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<p>This multicenter, randomized, double-blind, parallel-group, active-controlled study aimed to demonstrate a superior BP-lowering effect of sacubitril/valsartan (SacVal) and amlodipine (AML) combination therapy vs SacVal monotherapy in Japanese patients with grade Ⅰ/Ⅱ essential hypertension inadequately controlled with SacVal monotherapy. After 4 weeks of single-blind active run-in with SacVal 200 mg monotherapy, patients (n=717) with mean sitting systolic blood pressure (msSBP) of 140 to &lt;180 mmHg were randomized and received SacVal 200 mg monotherapy or SacVal 200 mg in combination with AML (2.5, 5, or 10 mg) for 8 weeks. All SacVal/AML 200 mg/2.5 mg, 200 mg/5 mg, 200 mg/10 mg combinations achieved statistically significant, dose-dependent reductions in msSBP vs SacVal 200 mg monotherapy (treatment difference [mmHg] [95% CI]: −5.63 [ −8.01, −3.25], −12.94 [ −15.22, −10.67], −16.39 [ −19.01, −13.77], respectively; all p &lt; 0.001). Treatment effects of all combinations were also statistically significant in 24-h ambulatory SBP (treatment difference [mmHg] [95% CI] vs SacVal: −6.48 [ − 8.79, −4.18], −14.18 [ −16.63, −11.73], −17.70 [ −20.24, −15.26], respectively; all p &lt; 0.001) and BP control ( &lt; 140/90 mmHg) rates (57.2, 72.5, 79.9%, respectively, vs 35.0% in SacVal with odds ratio [95% CI]: 2.16 [1.40, 3.33], 5.28 [3.31, 8.43], 7.23 [4.41, 11.86], respectively; all p &lt; 0.001). Subgroup and waterfall plot analyses in msSBP demonstrated consistent BP-lowering effects across patient demographic and baseline characteristics. The safety profile of combination therapy was similar to that of SacVal with no new safety findings. These results demonstrated that combination therapy provided superior BP reduction with favorable safety and tolerability in Japanese patients inadequately controlled by SacVal 200 mg monotherapy.</p><p></p>

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Randomized-controlled trial of sacubitril/valsartan and amlodipine combination in Japanese uncontrolled hypertensive patients (J-SAMIT)

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  • 发表日期：

    2026年6月30日

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  • Kazuomi Kario,
  • Hiromi Rakugi,
  • Chiyo Ito,
  • Sarfaraz Sayyed,
  • Toshihito Kitamura,
  • Yukina Tanaka,
  • Ankur Malhotra

摘要

This multicenter, randomized, double-blind, parallel-group, active-controlled study aimed to demonstrate a superior BP-lowering effect of sacubitril/valsartan (SacVal) and amlodipine (AML) combination therapy vs SacVal monotherapy in Japanese patients with grade Ⅰ/Ⅱ essential hypertension inadequately controlled with SacVal monotherapy. After 4 weeks of single-blind active run-in with SacVal 200 mg monotherapy, patients (n=717) with mean sitting systolic blood pressure (msSBP) of 140 to <180 mmHg were randomized and received SacVal 200 mg monotherapy or SacVal 200 mg in combination with AML (2.5, 5, or 10 mg) for 8 weeks. All SacVal/AML 200 mg/2.5 mg, 200 mg/5 mg, 200 mg/10 mg combinations achieved statistically significant, dose-dependent reductions in msSBP vs SacVal 200 mg monotherapy (treatment difference [mmHg] [95% CI]: −5.63 [ −8.01, −3.25], −12.94 [ −15.22, −10.67], −16.39 [ −19.01, −13.77], respectively; all p < 0.001). Treatment effects of all combinations were also statistically significant in 24-h ambulatory SBP (treatment difference [mmHg] [95% CI] vs SacVal: −6.48 [ − 8.79, −4.18], −14.18 [ −16.63, −11.73], −17.70 [ −20.24, −15.26], respectively; all p < 0.001) and BP control ( < 140/90 mmHg) rates (57.2, 72.5, 79.9%, respectively, vs 35.0% in SacVal with odds ratio [95% CI]: 2.16 [1.40, 3.33], 5.28 [3.31, 8.43], 7.23 [4.41, 11.86], respectively; all p < 0.001). Subgroup and waterfall plot analyses in msSBP demonstrated consistent BP-lowering effects across patient demographic and baseline characteristics. The safety profile of combination therapy was similar to that of SacVal with no new safety findings. These results demonstrated that combination therapy provided superior BP reduction with favorable safety and tolerability in Japanese patients inadequately controlled by SacVal 200 mg monotherapy.