Clinical effects of “pioglitazone”, an insulin sensitizing drug, on psoriasis vulgaris and its co-morbidities, a double blinded randomized controlled trialx1

Abstract

Objectives: To evaluate the therapeutic efficacy of pioglitazone on psoriasis vulgaris and its comorbidities.

Materials and methods: Forty-eight patients with moderate-to-severe psoriasis vulgaris were enrolled in this randomized double blinded placebo-controlled trial. Active treatment included: oral pioglitazone 30 mg daily for 10 weeks. Primary outcome (treatment success) was PASI-75. Secondary outcomes included changes in metabolic syndrome, insulin resistance and cardiovascular risk.

Results: Treatment success was achieved in 5/24 (21%) in the pioglitazone group compared to 1/24 (4%) in the placebo group; however, this difference was not significant (p = 0.081). Compared to placebo, no significant difference existed as regards high-sensitive C reactive protein. Metabolic syndrome and insulin resistance were not affected.

Conclusions: This short term (10 weeks duration) study revealed no effect of pioglitazone 30 mg daily neither on the clinical response of moderate-to-severe psoriasis nor on metabolic syndrome and insulin resistance. Cardio-protective role appears to be more related to improvement of psoriasis.

Limitation: Short duration of treatment and small number of subgroups.

• Cardiovascular risk
• insulin resistance
• metabolic syndrome
• psoriasis
• pioglitazone
• randomized controlled trial

Acknowledgements

A great help was received from residents and nurses of the Out-Patient Clinic, Dermatology Department, Faculty of Medicine, Cairo University. Statistical analysis was performed by Dr Magdy I Mostafa, Professor of Gynecology and Obstetrics, Fcaulty of Medicine, Cairo University and Director of Biostatistics Unit, Medical Education Development Centre, Faculty of Medicine, Cairo University.

Declaration of interest

This study was possible due to a partial grant from Cairo University to cover the expenses of the laboratory kits. Furthermore, Pioglitazone tablets (Actozone®) and their placebo were supplied and partially funded by Amoun Pharmaceutical Company, Egypt. The sponsors had no role in the design and conduct of the study; in the collection, analysis, and interpretation of data; or in the preparation, review or approval of the manuscript.

The authors certify that this work received no financial support other than described above and neither the authors nor their first degree relatives has any financial interest in the subject matter discussed in this work.

Notice of Correction:

In the version of this article published online on 1 July 2014, there were a number of formatting errors in the tables. These have been fixed in this version.