Compliance With Antihypertensive Telmisartan Therapy

Condition(s) targeted: Hypertension

Intervention: Telmisartan (Drug); Drug Reminder Device (Device)

Status: Not yet recruiting

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

Official(s) and/or principal investigator(s):
Krzysztof Narkiewicz, Professor, Study Director, Affiliation: Medical University of Gdansk, Regionalne Centrum Nadciśnienia Tętniczego, ul. Dębinki 7, 80-211 Gdansk, Poland

Overall contact:
Michal Wronka, Dr, Phone: 0048 022 572 38 81, Email: michal.wronka.mw@bayer-ag.de

The purpose of this study is to asses the efficacy and safety of Telmisartan depending on the use of an electronic therapy monitoring device (HelpingHand®) in a real life setting and to asses patients compliance to the therapy with Telmisartan in relation to use of electronic therapy monitoring device.

Official title: A Non-Interventional, Post-Marketing Surveillance, Phase IV Study to Assess Compliance With Antihypertensive Telmisartan Therapy

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

Detailed description: Arterial hypertension, which is one independent cardiovascular risk factor, belongs to the group of most important health problems of the global population. It is well known that the growing number of strokes, incidence of ischaemic heart disease and heart-failure are the consequences of insufficient high blood pressure control. In spite of great health-service development, cardiovascular diseases are still the main reason of mortality in Poland. NATPOL III PLUS study results, published in 2002, showed that over 29% of Poles are suffering from arterial hypertension. Furthermore, 30% of the 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 efficiently [Zdrojewski et al., J Hum Hypertens 2001]. The main conclusion of the NATPOL III PLUS study was that, despite the fact of high prevalence of arterial hypertension in the Polish population, the efficacy of its treatment is still inadequately low.

Poor control of high blood pressure may have various reasons. One of the most important is low adherence of patients to their medication regimen. The asymptomatic and chronic nature of the disease is one of the most important factors contributing to poor adherence. Studies on adherence to a prescribed medication regimen have consistently documented that patients involved in long-term treatment take approximately 50% of their prescribed medication dosage only [WHO Report, 2003]. As a fact, it is very difficult to detect low compliance and to improve it. The use of electronic device monitoring drug administration may help patients improve their compliance. Burnier et al. showed that monitoring adherence significantly improved blood pressure control in hypertensive outpatients with resistant hypertension [Burnier et al., J Hypertens 2001]. In case that inadequate adherence to medication has been identified, another strategy to improve adherence might be the selection of a “more forgiving” antihypertensive agent (with long half-life period), which efficacy will be affected to a lesser extent by delayed administration or missed doses. Usage of such kind of agents would probably help to keep blood pressure values more stable, despite non ideal patients compliance.

Usage of long acting antihypertensive drugs, positively influencing patient’s adherence is recommended by many Polish and World associations (AHA, ESH, PTNT). PRITOR® (telmisartan), an angiotensin II receptor blocker, is a long acting (over 24 h) and potent antihypertensive drug. Efficacy of telmisartan was confirmed in a number of clinical trials, also with difficult to treat patients with concomitant diabetes mellitus, renal insufficiency or congestive heart failure. To date, there are no mean data published related to the topic of patient adherence to the therapy with telmisartan. No study was performed using a therapy monitoring device during treatment with telmisartan. In the light of NATPOL III study results, it is very interesting if electronic monitoring may have influence on safety and efficacy of telmisartan therapy.

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

- Unwillingness to participate in the study

- Inability to use the drug reminder device

- Unwillingness to use the drug reminder device

Michal Wronka, Dr, Phone: 0048 022 572 38 81, Email: michal.wronka.mw@bayer-ag.de

Related publications:

Zdrojewski T, Pienkowski R, Szynkiewicz M, Krupa-Wojciechowska B. Have rapid socioeconomic changes influenced awareness of blood pressure in Poland? J Hum Hypertens. 2001 Apr;15(4):247-53.

Burnier M, Schneider MP, Chiolero A, Stubi CL, Brunner HR. Electronic compliance monitoring in resistant hypertension: the basis for rational therapeutic decisions. J Hypertens. 2001 Feb;19(2):335-41.

Starting date: April 2007
Ending date: August 2008
Last updated: April 10, 2007