Study Setting and Patients
The study was performed in the psoriasis outpatient clinic at Razi Hospital, Tehran University of Medical Sciences (Tehran, Iran). Patients aged 16–60 years with the clinical diagnosis of acute or chronic plaque-type psoriasis with body surface area (BSA) involvement of 10% or greater were included. Diagnosis of psoriasis was made by a dermatologist. Before participating in the study, patients were required to have a washout period of psoriasis pharmacotherapy for at least 1 month for phototherapy and systemic drugs, and 2 weeks for topical therapies. In addition, patients were not allowed to receive statins within 1 month before study participation.
Exclusion criteria were as follows: patients with types of skin psoriasis other than plaque; patients with psoriatic arthritis; patients who were pregnant or breastfeeding; and patients with any contraindication to atorvastatin.
The study was conducted in accordance with the Declaration of Helsinki and approved by the ethics committee of Tehran University of Medical Sciences. Written informed consent was obtained from all participants at study entry.
This study was a double-blind, randomized, placebo-controlled, 12-week trial. Eligible patients were randomly assigned by using a permuted block randomization table to receive either oral atorvastatin 40 mg/day or an identical placebo tablet. Other treatments permitted during the trial for psoriasis included emollients and other topical therapy with keratolytics and/or class V corticosteroids: fluocinolone acetonide 0.025% cream and/or salicylic acid 5% in petroleum, as well as triamcinolone acetonide 0.1% cream for face and flexures.
Efficacy was assessed by the Psoriasis Area and Severity Index (PASI) and percentage BSA involvement. The PASI is a measure of overall psoriasis severity and coverage, with a higher score indicating more severe psoriasis (scores range from 0 [no disease] to 72 [most severe disease]).[21,22] The primary outcomes were the degree of change in PASI scores and percentage BSA involvement from baseline to week 12. The PASI and BSA evaluations were performed at baseline, every 4 weeks, and at the end of week 12. Safety, patient-reported clinical improvement, and the proportion of patients who achieved at least 75% improvement in PASI score (PASI 75) by week 12 were assessed as secondary end points.
Safety of atorvastatin was evaluated through patients' reports of adverse effects at each clinic visit. Liver function tests were also performed and recorded at study entry and as needed to assess reported adverse effects.
SPSS software, version 11.5 (SPSS Inc., Chicago, IL), was used for statistical analysis. Continuous variables are reported as mean ± SD. A paired t test was used to compare the before and after changes. Comparison of mean difference between placebo and atorvastatin groups was performed by using univariate analysis of variance adjusted for baseline values. The percentage of change was compared by using χ2 analysis.
Pharmacotherapy. 2011;31(11):1045-1050. © 2011 Pharmacotherapy Publications
Cite this: Atorvastatin for the Treatment of Plaque-type Psoriasis - Medscape - Nov 01, 2011.