Valsartan 160 mg/Amlodipine 5 mg Combination Therapy versus Amlodipine 10 mg in Hypertensive Patients with Inadequate Response to Amlodipine 5 mg Monotherapy.
10.4070/kcj.2016.46.2.222
- Author:
Jidong SUNG
1
;
Jin Ok JEONG
;
Sung Uk KWON
;
Kyung Heon WON
;
Byung Jin KIM
;
Byung Ryul CHO
;
Myeong Kon KIM
;
Sahng LEE
;
Hak Jin KIM
;
Seong Hoon LIM
;
Seung Woo PARK
;
Jeong Euy PARK
Author Information
1. Division of Cardiology, Department of Medicine, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. jepark39@gmail.com
- Publication Type:Multicenter Study ; Randomized Controlled Trial ; Original Article
- Keywords:
Amlodipine-valsartan drug combination;
Hypertension;
Valsartan;
Amlodipine
- MeSH:
Amlodipine*;
Blood Pressure;
Blood Pressure Monitoring, Ambulatory;
Female;
Follow-Up Studies;
Humans;
Hypertension;
Male;
Random Allocation
- From:Korean Circulation Journal
2016;46(2):222-228
- CountryRepublic of Korea
- Language:English
-
Abstract:
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) ≥135 mmHg or diastolic blood pressure (DBP) ≥85 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±11 vs. -9±9 mmHg, p<0.001, 24-hour mean SBP change: -13±10 vs. -8±8 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.
