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Efficacy and tolerability of the combination of Candesartan cilexetil and hydrochlorothiazide in systemic hypertension
126A
AJM-APRIL
ASH XIV ABSTRACTS
1999-VOL.
12, NO. 4, PART 2
DO61
DO62
ANTIHYPERTENSIVE EFFECT OF ADDITIONAL FLUVASTATIN IN HYPERTENSIVE AND HYPERCHOLESTEROLEMIC PATIENTS TREATED WITH TRANDOLAPRIL S.D.*, A. Bucci, F. Costaatini. F. Cipollone. F. Cuccwllo. A. Mezzetti*. Hypertension Unit, Ikpartment of Medicine and Aging Science. University “Gabrieled’Aanunzio”.Chiiti. Italy The aim of the.study was to evaluate whether statins show additional antihypxtensive &zt in hypertensiveand hypercholesterotemicpatiene beated with ace-inhibitors. We selected35 patients (19 men and 16 wolneq age. 5M yrs) with Stage 1 hypextension ad hypercholestemlemis (total cbolesteml > 220 mg/dl and/a LDL cholesteml > 130 mg/dl) aftw 3 months of dietetic therapy. Patients undenventclinic visit, ambulatoryBP moniting (SpaceLabs 90207) ad lipid pmfde detemtiaationat baseline, aftez 1 month ml) of therapy with tramI&@ (2 mg/day) and afti other 2 months @2) of thempy with trar&lapril and fluvastatia (40-80 mglday). A subti of 18 patients u&went noninvasive evaluation of endothelium-dqendentvascdilatioa (EDD) of the bmchialamzy using high-resolutionuluasound. In rhe tit phase (Tl), 22 patients(63%) showed clinic BP < MO/90 mmHg. In the second phase (TZ), 32 patients(91%) had clinic BP < 140190 mmHg ad 29 patients (83%) had total cholesteml < 220 mgfdl aad!or LDL cholesterol < 130 mgjdl. Main data are repotted in the table:
REDUCTION IN VISUALSYMPTOMSDURlffi AHTIHYPERTENSIVE MONOTHERAPIES WiTHLONG-ACTING CALCIUMANTAGONISTS R HernBndez-Hem~ndez, MJ Arma-Hernindez, M V&SW* for the LASTLHYSteeringCommittee.Clinical PharmacologyUnits, Uniwnidad Centroccidenbl LlsandroAlvarado,Barqulrlmetoand Vagas Medical School: CentralUniversityof Venezuela,Caracas,Venezuela. Fixed-dose antihypertensive pharmacotherapies with lacidipine 4 mg (L) and with nifedipine GITS 30 mg (N), both given c~ncadaily, were compared in a multicentric open study. Patients with mild to moderate high blood pressure at the end of a 4-week placebo run-in (end of week -1) were randomly assigned to treatment with L or N for 16 weeks. 120 (age: 52.33 + 7.2; 81 female) and 128 (age: 51.57 + 6.4; 96 female) patients took L or N respectively. The attending physicians investigated visual symptoms throughout the reported symptoms visual darkening and blurred vision; answers from patients were scored.
Clinic BP, mmHg Daytime BP, mmHg Nighttime BP, mmHg 24-hour BP, mmHg Total cholesterol, mg/dl LDL cholesteml, mg/dl EDD, 40
Baseline
Tl
l-2
151f8/‘96+3 143f8/92k3 128+7/8(314 139&8/89?4 25228 16Ok27 3.3fl.O
138i7/88i4’ 134*5/85*4* 121fSi75f4’ 13(H7/82?6* 25Ok27 159i25 4.1+1.1*
133fSi83M’t 130-f4/81*3*t 118i5/73M*t 12@6/78fG*t
204f26’t 123f26.t 5.1*1.2*t
* P < 0.05 vs baseline;t P < 0.05 vs Tl.
End of study week
Numberofprtientr without (0) or witb mild (1). modente (21 or imwrtsnt (31 visual svmotoms LAClDfPlNE 4 mg ‘tiIFEDfP&& GITS 30 mp, 0 1 2 3 0 1 2 3
Visual Darkening 90 27 93 23 99 19 107 10 103 16 Blurred Vision -1 86 20 1 81 21 2 95 22 10 95 21 16 99 17
-1 1 2 10 16
_I.
.
3 4 2 3 1
0 0 0 0 0
103
24
1
110
18
0
114 110 112
12 15 1s
1 2 0
0 0 1 1 1
3 6 3 4 4
1 0 0 0 0
90 100 98 105 106
32 24 26 21 20
5 3 3 2 1
1 1 1 0 1
Contrasts within each of the treatment groups (Friedman): Visual Darkening Blurred Vision
Our data show thatfluvastatinhas additional aatibypertensiveeffect wbm given to hypertensive and hypzcholestemlemii patients heated with uan~l. This effect might be the result of furtheximprovement in endotheli function. It remains to be detami whether it is due. to cholesteml lowering or direct drug action or both.
Nifadipine 0.0001 0.0251 Lacidipine GITS 0.0062 0.0003 Both drugs improved visual symptoms, which maybe related with increments in internal carotid andlor vertebral circulation. Key Words: Lacidipine,Nifedpine.VisualSymptoms
Key words: hypertension. hypercholestemlemia, therapy
DO64
DO63 EFFICACY AND TOLERABILlTY OF THE COMBINATION OF CANDESARTAN CILEXETIL AND E IN SYSTEMIC HYDROCHLORoTHlAzID HYPERTENSION. V Pa&em&ha*, EL Miebekum, VA & Georgetown University Medkxd Centem, Wa~kington, DC. AT, receptor blockers &me or in combination are frequently used in the mmmgement of hyperhsioa We studii 275 pb with HTN (sittiq DBP 95-114 mm Hg), mean age 52 yrs, 44% female, 21% black, in a muMcenter doubh bliad, placebo eontrolled aweek tlallmxlt trial Cmldmartan eilexetil (a novel AT, refeptor bkcker, CATS), 32 mg QD given in eombkmtion witk IICTZ 12.5 iqg QD was cornpad to each component alone and to phceko. Primary ellicacy measore was mean red&ion from base&e in trough (24+3 hrs post dose) DBP at double blind week 8. Baseline cbmacteristks, SBP & DBP were similar between groups: Restdls indite decrease hm baseline. @mHp) Pheebo CAND HcrZ cAND+Ixrz (d) (62) @=72) (d0) SBP/DBP 3.213.7 8.6*/10.6’ 5.9163 22.1hl14.Sh aafl.05 vs PL; bap
Candesartan,
HCTZ
TOLERABILITY AND ANTIHYPERTENSIVE EFFICACY OF VALSARTAN OVER 24 HOURS COMPARED TO NIFEDIPINE RETARD F. Martfnez’, W, O&m&, .I. Pana Can&, L Michieleti’, and Vakartan Latam Invest@ba Gmup (VLIG) ‘Fundad Rusculleda, C&k& Afgentha; %osp. Univ. Pedm Em&o, Rio de Jamku, &a.~#;%Mihh da lnvestigacidn Ca~vascular. Guadhjam, Mexti; ‘hbvatils, @fmc.sfU8s, Agmtina This study compares the tolerability and antihypertensive efficacy of valsartan (VAL) vs. nifedipine retard (NIF) over 24 hours using ambulatory blood pressure monitoring (ABPM). 537 outpatients with mild to moderate uncomplicated essential hypertension ware randomized In this multinational, multicanter, open-label, parallel-group trial to receive either VAL 80 mg once daily or NIF 20 mg twice daily for 6 weeks. 24-hour ABPM was performed at baseline and study endpoint. Tolerability assessment included measuring both ankle circumferences. adverse events monitoring and laboratory parameters. VAL was significantly better tolerated then NIF. The sum of both ankle circumferences following 6 weaks of treatment was reduced by 2 mm in VAL patients, while in the NIF-treated gmup an S-mm increase was observed (p < 0.001). Significantly fewer patients in the VAL group experienced adverse events (28.1%) compared to 48.7% of patients in the NIF group (pcO.001). The incidence of headache, lowar limb swelling, flush and palpitations was 20.7%. 16.6%. 11.1%. and 6.3% for NIF; and 4.2%, 0.4%. 0% and 0% for VAL. respectively (p < 0.001). The analysis of ABPM was performed on 184 patients, 97 in the VAL group and 87 in the NIF group. A significant reduction in systolic and diastolic pressure during both periods (day and night) for both VAL and NIF was observed. with maintenance of circadian rhythm. In this study, Valsartan exhibits similar efficacy and superior tolerability, especially regarding ankle edema, compared to patients. Nifedipheretardinpelientswithmiklto made&a h-s&e Key words:
Diovan’, vakaftan, , Nif&ipihe retard, ambulatory blood presson, monitoring, edema
I
AJM-APRIL
ASH XIV ABSTRACTS
1999-VOL.
12, NO. 4, PART 2
DO61
DO62
ANTIHYPERTENSIVE EFFECT OF ADDITIONAL FLUVASTATIN IN HYPERTENSIVE AND HYPERCHOLESTEROLEMIC PATIENTS TREATED WITH TRANDOLAPRIL S.D.*, A. Bucci, F. Costaatini. F. Cipollone. F. Cuccwllo. A. Mezzetti*. Hypertension Unit, Ikpartment of Medicine and Aging Science. University “Gabrieled’Aanunzio”.Chiiti. Italy The aim of the.study was to evaluate whether statins show additional antihypxtensive &zt in hypertensiveand hypercholesterotemicpatiene beated with ace-inhibitors. We selected35 patients (19 men and 16 wolneq age. 5M yrs) with Stage 1 hypextension ad hypercholestemlemis (total cbolesteml > 220 mg/dl and/a LDL cholesteml > 130 mg/dl) aftw 3 months of dietetic therapy. Patients undenventclinic visit, ambulatoryBP moniting (SpaceLabs 90207) ad lipid pmfde detemtiaationat baseline, aftez 1 month ml) of therapy with tramI&@ (2 mg/day) and afti other 2 months @2) of thempy with trar&lapril and fluvastatia (40-80 mglday). A subti of 18 patients u&went noninvasive evaluation of endothelium-dqendentvascdilatioa (EDD) of the bmchialamzy using high-resolutionuluasound. In rhe tit phase (Tl), 22 patients(63%) showed clinic BP < MO/90 mmHg. In the second phase (TZ), 32 patients(91%) had clinic BP < 140190 mmHg ad 29 patients (83%) had total cholesteml < 220 mgfdl aad!or LDL cholesterol < 130 mgjdl. Main data are repotted in the table:
REDUCTION IN VISUALSYMPTOMSDURlffi AHTIHYPERTENSIVE MONOTHERAPIES WiTHLONG-ACTING CALCIUMANTAGONISTS R HernBndez-Hem~ndez, MJ Arma-Hernindez, M V&SW* for the LASTLHYSteeringCommittee.Clinical PharmacologyUnits, Uniwnidad Centroccidenbl LlsandroAlvarado,Barqulrlmetoand Vagas Medical School: CentralUniversityof Venezuela,Caracas,Venezuela. Fixed-dose antihypertensive pharmacotherapies with lacidipine 4 mg (L) and with nifedipine GITS 30 mg (N), both given c~ncadaily, were compared in a multicentric open study. Patients with mild to moderate high blood pressure at the end of a 4-week placebo run-in (end of week -1) were randomly assigned to treatment with L or N for 16 weeks. 120 (age: 52.33 + 7.2; 81 female) and 128 (age: 51.57 + 6.4; 96 female) patients took L or N respectively. The attending physicians investigated visual symptoms throughout the reported symptoms visual darkening and blurred vision; answers from patients were scored.
Clinic BP, mmHg Daytime BP, mmHg Nighttime BP, mmHg 24-hour BP, mmHg Total cholesterol, mg/dl LDL cholesteml, mg/dl EDD, 40
Baseline
Tl
l-2
151f8/‘96+3 143f8/92k3 128+7/8(314 139&8/89?4 25228 16Ok27 3.3fl.O
138i7/88i4’ 134*5/85*4* 121fSi75f4’ 13(H7/82?6* 25Ok27 159i25 4.1+1.1*
133fSi83M’t 130-f4/81*3*t 118i5/73M*t 12@6/78fG*t
204f26’t 123f26.t 5.1*1.2*t
* P < 0.05 vs baseline;t P < 0.05 vs Tl.
End of study week
Numberofprtientr without (0) or witb mild (1). modente (21 or imwrtsnt (31 visual svmotoms LAClDfPlNE 4 mg ‘tiIFEDfP&& GITS 30 mp, 0 1 2 3 0 1 2 3
Visual Darkening 90 27 93 23 99 19 107 10 103 16 Blurred Vision -1 86 20 1 81 21 2 95 22 10 95 21 16 99 17
-1 1 2 10 16
_I.
.
3 4 2 3 1
0 0 0 0 0
103
24
1
110
18
0
114 110 112
12 15 1s
1 2 0
0 0 1 1 1
3 6 3 4 4
1 0 0 0 0
90 100 98 105 106
32 24 26 21 20
5 3 3 2 1
1 1 1 0 1
Contrasts within each of the treatment groups (Friedman): Visual Darkening Blurred Vision
Our data show thatfluvastatinhas additional aatibypertensiveeffect wbm given to hypertensive and hypzcholestemlemii patients heated with uan~l. This effect might be the result of furtheximprovement in endotheli function. It remains to be detami whether it is due. to cholesteml lowering or direct drug action or both.
Nifadipine 0.0001 0.0251 Lacidipine GITS 0.0062 0.0003 Both drugs improved visual symptoms, which maybe related with increments in internal carotid andlor vertebral circulation. Key Words: Lacidipine,Nifedpine.VisualSymptoms
Key words: hypertension. hypercholestemlemia, therapy
DO64
DO63 EFFICACY AND TOLERABILlTY OF THE COMBINATION OF CANDESARTAN CILEXETIL AND E IN SYSTEMIC HYDROCHLORoTHlAzID HYPERTENSION. V Pa&em&ha*, EL Miebekum, VA & Georgetown University Medkxd Centem, Wa~kington, DC. AT, receptor blockers &me or in combination are frequently used in the mmmgement of hyperhsioa We studii 275 pb with HTN (sittiq DBP 95-114 mm Hg), mean age 52 yrs, 44% female, 21% black, in a muMcenter doubh bliad, placebo eontrolled aweek tlallmxlt trial Cmldmartan eilexetil (a novel AT, refeptor bkcker, CATS), 32 mg QD given in eombkmtion witk IICTZ 12.5 iqg QD was cornpad to each component alone and to phceko. Primary ellicacy measore was mean red&ion from base&e in trough (24+3 hrs post dose) DBP at double blind week 8. Baseline cbmacteristks, SBP & DBP were similar between groups: Restdls indite decrease hm baseline. @mHp) Pheebo CAND HcrZ cAND+Ixrz (d) (62) @=72) (d0) SBP/DBP 3.213.7 8.6*/10.6’ 5.9163 22.1hl14.Sh aafl.05 vs PL; bap
Candesartan,
HCTZ
TOLERABILITY AND ANTIHYPERTENSIVE EFFICACY OF VALSARTAN OVER 24 HOURS COMPARED TO NIFEDIPINE RETARD F. Martfnez’, W, O&m&, .I. Pana Can&, L Michieleti’, and Vakartan Latam Invest@ba Gmup (VLIG) ‘Fundad Rusculleda, C&k& Afgentha; %osp. Univ. Pedm Em&o, Rio de Jamku, &a.~#;%Mihh da lnvestigacidn Ca~vascular. Guadhjam, Mexti; ‘hbvatils, @fmc.sfU8s, Agmtina This study compares the tolerability and antihypertensive efficacy of valsartan (VAL) vs. nifedipine retard (NIF) over 24 hours using ambulatory blood pressure monitoring (ABPM). 537 outpatients with mild to moderate uncomplicated essential hypertension ware randomized In this multinational, multicanter, open-label, parallel-group trial to receive either VAL 80 mg once daily or NIF 20 mg twice daily for 6 weeks. 24-hour ABPM was performed at baseline and study endpoint. Tolerability assessment included measuring both ankle circumferences. adverse events monitoring and laboratory parameters. VAL was significantly better tolerated then NIF. The sum of both ankle circumferences following 6 weaks of treatment was reduced by 2 mm in VAL patients, while in the NIF-treated gmup an S-mm increase was observed (p < 0.001). Significantly fewer patients in the VAL group experienced adverse events (28.1%) compared to 48.7% of patients in the NIF group (pcO.001). The incidence of headache, lowar limb swelling, flush and palpitations was 20.7%. 16.6%. 11.1%. and 6.3% for NIF; and 4.2%, 0.4%. 0% and 0% for VAL. respectively (p < 0.001). The analysis of ABPM was performed on 184 patients, 97 in the VAL group and 87 in the NIF group. A significant reduction in systolic and diastolic pressure during both periods (day and night) for both VAL and NIF was observed. with maintenance of circadian rhythm. In this study, Valsartan exhibits similar efficacy and superior tolerability, especially regarding ankle edema, compared to patients. Nifedipheretardinpelientswithmiklto made&a h-s&e Key words:
Diovan’, vakaftan, , Nif&ipihe retard, ambulatory blood presson, monitoring, edema
I