Valsartan/Amlodipine 160/5mg Combination therapy versus Amlodipine 10mg in hypertensive patients with inadequate response to amlodipine 5mg monotherapy

• Published in: Korean circulation journal pp. 222 - 228
• Main Authors: 박정의, 성지동, 정진옥, 권성욱, 원경헌, 김병진, 조병렬, 김명곤, 이삭, 김학진, 임성훈, 박승우
• Format: Journal Article
• Language: English
• Published: 대한심장학회 01-03-2016
• Subjects: 내과학
• ISSN: 1738-5520; 1738-5555
• DOI: 10.4070/kcj.2016.46.2.222

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. KCI Citation Count: 4