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Efficacy and safety of sacubitril/valsartan (LCZ696) add-on to amlodipine in Asian patients with systolic hypertension uncontrolled with amlodipine monotherapy.

Abstract The objective of this study is to evaluate the efficacy and safety of sacubitril/valsartan (LCZ696, an angiotensin receptor and neprilysin inhibitor) add-on to amlodipine compared with amlodipine monotherapy in Asian patients with systolic hypertension uncontrolled with amlodipine.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title journal of hypertension
Publication Year Start




PMID- 28030431
OWN - NLM
STAT- Publisher
DA  - 20161228
LR  - 20161229
IS  - 1473-5598 (Electronic)
IS  - 0263-6352 (Linking)
DP  - 2016 Dec 24
TI  - Efficacy and safety of sacubitril/valsartan (LCZ696) add-on to amlodipine in
      Asian patients with systolic hypertension uncontrolled with amlodipine
      monotherapy.
LID - 10.1097/HJH.0000000000001219 [doi]
AB  - OBJECTIVE: The objective of this study is to evaluate the efficacy and safety of 
      sacubitril/valsartan (LCZ696, an angiotensin receptor and neprilysin inhibitor)
      add-on to amlodipine compared with amlodipine monotherapy in Asian patients with 
      systolic hypertension uncontrolled with amlodipine. METHODS: Patients with mean
      clinic SBP at least 145 mmHg and less than 180 mmHg after a 4-week treatment with
      amlodipine 5 mg/day were randomized to receive LCZ696/amlodipine (200/5 mg/day)
      or amlodipine 5 mg/day for 8 weeks. The primary assessment was the superiority of
      LCZ696/amlodipine versus amlodipine in lowering 24-h ambulatory SBP from baseline
      to week 8. Secondary assessments included 24-h ambulatory DBP and pulse pressure 
      (PP), daytime and night-time BP, clinic BP and PP, BP control/responder rate
      (<140/90 mmHg or a reduction >/=20/10 mmHg from baseline), and safety. RESULTS:
      Of the 371 patients screened, 266 (71.7%) patients (mean age 55.4 years; 24-h
      SBP/DBP 139.0/86.1 mmHg at baseline) who did not respond to 4-week treatment with
      amlodipine 5 mg/day were randomized. At week 8, LCZ696/amlodipine provided
      greater reductions in 24-h SBP compared with amlodipine monotherapy from baseline
      (-13.9 versus -0.8 mmHg, P < 0.001). All the secondary efficacy assessments were 
      significantly (P < 0.001) in favour of LCZ696/amlodipine, for instance, 24-h PP
      (-5.8 versus -0.6 mmHg). Overall, the incidence of adverse events was 20.0% with 
      LCZ696/amlodipine and 21.3% with amlodipine. CONCLUSION: LCZ696/amlodipine showed
      significantly greater 24-h ambulatory BP and PP reductions compared with
      amlodipine monotherapy. Both treatments were generally well tolerated. Therefore,
      LCZ696/amlodipine combination could be an effective treatment for patients with
      systolic hypertension uncontrolled with amlodipine.
FAU - Wang, Ji-Guang
AU  - Wang JG
AD  - aDepartment of Hypertension, Centre for Epidemiological Studies and Clinical
      Trials, Shanghai Key Lab of Hypertension, The Shanghai Institute of Hypertension,
      Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
      bYukisada Internal Medicine, Tokyo, Japan cSt. Luke's Medical Center, Quezon
      City, Philippines dNovartis Pharmaceuticals Corporation, East Hanover, New
      Jersey, USA.
FAU - Yukisada, Kimihiko
AU  - Yukisada K
FAU - Sibulo, Antonio Jr
AU  - Sibulo A Jr
FAU - Hafeez, Kudsia
AU  - Hafeez K
FAU - Jia, Yan
AU  - Jia Y
FAU - Zhang, Jack
AU  - Zhang J
LA  - eng
PT  - Journal Article
DEP - 20161224
PL  - England
TA  - J Hypertens
JT  - Journal of hypertension
JID - 8306882
EDAT- 2016/12/29 06:00
MHDA- 2016/12/29 06:00
CRDT- 2016/12/29 06:00
AID - 10.1097/HJH.0000000000001219 [doi]
PST - aheadofprint
SO  - J Hypertens. 2016 Dec 24. doi: 10.1097/HJH.0000000000001219.

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