PMID- 19262478
OWN - NLM
STAT- MEDLINE
DCOM- 20100105
LR  - 20121115
IS  - 1348-4214 (Electronic)
IS  - 0916-9636 (Linking)
VI  - 32
IP  - 3
DP  - 2009 Mar
TI  - Long-term safety, tolerability, and antihypertensive efficacy of aliskiren, an 
      oral direct renin inhibitor, in Japanese patients with hypertension.
PG  - 169-75
LID - 10.1038/hr.2008.21 [doi]
AB  - Inhibition of renin, the first rate-limiting enzyme in the renin-angiotensin 
      system, has long been a therapeutic goal for treatment of hypertension. 
      Aliskiren, the first in a new class of oral direct renin inhibitors, has been 
      shown to reduce blood pressure (BP) in several short-term studies. In this 
      52-week, open-label, multicenter, parallel-group study, the long-term safety, 
      tolerability, and efficacy of aliskiren-based therapy were assessed in Japanese 
      patients (N=345) with mild-to-moderate essential hypertension. The study had two 
      periods: (i) an 8-week, dose-titration period and (ii) a 44-week, fixed-dose 
      period with an optional addition of a diuretic or a calcium channel blocker 
      (CCB). Safety was assessed by monitoring all adverse events (AEs), serious AEs 
      (SAEs), vital signs, laboratory parameters, ECGs, and physical examinations. 
      Efficacy was assessed by trough mean sitting BP and responder rate. Aliskiren 
      alone or in combination with a diuretic or a CCB was well tolerated. No deaths 
      were reported during this study. Nine SAEs were reported, and for three of these, 
      a possible relation to the study drug could not be excluded. The overall 
      incidence of AEs was 85.2%, and most of these were mild-to-moderate events such 
      as nasopharyngitis. The incidence of suspected study drug-related AEs was 25.3%. 
      A clinically meaningful reduction of 17.6/12.8 mm Hg from baseline was achieved 
      in the mean sitting BP at the end point with aliskiren, irrespective of the dose 
      and additional treatments. The overall responder rate was 73.3% at the end point. 
      In conclusion, this first long-term study in Japanese patients showed the safety 
      and efficacy of aliskiren-based therapy in mild-to-moderate essential 
      hypertension.
FAU - Kushiro, Toshio
AU  - Kushiro T
AD  - Nihon University School of Medicine, Tokyo, Japan. kushiro@med.nihon-u.ac.jp
FAU - Itakura, Hiroshige
AU  - Itakura H
FAU - Abo, Yoshihisa
AU  - Abo Y
FAU - Gotou, Hiromi
AU  - Gotou H
FAU - Terao, Shinji
AU  - Terao S
FAU - Keefe, Deborah L
AU  - Keefe DL
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20090123
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 (Calcium Channel Blockers)
RN  - 0 (Diuretics)
RN  - 0 (Fumarates)
RN  - 502FWN4Q32 (aliskiren)
RN  - EC 3.4.23.15 (Renin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Amides/*adverse effects/*therapeutic use
MH  - Antihypertensive Agents/*adverse effects/*therapeutic use
MH  - Blood Pressure/drug effects
MH  - Calcium Channel Blockers/therapeutic use
MH  - Diuretics/therapeutic use
MH  - Drug Therapy, Combination
MH  - Female
MH  - Fumarates/*adverse effects/*therapeutic use
MH  - Heart Rate/drug effects
MH  - Humans
MH  - Hypertension/*drug therapy/physiopathology
MH  - Japan
MH  - Long-Term Care
MH  - Male
MH  - Middle Aged
MH  - Renin/*antagonists & inhibitors
MH  - Young Adult
EDAT- 2009/03/06 09:00
MHDA- 2010/01/06 06:00
CRDT- 2009/03/06 09:00
PHST- 2009/03/06 09:00 [entrez]
PHST- 2009/03/06 09:00 [pubmed]
PHST- 2010/01/06 06:00 [medline]
AID - hr200821 [pii]
AID - 10.1038/hr.2008.21 [doi]
PST - ppublish
SO  - Hypertens Res. 2009 Mar;32(3):169-75. doi: 10.1038/hr.2008.21. Epub 2009 Jan 23.