Long-term efficacy and safety of valsartan in 823 mild to moderate hypertensives

AJH-APRIL

1999-VOL.

POSTERS: Antihypertensive Drugs

12, NO. 4, PART 2

DO66

DO65 REDUCED DIURETIC-INDUCED HYPOKALEMIA WITH VALSARTAN IN COMBINATION WITH HCTZ F”,

A. G?f?, R. G/a&, Y. ShF’ Rush-Presbflenan-St. Luke’s Medical Center, IL; ‘Fort Leudmdak? FL: 3hbvmtis Phmmam Gx&vx&“., East Hanow, NJ Diuretics, when administered as antihypertensive monotherspy or in combination with other blood pressure-lowering agents, often Induce hypckslemis. Ths present study examines the amhypertensive &zcy and toLrsbilii of vslssrtsn M. s new angiotsnsin II receptor blocker, in mmbinabon &h hydrcdllor&iszidQ (HCTZ) 671 adult outpatients with uncomplicated essential hypertension were randomized to receive a combination of V (60 mg or 160 mg) and HCTZ (12.5 mg or 25 mg). or either drug alone, or placebo for 6 weeks All active treatments significantly reduced mean diastolic and Systokc BP (p
drug regimens(~~0.05). All treatments wre generally well tolerated with most adverse experiencesbeing mild to moderatein severity 77 patients (7 on placebo. 11 on MO. 6 on VlBO. 7 on HCTZ 12.5. 14 on HCTZ 25,4 on VBO/HCTZ 12.5, 6 on VlGO/HCTZ 12.5. 12 on VLIO/HCTZ 25. 7 on VlGO/HCTZ 25) The showed increases or decreases in serum potassium >20%. incidence of a clinically significant decrease in serum potassium was lower in the combination groups than with the HCTZ monotherapies. No potassium lsvels fell below the normal range in patients on valsartan monotherapy.

Valsartsn acts additively with HCTZto effectively lower blood pressure in patients with essential hypertension. The combination of valsartan and HCTZ is well tolerated, and valsartan ameliorates the hypokalemiceffect of HCTZ in many patients.

SUPERIOR TOLERABILITY OF VALSARTAN COMPARED TO CAPTOPRIL IN ASlATlC PATIENTS CM. Lee’,

Y. T. Lee’,

M.G. Lana’.

‘N&ma/ Taiwan Uv AG, Basle, Swikertend;

P. Prabowo’, P. Oddou-Stoc~

Has@! Taipei, TeMa”; ‘Novaftis Pherme Dr Suharto Hospital, Surabeya, Indonesia

Drug reactions with antihypertensive agents can vary significantly between ethnic orouos and oatients of Asiatic ortain aenerallv show a high inctden& of’dry cough when treated Gh iC:CE inhibitors. Valsartan (VAL), a new angiotensin II receptor blocker, has not been associated with side effects typical of ACE inhibition, although available comparative data predominantly involve Caucasian and Black patients. We report data from two open label, randomized 8week trials in Asiatic populations, comparing tolerability and efficacy of VAL with caotooril (CAP) in Tatwanese (Trial A. n=89) and Indonesian iTrial 6, n=l95j patients with mild to‘moderate essential hypertension. In both studies patients received 80mg VAL once daily (od) and 25mg CAP twice daily (bid), with optional titration to 160mg VAL od and 89mg CAP bid after 4 weeks in the Taiwanese trial. Slightly greater reductions in blood pressure (mmHg) at study endpoint were seen with VAL compared to CAP: -10.5 vs. 8.3 (dtotii) and -13.9 vs. -10.3 (systoltc)in trial A, and -11.4 vs. -10.2 and 17.8 vs. -12.8 respedlwty in tdal B. Higher responder rates with VAL in both studies were also not statistically significant. Both drugs were well tolerated, although adverse experiences considered related to study drug were more frequent with CAP, particularly dry cough. Adverse experiencee (AE) considered study druS_rerafeS VA4ln=ls8l CAP ln=lw TOtN AE Cough Hssdache Dizziness Other

11 (7.0%) 2 (1.3%) 2 (1 3%) 4 (2.5%) 3 (1.9%)

47 (28.6%) 37 (22 4%) 2 (1 2X) 1 (0.6%) 7 (4 2%)

*Pooled Data from both studlss DOVan*.

Key Words:

Valsartan exhibits similar efficacy and superior compared to captopril in Asiatic hypertensive patients.

, hydmchlomthia.dde,

~akartan,

hypokakmia Key words:

DO67 LONG-TERM EFFICACY AND SAFETY OF VALSARTAN IN 823 MILD TO MODERATE HYPERTENSIVES -, A.bmtd,p. A. He&, H. Che”d

S. cnnmnd. T. hisda&,

N. Fellciano’,

TodatemcetstudieswithangkMstnIImceptorbto&ershavebsenof shatdumticn.Threetongtermexte&onstudtisshavebsenpsrfomM vethvatsadangtvenatcneorklanlbtna6onvdthhydmcJlkm9ltt (HCTZ)asneededinatotal88Wpatienfl,paridngdataforupb3 VBBm themov ,-- - of ---.-.-r> No. psa.nts Exposum Doss: vu nclz

StudylIE 399 up to 36 months 40-80 mg 12.ws mg

Study 28E 48 (Msdy) 24 months 80 mg 12.5/25 mg

St& 3,E 376 12 months tmme 125i25mg

Acmssdlstudii,conMentradMtonsindiastdttbtoodtxesswe (DBP) and systo5cbtocd fxessure (BBP) ow Sms WBSB observed. In trial 11E,cdledtnodataovar3swcess& me-warfottoww oeriods. mean DBP red&s (mmHg) wm -12.7 (yearl.~@84), -12.i &an?, n=224) and -12.6 (yw3,n=88). DBP mdwkons Mth stats 28E and 31E at study endpoint were -15.3 and -14.1, respddy. -inbloodpresswe vbwesimitarforpa6entskeatadtiMllsartan mwcthempyandthose mceMngconcomitantHCT2BothDBPandSBPwewdloxttmttedat theandofthektals,mga&sssofthepattwwaga,gender,mcecf fxMoustMtmenLTherewsnoavktenwoftoleranca. Adwse~(AE),wramatniymtktornwdamteinsewtty, andckxunedatstmitarfmqusxyv&Lhvafsai+~andin combina8onuithHCti!.lnddsnceofAEaxwdwadatteastpossibly relatedto~medication~homl5.53o.l~~aRec1~and7.525.0% after 2 years xmss dudim, and WCWB 4.1% after 3 years. No s&M6cantkendsintabomtoryvatusswsnscbserwd,andthsmwsno mawseinfn3qusncyortypeofadwsearpadweow Z”“y. ThesekngtenrrdataareinkeeptngMththosemportsdinshod-term studiianddemcMMevatsadanantihypertensivethempy~a wthoutccncomitMHClZtootferccns&nt e6t=w~good tolembittt. Key words:

Dioven~ saMy,

valswten,

long ten”

hydtuchtomthiazide

eRcacy end

Diovan*,

vatsada”,

Asians,

captopri,

tolerability

127A