title: Effect of pioglitazone and its combination with statins in coronary artery disease patients with hyperinsulinemia.
abstract: The objective of the study was to demonstrate the effect of pioglitazone and pioglitazone in combination with statin on East Indian patients with hyperinsulinemia and hyperlipidemia. It was a randomized, placebo-controlled, double-blind study with a parallel-group design comprising 83 patients. Patients of either sex with cardiac complications, including hyperlipidemia and (or) diabetes mellitus with or without hyperinsulinemia, were enrolled. Patients over 70 years of age, with renal or hepatic failure, or with severe diabetes mellitus (total glucose >400 mg/dL) were excluded from the study. Enrolled patients were randomly assigned to 4 groups that received placebo, pioglitazone, atorvastatin, or both. Blood samples were collected before and after treatment for analysis of serum glucose, insulin, lipid profile, apolipoprotein (apo) A1, apo B, and fibrinogen. Data were compared with that of patients with normal insulin or hyperinsulinemia. The patients with hyperinsulinemia receiving only pioglitazone showed a significant decrease in insulin levels compared with those with normal insulin levels. These patients also showed a significant increase in HDL levels. However, no significant change was observed in patients treated with both atorvastatin and pioglitazone. Pioglitazone was also found to increase significantly the apo A1 levels in patients with hyperinsulinemia, but there was no significant increase in patients given both atorvastatin and pioglitazone. Our data suggests that pioglitazone should be given preferably to the patients with hyperinsulinemia and statin should not be coadministered.
authors.affiliation: Lallubhai Motilal College of Pharmacy, Navarangpura, Ahmedabad, GJ 380009, India.
authors.forename: Anita
authors.initials: A
authors.lastname: Mehta
authors.forename: Urmil
authors.initials: U
authors.lastname: Shah
authors.forename: Keyur
authors.initials: K
authors.lastname: Parikh
authors.forename: Milan
authors.initials: M
authors.lastname: Chag
authors.forename: Hemang
authors.initials: H
authors.lastname: Baxi
authors.forename: Anish
authors.initials: A
authors.lastname: Chandarana
authors.forename: Ajay
authors.initials: A
authors.lastname: Naik
authors.forename: Asha
authors.initials: A
authors.lastname: Naik
authors.forename: Kanan
authors.initials: K
authors.lastname: Shah
authors.forename: Ramesh
authors.initials: R
authors.lastname: Goyal
mesh_terms: D016632:Apolipoprotein A-I / Q000097:blood; D001055:Apolipoproteins B / Q000097:blood; D000069059:Atorvastatin; D001786:Blood Glucose / Q000378:metabolism; D015992:Body Mass Index; D008076:Cholesterol, HDL / Q000097:blood; D003324:Coronary Artery Disease / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D048909:Diabetes Complications / Q000097:blood / Q000188:drug therapy; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005340:Fibrinogen / Q000378:metabolism; D006538:Heptanoic Acids / Q000627:therapeutic use; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D006946:Hyperinsulinism / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007328:Insulin / Q000097:blood; D007329:Insulin Antagonists / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D000077205:Pioglitazone; D011758:Pyrroles / Q000627:therapeutic use; D045162:Thiazolidinediones / Q000627:therapeutic use*; D016896:Treatment Outcome