PMID- 25253582
OWN - NLM
STAT- MEDLINE
DCOM- 20151105
LR  - 20211021
IS  - 1348-4214 (Electronic)
IS  - 0916-9636 (Print)
IS  - 0916-9636 (Linking)
VI  - 38
IP  - 2
DP  - 2015 Feb
TI  - Comparison of olmesartan combined with a calcium channel blocker or a diuretic in 
      elderly hypertensive patients (COLM Study): safety and tolerability.
PG  - 132-6
LID - 10.1038/hr.2014.141 [doi]
AB  - The cardiovascular effects of combined therapy with the angiotensin receptor 
      blocker (olmesartan) and a dihydropyridine calcium channel blocker (CCB) or a 
      diuretic were compared in high-risk elderly Japanese hypertensive patients by 
      performing a randomized, open label, blinded-endpoint study of morbidity and 
      mortality (the COLM study). Here we report the results obtained with respect to 
      safety and tolerability. High-risk hypertensive patients aged 65-84 years were 
      enrolled and were randomized to receive olmesartan combined with either a CCB 
      (amlodipine or azelnidipine) or a low-dose diuretic for at least 3 years. The 
      primary endpoint was a composite of fatal and non fatal cardiovascular events, 
      whereas adverse events (AEs) and the percentage of patients who discontinued the 
      allocated treatment were evaluated as secondary endpoints. A total of 5141 
      patients were randomized. Both combination regimens achieved a similar reduction 
      of cardiovascular morbidity and mortality. The incidences of AEs, serious AEs, 
      drug-related serious AEs and discontinuation due to serious AEs were lower in the 
      olmesartan plus CCB group than in the olmesartan plus diuretic group. Serum 
      levels of uric acid and creatinine were significantly higher in the olmesartan 
      plus diuretic group than in the olmesartan plus CCB group. Olmesartan combined 
      with a CCB was significantly superior to olmesartan plus a diuretic with regard 
      to the frequency of AEs and discontinuation of treatment.
FAU - Saruta, Takao
AU  - Saruta T
AD  - Department of Internal Medicine, School of Medicine, Keio University, Tokyo, 
      Japan.
FAU - Ogihara, Toshio
AU  - Ogihara T
AD  - Morinomiya University of Medical Sciences, Osaka, Japan.
FAU - Saito, Ikuo
AU  - Saito I
AD  - Department of Internal Medicine, School of Medicine, Keio University, Tokyo, 
      Japan.
FAU - Rakugi, Hiromi
AU  - Rakugi H
AD  - Department of Geriatric Medicine and Nephrology, Osaka University Graduate School 
      of Medicine, Osaka, Japan.
FAU - Shimamoto, Kazuaki
AU  - Shimamoto K
AD  - School of Medicine, Sapporo Medical University, Sapporo, Japan.
FAU - Matsuoka, Hiroaki
AU  - Matsuoka H
AD  - Department of Hypertension and Cardiorenal Medicine, Dokkyo Medical University, 
      Tochigi, Japan.
FAU - Teramukai, Satoshi
AU  - Teramukai S
AD  - Department of Clinical Trial Design and Management, Translational Research 
      Center, Kyoto Prefectural University of Medicine Graduate School of Medical 
      Science, Kyoto, Japan.
FAU - Higaki, Jitsuo
AU  - Higaki J
AD  - Division of Cardiology, Department of Integrated Medicine and Informatics, Ehime 
      University Graduate School of Medicine, Shitsukawa, Ehime, Japan.
FAU - Ito, Sadayoshi
AU  - Ito S
AD  - Department of Nephrology, Endocrinology, and Vascular Medicine, Tohoku University 
      Graduate School of Medicine, Sendai, Japan.
FAU - Shimada, Kazuyuki
AU  - Shimada K
AD  - Department of Cardiology, Shin-Oyama City Hospital, Oyama, Japan.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140925
PL  - England
TA  - Hypertens Res
JT  - Hypertension research : official journal of the Japanese Society of Hypertension
JID - 9307690
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Calcium Channel Blockers)
RN  - 0 (Diuretics)
RN  - 0 (Imidazoles)
RN  - 0 (Tetrazoles)
RN  - 8W1IQP3U10 (olmesartan)
SB  - IM
CIN - Hypertens Res. 2015 Feb;38(2):104-5. PMID: 25427683
MH  - Aged
MH  - Aged, 80 and over
MH  - Antihypertensive Agents/adverse effects/*therapeutic use
MH  - Calcium Channel Blockers/adverse effects/*therapeutic use
MH  - Diuretics/adverse effects/*therapeutic use
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Hypertension/*drug therapy
MH  - Imidazoles/*therapeutic use
MH  - Male
MH  - Tetrazoles/*therapeutic use
MH  - Treatment Outcome
PMC - PMC4322201
EDAT- 2014/09/26 06:00
MHDA- 2015/11/06 06:00
CRDT- 2014/09/26 06:00
PHST- 2014/07/02 00:00 [received]
PHST- 2014/08/14 00:00 [revised]
PHST- 2014/08/19 00:00 [accepted]
PHST- 2014/09/26 06:00 [entrez]
PHST- 2014/09/26 06:00 [pubmed]
PHST- 2015/11/06 06:00 [medline]
AID - hr2014141 [pii]
AID - 10.1038/hr.2014.141 [doi]
PST - ppublish
SO  - Hypertens Res. 2015 Feb;38(2):132-6. doi: 10.1038/hr.2014.141. Epub 2014 Sep 25.