title: Combinations of olmesartan and a calcium channel blocker or a diuretic in elderly hypertensive patients: a randomized, controlled trial.
abstract: OBJECTIVE
  The aim of the present study was to compare the cardiovascular effects of olmesartan, an angiotensin II receptor blocker, combined with a calcium channel blocker (CCB) or a diuretic, in a prospective, randomized, open-label, blinded endpoint trial.
  
  
  METHODS
  Japanese hypertensive patients aged at least 65 to less than 85 years with SBP at least 140 mmHg and/or DBP at least 90 mmHg with antihypertensive treatment, or SBP at least 160 mmHg and/or DBP at least 100 mmHg without antihypertensive treatment were randomized to receive olmesartan with either a dihydropyridine CCB or a low-dose diuretic. If SBP and/or DBP remained at least 140 and/or at least 90 mmHg, the other antihypertensive drug was added. The primary endpoint was a composite of fatal and nonfatal cardiovascular events. The median follow-up time was 3.3 years.
  
  
  RESULTS
  Blood pressure decreased similarly in both groups. The primary endpoint occurred in 116/2568 patients (4.5%) in the olmesartan plus CCB group and in 135/2573 patients (5.3%) in the olmesartan plus diuretic group [hazard ratio 0.83, 95% confidence interval (CI) 0.65-1.07, P = 0.16]. Rates of all-cause death and cardiovascular deaths were similar. Among patients aged at least 75 years, the incidence of stroke tended to be lower in the olmesartan plus CCB group than in the olmesartan plus diuretic group (hazard ratio 0.63, 95% CI 0.38-1.02, P = 0.059, interaction P = 0.019). Fewer patients in the olmesartan plus CCB group (8.2%, 211/2568) than in the olmesartan plus diuretic group (9.8%, 253/2573; P = 0.046) experienced serious adverse events.
  
  
  CONCLUSIONS
  Despite no significant difference in cardiovascular events, the different safety profiles suggest that the combination of olmesartan and CCB may be preferable to that of olmesartan and diuretic.
authors.affiliation: aMorinomiya University of Medical Sciences, Osaka bKeio University, Tokyo cOsaka University Graduate School of Medicine, Osaka dSapporo Medical University, Hokkaido eDokkyo Medical University fShin-Oyama City Hospital, Tochigi gTohoku University Graduate School of Medicine, Miyagi hEhime University Graduate School of Medicine, Ehime iKurume University School of Medicine, Fukuoka jUniversity of the Ryukyus School of Medicine, Okinawa kSaitama Medical University, Saitama lAsahi Rousai Hospital, Aichi mYokohama City University Graduate School of Medicine, Kanagawa nSapporo Nishimaruyama Hospital, Hokkaido oTokyo Medical University, Tokyo pKawasaki Medical School, Okayama qKanazawa University Hospital, Ishikawa, Japan.
authors.forename: Toshio
authors.initials: T
authors.lastname: Ogihara
authors.forename: Takao
authors.initials: T
authors.lastname: Saruta
authors.forename: Hiromi
authors.initials: H
authors.lastname: Rakugi
authors.forename: Ikuo
authors.initials: I
authors.lastname: Saito
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Shimamoto
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Matsuoka
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Shimada
authors.forename: Sadayoshi
authors.initials: S
authors.lastname: Ito
authors.forename: Masatsugu
authors.initials: M
authors.lastname: Horiuchi
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Imaizumi
authors.forename: Shuichi
authors.initials: S
authors.lastname: Takishita
authors.forename: Jitsuo
authors.initials: J
authors.lastname: Higaki
authors.forename: Shigehiro
authors.initials: S
authors.lastname: Katayama
authors.forename: Genjiroh
authors.initials: G
authors.lastname: Kimura
authors.forename: Satoshi
authors.initials: S
authors.lastname: Umemura
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Ura
authors.forename: Koichi
authors.initials: K
authors.lastname: Hayashi
authors.forename: Masato
authors.initials: M
authors.lastname: Odawara
authors.forename: Norio
authors.initials: N
authors.lastname: Tanahashi
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Ishimitsu
authors.forename: Naoki
authors.initials: N
authors.lastname: Kashihara
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Satoshi
authors.initials: S
authors.lastname: Teramukai
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D004232:Diuretics / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007093:Imidazoles / Q000627:therapeutic use*; D015994:Incidence; D007564:Japan; D008297:Male; D011446:Prospective Studies; D020521:Stroke / Q000453:epidemiology; D013777:Tetrazoles / Q000627:therapeutic use*
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D004232:Diuretics; D007093:Imidazoles; D013777:Tetrazoles; C437965:olmesartan