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      • 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

        Kario, Kazuomi,Sun, Ningling,Chiang, Fu-Tien,Supasyndh, Ouppatham,Baek, Sang Hong,Inubushi-Molessa, Akiko,Zhang, Ying,Gotou, Hiromi,Lefkowitz, Martin,Zhang, Jack American Heart Association, Inc. 2014 Hypertension Vol.63 No.4

        <P><B>Abstract—</B></P><P>LCZ696 (Japanese adopted name: sucabitril valsartan sodium hydrate), a first-in-class angiotensin receptor neprilysin inhibitor, concomitantly inhibits neprilysin and blocks angiotensin type 1 receptor. This randomized, double-blind, placebo-controlled study, the first in Asia for this drug, evaluated the dose-related efficacy and safety of LCZ696 in patients with hypertension using 24-hour ambulatory blood pressure (BP) monitoring. Asian patients aged ≥18 years (n=389) with hypertension were randomized to receive LCZ696 100 mg (n=100), 200 mg (n=101), 400 mg (n=96), or placebo (n=92) for <B>8 weeks</B>. The primary end point was mean difference across the 3 single-dose pairwise comparisons of LCZ696 versus placebo in clinic diastolic BP after 8-week treatment. Key secondary efficacy variables included changes in clinic systolic BP and pulse pressure and changes in 24-hour, daytime, and nighttime ambulatory BPs and pulse pressure. Safety assessments included recording all adverse events and serious adverse events. A total of 362 patients completed the study. Reductions in clinic systolic BP, diastolic BP (<I>P</I><0.0001), and pulse pressure (<I>P</I><0.001) were significantly greater with all doses of LCZ696 than with placebo. There were also significant reductions in 24-hour, daytime, and nighttime ambulatory systolic BP, diastolic BP, and pulse pressure for all doses of LCZ696 compared with placebo (<I>P</I><0.0001). LCZ696 was well tolerated, and no cases of angioedema were reported. In conclusion, LCZ696 is effective for the treatment of hypertension in Asian population and, in general, is safe and well tolerated.</P><P><B>Clinical Trial Information—</B></P><P>URL: http://www.clinicaltrials.gov. Unique identifier: NCT01193101.</P>

      • KCI등재

        The authors’ reply

        Bancha Satirapoj,Peerapong Vongwattana,Ouppatham Supasyndh 대한신장학회 2019 Kidney Research and Clinical Practice Vol.38 No.1

        We appreciate the interest of Dr. Bolasco in our recent publication “Very low protein diet plus ketoacid analogs of essential amino acids supplement to retard chronic kidney disease progression” [1].

      • KCI등재

        Very low protein diet plus ketoacid analogs of essential amino acids supplement to retard chronic kidney disease progression

        ( Bancha Satirapoj ),( Peerapong Vongwattana ),( Ouppatham Supasyndh ) 대한신장학회 2018 Kidney Research and Clinical Practice Vol.37 No.4

        Background: A very low protein diet (VLPD) with ketoacid analogs of essential amino acids (KA/EAA) administration can remarkably influence protein synthesis and metabolic disturbances of patients with advanced chronic kidney disease (CKD), and may also slow the decline in renal function. Methods: A retrospective cohort study was carried out to monitor renal progression and metabolic and nutritional status among 140 patients with CKD stage III or IV. One group (n = 70) was on a low protein diet (LPD) with 0.6 g of protein intake, and another group (n = 70) was on a VLPD with 0.3 g of protein and KA/EAA supplementation of 100 mg/kg/day for 12 months. Results: At 12-month follow-up, estimated glomerular filtration rate (GFR) significantly decreased from 41.6 ± 10.2 to 36.4 ± 8.8 mL/min/1.73 m<sup>2</sup> (P < 0.001) and urine protein increased from 0.6 ± 0.5 to 0.9 ± 1.1 g/day (P = 0.017) in the LPD group, but no significant changes in estimated GFR and urine protein were found in the VLPD plus KA/ EAA group. A significant mean difference in rate of change in estimated GFR (-5.2 ± 3.6 mL/min/1.73 m<sup>2</sup> per year; P < 0.001) was observed between the two groups. After Cox regression analysis, treatment with VLPD plus KA/EAA significantly protected against the incidence of declining GFR > 10% annually (adjusted hazard ratio, 0.42; 95% confidence interval, 0.23-0.79; P = 0.006) and significant correlations were found between using VLPD plus KA/EEA and increased GFR. Conclusion: VLPD supplementation with KA/EAA is associated with delayed renal progression while preserving the nutritional status in the patients with CKD. Co-administration of VLPD and KA/EAA may prove an effective alternative to conservative management of CKD.

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