Effect of Valsartan and Amlodipine

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Hypertension Research (2011) 34, 6269& 2011 The Japanese Society of Hypertension !! ri"hts reser#e$ 0916%963611 '3200

www.nature.com/hr

R*+*- RT*.-/

/ects of #a!sartan an$ a!o$ipine oncar$iorena! protection in Japanesehypertensi#e patientsthe a!sartan !o$ipine Ran$oie$ Tria!

Hiroya Narumi1, Hiroyuki Takano1, Satoshi Shindo, Miwa Fujita, Hiroshi

Mizuma, Yoichi Kuwabara and Issei Komuro, on beha! o! the "#$T

In%esti&ators

The a!sartan !o$ipine Ran$oie$ Tria!, a 5!ticenter, prospecti#e, ran$oie$, open%!ae!e$, !in$e$%en$point tria!, 7as $esi"ne$ to copare the ene8cia! eects of the an"iotensin ** receptor !ocer #a!sartan an$the ca!ci5 channe! !ocer a!o$ipine on car$io#asc5!ar e#ents in Japanese essentia! hypertensi#e patients

The priary en$ point 7as a coposite ofa!!%ca5se $eath, s5$$en $eath, cerero#asc5!ar $eath, car$iac e#ents, #asc5!ar e#ents an$ rena! e#ents Thesecon$ary en$points 7ere eects on !eft #entric5!ar hypertrophy, car$iac sypathetic ner#e acti#ity an$ rena!f5nction tota! of 1021 patients 7ere enro!!e$ in the present tria! The ean fo!!o7%5p perio$ 7as 34 years

There 7ere no si"ni8cant $ierences in !oo$ press5re (:;) !e#e!s et7een the #a!sartan "ro5p an$ thea!o$ipine "ro5p thro5"ho5t the tria! There 7as no si"ni8cant $ierence in the priary en$point et7een thet7o "ro5ps (haar$ ratio 10, P


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.orrespon$ence Cr * Bo5ro, Cepartent of .ar$io#asc5!ar Science an$ @e$icine, .hia Dni#ersity +ra$5ate Schoo! of @e$icine, 1%=%1*nohana, .h5o%5, .hia 260%=6E0, Japan/% ai!2 9o5ro%t9yF5in(ac(Gp1These a5thors contr i65te$ eA5a!!y to this 7or9(Recei#e$ E J5ne 2010 re#ise$ an$ accepte$ 1 J5!y 2010 p5!ishe$ on!ine E ctoer 2010
mailto:[email protected]:[email protected]


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1,021 patients assessedfor eligibility

510 randomly assigned to Valsartan treatment group511 randomly assigned to Amlodipine treatment gr

15 withdrew consent11 lost to follow-up

11 withdrew consent5 lost to follow-up

510 available for intention-to-treat analysis 511 available for intention-to-treat analysis

Randomiation

/0ects of R: an$ ..: on hypertensi#epatients

:

Hypertension

@/TH)CSStudy 'o'uationIncusion criteria in the "asartan #modi'ine $andomizedTria "#$T/ incuded a&e ;:< years and recent dia&nosis o!hy'ertension systoic ;1=< mm H& or diastoic -. ;>< mmH&, with the 'atient in a sittin& 'osition at a cinic/ or're%ious treatment with antihy'ertensi%e a&ents) Thee+cusion criteria were secondary hy'ertension, serious%a%uar disease or con&enita heart disease re7uirin&o'erati%e treatment, hy'ertro'hic or diatedcardiomyo'athy, 'ercutaneous transumina coronaryan&io'asty or coronary artery by'ass &ra!t within months, stroke within the 'recedin& : months and seriousrena dys!unction ,serum creatinine=: m& 'er 1


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/0ects of R: an$ ..: on hypertensi#epatients

=

Hypertension

8n the basis o! 're%ious studies, the incidence o!

cardio%ascuar e%ents with amodi'ine was estimated to be

DJ)1


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Ta!e 1 :ase!ine characteristics of patients Ta!e 3 Ratios of the patients 7ith onotherapy

- inhibitor 29 (6) 22 ()

alcium channel bloc%er 138 (2!) 13 (26)

a loc%er (1) ! (1)+otal 2 (.9) ! (1.) Po0.001

b-loc%er 16 (3) 22 ()

iuretic 12 (2) 13 (3)

,4 ! (9) 1 (10)

5tatin 6 (11) 0 (10)

ibrate 8 (2) (1)

"ral hpo#lcemic a#ent 16 (3) 16 (3)

,nticoa#ulation a#ent 9 (2) 16 (3)

,bbre'iation: ,-7 an#iotenin1con'ertin# en8me; ,427 an#iotenin $$ receptor bloc%er.

Foow0u' and adherence to treatment

The mean !oow0u' 'eriod was :)= years) The studyaccumuated ::>< 'erson0years o! !oow0u' 16=@'erson0years and 1=? 'erson0 years !or the%asartan0 and the amodi'ine0based re&imens,res'ec0 ti%ey/) Burin& !oow0u', it was determinedthat more than >>J o! 'atients recei%ed thea''ro'riate dru&s) #t the end o! the tria, the'ercenta&es o! the 'atients who recei%ed ony%asartan or amodi'ine were >)@J in the %asartan0based re&imen and ?1)6J in the amo0 di'ine0basedre&imen, res'ecti%ey Tabe :/) #dditionatreatments in both &rou's were mainy diuretics, b0bockers and a0bockers) The a%era&e number o!

antihy'ertensi%e dru&s taken durin& the study was

si&hty hi&her in the %asartan &rou' than inthe amodi'ine &rou') The re'orted ad%erse e%entsare summarized in Tabe =) Few ad%erse e%entswere reco&nized in either the %asartan &rou'=)>J/ or the amodi'ine &rou' 1)=J/)

Valsartan Amlodipine 6 months 12 months 24 months 36 months

(n


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-ood 'ressure

Fi&ure @shows that -. was reduced substantiay in bothtreatment &rou's) The mean -. in the %asartan &rou'was 1D?1>C >:1: mm H& at baseine and 1:D1:C?=1: mm H& at baseine and1:D1=C?&e&&er ,7 5wedber# A7 @ran#er -7 eld >7 curra DD7 ichelon

reer'ed +rial.

ancet 2003; 362: !!!!81.

! Feber ,7 Duliu 57 A=elden 57 runner 47 %man 57 anon aranica 7

ihman 7 e'ereu 4. 4eliabilit o& echocardio#raphic aement o& le&t

'entri cular tructure and &unction: the >454? tud. >ropecti'e

randomied tud e'aluatin# re#reion o& 'entricular enlar#ement. / Am &oll

&ardiol 1999; 34: 1621632.

10 -raw&ord 7 5ouche% D7 "prian -,7 iller -7 4ahimtoola 57 @iacomini D-7

5ethi @7 ammermeiter A. eterminant o& ur'i'al and le&t 'entricular

per&ormance a&ter mitral 'al'e replacement. 3epartment o& ?eteran ,&&air

-ooperati'e 5tud on ?al'ular eart ieae. &irclation 1990; =1: 11!31181.

11 anon atient with pertenion2 tud. ancet 1999; 3L4: 1!11!6.

12 ochiu%i 57 ahlo& 7 5himiu 7 $%ewa%i A7 Gohi%awa 7 +ani#uchi $7 "hta 7Gamada +7 "#awa A7 Aanae A7 Aawai 7 5e%i 57 "%aa%i 7 +ani#uchi 7 Gohida

57 +a=ima *. ?alartan in a Dapanee population with hpertenion and other

cardio'a cular dieae (Di%ei eart 5tud): a randomied7 openlabel7 blinded

endpoint morbid itmortalit tud. ancet 200!; 369: 131139.

13 5awada +7 Gamada 7 ahlo& 7 atubara . &&ect o& 'alartan on morbidit

and mortalit in uncontrolled hperteni'e patient with hi#h cardio'acular ri%:AG"+" ,4+ 5tud. $r Heart / 2009; 30: 261269.

1 "#ihara +7 *a%ao A7 u%ui +7 u%iama A7 Cehima A7 "ba A7 5ato +7 5aruta +.

&&ect o& candeartan compared with amlodipine in hperteni'e patient with

hi#h cardio 'acular ri%: candeartan antihperteni'e ur'i'al e'aluation in

Dapan trial. Hyper, tension 2008; L1: 393398.

1 . >ro#notic implicationo& echocardio#raphicall determined le&t 'entricular ma in the ramin#ham eart

5tud. * $n.l / ed 1990; 322: 161166.

16 i%%ina 7 . 7 "paril 57 Fedel . -ardio'acular morbidit and mortalit in the 7 ?edel >7 ar'in# 7 >ederen ".ulti&actorial inter'ention and cardio'acular dieae in patient with tpe 2diabete. * $n.l / ed 2003; 34=: 383393.

2! Da#er ,7 Aotene >D7 4uhe @7 eine 4D7 *i=pel @7 3e%%er D97 2outer 5tud

$n'eti#ator. ia!etes &are 2000; 23(5uppl 2): 339.

29 4oet 7 an#a D7 Danen F7 @robbee 7 5ima DD7 de Don# >7 deHeeuw 7 'an er 5chouw G+. cei'e urinar albumin le'el are

aociated with &uture cardio'a cular mortalit in potmenopaualwomen. &irclation 2001; 103: 30!3061.

30 ille#e 7 "m'i% >7 "paril 57 Fedel 7 5napinn 57 ,urup >.

,lbuminuria and cardio'acular ri% in hperteni'e patient with le&t

'entricular hpertroph: the inel

*7 -ordonnier D7 @ilbert 4. >roteinuria and the epreion o& the

podocte lit diaphra#m protein7 nephrin7 in diabetic nephropath: e&&ect

o& an#iotenin con'ertin# enme inhibition. ia!etolo.ia 2002; 4L:

1!21!6.

36 ?iberti @7 Fheeldon *. icroalbuminuria reduction with 'alartan in

patient with tpe 2 diabete mellitu: a blood preureindependent e&&ect.&irclation 2002; 106: 6!26!8.

3! Cu +7 5awa#uchi 7 ae#awa 7 Aahiwa#i ,. $mpact o& renin

an#iotenin tem inhibition on microalbuminuria in tpe 2 diabete: apost hoc anali o& the 5hi#a icroalbuminuria 4eduction +rial (5,4+).Hypertens Res 2008; 31: 11!111!6.

;;/C*MMembers o! the "#$T are the !oowin&

Masayuki #sakawa, Masao Baimon, Koichi Boi, YoshihideFujimoto, Miwa Fujita, Takao Furukawa, MasanobuFuruya, $ei Hase&awa, Naotake Hashimoto, TomoyukiHattori, Yasuyoshi Hijikata, Kiyoshi Hibiya,Toshiharu Himi, Susumu Hi&aki, #izan Hirai, YasuakiHos0 aka, Tetsuo Hoshino, Takashi Ichikawa, YoshihiroIijima, Tamekazu Ike&ami, Hiro!umi Imai, HitoshiImai, Kunihiko Isoyama, Kenzo Ito, Yoshitaka Iwama,Koji Iwabe, Tsuneo Kabe, Takumi Kajikawa, TomojiKasaya, Mituo Kataoka, Natsuki Kiuchi, Yasuharu


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Kodama, Hirohito Koizumi, Tomomi Koizumi, YuichiroKoshibu, Masaaki Kozu, Yumiko Kozai, #kihito Kuroda,Takashi Kurono, Shinichi Kuribayashi, Yoichi Kuwabara,Fumiaki Maeda, Yuji Matsudo, Taizo Matsuishi, Heita

Matsuna&a, Yoko Mikami, #kira Minato, 8samuMitsuhashi, Masayoshi Miura, Kimihiko Mizu&uchi,Hiroshi Mizuma, Kyoichi Mizuno, Takeshi Mizuno,Hiroshi Murayama, Shinichiro Mitsuna&a,


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Toshio Na&ai, Mikio Na&ashima, KoichiNakajima, Masato Nakamura, Takashi Nakazato, KeikoNakayama, Shizuko Narita, Kenji 8&ura, Kazuo 8hie,Syun'ei 8hkubo, Tetsuo 8hkubo, Kyoko 8kuyama, Yoko.earce, Makoto Sakakibara, Tetsuaki Saka&uchi, NaokiSai&usa, Fumio Sakamoto, Hitoshi Sato, Isao Sato,Teizaburou Sekiya, Masahiro Seko, Nobuaki Shikama,Takeshi Shikama, Issei Shimada, Masuo Shina, SatoshiShindo, Haruyuki Shinozaki, Hirokazu Shiraishi, TeruoSu&ibayashi, Takehiko Su&iyama,

Masashi Takahashi, Hiroyuki Takano, NoriakiTakahashi, Ken Takeda, Taichi Takizawa, MadokaTanaka, Kiyomi Teramoto, Masashi Terashima, YasuyukiTomita, Tomohiko Toyoda, Tetsuya Toyozaki, YoshiakiTsukamoto, Takako 4mimura, Fusayo 9a&ai, Keisuke9akisaka, Shi&eru 9atanabe, Toshio Yajima, MasatoYamanouchi, Katsumi Yamada, Masahiko Yamada, enjuYamada, Masashi Yamamoto, Tsutomu Yokosuka, HideoYoshida and Katsuya Yoshida)

Documents

Effect of Valsartan and Amlodipine