title: Pioglitazone improves the cardiovascular profile in patients with uncomplicated systemic lupus erythematosus: a double-blind randomized clinical trial.
abstract: OBJECTIVE
  We studied the effect of pioglitazone on insulin levels, inflammation markers, high-density lipoprotein (HDL) composition and subclasses distribution, in young women with uncomplicated systemic lupus erythematosus (SLE).
  
  
  METHODS
  This double-blind trial included 30 premenopausal women (30 ±8 years old) with SLE, who were randomized to pioglitazone (30 mg/day) or placebo treatment for 3 months. Plasma and HDL lipids were determined by colorimetric enzymatic assays, insulin by radioimmunometric assay, inflammation by immunonephelometry and HDL size and subclasses distribution by a native 4-30% polyacrylamide gradient gel electrophoresis.
  
  
  RESULTS
  Compared with placebo, pioglitazone significantly increased HDL-cholesterol plasma levels (14.2%), reduced fasting insulin plasma levels (23.6%) and the homeostasis model assessment-insulin resistance (31.7%). C-reactive protein (70.9%) and serum amyloid A (34.9%) were also significantly reduced with the pioglitazone use, whereas the HDL particle size was increased (8.80 nm vs. 8.95 nm; p = 0.044) by changes in the distribution of HDL(2b), HDL(3b), and HDL(3c) subclasses. The change in HDL size correlated with a rise in free and cholesterol-ester content in the HDL particles.
  
  
  CONCLUSIONS
  Pioglitazone significantly enhanced insulin sensitivity, reduced inflammation, and modified HDL characteristics, suggesting a potential beneficial effect of this drug in patients with SLE with a risk to develop cardiovascular disease.
  
  
  BACKGROUND
  This trial is registered at ClinicalTrials.gov Protocol Registration System, with the number NCT01322308.
authors: Endocrinology Department, National Institute of Cardiology "Ignacio Chávez", Mexico.
authors: J G
authors: JG
authors: Juárez-Rojas
authors: A X
authors: AX
authors: Medina-Urrutia
authors: E
authors: E
authors: Jorge-Galarza
authors: N A
authors: NA
authors: Caracas-Portilla
authors: R
authors: R
authors: Posadas-Sánchez
authors: G C
authors: GC
authors: Cardoso-Saldaña
authors: M V
authors: MV
authors: Goycochea-Robles
authors: L H
authors: LH
authors: Silveira
authors: L
authors: L
authors: Lino-Pérez
authors: J
authors: J
authors: Mas-Oliva
authors: O
authors: O
authors: Pérez-Méndez
authors: C
authors: C
authors: Posadas-Romero
mesh_terms: D000328:Adult; D002318:Cardiovascular Diseases / Q000209:etiology* / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008180:Lupus Erythematosus, Systemic / Q000150:complications* / Q000188:drug therapy*; D000077205:Pioglitazone; D010919:Placebos / Q000627:therapeutic use; D011446:Prospective Studies; D045162:Thiazolidinediones / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D007004:Hypoglycemic Agents; D010919:Placebos; D045162:Thiazolidinediones; D000077205:Pioglitazone