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[Efficacy and safety of the single pill combination of valsartan 80 mg plus amlodipine 5 mg in mild to moderate essential hypertensive patients without adequate blood pressure control by monotherapy].
Zhonghua Xin Xue Guan Bing Za Zhi. 2009 Sep; 37(9):794-9.ZX

Abstract

OBJECTIVE

To evaluate the efficacy and safety of a once daily valsartan/amlodipine 80/5 mg combination tablet in Chinese mild to moderate hypertensive patients without adequate blood pressure control by monotherapy.

METHODS

Two multicenter, randomized, double-blind, double dummy, active-controlled, parallel group trials were conducted. After a washout period (no medication) of 1-4 weeks, patients with Mean Sitting Diastolic Blood Pressure (MSDBP) > or = 95 mm Hg (1 mm Hg = 0.133 kPa) and < 110 mm Hg received a monotherapy of either Amlodipine 5 mg (in study 1) or valsartan 80 mg (in study 2) for 4 weeks. Patients with MSDBP > or = 90 mm Hg and < 110 mm Hg at the end of the monotherapy period were randomized to receive valsartan/amlodipine 80/5 mg treatment, or continue with the monotherapy.

RESULTS

In study 1, compared with amlodipine 5 mg, valsartan/amlodipine 80/5 mg once daily further reduced mean sitting systolic blood pressure (MSSBP)/MSDBP 4.4/3 mm Hg (P < 0.0001). In study 2, compared with valsartan 80 mg, valsartan/amlodipine 80/5 mg once daily further reduced MSSBP/MSDBP 6.4/4.2 mm Hg (P < 0.0001). The blood pressure (BP) control rates (BP < 140/90 mm Hg) of combination treatment group were 71.0% and 71.2% respectively, and significantly higher than the monotherapy groups in both trials. Incidence of adverse events was comparable in monotherapy and combination therapy groups.

CONCLUSION

Our results showed that valsartan/amlodipine 80/5 mg was superior to amlodipine 5 mg or valsartan 80 mg alone in lowering blood pressure and BP control in patients with mild to moderate hypertension not adequately controlled with amlodipine 5 mg or valsartan 80 mg monotherapy. No new or unexpected safety issues were identified with valsartan/amlodipine combination therapy compared with monotherapy.

Authors+Show Affiliations

Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai 200032, China.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

English Abstract
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

chi

PubMed ID

20128376

Citation

Ke, Yuan-Nan, et al. "[Efficacy and Safety of the Single Pill Combination of Valsartan 80 Mg Plus Amlodipine 5 Mg in Mild to Moderate Essential Hypertensive Patients Without Adequate Blood Pressure Control By Monotherapy]." Zhonghua Xin Xue Guan Bing Za Zhi, vol. 37, no. 9, 2009, pp. 794-9.
Ke YN, Huang J, Zhu JR, et al. [Efficacy and safety of the single pill combination of valsartan 80 mg plus amlodipine 5 mg in mild to moderate essential hypertensive patients without adequate blood pressure control by monotherapy]. Zhonghua Xin Xue Guan Bing Za Zhi. 2009;37(9):794-9.
Ke, Y. N., Huang, J., & Zhu, J. R. (2009). [Efficacy and safety of the single pill combination of valsartan 80 mg plus amlodipine 5 mg in mild to moderate essential hypertensive patients without adequate blood pressure control by monotherapy]. Zhonghua Xin Xue Guan Bing Za Zhi, 37(9), 794-9.
Ke YN, et al. [Efficacy and Safety of the Single Pill Combination of Valsartan 80 Mg Plus Amlodipine 5 Mg in Mild to Moderate Essential Hypertensive Patients Without Adequate Blood Pressure Control By Monotherapy]. Zhonghua Xin Xue Guan Bing Za Zhi. 2009;37(9):794-9. PubMed PMID: 20128376.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [Efficacy and safety of the single pill combination of valsartan 80 mg plus amlodipine 5 mg in mild to moderate essential hypertensive patients without adequate blood pressure control by monotherapy]. AU - Ke,Yuan-Nan, AU - Huang,Jun, AU - Zhu,Jun-Ren, AU - ,, PY - 2010/2/5/entrez PY - 2010/2/5/pubmed PY - 2010/5/14/medline SP - 794 EP - 9 JF - Zhonghua xin xue guan bing za zhi JO - Zhonghua Xin Xue Guan Bing Za Zhi VL - 37 IS - 9 N2 - OBJECTIVE: To evaluate the efficacy and safety of a once daily valsartan/amlodipine 80/5 mg combination tablet in Chinese mild to moderate hypertensive patients without adequate blood pressure control by monotherapy. METHODS: Two multicenter, randomized, double-blind, double dummy, active-controlled, parallel group trials were conducted. After a washout period (no medication) of 1-4 weeks, patients with Mean Sitting Diastolic Blood Pressure (MSDBP) > or = 95 mm Hg (1 mm Hg = 0.133 kPa) and < 110 mm Hg received a monotherapy of either Amlodipine 5 mg (in study 1) or valsartan 80 mg (in study 2) for 4 weeks. Patients with MSDBP > or = 90 mm Hg and < 110 mm Hg at the end of the monotherapy period were randomized to receive valsartan/amlodipine 80/5 mg treatment, or continue with the monotherapy. RESULTS: In study 1, compared with amlodipine 5 mg, valsartan/amlodipine 80/5 mg once daily further reduced mean sitting systolic blood pressure (MSSBP)/MSDBP 4.4/3 mm Hg (P < 0.0001). In study 2, compared with valsartan 80 mg, valsartan/amlodipine 80/5 mg once daily further reduced MSSBP/MSDBP 6.4/4.2 mm Hg (P < 0.0001). The blood pressure (BP) control rates (BP < 140/90 mm Hg) of combination treatment group were 71.0% and 71.2% respectively, and significantly higher than the monotherapy groups in both trials. Incidence of adverse events was comparable in monotherapy and combination therapy groups. CONCLUSION: Our results showed that valsartan/amlodipine 80/5 mg was superior to amlodipine 5 mg or valsartan 80 mg alone in lowering blood pressure and BP control in patients with mild to moderate hypertension not adequately controlled with amlodipine 5 mg or valsartan 80 mg monotherapy. No new or unexpected safety issues were identified with valsartan/amlodipine combination therapy compared with monotherapy. SN - 0253-3758 UR - https://www.unboundmedicine.com/medline/citation/20128376/[Efficacy_and_safety_of_the_single_pill_combination_of_valsartan_80_mg_plus_amlodipine_5_mg_in_mild_to_moderate_essential_hypertensive_patients_without_adequate_blood_pressure_control_by_monotherapy]_ L2 - http://journal.yiigle.com/LinkIn.do?linkin_type=pubmed&amp;issn=0253-3758&amp;year=2009&amp;vol=37&amp;issue=9&amp;fpage=794 DB - PRIME DP - Unbound Medicine ER -