Metabolic and Cardiovascular Effects of Armolipid Plus in Subjects With Metabolic Syndrome

Launched by ROTTAPHARM · Nov 19, 2014

Keywords

ClinConnect Summary

Metabolic syndrome (MetS) is a highly prevalent condition characterized by visceral obesity, abnormalities of glucidic and lipid metabolism, and increased risk for cardiovascular events. Such findings appear to be associated with a decrease in insulin sensitivity. Management of metabolic syndrome is currently aimed at treating individual components of the disease without addressing this underlying pathophysiologic mechanism; this translates into multidrug regimens, high costs and patient compliance issues.

A complication of hypertension is hypertrophy of the left ventricle (LV), which is c...

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Eligibility criteria

• Inclusion Criteria:
• * male and Female 18-70 aged, with diagnosis of metabolic syndrome, defined by the presence of waist circumference \>102 cm (♂) or \>88 cm(♀), and two or more of these criteria:
• • fasting blood glucose \>100 mg
• • systolic blood pressure \>135 or diastolic blood pressure \>85 mmHg or patients in treatment with antihypertensive drugs
• • triglyceridemia \>150 mg/dl
• • HDL cholesterolemia \< 40 mg/dl(M), \< 50 mg/dl(F).
• • left ventricular hypertrophy: left ventricular mass indexed to height \>44 g/m2,7(♀)or \>48 g/m2(♂).
• • antihypertensive and lipid-lowering therapy (if applicaple) stable for at least three months.
• • ability to understand and sign an informed consent form.
• Exclusion Criteria:
• • pregnancy or lactation period
• • diabetes mellitus or pharmacological treatment for this condition
• • hepatic failure
• • creatininemia \>2mg/dl
• • triglyceridemia \>500mg/dl
• • severe obesity (BMI \>35)
• • chronic renal failure with glomerular filtration rate \<30ml/min
• • triglycerides \>500mg/dl
• • left ventricular systolic dysfunction (LVEF \<40%)
• • hypertrophic cardiomyopathy
• • valvular stenosis
• • previous myocardial infarction with acinesie
• • intermediate or severe cardiac valve disorders
• • intolerance to any components of Armolipid Plus
• • pacemaker generated arrhythmia
• • Inadequately controlled high blood pressure during therapy optimization (SBP \>140mmHg or DBP \>90mmHg)
• • patients with comorbidities are allowed (e.g. ischemic heart disease, dysthyroidism) but they have got to be in stable therapy for at least 3 months and they did not have major clinical events in the last three months;
• • heart failure.