The efficacy and safety of moxonidine in patients with metabolic syndrome (the O.B.E.Z.I.T.A. trial)
Authors:
J. Krupička 1; M. Souček 2; K. Chroust 3
Authors‘ workplace:
Kardiologická ambulance Brandýs nad Labem
1; II. interní klinika Lékařské fakulty MU a FN u sv. Anny Brno, přednosta prof. MUDr. Miroslav Souček, CSc.
2; Institut biostatistiky a analýz Lékařské a Přírodovědecké fakulty MU Brno, ředitel doc. RNDr. Ladislav Dušek, Ph. D.
3
Published in:
Vnitř Lék 2011; 57(6): 541-545
Category:
Original Contributions
Overview
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.
Key words:
metabolic syndrome – uncontrolled hypertension – metabolically neutral products – obesity – clinical trial
Sources
1. Alberti KG, Eckel RH, Grundy SM et al. International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the Metabolic Syndrome: A Joint Interim Statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation 2009; 120: 1640–1645.
2. Scholze J, Alegria E, Ferri C et al. Epidemiological and economic burden of metabolic syndrome and its consequences in patients with hypertension in Germany, Spain and Italy; a prevalence-based model. BMC Public Health 2010; 10: 529.
3. Mancia G, Laurent S, Agabi-Rosei E et al. Reappraisal of European guidelines on hypertension managment: a European Society of Hypertension Task Force document. J Hypertens 2009; 27: 2121–2158.
4. Cífková R, Škodová Z, Bruthans J et al. Longitudinal trends in major cardiovascular risk factors in the Czech population between 1985 and 2007/8. Czech MONICA and Czech post-MONICA. Atherosclerosis 2010, doi:10.1016/j.atherosclerosis.2010.04.007.
5. Wright JT Jr, Harris-Haywood S, Pressel S et al. Clinical outcomes by race in hypertensive patients with and without the metabolic syndrome. Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Arch Intern Med 2008; 168: 207–217.
6. Vaverková H, Soška V, Rosolová H et al. Doporučení pro diagnostiku a léčbu dyslipidemií v dospělosti, vypracované výborem České společnosti pro aterosklerózu.Vnitř Lék 2007; 53: 181–197.
7. Eckel RH, Grundy SM, Zimmet PZ. The metabolic syndrome. Lancet 2005; 365: 1415–1428.
8. Kahn R, Buse J, Ferrannini E et al. American Diabetes Association; European Association for the Study of Diabetes. The metabolic syndrome: Time for a critical appraisal : joint statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2005; 28: 2289–2304.
9. Alberti KG, Zimmet P. The metabolic syndrome: time to reflect. Curr Diab Rep 2006; 6: 259–261.
10. Grundy S, Cleeman J, Daniels S et al. American Heart Association; National Heart, Lung, and Blood Institute. Diagnosis and Management of the Metabolic Syndrome: An American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation 2005; 112: 2735–2752.
11. Fruchart JC, Sacks FM, Hermans MP et al. Residual Risk Reduction Initiative (R3I). The Residual Risk Reduction Initiative: a call to action to reduce residual vascular risk in dyslipidaemic patient. Diab Vasc Dis Res 2008; 5: 319–335.
12. Fenton C, Keating GM, Lyseng-Williamson KA. Moxonidine: A review of its use in essential hypertension. Drugs 2006; 66: 477–496.
13. Krupička J, Ceypová K, Kristenová P et al. The safety of long-term administration of losartan in current clinical practice: a non-intervention NCT-CZ 14/04/LOZ study. Vnitř Lék 2008; 54: 1031–1038.
14. Davis BR, Oberman A, Blaufox MD et al. Effect of antihypertensive therapy on weight loss. The Trial of Antihypertensive Interventions and Management Research Group. Hypertension 1992; 19: 393–399.
15. Lewington S, Clarke R, Qizilbash N et al. Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002; 360: 1903–1913.
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Diabetology Endocrinology Internal medicineArticle was published in
Internal Medicine
2011 Issue 6
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