The Real-Life Efficacy and Safety of Telmisartan in Patients With Arterial Hypertension

Condition(s) targeted: Hypertension

Status: No longer recruiting

Sponsored by: Bayer Schering Pharma Sp. z o.o., Polska

Official(s) and/or principal investigator(s):
Piotr Abramczyk, Dr Dr, Study Chair, Affiliation: Medical University of Warsaw, Katedra i Klinika Chorób Wewnętrznych, Nadciśnienia Tętniczego i Angiologii, ul. Banacha 1a, 02-097 Warsaw, Poland

The main purpose of this study is to asses the efficacy and safety of telmisartan, with the special attention on the influence of telmisartan on selected metabolic parameters of patients

Official title: A Non-Interventional, Post-Marketing Surveillance Phase IV Study to Asses the Efficacy and Safety of Telmisartan, With the Special Attention on the Influence of Telmisartan on Selected Metabolic Parameters of Patients

Study design: Observational, Screening, Longitudinal, Defined Population, Prospective Study

Detailed description: Arterial hypertension, which is one of independent cardiovascular risk factors, belong to the group of most important heath problems of the global population. It is well known that the growing number of strokes, accidence of ischaemic heart disease and heart-failure are the consequences of insufficient blond pressure control. In spite of great health-service development, cardiovascular events are still the main reason of mortality in Poland. NATPOL III PLUS study results, published in 2002, showed that over 29% of poles are hypertensive. Whatmore, 30% of polish population have high normal blood pressure. In the same study detectability of new cases of hypertension was 67%, but only 12,5% of hypertensive patients had their blood pressure controlled properly. The main conclusion of the NATPOL III PLUS study was that, despite the fact of high frequency of arterial hypertension in polish population, the efficacy of its treatment is inadequate low.

According to the guidelines of polish and world associations (AHA, ESH, PTNT), the main goal of arterial hypertension treatment should be cardiovascular-risk reduction, which can be achieved by reducing blood pressure below 140/90 mmHg and by controlling other than arterial hypertension risk factors. The population of people with arterial hypertension is very heterogenic. Hypertensive people are very often coursed by many other cardio-vascular risk factors like; metabolic disorders (diabetes mellitus, hypercholesterolemia), atherosclerosis, obesity. The arterial hypertension therapy depends mainly on the global cardiovascular risk assessment.

Present pharmacotherapy of arterial hypertension stress the individualization of the treatment. Usage of long duration antihypertensive drugs, positively influencing compliance is recommended. PRITOR® (telmisartan), angiotensin II receptor blocker, is a long acting (over 24 h) and potent antihypertensive drug. Efficacy of telmisartan was confirmed in a great number of clinical trials, also with difficult to treat patients with concurrent diabetes mellitus, renal insufficiency or congestive heart failure. Recent data suggest, that telmisartan apart form antihypertensive actions, may have positive influence on metabolic profile of patients with diabetes mellitus, hypercholesterolemia and coronary disease. In these patients, after 6 months of telmisartan treatment period, blood concentrations of glucose, triglycerides and cholesterol was significantly lowered. [Drug Safety 2004; 27 (5): 335-344, Cardiovascular Diabetology 2005, 4: 6]. Telmisartan appears to be a broadly acting drug, reducing cardiovascular risk not only by lowering blood pressure but also by influencing the metabolic profile of hypertensive patients.

Minimum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- age over 18

- untreated or ineffectively treated arterial hypertension

Exclusion Criteria:

- cholestatic disorders and severe hepatic failure

- allergy to telmisartan

- pregnancy and lactation period

Szpital Powiatowy, Leżajsk 37-300, Poland

Related publications:

Michel MC, Bohner H, Koster J, Schafers R, Heemann U. Safety of telmisartan in patients with arterial hypertension : an open-label observational study. Drug Saf. 2004;27(5):335-44.

Vitale C, Mercuro G, Castiglioni C, Cornoldi A, Tulli A, Fini M, Volterrani M, Rosano GM. Metabolic effect of telmisartan and losartan in hypertensive patients with metabolic syndrome. Cardiovasc Diabetol. 2005 May 15;4:6.

Starting date: October 2006
Ending date: May 2007
Last updated: April 10, 2007