Vnitr Lek 2011, 57(6):541-545

The efficacy and safety of moxonidine in patients with metabolic syndrome (the O.B.E.Z.I.T.A. trial)

J. Krupička^1,*, M. Souček², K. Chroust³

¹ Kardiologická ambulance Brandýs nad Labem

² II. interní klinika Lékařské fakulty MU a FN u sv. Anny Brno, přednosta prof. MUDr. Miroslav Souček, CSc.

³ Institut biostatistiky a analýz Lékařské a Přírodovědecké fakulty MU Brno, ředitel doc. RNDr. Ladislav Dušek, Ph.D.

Introduction:
Treatment with agents neutral to lipid metabolism but with a positive effect on glucose metabolism might significantly improve the long-term prognosis of patients with metabolic syndrome and hypertension. The aim of our non-interventional observational clinical study was to evaluate the safety of treatment with moxonidine and to assess changes to the metabolic syndrome-related laboratory parameters.

Materials and methods:
A total of 748 patients over 18 years of age (22-87; mean 59; median 60) were included in a 6-month evaluation (two 3-monthly study visits). There were slightly more female patients (n = 401, 54%) with metabolic syndrome (≥ 3 NCE ATP III risk factors) and poorly controlled hypertension. A standardized data collection form was used, blood pressure measurement was standardized as per the guidelines and laboratory samples were assessed in a certified laboratory. The study medication (moxonidine, Cynt®) was prescribed to patients with newly diagnosed hypertension and/or patients with hypertension poorly controlled at an initial visit.

Results:
The majority of patients (98.8%) completed the study. No adverse effects were reported during the study. Moxonidine was mostly prescribed as an add-on treatment to other antihypertensives (81.1% patients) due to the lack of efficacy of the present antihypertensive treatment. The most frequent dose was 0.4 mg/day as monotherapy (44.9% of patients) as well as add on treatment (59.8% of patients). A change to the treatment was performed in 142 (19.2%) of patients during the follow up visit and in 57 (7.7%) of patients during the last study visit. All parameters (blood pressure, body weight, waist circumference, total cholesterol, LDL- and HDL-cholesterol, triglycerides, glycaemia and pulse) have changed highly significantly (p < 0,001).

Conclusion:
Over the 6-month follow up, a highly significant change was observed to all monitored parameters. An addition of monoxidine (Cynt®) to an existing treatment resulted not only in a reduction to blood pressure but also in highly significant changes to metabolic parameters without any significant modifications of the treatment. Treatment with monoxidine can be considered as metabolically neutral with an added value of positive effect on metabolic parameters. This is in line with the results of other studies.

Keywords: metabolic syndrome; uncontrolled hypertension; metabolically neutral products; obesity; clinical trial

Received: December 13, 2010; Accepted: February 10, 2011; Published: June 1, 2011  Show citation