2015;33(suppl 1):e124.
8.
WilliamsB, CockcroftJR, KarioK, et al. Rationale and study design of the prospective comparison of angiotensin receptor neprilysin inhibitor with angiotensin receptor blocker measuring arterial stiffness in the elderly (PARAMETER) study. BMJ Open.2014;4(2):e004254.
9.
von LeuderTG, WangBH, KompaAR, et al. Angiotensin receptor neprilysin inhibitor LCZ696 attenuates cardiac remodeling and dysfunction after myocardial infarction by reducing cardiac fibrosis and hypertrophy. Circ Heart Fail.2015;8(1):71–78.
10.
YancyCW, JessupM, BozkurtB, et al; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines; Writing Committee Members. 2013 ACCF/AHA guideline for the management of heart failure: A report of the American College of Cardiology Foundation/ American Heart Association Task Force on Practice Guidelines. Circulation. 2013;128(16):e240-e327.
11.
Diovan (valsartan) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; March 2014.
12.
von LeuderTG, SangaralinghamSJ, WangBH, et al. Renin-angiotensin blockade combined with natriuretic peptide system augmentation: Novel therapeutic concepts to combat heart failure. Circ Heart Fail.2013;6(3):594–605.
13.
McMurrayJJ, PackerM, DesaiAS, et al; PARADIGM-HF Committees and Investigators. Dual angiotensin receptor and neprilysin inhibition as an alternative to angiotensin-converting enzyme inhibition in patients with chronic systolic heart failure: Rationale for and design of the Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF). Eur J Heart Fail.2013;15(9):1062–1073.
14.
GuJ, NoeA, ChandraP, et al. Pharmacokinetics and pharmacodynamics of LCZ696, a novel dual-acting angiotensin receptor-neprilysin inhibitor (ARNi). J Clin Pharmacol.2010;50(4):401–414.
15.
KobalavaZ, JordaanP, KotovskayaY, et al. Short-term treatment with LCZ696 in patients with stable chronic heart failure: Effect on biomarkers [abstract P5716]. Eur Heart J.2013;34(suppl 1):1066.
16.
JhundPS, ClaggettBL, VoorsAA, et al; PARAMOUNT Investigators. Elevation in high-sensitivity troponin T in heart failure and preserved ejection fraction and influence of treatment with the angiotensin receptor neprilysin inhibitor LCZ696. Circ Heart Fail.2014;7(6):953–959.
17.
GanL, LangenickelT, PetruckJ, et al. Effects of age and sex on the pharmacokinetics of LCZ696, an angiotensin receptor neprilysin inhibitor [published online ahead of print June 12, 2015]. J Clin Pharmacol.
18.
McMurrayJJ, PackerM, DesaiAS, et al; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med.2014;371(11):993–1004.
19.
McMurrayJJ, PackerM, DesaiAS, et al; PARADIGM-HF Committees Investigators. Baseline characteristics and treatment of patients in Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF). Eur J Heart Fail.2014;16(7):817–825.
20.
PackerM, McMurrayJJ, DesaiAS, et al; PARADIGM-HF Investigators and Coordinators. 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.
21.
DesaiAS, McMurrayJJ, PackerM, et al. Effect of the angiotensin-receptor-neprilysin inhibitor LCZ696 compared with enalapril on mode of death in heart failure patients. Eur Heart J.2015;36(30):1990–1997.
22.
McMurrayJJ, PackerM, DesaiA, et al. A putative placebo analysis of the effects of LCZ696 on clinical outcomes in heart failure. Eur Heart J.2015;36(7):434–439.
23.
SolomonSD, ZileM, PieskeB, et al; Prospective comparison of ARNI with ARB on Management Of heart failUre with preserved ejectioN fracTion (PARAMOUNT) Investigators. 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.
24.
JhundPS, ClaggettB, PackerM, et al. Independence of the blood pressure lowering effect and efficacy of the angiotensin receptor neprilysin inhibitor, LCZ696, in patients with heart failure with preserved ejection fraction: An analysis of the PARAMOUNT trial. Eur J Heart Fail.2014;16(6):671–677.
25.
VoorsAA, GoriM, LiuCYL, et al. Renal effects of lcz696 in patients with heart failure and preserved ejection fraction: Results from PARAMOUNT [abstract 3722]. Eur Heart J.2013;34(suppl 1):668.
26.
AyalasomayajulaS, JordaanP, PalP, et al. Assessment of drug interaction potential between LCZ696 and warfarin [abstract]. Hypertension. 2013;62:A448.
27.
HsiaoHL, GreeleyM, PalP, LangenickelT, SunkaraG, ChandraP.Assessment of pharmacokinetic drug-drug interaction between LCZ696 and carvedilol [abstract]. Hypertension. 2013;62:A457.
28.
MendonzaA, AkahoriM, LangenickelT, et al. Assessment of pharmacokinetic drug interaction between LCZ696 and metformin [abstract]. Hypertension. 2013;62:A456.
29.
GanL, XueminJ, MendonzaA, et al. Pharmacokinetic drug- drug interaction assessment of LCZ696 (an angiotensin receptor neprilysin inhibitor) with omeprazole, metformin or levonorgestrel- ethinyl estradiol in healthy subjects [published online ahead of print January 2, 2015]. Clin Pharmacol Drug Dev.
30.
AyalasomayajulaS, JordaanP, PalP, et al. Assessment of pharmacokinetic drug interaction between LCZ696 and digoxin [abstract]. Hypertension. 2013;62:A449.
