title: Study comparing the effect of pioglitazone in combination with either metformin or sulphonylureas on lipid profile and glycaemic control in patients with type 2 diabetes (ECLA).
abstract: OBJECTIVE
  To explore whether the improvement of lipid profile and glycaemic control observed in randomized control trials with pioglitazone (PIO) is replicated under conditions of general clinical practice.
  
  
  METHODS
  We studied 2388 patients with type 2 diabetes (T2DM) not adequately controlled by monotherapy on either metformin (MET) or sulphonylurea (SU). Addition of a second drug, according to the treating physician's choice, resulted in three groups, PIO + MET, PIO + SU and MET + SU, followed for twelve months, while efficacy and safety parameters were measured at baseline, at six and at twelve months.
  
  
  RESULTS
  A total of 2116 (88.6%) patients completed the study. Diabetic control and lipid profile improved in all three groups, but the improvement was always greater in the two PIO groups. At 12 months PIO + SU and PIO + MET groups compared to SU + MET showed greater increase in HDL cholesterol (8.3% and 9.2 versus 4.3% p < 0.001) and greater decrease in HbA1c (1.53% and 1.46% versus 0.97%, p < 0.001 for both), in triglycerides (20.7% and 21.5% versus 15.2%, p < 0.001) and in LDL cholesterol (15.2% and 14.6% versus 11.3%, p < 0.001 and p < 0.01, respectively). All changes were greater in patients already taking hypolipidaemic drugs. As ECLA was an observational study, the major limitation is the introduction of confounding bias which, however, was accounted for in the statistical analysis.
  
  
  CONCLUSIONS
  Since improvement of both glycaemic control and lipid profile are considered main targets in the management of the diabetic patient, the results of the present study, conducted under conditions of everyday clinical practice, show that pioglitazone may be considered a potential choice for the treatment of type 2 diabetes, when lifestyle and metformin fail.
authors.affiliation: Diabetes Center, 2nd Department of Internal Medicine and Research Laboratory, National University of Athens, Hippokration General Hospital, Athens, Greece. diavitologiko1@hippocratio.gr
authors.forename: B
authors.initials: B
authors.lastname: Karamanos
authors.forename: A
authors.initials: A
authors.lastname: Thanopoulou
authors.forename: V
authors.initials: V
authors.lastname: Drossinos
authors.forename: E
authors.initials: E
authors.lastname: Charalampidou
authors.forename: S
authors.initials: S
authors.lastname: Sourmeli
authors.forename: A
authors.initials: A
authors.lastname: Archimandritis
mesh_terms: D000328:Adult; D000368:Aged; D000465:Algorithms; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000378:metabolism; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000494:pharmacology; D050356:Lipid Metabolism / Q000187:drug effects; D008055:Lipids / Q000097:blood*; D008297:Male; D055442:Metabolome / Q000187:drug effects; D008687:Metformin / Q000008:administration & dosage*; D008875:Middle Aged; D000077205:Pioglitazone; D013453:Sulfonylurea Compounds / Q000008:administration & dosage*; D045162:Thiazolidinediones / Q000008:administration & dosage* / Q000494:pharmacology*
chemical_list: D001786:Blood Glucose; D004338:Drug Combinations; D007004:Hypoglycemic Agents; D008055:Lipids; D013453:Sulfonylurea Compounds; D045162:Thiazolidinediones; D008687:Metformin; D000077205:Pioglitazone