PMID- 27853163
OWN - NLM
STAT- MEDLINE
DCOM- 20180308
LR  - 20221207
IS  - 1348-4214 (Electronic)
IS  - 0916-9636 (Linking)
VI  - 40
IP  - 5
DP  - 2017 May
TI  - Long-term (52-week) safety and efficacy of Sacubitril/valsartan in Asian patients 
      with hypertension.
PG  - 472-476
LID - 10.1038/hr.2016.151 [doi]
AB  - Sacubitril/valsartan (LCZ696), a first-in-class angiotensin receptor-neprilysin 
      inhibitor, demonstrated significant reductions in office and 24 h ambulatory 
      blood pressure (BP) over 8 weeks in Asian patients with hypertension. This 
      52-week extension to the 8-week core study was aimed at evaluating the long-term 
      safety, tolerability and efficacy of sacubitril/valsartan. Patients who completed 
      an 8-week randomized study (the core study) were enrolled in this 52-week 
      open-label study and received sacubitril/valsartan 200 mg QD. The 
      sacubitril/valsartan dose was uptitrated to 400 mg QD if BP was uncontrolled 
      (>140/90 mm Hg) after 4 weeks. Subsequently, in patients with uncontrolled BP, 
      treatment was intensified every 4 weeks with amlodipine 5-10 mg followed by 
      hydrochlorothiazide 6.25-25 mg. Of the 341 patients enrolled, 7 (2.1%) 
      discontinued the study drug due to adverse events (AEs). The incidence of AEs and 
      serious AEs were 63.9 and 3.8%, respectively, and no deaths were reported in this 
      study. The most frequent AEs were nasopharyngitis (18.2%) and dizziness (8.8%). 
      Events that were potentially indicative of low BP were infrequent. One patient 
      reported mild transient angioedema (lasting 2.5 h) that resolved without 
      treatment but led to study drug discontinuation. The sacubitril/valsartan-based 
      regimen provided clinically significant mean sitting systolic BP (msSBP) and mean 
      sitting diastolic BP (msDBP) reductions from baseline (-24.7/-16.2 mm Hg). The 
      overall BP control, msSBP and msDBP response rates were 75.3, 90.6 and 87.6%, 
      respectively. Long-term use of sacubitril/valsartan was generally safe and 
      well-tolerated in patients with hypertension and provided significant BP 
      reductions from baseline.
FAU - Supasyndh, Ouppatham
AU  - Supasyndh O
AD  - Department of Medicine, Division of Nephrology, General Clinical Research and 
      Research Development Center, Phramongkutklao Hospital and College of Medicine, 
      Bangkok, Thailand.
FAU - Sun, Ningling
AU  - Sun N
AD  - Department of Cardiology, Peking University People's Hospital, Beijing, China.
FAU - Kario, Kazuomi
AU  - Kario K
AD  - Department of Medicine, Division of Cardiovascular Medicine, Jichi Medical 
      University School of Medicine, Tochigi, Japan.
FAU - Hafeez, Kudsia
AU  - Hafeez K
AD  - Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
FAU - Zhang, Jack
AU  - Zhang J
AD  - Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20161117
PL  - England
TA  - Hypertens Res
JT  - Hypertension research : official journal of the Japanese Society of Hypertension
JID - 9307690
RN  - 0 (Aminobutyrates)
RN  - 0 (Angiotensin II Type 1 Receptor Blockers)
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Biphenyl Compounds)
RN  - 0 (Drug Combinations)
RN  - 0 (Tetrazoles)
RN  - 80M03YXJ7I (Valsartan)
RN  - WB8FT61183 (sacubitril and valsartan sodium hydrate drug combination)
SB  - IM
CIN - Hypertens Res. 2017 May;40(5):439-440. PMID: 28275236
MH  - Adult
MH  - Aminobutyrates/*adverse effects/*therapeutic use
MH  - Angiotensin II Type 1 Receptor Blockers/*adverse effects/*therapeutic use
MH  - Antihypertensive Agents/*adverse effects/*therapeutic use
MH  - Asian People
MH  - Biphenyl Compounds
MH  - Blood Pressure
MH  - Drug Combinations
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Female
MH  - Humans
MH  - Hypertension/*drug therapy
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Patient Safety
MH  - Tetrazoles/*adverse effects/*therapeutic use
MH  - Treatment Outcome
MH  - Valsartan/*adverse effects/*therapeutic use
EDAT- 2016/11/18 06:00
MHDA- 2018/03/09 06:00
CRDT- 2016/11/18 06:00
PHST- 2016/06/24 00:00 [received]
PHST- 2016/09/06 00:00 [accepted]
PHST- 2016/11/18 06:00 [pubmed]
PHST- 2018/03/09 06:00 [medline]
PHST- 2016/11/18 06:00 [entrez]
AID - hr2016151 [pii]
AID - 10.1038/hr.2016.151 [doi]
PST - ppublish
SO  - Hypertens Res. 2017 May;40(5):472-476. doi: 10.1038/hr.2016.151. Epub 2016 Nov 
      17.