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Losartan treatment of patients with isolated systolic hypertension.
ASH XIV ABSTRACTS
140A
A]H-APRIL
1999-VOL.
12, NO. 4, PART 2
E005
E006
USEFULNESS OF THE LOANED SELF-MEASUREMENT FOR DIAGNOSIS AND EQUIPMENT MODEL TREATMENT ADJUSTMENT DURING A CLINICAL TRIAL USING VALSARTAN. CG Calve-Varms*, D Galarm, C Garcia-Gutikrez’, on behalj of the Asociacidn de Medicina Interna de M&rim research group. It has not been defined if loaned self-measurement equipment model (LSEM) blood pressure (BP) readings are more useful than clinic BP readings for hypertension diagnosis and
THE EFFICACY AND SAFETY OF ZOFENOPRIL COMPARED TO AMLODIPINE IN PATIENTS WITH MILD TO MODERATE HYPERTENSION
antihypertensive randomised
treatment
clinical
adjustment
during
a clinical
trail was used to compare
trail.
A
these two types of
readings and LSEM were done simultaneously. The LSEM used automatic sphygmomanometers (OMRON HEM 713 C) belonging to the clinic and loaned to patients for three-day periods. After a four-week washout should have been diagnosed as the patients period, hypertensive(>140/90 mmHg) with both techniques. Valsattan (SO&day) was administered for following four weeks. During the following stage, in the case of uncontrolled patients (1140190 mmHg), the study population was randomized to decide on the addition or non-addition of hydrochlorothiazide (12.5 mgiday), group I (n=23) using clinic readings, and group 2 (n=27) using LSEM readings.A total ‘of 106 patients finished the washout period; 50 (47%) were hypertense with both reading techniques. The clinic BP readings at the beginning of the study were 159?12/95+7 mmHg, and at the end 137+13/X6+9 mmHg. The initial HSEM readings were 154+12/93?7 mmHg and the final BP readings.
At first, Clinic
132?13/80*9
mmHg.
the two
The difference
techniques
I cases
group
BP
was
in BP reduction
not statistically
required treatment
between
significant.
adjustment,
65%
A.Giusti*‘,M. Bertolottl’, W.I.C.Clark’, F.J.J. Harrison’, S. de la Matte’ and A. Casini’. ‘Menarini Rxenjhe, Florence, Italy; ‘The Surgey, Buckingamshire, United Kingdom; Harrison Clinical Research, Munich, Germany. The efficacy and safety of zofenopril, a new ACE inhibitor with cardmprotective actwity due to the scavenging properties of its -SH group, was compared wth amlodipine in this multicenter, double-blind, randomized trial performed m 27 centres located in Germany and United Kindom. After 4 weeks of placebo run-m, 303 patxnts with mdd to moderate hypertensmn were randomued to receive zofenoprol30 mg O.D. (151) or an&&pine 5 mg O.D. (153), for a period of I2 weeks. After four weeks of therapy, 58% of the zofenopril treated patients and 62.5% of the amlodipine treated patients were classified as “responders” (i.e., DBP < 90 mmHg, or DBPSlO mmHg from baseline). At the end of the study period, the mean sitting DBP was sigmticantly reduced as compared to baseline values both for zofenopril (-9.2 mmHg) and for amlodipine (-11.9 mmHg). The adverse events observed were typical of the test drugs. The most prominent treatment-related adverse events were cough in the zofenopril group and oedema in the amlodipine group. Cough was experienced by 5 patients in the zofenopril group (3.3%) and by 2 patients in the amlodipine group (1.3%); oedema was experienced by I7 patxnts (11.1%) in the amlodlpme group and by no patient of the zofenopril group. Accordmg to the study hypothesis, theraupetlcal equivalence of zofenopril and amlodipine was demonshated; both drugs were well tolerated, with less patxnts m the zofenopril group than in the amlodlpine group showing side-effect typical of the respective drug class.
of
but only 48% of the
group 2 cases.
LSEM
showed
that
47%
of
the
subjects
were
not
truly
end of the washout period. Patients monitored with LSEM require less posterior treatment adjustments.
hypertensive
Key
at the
Words:
Blood
pressure
sive treatment,
self-measurement, Valsartan,
antihyperten-
blood pressure control.
treatment
of
patients with Isolated systolic
hypertension. C. Farsanq. J. Garcia-Puig. F.Vrijens,
G.
Bortman
Investigators
Group
The
of losartan
effects
(SiSBP)
were evaluated
hypertension
(ISH).
study the efficacy with the effects
J.Niegowska, for
the
A.Quintero
Losartan
on sitting
systolic
Baiz.
ISH
blood
Trial
pressure
in 273 patients with isolated systolic
In this randomized, and tolerability
of atenolol.
double-blind,
of losartan
Patients
with
placebo for 4 wks and then randomized
parallel
were compared ISH
were
given
to either losartan
50
mg or atenolol 50 mg daily for 16 wks. At wk 8 or 12. patients in either group not controlled (sitting systolic blood pressure ~160
mmHg)
the patients atenolol
were given additional randomized
remained
HCTZ
to losartan
12.5 mg.
and 64%
on monotherapy.
The
67%
of patients
baseline
of on
SiSBP
(mean f SD) was 174 f 10 and 174 f 11 mm Hg in the two treatment 24.7
f
mmHg
groups. The losartan
15.5 mmHg
treatment
at 16 weeks
for the atenolol
treatment
reduced
compared (P
SiSBP
to 25.3
by
+ 14.7
vs baseline
both
groups, ns between groups). The response rate (SiSBPI60 but a reduction of Z 20 mmHg) was 87% with losartan and 84% with atenolol. experiences (CAEs) treated with losartan (P=O.O29). losartan
zofenopril, amlodipine,
antlhypertensive efficacy
E008
E007 Los&an
Key Words:
Withdrawals
and 7.2%
Drug-related
clinical adverse
were observed in 10.4% of patients and in 20.3% of patients with atenolol due
to
with atenolol
CAEs (P=O.O35).
were
1.5%
with
It is concluded,
that losartan 50 mg and atenolol 50 mg produced comparable significant reductions in SiSBP in patients with isolated systolic greater incidence
hypertension of drug-related
but atenolol produced a CAEs and withdrawals due
to CAEs.
SAFETY OF ADENOSME PRARMA COMGIC STRESS TESTING IN SUBJECTS WITH LOW SYSTOLIC ARTERIAL PRESSURE. SA Eji, GS Alkostnmi, A Movahed. East Carolina University, Greenville, NC, USA. Purpose: Adenosine (AD) can be used as a pharmacologic stress agent in conjunction with radionuclide myocardial perfusion imaging in the evaluation of coronary artery disease. AD is known to cause a drop in systolic arterial pressure (SAP) and atrioventricnlar block (AVB). There is incomplete data regarding the safety of AD stress testing in subjects with low SAP. We evaluated the safew of AD stress testing in subiects with SAP of ~100 mm Hg who bad no &nptoms due to low-& * Methods: The study consisted of a total of 3 1 consecutive subjects (18 men and 13 women, mean age 59.8 years) with SAP < 100 mm Hg, who underwent AD pharmacologic stress testing in conjunction with radionuclide myocardial perfusion imaging from January 1996 to November 1998. The subjects had no symptoms due to low SAP. AU subjects received AD infusion at dose of 140 p@kg/min. for 6 minutes. The signs and symptoms of hemodynamic instability, blood pressure changes and the incidence of second and third degree AVB were recorded. Results: A total of 31 subjects were found to have a supine SAP of ~100 mm Hg at baseline with no symptoms due to low SAP. Of these, 14 subjects had a SAP of 95-99 mm Hg aad 17 subjects bad a SAP of i 94 mm Hg (range 78-94). There was a mean SAP drop of 5 and 10 mm Hg in the hvo groups respectively that was transient during or post AD infusion and was not associated with any specific symptoms. Only one subject in the group with SAP < 94 had symptomatic hypotension (SAP=76) beginning five minutes post AD infusion, which responded to saline infusion with SAP rehuning to baseline at eight minutes post AD infusion. Only 1 (7%) subjact in the group with SAP of 95-99 bad a transient second degree AVB while 3 (17%) subjects in the group with SAP i 94 develop& tmasient second or third degree AVB. No subject required specific treatment or termination of AD infusion due to drop in SAP, second or third degree AVB. Conclusion: Adenosine pharmacologic stress testing in conjunction with mdionuclide myocardial periiz&n imaging can be used safely for diagnosis and assessment of coronary artery disease in subjects with low SAP who have no symptoms due to low SAP.
Key Words: Key Words: Isolated systolic hypertension,
Losartan
Adenosine, hypotension, pbam~cologic,
stress, atrioventricular block
140A
A]H-APRIL
1999-VOL.
12, NO. 4, PART 2
E005
E006
USEFULNESS OF THE LOANED SELF-MEASUREMENT FOR DIAGNOSIS AND EQUIPMENT MODEL TREATMENT ADJUSTMENT DURING A CLINICAL TRIAL USING VALSARTAN. CG Calve-Varms*, D Galarm, C Garcia-Gutikrez’, on behalj of the Asociacidn de Medicina Interna de M&rim research group. It has not been defined if loaned self-measurement equipment model (LSEM) blood pressure (BP) readings are more useful than clinic BP readings for hypertension diagnosis and
THE EFFICACY AND SAFETY OF ZOFENOPRIL COMPARED TO AMLODIPINE IN PATIENTS WITH MILD TO MODERATE HYPERTENSION
antihypertensive randomised
treatment
clinical
adjustment
during
a clinical
trail was used to compare
trail.
A
these two types of
readings and LSEM were done simultaneously. The LSEM used automatic sphygmomanometers (OMRON HEM 713 C) belonging to the clinic and loaned to patients for three-day periods. After a four-week washout should have been diagnosed as the patients period, hypertensive(>140/90 mmHg) with both techniques. Valsattan (SO&day) was administered for following four weeks. During the following stage, in the case of uncontrolled patients (1140190 mmHg), the study population was randomized to decide on the addition or non-addition of hydrochlorothiazide (12.5 mgiday), group I (n=23) using clinic readings, and group 2 (n=27) using LSEM readings.A total ‘of 106 patients finished the washout period; 50 (47%) were hypertense with both reading techniques. The clinic BP readings at the beginning of the study were 159?12/95+7 mmHg, and at the end 137+13/X6+9 mmHg. The initial HSEM readings were 154+12/93?7 mmHg and the final BP readings.
At first, Clinic
132?13/80*9
mmHg.
the two
The difference
techniques
I cases
group
BP
was
in BP reduction
not statistically
required treatment
between
significant.
adjustment,
65%
A.Giusti*‘,M. Bertolottl’, W.I.C.Clark’, F.J.J. Harrison’, S. de la Matte’ and A. Casini’. ‘Menarini Rxenjhe, Florence, Italy; ‘The Surgey, Buckingamshire, United Kingdom; Harrison Clinical Research, Munich, Germany. The efficacy and safety of zofenopril, a new ACE inhibitor with cardmprotective actwity due to the scavenging properties of its -SH group, was compared wth amlodipine in this multicenter, double-blind, randomized trial performed m 27 centres located in Germany and United Kindom. After 4 weeks of placebo run-m, 303 patxnts with mdd to moderate hypertensmn were randomued to receive zofenoprol30 mg O.D. (151) or an&&pine 5 mg O.D. (153), for a period of I2 weeks. After four weeks of therapy, 58% of the zofenopril treated patients and 62.5% of the amlodipine treated patients were classified as “responders” (i.e., DBP < 90 mmHg, or DBPSlO mmHg from baseline). At the end of the study period, the mean sitting DBP was sigmticantly reduced as compared to baseline values both for zofenopril (-9.2 mmHg) and for amlodipine (-11.9 mmHg). The adverse events observed were typical of the test drugs. The most prominent treatment-related adverse events were cough in the zofenopril group and oedema in the amlodipine group. Cough was experienced by 5 patients in the zofenopril group (3.3%) and by 2 patients in the amlodipine group (1.3%); oedema was experienced by I7 patxnts (11.1%) in the amlodlpme group and by no patient of the zofenopril group. Accordmg to the study hypothesis, theraupetlcal equivalence of zofenopril and amlodipine was demonshated; both drugs were well tolerated, with less patxnts m the zofenopril group than in the amlodlpine group showing side-effect typical of the respective drug class.
of
but only 48% of the
group 2 cases.
LSEM
showed
that
47%
of
the
subjects
were
not
truly
end of the washout period. Patients monitored with LSEM require less posterior treatment adjustments.
hypertensive
Key
at the
Words:
Blood
pressure
sive treatment,
self-measurement, Valsartan,
antihyperten-
blood pressure control.
treatment
of
patients with Isolated systolic
hypertension. C. Farsanq. J. Garcia-Puig. F.Vrijens,
G.
Bortman
Investigators
Group
The
of losartan
effects
(SiSBP)
were evaluated
hypertension
(ISH).
study the efficacy with the effects
J.Niegowska, for
the
A.Quintero
Losartan
on sitting
systolic
Baiz.
ISH
blood
Trial
pressure
in 273 patients with isolated systolic
In this randomized, and tolerability
of atenolol.
double-blind,
of losartan
Patients
with
placebo for 4 wks and then randomized
parallel
were compared ISH
were
given
to either losartan
50
mg or atenolol 50 mg daily for 16 wks. At wk 8 or 12. patients in either group not controlled (sitting systolic blood pressure ~160
mmHg)
the patients atenolol
were given additional randomized
remained
HCTZ
to losartan
12.5 mg.
and 64%
on monotherapy.
The
67%
of patients
baseline
of on
SiSBP
(mean f SD) was 174 f 10 and 174 f 11 mm Hg in the two treatment 24.7
f
mmHg
groups. The losartan
15.5 mmHg
treatment
at 16 weeks
for the atenolol
treatment
reduced
compared (P
SiSBP
to 25.3
by
+ 14.7
vs baseline
both
groups, ns between groups). The response rate (SiSBP
zofenopril, amlodipine,
antlhypertensive efficacy
E008
E007 Los&an
Key Words:
Withdrawals
and 7.2%
Drug-related
clinical adverse
were observed in 10.4% of patients and in 20.3% of patients with atenolol due
to
with atenolol
CAEs (P=O.O35).
were
1.5%
with
It is concluded,
that losartan 50 mg and atenolol 50 mg produced comparable significant reductions in SiSBP in patients with isolated systolic greater incidence
hypertension of drug-related
but atenolol produced a CAEs and withdrawals due
to CAEs.
SAFETY OF ADENOSME PRARMA COMGIC STRESS TESTING IN SUBJECTS WITH LOW SYSTOLIC ARTERIAL PRESSURE. SA Eji, GS Alkostnmi, A Movahed. East Carolina University, Greenville, NC, USA. Purpose: Adenosine (AD) can be used as a pharmacologic stress agent in conjunction with radionuclide myocardial perfusion imaging in the evaluation of coronary artery disease. AD is known to cause a drop in systolic arterial pressure (SAP) and atrioventricnlar block (AVB). There is incomplete data regarding the safety of AD stress testing in subjects with low SAP. We evaluated the safew of AD stress testing in subiects with SAP of ~100 mm Hg who bad no &nptoms due to low-& * Methods: The study consisted of a total of 3 1 consecutive subjects (18 men and 13 women, mean age 59.8 years) with SAP < 100 mm Hg, who underwent AD pharmacologic stress testing in conjunction with radionuclide myocardial perfusion imaging from January 1996 to November 1998. The subjects had no symptoms due to low SAP. AU subjects received AD infusion at dose of 140 p@kg/min. for 6 minutes. The signs and symptoms of hemodynamic instability, blood pressure changes and the incidence of second and third degree AVB were recorded. Results: A total of 31 subjects were found to have a supine SAP of ~100 mm Hg at baseline with no symptoms due to low SAP. Of these, 14 subjects had a SAP of 95-99 mm Hg aad 17 subjects bad a SAP of i 94 mm Hg (range 78-94). There was a mean SAP drop of 5 and 10 mm Hg in the hvo groups respectively that was transient during or post AD infusion and was not associated with any specific symptoms. Only one subject in the group with SAP < 94 had symptomatic hypotension (SAP=76) beginning five minutes post AD infusion, which responded to saline infusion with SAP rehuning to baseline at eight minutes post AD infusion. Only 1 (7%) subjact in the group with SAP of 95-99 bad a transient second degree AVB while 3 (17%) subjects in the group with SAP i 94 develop& tmasient second or third degree AVB. No subject required specific treatment or termination of AD infusion due to drop in SAP, second or third degree AVB. Conclusion: Adenosine pharmacologic stress testing in conjunction with mdionuclide myocardial periiz&n imaging can be used safely for diagnosis and assessment of coronary artery disease in subjects with low SAP who have no symptoms due to low SAP.
Key Words: Key Words: Isolated systolic hypertension,
Losartan
Adenosine, hypotension, pbam~cologic,
stress, atrioventricular block