Effects of Nebivolol Versus Metoprolol Succinate on Endothelial Function (NEMENDAS)

Berlin Chemie

Status and phase

Completed

Phase 4

Conditions

Hypertension

Treatments

Drug: Nebivolol

Drug: metoprolol succinate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01248338

MeES/05/Neb-EnD/001

Details and patient eligibility

About

An impairment of endothelial function plays the central role in the pathogenesis of cardiovascular diseases and their complications. Most of cardiovascular risk factors are known to impair endothelial function and the established disease further aggravates endothelial dysfunction.

The aim of the present study is to investigate the effects of nebivolol or metoprolol succinate on endothelial function and large artery stiffness.

Full description

The aim of this study was to compare the effects between the vasodilating β-blocker nebivolol and the cardioselective β-blocker metoprolol succinate on aortic blood pressure and left ventricular wall thickness. We conducted a randomized, double-blind study in 80 hypertensive patients. Patients received either nebivolol 5 mg or metoprolol succinate 50-100 mg daily for one year. Their heart rate, central and brachial blood pressure, mean arterial pressure, augmentation index, carotid-femoral pulse wave velocity and left ventricular wall thickness were measured at baseline and at the end of the study.

Enrollment

80 patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with mild to moderate essential hypertension (systolic BP 140-179 mmHg and/or diastolic BP 90-109 mmHg)*
Male and female patients aged 30-65 years Newly diagnosed untreated patients or previously diagnosed patients who were without treatment at least two weeks prior to screening* If patient has been taken previously antihypertensive medication the BP values are originated after untreated two weeks before randomization

Exclusion criteria

Concomitant medication: Cyclic antidepressants, MAO inhibitors, corticosteroids
Diabetes I or II type (fasting venous plasma glucose > 6.4 mmol/l)
Bronchial asthma and chronic obstructive airway disease
Body mass index > 30 kg/m2
Ischaemic heart disease (III, IV stage, Canadian Cardiovascular Society)
Clinically relevant heart failure (NYHA class II - IV)
Clinically relevant valve disease (physical examination)
Arrhythmias and conduction disturbances, requiring therapy, sinus bradycardia at rest < 50 b/min, sick sinus syndrome, AV - block stage II - III
Secondary hypertension (urea >8.3 mmol/l, creatinine >120μmol/l (males), >103 μmol/l (females), TSH > 4.0mIU/l, free T4 > 27 pmol/l)
Clinically relevant atherosclerotic disease of lower extremities
Acute inflammation (according to CRP > 10mg/l)
Hypercholesterolemia (> 6,5 mmol/l)
Allergic reaction to beta-blockers
Pregnant or breast-feeding women
History of hepatic, renal, metabolic or endocrine diseases
Smoking > 10 cigarettes per day
Alcohol consumption > 7 drinks per week (drink = 0,33 l beer, 120 ml wine or 30 ml strong alcoholic drink)
The patient has had surgery or disease of the gastrointestinal tract which, in the opinion of the investigator, may influence the absorption or elimination of the study drug.
The patient has a severe organic disorder that may interfere with the absorption, pharmacokinetics, or elimination of the study medication.
The patient has a comorbid condition that would be expected to result in death during the trial period (e.g., terminal cancer, AIDS).
The patient has chronic psychoses or behavioural conditions that would limit the ability of the patient to comply with the requirements of this study.
The patient has known hypersensitivity to Nebivolol, Metoprolol or hydrochlorothiazide related compounds.
Patient is enrolled in another clinical trial.