Influence of Atorvastatin on Psoriasis Severity and Endothelial Function

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.

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.

Study Overview

• Status: Withdrawn
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Atorvastatin; Drug: Atorvastatin placebo

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Petach Tikva, Israel, 49100
    • Rabin Medical Center, Beilinson Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Atorvastatin placebo; Atorvastatin 80mg during 6 month and 40mg in additional 6 month period once daily.
Experimental: Atorvastatin	Drug: Atorvastatin; Drug: Atorvastatin 80 mg for 6 months following by 40 mg for additional 6 months once daily.; Other Names: Lipitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Patient invited to clinic visits at 3,6 and 12 month follow up.At this visits in addition primary outcome will be measured.	3,6 and 12 months after randomization.

Collaborators and Investigators

• Sponsor: shmuel fuchs
• Investigators: Study Director: Shmuel Fuchs, Professor, Rabin Medical Center, Israel

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: January 15, 2012
• First Submitted That Met QC Criteria: February 3, 2012
• First Posted (Estimate): February 6, 2012

Study Record Updates

• Last Update Posted (Estimate): November 17, 2015
• Last Update Submitted That Met QC Criteria: November 16, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Endothelial Function; Dermatology; Pharmacologic Actions; Skin Disease; Inflammatory Disease
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: 0263 - 11 - RMC