The Role of Rosuvastatin on Vascular Involvement in Behçet's Disease

University of Alexandria

Status: Completed

Conditions: Behcet's Disease

Treatments: Drug: Rosuvastatin calcium 40mg; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04328064

alexmed116619312

Details and patient eligibility

About

Behçet's Disease(BD) is a systemic inflammatory vasculitis, which affects all types and sizes of vessels. Statins display numerous effects often independent of the well-established lipid-lowering effects that may be of benefit in retarding or preventing vascular injury and ischaemic vascular events. The aim of the present study was to determine the efficacy of rosuvastatin in improving vascular dysfunction and vascular inflammation and to assess the effect of rosuvastatin on vascular involvement in BD patients. Fifty-six BD patients (51 males and 5 females) mean age 33.4 years, mean disease duration 5.8 years), all fulfilling the classification criteria of the International Study Group for Behçet's disease were recruited.Patients were randomised into 2 groups.

The first group (n=27: 20 active and 7 inactive) were assigned to receive 40 mg of rosuvastatin and the second group(n=29: 21 active and 8 inactive) received placebo for 12 months. Inflammatory and endothelial dysregulation markers were measured at baseline and after 12 months. All patients were examined for vascular involvement. Venous or arterial system involvement was defined as present when confirmed by Doppler ultrasonography, magnetic resonance angiography, conventional angiography or CT.

Enrollment: 56 patients

Sex: All

Ages: 17 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• all patients fulfilling the classification criteria of the International Study Group for Behçet's disease

Exclusion criteria

• smoking,
• diabetes mellitus,
• hypercholesterolaemia,
• hypertension,
• cardiac insufficiency,
• coexisting hepatic and renal diseases
• inflammatory diseases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

Rosuvastatin Drug

Active Comparator group

Description:

Active drug-rosuvastatin 40 mg

Treatment:

Drug: Placebo oral tablet

Drug: Rosuvastatin calcium 40mg

Placebo drug

Placebo Comparator group

Description:

Placebo oral tablet

Treatment:

Drug: Placebo oral tablet

Drug: Rosuvastatin calcium 40mg