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

Study Overview
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Brief Summary
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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.

Conditions
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Behcet's Disease

Intervention / Treatment
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* Drug: Rosuvastatin calcium 40mg
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rosuvastatin Drug<br>Active drug-rosuvastatin 40 mg | Drug: Rosuvastatin calcium 40mg<br>* Active drug -Rosuvastatin<br>* Other names: Experimental active drug;Drug: Placebo oral tablet<br>* 40 mg placebo for 12 months<br>* Other names: Placebo comparator;|
| Placebo Comparator: Placebo drug<br>Placebo oral tablet | Drug: Rosuvastatin calcium 40mg<br>* Active drug -Rosuvastatin<br>* Other names: Experimental active drug;Drug: Placebo oral tablet<br>* 40 mg placebo for 12 months<br>* Other names: Placebo comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in endothelial and vascular inflammatory markers | Outcome measures included alterations in endothelial injury and vascular inflammatory markers. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of new-onset vascular involvement |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behcet's Disease, Rosuvastatin, Vascular Markers, Improvement in vascular involvement in Behcet's Disease