Impact of socio-economic factors on the long-term effectiveness of antihypertensive treatment with an angiotensin II receptor blocker: an observational study

Abstract

Objective:

To investigate the role of socio-economic factors on the therapeutic effectiveness of and therapeutic adherence to the angiotensin II receptor blocker (ARB) olmesartan (OM) alone or in combination with hydrochlorothiazide in the treatment of arterial hypertension.

Research design and methods:

In a multi-center, open-label, prospective and long-term observational study, data from hypertensive patients treated with OM were analyzed at baseline, month 3 and month 12 within the context of patients’ socio-economic status (SES), determined using pre-defined criteria by physicians in outpatient practices and including multivariate analysis.

Results:

Overall, 7724 patients were assigned to three subgroups representing low, medium and high socio-economic status. Baseline conditions differed significantly between the subgroups. Patients of low SES had worse nutritional habits, less physical activity and more concomitant medication compared to patients of high SES. Cardiovascular risk factors were more common in the low SES group as were concomitant diseases such as heart failure, coronary heart disease, atherosclerosis and renal failure. OM therapy led to a significant decrease in blood pressure (23.0/11.6 mmHg) in all patients. The blood pressure target of <140/90 mmHg was achieved in about 70% of the documented population. Effectiveness was comparable between patients with low, medium or high SES. Treatment adherence was high in the overall population with only minor differences between the subgroups. In total the incidence of adverse events (AEs) was 1.6% documented in 98 patents (1.3%) during the course of the study. Of this total number only 1.0% was related to the drug, matching the percentage expressed in the Summary of Product Characteristics (SmPC).

Conclusions:

The ARB OM is effective and well tolerated in all patients, irrespective of their socio-economic status. The risk status and the established cardiovascular disease of hypertensive patients are strongly influenced by the SES. To validate these interesting data a randomized controlled trial is needed.

Keywords::

• Angiotensin II receptor blocker
• Cardiovascular risk factors
• Hypertension
• Olmesartan
• Socio-economic status

Transparency

Declaration of funding

The LEO study was funded by Berlin-Chemie AG.

Declaration of financial/other relationships

J.S., A.W. and R.K have disclosed that they have received lecture fees and advisory board honoraria from Berlin-Chemie AG, as well as from other pharmaceutical companies developing products for treatment of patients with hypertension. R.L. and F.K. are employees of Berlin-Chemie AG.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.