title: Assessment on the Prevention of Progression by Rosiglitazone on Atherosclerosis in diabetes patients with Cardiovascular History (APPROACH): study design and baseline characteristics.
abstract: BACKGROUND
  Rosiglitazone, a thiazolidinedione, has effects on insulin sensitivity and cardiovascular risk factors that may favorably impact the progression of coronary atherosclerosis.
  
  
  METHODS
  APPROACH is a double-blind randomized clinical trial comparing the effects of the insulin sensitizer rosiglitazone with the insulin secretagogue glipizide on the progression of coronary atherosclerosis. Patients with type 2 diabetes and coronary artery disease undergoing clinically indicated coronary angiography or percutaneous coronary intervention are randomized to receive rosiglitazone or glipizide for 18 months using a titration algorithm designed to provide comparable glycemic control between treatment groups. The primary end point is change in percent atheroma volume from baseline to study completion in a nonintervened coronary artery, as measured by intravascular ultrasound. Cardiovascular events are adjudicated by an end point committee.
  
  
  RESULTS
  A total of 672 patients were randomized. The mean age was 61 years, hemoglobin A(1c) (HbA(1c)) 7.2%, body mass index 29.5 kg/m(2), and median duration of diabetes 4.8 years. At baseline, approximately half of the participants were receiving oral antidiabetic monotherapy (53.9%) with 27.5% receiving dual combination therapy and 17.9% treated with diet and exercise alone. Approximately two thirds of the participants (68%) had dyslipidemia, 79.9% hypertension, and 24% prior myocardial infarction.
  
  
  CONCLUSIONS
  APPROACH has fully enrolled a high-risk patient population and will compare the glucose-independent effects of rosiglitazone and glipizide on the progression of coronary atherosclerosis, as well as provide additional data on the cardiovascular safety of rosiglitazone in patients with type 2 diabetes and coronary artery disease.
authors.affiliation: MedStar Research Institute, Washington, DC, USA. Robert.ratner@medstar.net
authors.forename: Robert E
authors.initials: RE
authors.lastname: Ratner
authors.forename: Christopher P
authors.initials: CP
authors.lastname: Cannon
authors.forename: Hertzel C
authors.initials: HC
authors.lastname: Gerstein
authors.forename: Richard W
authors.initials: RW
authors.lastname: Nesto
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Gerrit-Anne
authors.initials: GA
authors.lastname: Van Es
authors.forename: Nikheel S
authors.initials: NS
authors.lastname: Kolatkar
authors.forename: Barbara G
authors.initials: BG
authors.lastname: Kravitz
authors.forename: Andrew
authors.initials: A
authors.lastname: Zalewski
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Fitzgerald
mesh_terms: D000328:Adult; D000368:Aged; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000517:prevention & control*; D003924:Diabetes Mellitus, Type 2 / Q000000981:diagnostic imaging / Q000188:drug therapy*; D003925:Diabetic Angiopathies / Q000000981:diagnostic imaging / Q000517:prevention & control*; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D005913:Glipizide / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D000077154:Rosiglitazone; D045162:Thiazolidinediones / Q000009:adverse effects / Q000627:therapeutic use*; D018084:Ultrasonography, Interventional
chemical_list: D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D000077154:Rosiglitazone; D005913:Glipizide