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Publication
1
Joesbury HE, Phillips CA, Garrett RT,
Wilkes E, Smith AJ.
Mild hypertension: a clinical trial conducted
in hospital general practice.
Br Med J 1976, 18 : 2(6050) 1476-9
Intérêt de cette étude
L'intérêt
de cette étude est d'abord de comparer
le même type de traitement antihypertenseur
en médecine de ville et en milieu
hospitalier. Un autre intérêt
est que cette étude porte sur l'association
réserpine et bendrofluméthiazide
(étude en double aveugle en cross
over).
Les résultats
à court terme (8 semaines) et à
long terme (24 semaines) montrent une
normalisation des chiffres tensionnels.
Abstract
To compare
findings in a hospital trial of hypotensive
drugs with those in a general practice
trial several patients with mild hypertension
were studied at the same time in hospital
and in general practice. They received
bendrofluazide and potassium chloride
or bendrofluazide, potassium chloride,
and reserpine according to a double-blind
crossover protocol, and blood biochemical
values were studied over eight weeks and
six months. When reserpine was withdrawn
from nine women they followed a modified
protocol comparing bendrofluazide and
potassium chloride with potassium chloride
alone. The blood pressure values measured
by the general practitioners were similar
to those measured in hospital. Both the
diuretic alone and the diuretic with reserpine
produced significant falls in blood pressures.
Although plasma renin activity increased
on diuretic treatment, continued treatment
did not produce a further increase, and
levels gradually declined towards normal.
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Publication
2
Griebenow R, Pittrow D and col.
Low dose reserpine/thiazide combination
in first line treatment of hypertension
: efficacy and safety compared to an ACE
inhibitor.
Blood Pressure. 1997, 6 : 299-306
Intérêt de cette étude
Cette étude
compare en double aveugle un traitement
de l'hypertension modérée
à moyenne par l'association à
faibles doses réserpine et thiazide
versus un inhibiteur de l'enzyme de conversion,
l'enalapril. Les résultats montrent
que l'association est "considérablement
plus efficace" que la monothérapie
seule, avec la même tolérance.
Les auteurs suggèrent que cette
ancienne association réserpine
et thiazidique apparaît comme aussi
efficace que les "monothérapies
modernes."
Abstract
The concept
of initiating treatment of mild-to-moderate
hypertension with a low-dose combination
of reserpine and the thiazide clopamide
in comparison to monotherapy with an ACE
inhibitor was investigated. A total of
127 adult outpatients with diastolic blood
pressure between 100 and 114 mmHg
were randomized into this double-blind,
parallel group study. After a 2-week wash-out
period and a subsequent 2-week placebo
run-in period, they were allocated to
once-daily treatment with 0.1 mg reserpine
plus 5 mg clopamide (R/C), or 5 mg enalapril.
If diastolic blood pressure was not normalized
after 3 weeks of therapy (i.e. DBP <
90 mmHg), the dosage was doubled from
week 4 to 6. The primary efficacy variables
were the change from baseline in mean
sitting diastolic and systolic blood pressure
(DBP/SBP) after 3 weeks of therapy. Secondary
variables included the change in DBP and
SBP after 6 weeks of therapy, the BP normalization
rates at 3 and 6 weeks and, concerning
tolerability, the rates of adverse events
after 6 weeks of therapy. An intent-to-treat
analysis was performed. The reserpine/
clopamide and enalapril groups did not
differ with regard to demographic and
baseline characteristics (mean age 57
or 58 years, respectively; 63 % or
56 % males, respectively; mean SBP/DBP
after the 2-week placebo period = 156 mmHg/104
mmHg in both groups). After 3 weeks of
treatment with one capsule daily, mean
SBP/DBP reduction from baseline (24 h
after last medication intake) in the R/C
combination group was -19.6/ -17.0 mmHg,
in the enalapril group -6.1/ -9.5 mmHg
(between-group comparison: 2p < 0.01
for both parameters). The normalization
rates for DBP (< 90 mmHg) were 64.1
% (R/C) and 28.6% (enalapril) (2p <
0.01). Adverse events that were considered
possibly or definitely drug-related by
the investigator were noted in 11 patients
(17.2 %) in the R/C group and in
9 patients (14.3 %) in the enalapril group
(NS). Two patients in the enalapril group
discontinued the study prematurely due
to adverse events (cough; skin eruption).
In the treatment of mild-to-moderate hypertension,
a low-dose combination of reserpine and
clopamide once a day is considerably more
effective than, and as tolerable as, 5-10
mg of enalapril once a day. These findings
suggest that treatment with a combination
of different antihypertensives with different
modes of action in low doses is a rational
alternative to conventional monotherapy
in the first-line treatment of hypertension.
Besides, the "old" reserpine-diuretic
regimen also in these days appears to
be a rational alternative to "modern"
monotherapies.
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