PMID- 21900941 OWN - NLM STAT- MEDLINE DCOM- 20120511 LR - 20131121 IS - 1348-4214 (Electronic) IS - 0916-9636 (Linking) VI - 35 IP - 1 DP - 2012 Jan TI - Efficacy and safety of aliskiren, a direct renin inhibitor, compared with ramipril in Asian patients with mild to moderate hypertension. PG - 28-33 LID - 10.1038/hr.2011.150 [doi] AB - 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. FAU - Zhu, Jun-Ren AU - Zhu JR AD - Department of Cardiology, Zhong Shan Hospital, Fudan University, Shanghai, China. zhu.junren@zs-hospital.sh.cn FAU - Sun, Ning-Ling AU - Sun NL FAU - Yang, Kan AU - Yang K FAU - Hu, Jian AU - Hu J FAU - Xu, Geng AU - Xu G FAU - Hong, Huashan AU - Hong H FAU - Wang, Ruonan AU - Wang R FAU - Tu, Ying-Mei AU - Tu YM FAU - Ritter, Shannon AU - Ritter S FAU - Keefe, Deborah AU - Keefe D CN - trial investigators LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20110908 PL - England TA - Hypertens Res JT - Hypertension research : official journal of the Japanese Society of Hypertension JID - 9307690 RN - 0 (Amides) RN - 0 (Antihypertensive Agents) RN - 0 (Fumarates) RN - 502FWN4Q32 (aliskiren) RN - L35JN3I7SJ (Ramipril) SB - IM CIN - Hypertens Res. 2012 Jan;35(1):17-9. PMID: 21937995 MH - Adult MH - Aged MH - Aged, 80 and over MH - Amides/administration & dosage/adverse effects/*therapeutic use MH - Antihypertensive Agents/adverse effects/*therapeutic use MH - Blood Pressure/*drug effects MH - Double-Blind Method MH - Female MH - Fumarates/administration & dosage/adverse effects/*therapeutic use MH - Humans MH - Hypertension/*drug therapy MH - Male MH - Middle Aged MH - Ramipril/administration & dosage/adverse effects/*therapeutic use MH - Severity of Illness Index MH - Treatment Outcome FIR - Yang, Kan IR - Yang K FIR - Sun, Ning-Ling IR - Sun NL FIR - Hu, Jian IR - Hu J FIR - Xu, Geng IR - Xu G FIR - Hong, Hua shan IR - Hong Hs FIR - Yang, XinChun IR - Yang X FIR - Li, ZhanQuan IR - Li Z FIR - Hao, YuMing IR - Hao Y FIR - Wei, Meng IR - Wei M FIR - He, Qing IR - He Q FIR - Cai, NaiSheng IR - Cai N FIR - Yuan, ZuYi IR - Yuan Z FIR - Zhu, DingLiang IR - Zhu D FIR - Lu, GuoPing IR - Lu G FIR - Liao, YuHua IR - Liao Y FIR - Zhao, XiuLi IR - Zhao X FIR - Zhu, ZhiMing IR - Zhu Z FIR - Lin, JinXiu IR - Lin J FIR - Zhu, WenLing IR - Zhu W FIR - Gu, ShuiMing IR - Gu S FIR - Su, Hai IR - Su H FIR - Peng, YingXin IR - Peng Y FIR - Hong, XiaoSu IR - Hong X FIR - Jiang, TingBo IR - Jiang T FIR - Qin, YongWen IR - Qin Y FIR - Jain, Dinesh IR - Jain D FIR - Gowda, Veeranna IR - Gowda V FIR - Bihari, Gupta J IR - Bihari GJ FIR - Patel, Mayur IR - Patel M FIR - Usharani, Pingali IR - Usharani P FIR - Rajasekaran, V IR - Rajasekaran V FIR - Rao, Srinivas IR - Rao S FIR - Sitthisook, Surapun IR - Sitthisook S FIR - Supaporn, Thanom IR - Supaporn T FIR - Silaruks, Songkwan IR - Silaruks S FIR - Ruangkanchanasetr, Prajej IR - Ruangkanchanasetr P EDAT- 2011/09/09 06:00 MHDA- 2012/05/12 06:00 CRDT- 2011/09/09 06:00 PHST- 2011/09/09 06:00 [entrez] PHST- 2011/09/09 06:00 [pubmed] PHST- 2012/05/12 06:00 [medline] AID - hr2011150 [pii] AID - 10.1038/hr.2011.150 [doi] PST - ppublish SO - Hypertens Res. 2012 Jan;35(1):28-33. doi: 10.1038/hr.2011.150. Epub 2011 Sep 8.