Efficacy of Atorvastatin as Adjunctive Treatment for Chronic Plaque Type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aimed to assess the efficacy and safety of atorvastatin 40 mg/day as an adjunct to
      betamethasone valerate 0.1% ointment applied twice daily in the treatment of patients with
      mild to moderate chronic plaque type psoriasis, as determined by mean reduction in PASI
      scores. Specific objectives included the determination and comparison of the absolute number
      and proportion of patients who achieved PASI-50 and the mean reductions in lipid profile
      (total cholesterol, HDL, LDL, triglycerides) and high-sensitivity C-reactive protein (hsCRP)
      measured from baseline and every month thereafter up to 6 months of treatment. This study
      also investigated the impact of atorvastatin treatment on the patients' quality of life as
      well as the association of clinical response to the lipid-lowering and anti-inflammatory
      effects of atorvastatin.
    

Detailed description: 
      This was a single-center, parallel-group, randomized, double-blind, placebo-controlled
      clinical trial. The study was conducted from February 2013 to October 2013 at a dermatology
      out-patient clinic in a tertiary hospital in the Philippines. Twenty-eight patients aged
      19-65 years old assessed to have mild to moderate chronic plaque psoriasis, with psoriasis
      area and severity index (PASI) scores less than 10, were enrolled into the study and
      randomized into two equal treatment groups. Before participating in the study, patients were
      required to have a washout period of psoriasis pharmacotherapy for at least 2 months for
      phototherapy and systemic drugs, and 2 weeks for topical therapies.

      Exclusion criteria were as follows: patients with uncontrolled hypertension, endocrine or
      other metabolic diseases; patients with known allergy to any of the treatments; patients with
      active liver disease or liver enzymes (AST and ALT) thrice the upper limit; patients with any
      myopathy or presence of elevated creatine kinase (CK-MM) levels; patients taking any drug
      that might interact with statins and those already taking statins or patients with clear
      indications for statin treatment; patients with impaired renal function or creatinine > 2.0
      mg/dL; patients with active infection or white blood cell (WBC) > 10 and pregnant or
      lactating females. The study was conducted in accordance with the Declaration of Helsinki and
      approved by the ethics committee. Informed consent was obtained from all participants at
      study entry.

      Patients were randomly assigned into the two groups through a computer-generated
      randomization table with sequencing of assignments unknown to the primary investigator. The
      assigned interventions were placed in sequentially-numbered, opaque envelopes, which were
      opened by one of the secondary investigators only after the patient had agreed to participate
      in the study. Patients were assigned numerical codes that were indicated in their case record
      forms.

      Fourteen patients took atorvastatin 40 mg once a day while 14 patients took a similar-looking
      placebo tablet once a day. The study duration was 6 months. All patients were allowed to
      continue the use of betamethasone valerate 0.1% ointment twice a day for the duration of the
      study. Dispensing of the medications was done by a secondary investigator, while clinical
      assessment was done by the primary investigator who was blinded to the treatment assignments.

      Patients' PASI scores, lipid profiles, aspartate aminotransferase (AST), alanine
      aminotransferase (ALT), hsCRP levels, and dermatology life and quality index (DLQI) scores
      were taken at baseline. Recording of the lipid profile, and AST, ALT values was done by
      another secondary investigator so that the primary investigator would not be biased by the
      decreasing values of the lipid profile or elevations in the AST or ALT. Photo-documentation
      was done throughout the study. Patients were also asked to bring their medications each visit
      so that the primary investigator could check for compliance. PASI scores, lipid profiles,
      AST, and ALT levels were monitored monthly, while DLQI scores and hsCRP levels were evaluated
      again after 6 months of therapy. Difference in the mean changes in PASI scores, lipid profile
      levels, DLQI scores, and hsCRP levels between groups were compared. Difference in the
      proportion of patients reaching 50% reduction in PASI scores (PASI-50) after 3 months and
      that after 6 months of therapy were compared. Correlation between the changes in PASI scores
      and the changes in lipid profile levels, as well as correlation between the changes in PASI
      scores and the changes in hsCRP levels were computed.

      The period of observation for adverse events started from the time the subject received the
      first dose of the study drug until his last follow-up. Adverse event monitoring was by active
      query and spontaneous reporting.

      Intention-to-treat analysis was the primary efficacy analysis. Patients included were those
      who had at least one assessment beyond baseline (Month 1). The last measurement of each
      randomized patient was moved forward to represent the end-of-treatment measurement at 6
      months. Per-protocol analysis was the secondary efficacy analysis. All data analyses were
      performed using a statistical software (STATA 12.0).
    

Intervention name(s): Atorvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Atorvastatin is a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor used to treat dyslipidemia; Placebo tablets, made to look like the interventional drug
Other intervention name(s): Atopitar
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic plaque psoriasis; psoriasis; atorvastatin; psoriasis area and severity index; betamethasone valerate