| 1.
What are the advantages of the new form:
NATRILIX SR |
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NATRILIX SR is first
of all a new sustained release formulation,
which maintains plasma levels at optimal
values, 24 hours a day, and which
eliminates superfluous plasma peaks.
In practice, this means:
- the certainty of perfect, 24-hour
antihypertensive efficacy, in all
your hypertensive patients controlled
by NATRILIX SR,
- the certainty of an antihypertensive
efficacy maintained in the long-term,
without therapeutic escape,
- and, due to the reduction of the
dose strength with this new form,
the certainty of an even better
acceptability and safety of use.
All of these points
make NATRILIX SR the diuretic antihypertensive
which most closely corresponds to
the recommendations of leading international
authorities. |
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References:
- Guez D, Mallion JM, Degaute JP, et al. Arch Mal Coeur Vaiss.
1996;89:17-26
- Schiavi P, Jochemsen R, Guez D, et al. Fundam Clin Pharmacol.
2000;14:139-146
- Ambrosioni E, Safar M, Degaute JP, et al. J Hypertens. 1998;16:1677-1684.
- Mallion JM, Asmar R, Boutelant S, et al. J Cardiovasc Pharmacol.
1998;32:673-678.
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| 2.
And what about kalaemia with NATRILIX
SR? |
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The reduction of
the dose strength with the new sustained
release formulation means that hypokalemia
is rare.
In the recent randomized, controlled
studies conducted with NATRILIX SR,
the decrease of serum potassium is
modest: an average reduction of between
0.2 and 0.3 mmol/L.
In terms of incidence, a reduction
of serum potassium in a patient treated
with NATRILIX SR is rare; less than
1 patient in 10 might experience low
serum potassium below 3.4 mmol/L,
confirming the optimized safety of
use of NATRILIX SR.
However, it remains logical,
during introduction of
treatment with NATRILIX
SR, to assay serum potassium in the
context of the initial assessment
of a hypertensive patient.
References:
- Ambrosioni E, Safar M, Degaute
JP, et al. J Hypertens. 1998;16:1677-1684.
- Grimm M, Weidmann P, Meier A,
et al. Current Medical Research
and Opinion. 1983;8(suppl 3):38-46.
- Hamilton S and Kelly D. Journal
of the Irish Medical Association.
1977;70:462-465.
- Houde M and Carrière. Current
Medical Research and Opinion.
1983;8(suppl 3):68-76.
- Noble R.E, Webb E.L, Godfrey J.C,
et al. Current Medical Research
and Opinion. 1983;8(suppl
3):93-104.
- Santoro A, Chiarini C, Degli E.E, et al. Nefrologia, Dialisi, Trapianto.
1982:225-228.
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| 3.
And concerning carbohydrate and lipid
parameters? |
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Various studies had
already shown that NATRILIX SR differs
from other diuretics by the fact that
it preserves carbohydrate and lipid
metabolisms.
Concerning carbohydrate
parameters, the results of studies
conducted by Dr Harrower showed that,
even in hypertensive diabetics, NATRILIX
does not modify either blood glucose
or plasma insulin.
At the 10th congress of the American
Society of Hypertension, Prof. Ames
presented a review of studies demonstrating
the excellent preservation of the
lipid profile by NATRILIX, in contrast
with thiazides, even low-dose thiazides.
This unique property has been again
recognized by recent JNC VI report.
The excellent metabolic
safety of NATRILIX SR was again confirmed
in the context of its development
in the short and the long term.
For example, in the
phase III clinical study:
- the mean fasting blood glucose
was not modified (5.4 to 5.5 mmol/L
- not significant -after 12 months
of treatment) by NATRILIX SR;
- the mean serum cholesterol was
not modified (6.1 to 6.2 mmol/L
- not significant -after 12 months
of treatment) by NATRILIX SR.
References:
- Meyer-Sabellek W, Gotzen R, Hertz
J, et al. Hypertension. 1985;7(suppl
II):170-174.
- Leonetti G, Rappelli A, Salvetti
A, et al. Am J Cardiol. 1990;65:67H-71H.
- Scalabrino A, Galeone F, Giuntoli F, et al. Curr Ther Res.
1984;35:17-22.
- Raggi U, Palumbo P, Moro B, et al. Hypertension. 1985;7(suppl
2):157-160.
- Harrower ADB, McFarlane G. Am
J Med. 1988;84(suppl 1B):89-91.
- Ames RP, Griffing G, Marbury T, et al. Am J Cardiol.
1992;69:267-270.
- Joint National Committee on Detection,
Evaluation, and Treatment of High
Blood Pressure. The sixth report
of the Joint National Committee
on Detection, Evaluation, and Treatment
of High Blood Pressure (JNC-VI).
Arch Intern Med. 1997;157:2413-2446.
- Guez D, Mallion JM, Degaute JP,
et al. Arch Mal
Coeur Vaiss.
1996;89:17-26.
- Ambrosioni E, Safar M, Degaute JP, et al. J Hypertens.
1998;16:1677-1684.
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| 4.
But all antihypertensives reduce LVH,
even diuretics! |
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Lowering of blood pressure, even with
a diuretic, may reduce the global
left ventricular mass. However, NATRILIX
SR differs by the fact that the reduction
clearly concerns the thickness of
the ventricular wall, while conventional
diuretics classically cause a decrease
in the diameter of the ventricular
cavity.
The LIVE study confirmed the properties
of NATRILIX SR in reducing left ventricular
hypertrophy in hypertensive patients.
The objective of the LIVE study was
to compare the efficacy of NATRILIX
SR versus enalapril 20 mg on the regression
of left ventricular hypertrophy in
hypertensive patients. This is the
first study of a type using the most
stringent methodology. The LIVE study
meets point by point the criteria
drawn up by Professor Devereux, for
a rigorous trial or LVH regression
i.e. :
- a multicenter randomized double-blind
design,
- more than 200 patients per treatment
group,
- adequate gender mix
- 1 year's treatment, and centralized
interpretation of echocardiograms.
One of the key points
of this methodology, now indispensable
in any study on regression of LVH,
is the centralized interpretation
of echocardiograms. The first phase
of this centralized interpretation
concerned the quality control in real
time of echocardiograms throughout
the study. This enabled the elimination
of 27% of records at inclusion, and
the redoing of 22% of records during
one year follow-up of patients. The
main reason for this selection of
records was the overestimation of
left ventricular mass by investigators.
The second phase
was final, centralized, randomized
interpretation of all echocardiograms,
blinded to the treatment, the patient,
the center and the sequence of the
recordings.
The LIVE
study confirmed the
superiority of NATRILIX
SR versus enalapril 20
mg (p=0.013) in terms of regression
of LVH, at equivalent lowering of
blood pressure. In addition, the regression
of left ventricular mass seen on NATRILIX
SR essentially concerned the walls
of the left ventricle. Both interventricular
septum thickness (p<0.01) and posterior
wall thickness (p<0.05) are better
regressed by NATRILIX SR treatment.
The regression of
left ventricular mass and left ventricle
wall thickness induced by NATRILIX
SR was progressive between weeks 24
and 48, while that induced by enalapril
20 mg per day reversed between these
two measurements. In addition to a
specific action at the cardiac wall
level, with significant reduction
of the cardiomyocytes width and volume,
and significant reduction of the extracellular
matrix proteins, the complete antihypertensive
efficacy 24 hours a day and in the
long-term of NATRILIX SR contributed
to this result.
References:
- Daflöf B, Pennert K, Hansson
L. Am J Hypertens.1992;5:95-110.
- Gosse P, Guez D,
Guéret P, et al. J Hypertens.
1998;16:531-535.
- Devereux R. Circulation.
1997;95:1983-1985.
- Gosse P, Dubourg
O, Zannad F, et al. J Hypertens.
2000;18:1465-1475.
- Böcker W, Hupf H, Grimm D, et al. J Cardiovasc Pharmacol. 2000:36:481-486.
- Böcker W, Hupf H, Grimm D, et al. J Hypertens. 2000;18(suppl
4):S1.8.
- Mallion JM, Asmar R, Boutelant
S, et al. J Cardiovasc Pharmacol.
1998;32:673-678.
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| 5.
Are there any Indian studies with Natrilix
SR? |
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A recent study done in Indian patients
confirms the usefulness of Natrilix SR
as a first choice drug in hypertension.
This study confirms a high prevalence
of left ventricular hypertrophy (LVH)
amongst newly diagnosed Indian hypertensives
and demonstrates the efficacy of Natrilix
SR not only in reducing blood pressure
but also importantly in regressing LVH
(1), an important cardiovascular risk
factor.
References:
-
Lokhandwala Y, Damle
A. Left ventricular hypertrophy in hypertensive
patients in Indian primary care: prevalence
and effect of treatment with sustained
release indapamide. Current Medical
Research and Opinion 2004; 20(5): 639-644.
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