H49 Safety and blood pressure response of bisoprolol in a general practice population with essential hypertension

A

1997-VOL. 10, NO. 4, PART 2

POSTERS: Clinical Trials

H49

H50

SAFETY AND BLOOD PRESSURE RESPONSE OF BISOPROLOL IN A GENERAL PRACTICE POPULATION WITH ESSENTIAL HYPERTENSION. ~, A. Hohne, W, Mohrke, Section Pharmacotherapy, University of Ulm, Verum StaticOn, Planegg, and Procter & Gamble Pharmaceuticals, Weiterstadt, Germany The objective of the study was to observe safety, reduction of blood pressure and responder rates (RR) in patients with essential hypertension under conditions of general practice treated with the cardioselective beta adrenoceptor blocker bisopmlol. In a post marketing surveillance (PMS) 16420 patients (54t12 years, all values mean * s.d.) were treated with 5 mg bisoprolol (B5; n = 9540) or 10 mg bisoprolol (BIO; n = 3021) or 5 mg bisoprolol and 12.5 mg hydrochlorothiazide (B/HCT; n = 3728) for a period of 4 to S weeks. Almost all patients (n . 16098) were treated for essential hype~ensi’m 23% of Patients had accompanying CHO and 48% of patients other accompanying diseases. 43% of all patients had been treated with other antihyperfensives previously. Blood presswe (BP) and heat rate (HR) were measured (Riva.Rocci, Korotkoff V) after 5 min rest in the sitting position. BP values were reduced from 173+16/100+9 mmHg to 146+13/86+8 mmHg by 27+15/14+9 mmHg and the HR from 62*11 rein-? to 73*6 rein-l by 10+10 rein-l at a median treatment period of 6.3 weeks. Responder rates as defined by different criteria are depicted in the table Treatment B5 BIO BIHCT

RRI (%) 19.0 10.6 11.1

RR2 (“/0) 50.7 44.4 45,8

RR3 (%) 51.2 44.6 45.9

RR4 (“/0) 64.6 85.7 86.6

RR5 (%) 90,8 90.1 91.0

RR1 BPd . 90 mnHg md BPs < 140 rmnHg (WHO normal, JNC V normal or hqh normal]:RR2: BPd .90 rnrnHgand ABPd > 10 nmHg: RR3 BPd .90 mnHgi RR4: BPd .90 nmH9 o, ABPd >10 nmHg; RR5, BPd <90 nmHg or ABPd >10 rmnHg

469 patients (2.9%) repoited adverse drug reactions, 3.1% with B5, 2.0°Awith BIO and 2,8°Awith B/HCT. Most frequently repotied symptoms were dizziness (0.4”A), nausea (0.30/0), bradycardia (0.3%), headache (0.2%) and fatigue (0.2%), 21 events were rated as serious. In 572 patients (4.0%) treatment was discontinued most frequently on account of insufficient BP response, of non-compliance or of adverse events. It is evident that the response rates vary widely depending on the respedive definitions.The higher response rates of low dose bisoprolol may be explained at least in pat by the fact that those patients had a lower pretreatment blood pressure. The rare incidence of spontaneously repotied adverse drug reactions underlines the safety of therapy with B. These results compare favorably with data obtained in PfvfSwith other antihypetiensive agents and .dsowith studies under controlleddouble-blindconditions.

A total of

E3?FECTOF L3S3NOPRILON THE PROGRESS1ON OF NOND3ABETICCHRONIC RENAL FA3LURE.GACinofd,PCZucchelli, onbshslfofthe combinedinvestigators. Div.Nephrology,University“La Sapienza”,Roma,Itafy. Mostclinicalstudiesdesigned to determine whether the protrcfive effect of ACE-inhibitors on renal function is independent of their snfihypmensiveactionhsvegivencontroversial results. Inanopen, mtdticenter, randomized study, 151ptswithu6trrsted supine diastolic blowl pressure(.DBP)2 95 nmd-lgor in treatmentwith .mnihyperfensive drugsandachronic rendfailure (Crratinine clearance, Clcr, between 20-50ndhdn)duetoprimary renopwcnchimaf disrases, wererandomized tolkinopril (L)oralternativeantihypertensive therspy (C); the demographic,clinicsf, and labmstorycharacteristicsand the underlyingrend diseaseswere similar in both groups,During three months(4 visits)theantihypertrnsive therapywastitratedin bothgroups to obtsina supineDBP <90 mmHg (L 5-10 mg or 10 mg associated withanotherantihypertensive, C in monotherapy or with no morethan onotk antihypsrtensive drug),GFRwas determinedby Cla in esch centerandby Imdinclearsnce,(Clin)at a centraflaboratory. Afterthrre months121ptswithstabilizedsupineDBP<90 mmHgandreproducible renalfimctionenteredthe studyandbadsdcient datato be evalusted. Adverserractionswereassessrdat eachvisit by spontaneousrcportimg andon clinicafandIaboratmy basis.Themat periodofobsemationwas 20 months(10visits).DuringthestudytheDBPwas 83.S5+-8.6in L and 84.93+7.56nutd+gin C (reranDBPdifferencsbetwrcn groupsattheend of thestudy:1 mmHg); SBP 137.8*14.6in L, 142.79+14.1mmHgin C (meanSBPdi3Terence Mw&mtgroupsatthe end of the study:5 mmHg). Therateof declineof Cl,.rwas signitkanffylowerin L (-3.39%)thanin C (-16.9%)(ps 0,01). The Cl~ did not change in L, ditTering signitkmffyfromC (@o.04). At the end of follow-upproteimuiawas reducrdby 25Y.in L end lIY. in C tJW),Ninepfs (3 in L and 6 in C, odds ratio0.49) had a doublingof 3.x andhr hslving of GFR;7 pfs requireddialysis,2 in L and5 in C (oddsratio0.39). We concludethat this study,employingsensitivemeasurement of rend functionandwith remarkablysimilar blood pressurein both groups, provides strong supportto the hypothesisthat Lisinoprilhas a sprdlc renoprotrctive effect,addifion.dtobhwdpressurecontrol. Key Words:

Key Words: Bisoprolol,drug surveillance responderrates,adverse events

Lisinopril,renddiseeses,hypertension, renoprotwfion.

H51

H52

ANT3HVPERTENS3VF EFFECT AND ACCEPTABILITY OF PE3uNDoP3GL 3N HYFERTENS3VE AND NON-UWULIN DEPENDENT DMBE3TC PATIENTS.ONE YEAR DOURLE-BLIND PARAL35LSTUDYVERSUSATENOLOL ~, IGHRanderee. Department ofMedicine, University ofNatal,

ANTIHYPERTENSIVB EFFICACY OF AMLODIPINE VS QUINAPRIL IN PATIENTSVITH MILDTO MGDERATR ESSENTIAL HYPERTENSIONAND DIFFERENT LEVELS OF SALT INTAR33 Calvo C,Gude F,Perez-Leirc5s P,Vega A,Jimenez A,Fen nandez MI,EspejoJ.HypertensionUnit.Hospital Cli: nico Universitariode Santiago de Compostela and Medical Division of Pfizer.Madrid.Spain. ‘fhe~le of salt restriction in the antifwpertens: ve therapy is subject to debate .The purpose of the present study was to compare the antihypertensive efficacy of Amlodipine(A)versus Quinapril(Q) in patients with mild to moderate hypertensionwith three salt regimes. Study design:Randomized, crossover,clinical trial. After a 4 week washout period,105 patients were randomized in two groups:Amlodipine( 5-10 mg/day) and Quinapril(10-20 mg/day).After a normal salt i take period(8 weeks),patientswere randomly alloc ted to a high/low salt intake or viceversa(8week! Results : 66 patients (6S%) completed the study. Baseline Standard High (*)SBP (A) 172,3*5,8 141,8*8,5 140,0i4,9 %*5,4 (Q) 171,9*6,5 142,9+5,2 143,8+5,9 14G,9+4,q

Durban

‘fhis studymmparedthe antibwensive effect and acceptability of depe”dent diabetic paimhmnlto atenololin byperfensive andnon-insulin fitients~Onehundred ambkmtpatientsbetweentheases of 18-70yews wererecmitedi“tothismcmcccatric, randomized, double-blind studyin 2 parallelgroups, for I year at?.era l-month wash-out period on placebo AU patients had stable, ewential hypertension ofbefween295

mmltg ands 115

mmHg,diabetes type ff with H8AIC s 12”4 and albuminuria s 3.5g124 hours. ,40 andbyprtensive therapy was stopped for 4 weeks. There were 50 patients per treatment group and 2 patient population groups were studied, intention to -t (ITT) and per protc+ol (PP).The formerconstituted all patients whilst k latter included those without major protocol deviation and who ended the 12-montb study. The study chugs were pedndopril (P)4-8mg oncedaily or atenolol (A) 50-100mg once daily. fn each g$oup therapeutic adjustment was planned by doubling the dose and then by the addition of bycfnxbtorofbiazide25MS daily. Nifedipine 30-60mg daily was subsequently added if the desired drop in BP was not obtained. me tTT was analysed by ON Student’s t-test whilst a two way analysis of variance was performed for the PPpopulation. There were 100 patients (50 in each group), 88F, with a mean age of 55.4 + 7.2 years, hypertension was diagnosed for 8.2 i 6.2 years and diabetes for 6.6 + 5.4 years Baseline sitting SBP and DBP were respectively 173.2 + 19.1 mndfg and 102.5 + 5.0 II!MHS, baseline fasting glucose was 10.91 t 4.11 mmof/f. Jmthe ITT BP decreased similarly in both groups (86% in the A group and 82% in the P group : p=O.59NS), whilst in the PPgroup BP control at rnonti 12 was achieved in 84.4% in the A group and 83,7% in the P group (P=I193 NS). Glycaemia control was similar for HMfC, fmting and postprandial glucose in the ITT population, while fasting gfumse increased over time Oom 10.7 +4.1 to 12.0+ 3.4 mmofif: p .0.001 in the PP population on atenolol. There was a significant decrem. in ACE activity in the P group (p< 0.001). A significant decrease in heart rate was noted in the A group compared to the P group : p < 0.0+31.There was a low drop out rate in each group with 12 withdrawals (7 P : 5A). Co”gb mostly mild w the main side effect in the P group (42°A P vs. 140/. A). The percentage of normalised patients (sitting DBP<90 mndlg)wassimilarin bothgroups, The reduction in SBP was more marked in the P groupwbilst therewasa greaterfall in DBP in the A group. ‘flere was a significant Key WordS: incr.%weinfasting blcod sugar in tbe A group (p. 0.001).

Perindopril versusAtcnolol -14ffJDiabetes MeOitus Hypertensive Patients.

(● )DBP (A) 106,1*2,6 85,4+6,3 82,1*4,5 79,6*4, (Q) 104,6*3,4 86,7i2,4 87,4t2,2 85,7*3, (*) p = 0,05 Conclusions :(l)Both Amlodipine and Quinapril were effective in decreasing systolic and diastolic blood pressure in high,standard and low sodium of diet.(2)Amlodipine was more effective in decrea sing systolic and diastolic blood pressure than Quinapril in patients with mild to moderate hyper~ tension in different salt intake regimes.

Key Words:

hypertension,antlodipine ,quinapril, sodiuti antihypertensiveagents

89A