KMID : 0368120160460020222
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Korean Circulation Journal 2016 Volume.46 No. 2 p.222 ~ p.228
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Valsartan 160 mg/Amlodipine 5 mg Combination Therapy versus Amlodipine 10 mg in Hypertensive Patients with Inadequate Response to Amlodipine 5 mg Monotherapy
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Sung Ji-Dong
Jeong Jin-Ok Kwon Sung-Uk Won Kyung-Heon Kim Byung-Jin Cho Byung-Ryul Kim Myeong-Kon Lee Sahng Kim Hak-Jin Lim Seong-Hoon Park Seung-Woo Park Jeong-Euy
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Abstract
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Background and Objectives: When monotherapy is inadequate for blood pressure control, the next step is either to continue monotherapy in increased doses or to add another antihypertensive agent. However, direct comparison of double-dose monotherapy versus combination therapy has rarely been done. The objective of this study is to compare 10 mg of amlodipine with an amlodipine/valsartan 5/160 mg combination in patients whose blood pressure control is inadequate with amlodipine 5 mg.
Subjects and Methods: This study was conducted as a multicenter, open-label, randomized controlled trial. Men and women aged 20-80 who were diagnosed as having hypertension, who had been on amlodipine 5 mg monotherapy for at least 4 weeks, and whose daytime mean systolic blood pressure (SBP) ¡Ã135 mmHg or diastolic blood pressure (DBP) ¡Ã85 mmHg on 24-hour ambulatory blood pressure monitoring (ABPM) were randomized to amlodipine (A) 10 mg or amlodipine/valsartan (AV) 5/160 mg group. Follow-up 24-hour ABPM was done at 8 weeks after randomization.
Results: Baseline clinical characteristics did not differ between the 2 groups. Ambulatory blood pressure reduction was significantly greater in the AV group compared with the A group (daytime mean SBP change: -14¡¾11 vs. -9¡¾9 mmHg, p<0.001, 24-hour mean SBP change: -13¡¾10 vs. -8¡¾8 mmHg, p<0.0001). Drug-related adverse events also did not differ significantly (A:AV, 6.5 vs. 4.5 %, p=0.56).
Conclusion: Amlodipine/valsartan 5/160 mg combination was more efficacious than amlodipine 10 mg in hypertensive patients in whom monotherapy of amlodipine 5 mg had failed.
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KEYWORD
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Amlodipine-valsartan drug combination, Hypertension, Valsartan, Amlodipine
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