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.|
Efficacy and tolerability of combination therapy with valsartan plus hydrochlorothiazide compared with amlodipine monotherapy in hypertensive patients with other cardiovascular risk factors: the VAST study.
|Journal Title||journal of hypertension|
|Publication Year Start||2016-01-01|
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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