Clinical trial NCT01527097: Influence of Atorvastatin on Psoriasis Severity and Endothelial Function
Official title: Atorvastatin to Reduce Psoriasis Severity and Improve Endothelial Function in Patients With Severe Psoriasis and Non-Elevated LDL Levels: A Randomized, Double Blind, Placebo-Controlled Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Psoriasis
Keywords: Cardiovascular Diseases
Pharmacologic Actions
Endothelial Function
Dermatology
Inflammatory Disease
Skin Disease
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2012-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary efficacy outcome variable of the study is defined as the composite endpoint of improving of psoriatic severity and endothelial function (assessed by FMD changes).
timeFrame: 3,6 and 12 months after randomization.
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center, Beilinson Hospital
Study officials:
affiliation: Rabin Medical Center, Israel
name: Shmuel Fuchs, Professor
role: STUDY_DIRECTOR
References: