Influence of Atorvastatin on Psoriasis Severity and Endothelial Function

shmuel fuchs

Status and phase

Withdrawn

Phase 3

Conditions

Psoriasis

Treatments

Drug: Atorvastatin

Drug: Atorvastatin placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01527097

0263 - 11 - RMC

Details and patient eligibility

About

Patients with psoriasis seem to have increased risk for developing atherosclerosis. This may be due to the fact that psoriasis and atherosclerosis are both caused by inflammation and involvement of cells of the immune system. Atherosclerosis is frequently treated by statins (class of cholesterol lowering drugs), which lower bad cholesterol levels and also reduce inflammation. Some new evidences also suggest that therapy with statins may improve psoriasis skin disease.

The current study aims are to evaluate whether a strong statin named Atorvastatin can improve psoriatic skin disease and functioning of the arteries. The study also aims to evaluate if the activity of these two diseases are related to levels of common inflammatory biomarkers (substance in blood) and whether Atorvastatin can change their levels.

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients older than 20 years
Patients with psoriasis of at least 3-years duration
Current moderate to severe psoriatic disease (PASI ≥12, IGA≥3)
Statin-naïve patients
No history of cardiovascular disease (ischemic heart disease, peripheral vascular disease or cerebrovascular disease)
LDL levels
- LDL level > 70 mg% and < 160 mg% in low risk patients (defined as having none or a single risk factor*)
- LDL > 70 mg% and < 130 mg% in moderate risk patients (defined as the presence of 2 or more risk factors*)
- LDL > 70 mg% and < 100 mg% in patients with type II diabetes
hsCRP ≥ 1 mg/l * Risk factors: smoking, hypertension (blood pressure > 140/90 or current treatment with blood pressure lowering agents, HDL < 40 mg%, family history of premature coronary artery disease in a first degree relative younger than 45 (men) or 55 (women) and obesity (BMI ≥ 30).

Exclusion criteria

Current statin therapy
Patents with Atrial Fibrillation
Elevated liver enzymes (> X3 ULN)
History of statin-induced liver enzyme elevation
Elevated CPK levels (> X3 ULN)
History of myopathy including statin-induced
Severe chronic renal failure (GFR <30 ml/min)
Pregnant or breast-feeding women
Individuals at risk for poor protocol, or medication compliance
Patients with life-expectancy of less than 2 years
Patients who are currently participating in another clinical trial
Other current active inflammatory and/or infectious conditions
Sensitivity to any of atorvastatin ingredients
Concomitant drug therapy, taken on a regular basis, which may interact with Atorvastatin