Περίληψη:
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. Research design and 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, PIOMET, PIOSU and METSU, 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 PIOSU and PIOMET groups compared to SUMET 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. © 2011 Informa UK Ltd All rights reserved.
Συγγραφείς:
Karamanos, B.
Thanopoulou, A.
Drossinos, V.
Charalampidou, E.
Sourmeli, S.
Archimandritis, A.
Λέξεις-κλειδιά:
antilipemic agent; atorvastatin; fluindostatin; glibenclamide; gliclazide; glimepiride; hemoglobin A1c; high density lipoprotein cholesterol; lipid; low density lipoprotein cholesterol; metformin; mevinolin; pioglitazone; pravastatin; rosuvastatin; simvastatin; sulfonylurea derivative; triacylglycerol, adult; anemia; article; cholesterol blood level; clinical practice; comparative study; diabetic patient; diarrhea; dizziness; drug dose titration; drug efficacy; drug safety; edema; female; flatulence; glycemic control; headache; human; hypoglycemia; lipid analysis; major clinical study; male; multicenter study; non insulin dependent diabetes mellitus; phase 4 clinical trial; randomized controlled trial; treatment duration; treatment outcome; triacylglycerol blood level, Adult; Aged; Algorithms; Blood Glucose; Diabetes Mellitus, Type 2; Drug Combinations; Female; Humans; Hypoglycemic Agents; Lipid Metabolism; Lipids; Male; Metabolome; Metformin; Middle Aged; Sulfonylurea Compounds; Thiazolidinediones
