Vol 6, No 4 (2002)
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Published online: 2002-10-18

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Efficacy and Acceptability of Fixed Low Dose Combination of Perindopril and Indapamide in Patients with Mild to Moderate Hypertension and/or Ischaemic Heart Disease and/or Type II Diabetes and/or Renal Insufficiency. 12-Weeks, Open, Multicenter Study

Maria Trusz-Gluza, Anna Czech, Stanisław Czekalski, Marta Kucharska, Agnieszka Starościak-Rozwadowska, Robert Pachocki
Nadciśnienie tętnicze 2002;6(4):243-252.

Abstract

Background In the majority of patients arterial hypertension is combined with other disorders that increase its effect on the function of the cardiovascular system. In patients with cardiovascular risk factors as diabetes, coronary artery diseases or renal failure, the optimal control of blood pressure is very important.
It has been proven that the decrease in the cardiovascular risk caused by the hypotensive treatment depends on the achieved arterial blood pressure.
The combination of fixed low dose of hypotensive drugs created new opportunities in the treatment of arterial hypertension.
The main objective of this study was to evaluate the hypotensive efficacy and tolerance of Noliprel (0,625 inapamide and 2 mg peryndopryl) in patients with mild or moderate arterial hypertension with diabetes and/or coronary artery disease and/or renal failure.
Material and methods This is a multicenter study performed in different Polish in specialistic outpatient clinics. The treatment was continued over 12 weeks and preceded by a 2-week selection period.
During the treatment phase the patients were given Noliprel in the dose of 1 tablet daily.
In patients that after 6 weeks did not reach an appropriate control of the arterial blood pressure the Noliprel dose was increased to 2 tablets daily.
After 12 weeks of treatment (W 12 visit) investigators assessed the efficacy and tolerance of the used hypotensive treatment. Patients were also asked to assess the subjective tolerance of the treatment.
Results Four hundred eighty-nine patients with arterial hypertension and coronary artery disease (51%) and/or type 2 diabetes (49%) and/or renal failure (15%) participated in the study. The mean reduction of the blood pressure was: 21/12 mm Hg (p < 0,01) in the whole study population, 19/12 (p < 0,01) in the group of patients with ischemic heart disease, 22/11 (p < 0,01) in the group of patients with diabetes and 21/14 in patients with renal failure. In 80,1% of patients the reduction of the diastolic blood pressure to < 90 mm Hg (in patients with diabetes to < 85 mm Hg) or the decrease of the DBP ł10 mm Hg were achieved.
In the entire population as in the subgroups a significant reduction of the pulse pressure was attained.
No statistically significant changes of glucose, creatinine and cholesterol level were found in the whole population and in the subgroups. Only 5 patients (1%) required potassium supplementation in the week 12 of the treatment.
The efficacy of Noliprel treatment was assessed by 93% of patients as very good or good. The tolerance of the treatment was assessed by 99% of patients and 98% of study doctors as very good or good.
Conclusions Noliprel is a very interesting therapeutic option in patients with mild or moderate arterial hypertension with concomitant coronary artery disease and/or type 2 diabetes and/or renal failure because it is an effective, well tolerated and metabolically neutral preparation.

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