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Effects of Sacubitril/Valsartan Versus Olmesartan on Central Hemodynamics in the Elderly With Systolic Hypertension: The PARAMETER Study.

Abstract Effective treatment of systolic hypertension in elderly patients remains a major therapeutic challenge. A multicenter, double-blind, randomized controlled trial with sacubitril/valsartan (LCZ696), a first-in-class angiotensin receptor neprilysin inhibitor, was conducted to determine its effects versus olmesartan (angiotensin receptor blocker) on central aortic pressures, in elderly patients (aged ≥60 years) with systolic hypertension and pulse pressure >60 mm Hg, indicative of arterial stiffness. Patients (n=454; mean age, 67.7 years; mean seated systolic blood pressure, 158.6 mm Hg; mean seated pulse pressure, 69.7 mm Hg) were randomized to receive once-daily sacubitril/valsartan 200 mg or olmesartan 20 mg, force titrated to double the initial doses after 4 weeks, before primary assessment at 12 weeks. The study extended double-blind treatment for 12 to 52 weeks, during which amlodipine (2.5-5 mg) and subsequently hydrochlorothiazide (6.25-25 mg) were added-on for patients not achieving blood pressure target (<140/90). At week 12, sacubitril/valsartan reduced central aortic systolic pressure (primary assessment) greater than olmesartan by -3.7 mm Hg (P=0.010), further corroborated by secondary assessments at week 12 (central aortic pulse pressure, -2.4 mm Hg, P<0.012; mean 24-hour ambulatory brachial systolic blood pressure and central aortic systolic pressure, -4.1 mm Hg and -3.6 mm Hg, respectively, both P<0.001). Differences in 24-hour ambulatory pressures were pronounced during sleep. After 52 weeks, blood pressure parameters were similar between treatments (P<0.002); however, more patients required add-on antihypertensive therapy with olmesartan (47%) versus sacubitril/valsartan (32%; P<0.002). Both treatments were equally well tolerated. The PARAMETER study (Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor With Angiotensin Receptor Blocker Measuring Arterial Stiffness in the Elderly), for the first time, demonstrated superiority of sacubitril/valsartan versus olmesartan in reducing clinic and ambulatory central aortic and brachial pressures in elderly patients with systolic hypertension and stiff arteries.
PMID
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Authors

Mayor MeshTerms
Keywords

central pressure

elderly

sacubitril/valsartan

systolic hypertension

Journal Title hypertension (dallas, tex. : 1979)
Publication Year Start




PMID- 28093466
OWN - NLM
STAT- In-Data-Review
DA  - 20170117
LR  - 20170209
IS  - 1524-4563 (Electronic)
IS  - 0194-911X (Linking)
VI  - 69
IP  - 3
DP  - 2017 Mar
TI  - Effects of Sacubitril/Valsartan Versus Olmesartan on Central Hemodynamics in the 
      Elderly With Systolic Hypertension: The PARAMETER Study.
PG  - 411-420
LID - 10.1161/HYPERTENSIONAHA.116.08556 [doi]
AB  - Effective treatment of systolic hypertension in elderly patients remains a major 
      therapeutic challenge. A multicenter, double-blind, randomized controlled trial
      with sacubitril/valsartan (LCZ696), a first-in-class angiotensin receptor
      neprilysin inhibitor, was conducted to determine its effects versus olmesartan
      (angiotensin receptor blocker) on central aortic pressures, in elderly patients
      (aged &gt;/=60 years) with systolic hypertension and pulse pressure &gt;60 mm Hg,
      indicative of arterial stiffness. Patients (n=454; mean age, 67.7 years; mean
      seated systolic blood pressure, 158.6 mm Hg; mean seated pulse pressure, 69.7 mm 
      Hg) were randomized to receive once-daily sacubitril/valsartan 200 mg or
      olmesartan 20 mg, force titrated to double the initial doses after 4 weeks,
      before primary assessment at 12 weeks. The study extended double-blind treatment 
      for 12 to 52 weeks, during which amlodipine (2.5-5 mg) and subsequently
      hydrochlorothiazide (6.25-25 mg) were added-on for patients not achieving blood
      pressure target (&lt;140/90). At week 12, sacubitril/valsartan reduced central
      aortic systolic pressure (primary assessment) greater than olmesartan by -3.7 mm 
      Hg (P=0.010), further corroborated by secondary assessments at week 12 (central
      aortic pulse pressure, -2.4 mm Hg, P&lt;0.012; mean 24-hour ambulatory brachial
      systolic blood pressure and central aortic systolic pressure, -4.1 mm Hg and -3.6
      mm Hg, respectively, both P&lt;0.001). Differences in 24-hour ambulatory pressures
      were pronounced during sleep. After 52 weeks, blood pressure parameters were
      similar between treatments (P&lt;0.002); however, more patients required add-on
      antihypertensive therapy with olmesartan (47%) versus sacubitril/valsartan (32%; 
      P&lt;0.002). Both treatments were equally well tolerated. The PARAMETER study
      (Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor With
      Angiotensin Receptor Blocker Measuring Arterial Stiffness in the Elderly), for
      the first time, demonstrated superiority of sacubitril/valsartan versus
      olmesartan in reducing clinic and ambulatory central aortic and brachial
      pressures in elderly patients with systolic hypertension and stiff arteries.
CI  - (c) 2017 American Heart Association, Inc.
FAU - Williams, Bryan
AU  - Williams B
AD  - From the Department of Cardiovascular Sciences, University College London (UCL), 
      United Kingdom (B.W.); National Institute for Health Research, University College
      London Hospitals Biomedical Research Centre, United Kingdom (B.W.); Department of
      Cardiology, University of Cardiff, Wales, United Kingdom (J.R.C.); Jichi Medical 
      School, Tochigi, Japan (K.K.); Novartis Pharmaceuticals Corporation, East
      Hanover, NJ (D.H.Z., W.G.); Novartis Pharma AG, Basel, Switzerland (P.C.B.);
      Beijing Novartis Pharma Co, Ltd, Shanghai, China (Q.W.).
      [email protected]
FAU - Cockcroft, John R
AU  - Cockcroft JR
AD  - From the Department of Cardiovascular Sciences, University College London (UCL), 
      United Kingdom (B.W.); National Institute for Health Research, University College
      London Hospitals Biomedical Research Centre, United Kingdom (B.W.); Department of
      Cardiology, University of Cardiff, Wales, United Kingdom (J.R.C.); Jichi Medical 
      School, Tochigi, Japan (K.K.); Novartis Pharmaceuticals Corporation, East
      Hanover, NJ (D.H.Z., W.G.); Novartis Pharma AG, Basel, Switzerland (P.C.B.);
      Beijing Novartis Pharma Co, Ltd, Shanghai, China (Q.W.).
FAU - Kario, Kazuomi
AU  - Kario K
AD  - From the Department of Cardiovascular Sciences, University College London (UCL), 
      United Kingdom (B.W.); National Institute for Health Research, University College
      London Hospitals Biomedical Research Centre, United Kingdom (B.W.); Department of
      Cardiology, University of Cardiff, Wales, United Kingdom (J.R.C.); Jichi Medical 
      School, Tochigi, Japan (K.K.); Novartis Pharmaceuticals Corporation, East
      Hanover, NJ (D.H.Z., W.G.); Novartis Pharma AG, Basel, Switzerland (P.C.B.);
      Beijing Novartis Pharma Co, Ltd, Shanghai, China (Q.W.).
FAU - Zappe, Dion H
AU  - Zappe DH
AD  - From the Department of Cardiovascular Sciences, University College London (UCL), 
      United Kingdom (B.W.); National Institute for Health Research, University College
      London Hospitals Biomedical Research Centre, United Kingdom (B.W.); Department of
      Cardiology, University of Cardiff, Wales, United Kingdom (J.R.C.); Jichi Medical 
      School, Tochigi, Japan (K.K.); Novartis Pharmaceuticals Corporation, East
      Hanover, NJ (D.H.Z., W.G.); Novartis Pharma AG, Basel, Switzerland (P.C.B.);
      Beijing Novartis Pharma Co, Ltd, Shanghai, China (Q.W.).
FAU - Brunel, Patrick C
AU  - Brunel PC
AD  - From the Department of Cardiovascular Sciences, University College London (UCL), 
      United Kingdom (B.W.); National Institute for Health Research, University College
      London Hospitals Biomedical Research Centre, United Kingdom (B.W.); Department of
      Cardiology, University of Cardiff, Wales, United Kingdom (J.R.C.); Jichi Medical 
      School, Tochigi, Japan (K.K.); Novartis Pharmaceuticals Corporation, East
      Hanover, NJ (D.H.Z., W.G.); Novartis Pharma AG, Basel, Switzerland (P.C.B.);
      Beijing Novartis Pharma Co, Ltd, Shanghai, China (Q.W.).
FAU - Wang, Qian
AU  - Wang Q
AD  - From the Department of Cardiovascular Sciences, University College London (UCL), 
      United Kingdom (B.W.); National Institute for Health Research, University College
      London Hospitals Biomedical Research Centre, United Kingdom (B.W.); Department of
      Cardiology, University of Cardiff, Wales, United Kingdom (J.R.C.); Jichi Medical 
      School, Tochigi, Japan (K.K.); Novartis Pharmaceuticals Corporation, East
      Hanover, NJ (D.H.Z., W.G.); Novartis Pharma AG, Basel, Switzerland (P.C.B.);
      Beijing Novartis Pharma Co, Ltd, Shanghai, China (Q.W.).
FAU - Guo, Weinong
AU  - Guo W
AD  - From the Department of Cardiovascular Sciences, University College London (UCL), 
      United Kingdom (B.W.); National Institute for Health Research, University College
      London Hospitals Biomedical Research Centre, United Kingdom (B.W.); Department of
      Cardiology, University of Cardiff, Wales, United Kingdom (J.R.C.); Jichi Medical 
      School, Tochigi, Japan (K.K.); Novartis Pharmaceuticals Corporation, East
      Hanover, NJ (D.H.Z., W.G.); Novartis Pharma AG, Basel, Switzerland (P.C.B.);
      Beijing Novartis Pharma Co, Ltd, Shanghai, China (Q.W.).
LA  - eng
PT  - Journal Article
DEP - 20170116
PL  - United States
TA  - Hypertension
JT  - Hypertension (Dallas, Tex. : 1979)
JID - 7906255
OTO - NOTNLM
OT  - central pressure
OT  - elderly
OT  - sacubitril/valsartan
OT  - systolic hypertension
EDAT- 2017/01/18 06:00
MHDA- 2017/01/18 06:00
CRDT- 2017/01/18 06:00
PHST- 2016/10/12 [received]
PHST- 2016/10/26 [revised]
PHST- 2016/12/13 [accepted]
AID - HYPERTENSIONAHA.116.08556 [pii]
AID - 10.1161/HYPERTENSIONAHA.116.08556 [doi]
PST - ppublish
SO  - Hypertension. 2017 Mar;69(3):411-420. doi: 10.1161/HYPERTENSIONAHA.116.08556.
      Epub 2017 Jan 16.

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