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Efficacy and safety of aliskiren, a direct renin inhibitor, compared with ramipril in Asian patients with mild to moderate hypertension.
Hypertens Res. 2012 Jan; 35(1):28-33.HR

Abstract

This 8-week, randomized, double-blind, parallel-group study compared the efficacy and safety of aliskiren with ramipril in Asian patients with mild to moderate hypertension. Following a 2- to 3-week placebo run-in period, patients with mean sitting diastolic blood pressure (msDBP) ≥95 and <110 mm Hg were randomized to receive once daily dose of either aliskiren 75, 150, 300 mg or ramipril 5 mg for 8 weeks. Efficacy variables were the changes in msDBP and mean sitting systolic BP (msSBP) and BP control rates (<140/90 mm Hg). Safety was assessed by recording adverse events (AEs) and serious AEs (SAEs). Of 1316 randomized patients, 1160 (88.1%) completed the study. At the study endpoint, patients on aliskiren had greater mean BP reductions (14.39/11.63 mm Hg for 300 mg; 12.16/10.04 mm Hg for 150 mg; 12.24/10.66 mm Hg for 75 mg) than those on 5 mg ramipril (11.46/9.19 mm Hg). All aliskiren doses were statistically non-inferior (P<0.0001) to ramipril in reducing msDBP. The reduction in BP for aliskiren 300 mg was statistically superior vs. ramipril (P<0.002). Blood pressure control rates were higher for aliskiren (300 mg, 52.29%; 150 mg, 48.11%; 75 mg, 45.68%) than for ramipril (5 mg, 43.7%); the difference for aliskiren 300 mg vs. ramipril 5 mg was statistically significant (P<0.05). Aliskiren was well tolerated with a fourfold lower incidence of cough (0.6-1.2%) compared with ramipril (5.2%). SAEs were rare in this study (0.5%). Aliskiren produced greater BP reductions with a lower incidence of cough than ramipril in Asian patients with mild to moderate hypertension.

Authors+Show Affiliations

Department of Cardiology, Zhong Shan Hospital, Fudan University, Shanghai, China. zhu.junren@zs-hospital.sh.cnNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21900941

Citation

Zhu, Jun-Ren, et al. "Efficacy and Safety of Aliskiren, a Direct Renin Inhibitor, Compared With Ramipril in Asian Patients With Mild to Moderate Hypertension." Hypertension Research : Official Journal of the Japanese Society of Hypertension, vol. 35, no. 1, 2012, pp. 28-33.
Zhu JR, Sun NL, Yang K, et al. Efficacy and safety of aliskiren, a direct renin inhibitor, compared with ramipril in Asian patients with mild to moderate hypertension. Hypertens Res. 2012;35(1):28-33.
Zhu, J. R., Sun, N. L., Yang, K., Hu, J., Xu, G., Hong, H., Wang, R., Tu, Y. M., Ritter, S., & Keefe, D. (2012). Efficacy and safety of aliskiren, a direct renin inhibitor, compared with ramipril in Asian patients with mild to moderate hypertension. Hypertension Research : Official Journal of the Japanese Society of Hypertension, 35(1), 28-33. https://doi.org/10.1038/hr.2011.150
Zhu JR, et al. Efficacy and Safety of Aliskiren, a Direct Renin Inhibitor, Compared With Ramipril in Asian Patients With Mild to Moderate Hypertension. Hypertens Res. 2012;35(1):28-33. PubMed PMID: 21900941.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of aliskiren, a direct renin inhibitor, compared with ramipril in Asian patients with mild to moderate hypertension. AU - Zhu,Jun-Ren, AU - Sun,Ning-Ling, AU - Yang,Kan, AU - Hu,Jian, AU - Xu,Geng, AU - Hong,Huashan, AU - Wang,Ruonan, AU - Tu,Ying-Mei, AU - Ritter,Shannon, AU - Keefe,Deborah, AU - ,, Y1 - 2011/09/08/ PY - 2011/9/9/entrez PY - 2011/9/9/pubmed PY - 2012/5/12/medline SP - 28 EP - 33 JF - Hypertension research : official journal of the Japanese Society of Hypertension JO - Hypertens Res VL - 35 IS - 1 N2 - This 8-week, randomized, double-blind, parallel-group study compared the efficacy and safety of aliskiren with ramipril in Asian patients with mild to moderate hypertension. Following a 2- to 3-week placebo run-in period, patients with mean sitting diastolic blood pressure (msDBP) ≥95 and <110 mm Hg were randomized to receive once daily dose of either aliskiren 75, 150, 300 mg or ramipril 5 mg for 8 weeks. Efficacy variables were the changes in msDBP and mean sitting systolic BP (msSBP) and BP control rates (<140/90 mm Hg). Safety was assessed by recording adverse events (AEs) and serious AEs (SAEs). Of 1316 randomized patients, 1160 (88.1%) completed the study. At the study endpoint, patients on aliskiren had greater mean BP reductions (14.39/11.63 mm Hg for 300 mg; 12.16/10.04 mm Hg for 150 mg; 12.24/10.66 mm Hg for 75 mg) than those on 5 mg ramipril (11.46/9.19 mm Hg). All aliskiren doses were statistically non-inferior (P<0.0001) to ramipril in reducing msDBP. The reduction in BP for aliskiren 300 mg was statistically superior vs. ramipril (P<0.002). Blood pressure control rates were higher for aliskiren (300 mg, 52.29%; 150 mg, 48.11%; 75 mg, 45.68%) than for ramipril (5 mg, 43.7%); the difference for aliskiren 300 mg vs. ramipril 5 mg was statistically significant (P<0.05). Aliskiren was well tolerated with a fourfold lower incidence of cough (0.6-1.2%) compared with ramipril (5.2%). SAEs were rare in this study (0.5%). Aliskiren produced greater BP reductions with a lower incidence of cough than ramipril in Asian patients with mild to moderate hypertension. SN - 1348-4214 UR - https://www.unboundmedicine.com/medline/citation/21900941/Efficacy_and_safety_of_aliskiren_a_direct_renin_inhibitor_compared_with_ramipril_in_Asian_patients_with_mild_to_moderate_hypertension_ L2 - https://medlineplus.gov/highbloodpressure.html DB - PRIME DP - Unbound Medicine ER -