title: Health and economic outcomes for exenatide once weekly, insulin, and pioglitazone therapies in the treatment of type 2 diabetes: a simulation analysis.
abstract: BACKGROUND
  Patients with type 2 diabetes (T2DM) are at risk of long-term vascular complications. In trials, exenatide once weekly (ExQW), a GLP-1R agonist, improved glycemia, weight, blood pressure (BP), and lipids in patients with T2DM. We simulated potential effects of ExQW on vascular complications, survival, and medical costs over 20 years versus standard therapies.
  
  
  METHODS
  The Archimedes model was used to assess outcomes for ~25,000 virtual patients with T2DM (NHANES 1999-2006 [metformin ± sulfonylureas, age 57 years, body mass index 33 kg/m(2), weight 94 kg, duration T2DM 9 years, hemoglobin A1c [A1C] 8.1%]). The effects of three treatment strategies were modeled and compared to moderate-adherence insulin therapy: advancement to high-adherence insulin at A1C ≥ 8% (treat to target A1C < 7%) and addition of pioglitazone (PIO) or ExQW from simulation start. ExQW effects on A1C, weight, BP, and lipids were modeled from clinical trial data. Costs, inflated to represent 2010 $US, were derived from Medicare data, Drugstore.com, and publications. As ExQW was investigational, we omitted ExQW, PIO, and insulin pharmacy costs.
  
  
  RESULTS
  By year 1, ExQW treatment decreased A1C (~1.5%), weight (~2 kg), and systolic BP (~5 mmHg). PIO and high-adherence insulin decreased A1C by ~1%, increased weight, and did not affect systolic BP. After 20 years, A1C was ~7% with all strategies. ExQW decreased rates of cardiovascular and microvascular complications more than PIO or high-adherence insulin versus moderate-adherence insulin. Over 20 years, ExQW treatment resulted in increased quality-adjusted life-years (QALYs) of ~0.3 years/person and cost savings of $469/life-year versus moderate adherence insulin. For PIO or high-adherence insulin, QALYs were virtually unchanged, and costs/life-year versus moderate-adherence insulin increased by $69 and $87, respectively.
  
  
  CONCLUSIONS
  This long-term simulation demonstrated that ExQW treatment may decrease rates of cardiovascular and some microvascular complications of T2DM. Increased QALYs, and decreased costs were also projected.
authors.affiliation: Amylin Pharmaceuticals, Inc, San Diego, CA, USA.
authors.forename: Julia A
authors.initials: JA
authors.lastname: Gaebler
authors.forename: Gerardo
authors.initials: G
authors.lastname: Soto-Campos
authors.forename: Peter
authors.initials: P
authors.lastname: Alperin
authors.forename: Marc
authors.initials: M
authors.lastname: Cohen
authors.forename: Amy
authors.initials: A
authors.lastname: Blickensderfer
authors.forename: Matthew
authors.initials: M
authors.lastname: Wintle
authors.forename: David
authors.initials: D
authors.lastname: Maggs
authors.forename: Byron
authors.initials: B
authors.lastname: Hoogwerf
authors.forename: Jenny
authors.initials: J
authors.lastname: Han
authors.forename: Richard
authors.initials: R
authors.lastname: Pencek
authors.forename: Barbara
authors.initials: B
authors.lastname: Peskin
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D003198:Computer Simulation; D003362:Cost-Benefit Analysis; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000191:economics* / Q000401:mortality; D003925:Diabetic Angiopathies / Q000191:economics / Q000401:mortality / Q000517:prevention & control; D004334:Drug Administration Schedule; D016527:Drug Costs; D000077270:Exenatide; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000191:economics*; D007328:Insulin / Q000008:administration & dosage / Q000191:economics*; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D018803:Models, Economic; D009749:Nutrition Surveys; D010043:Outcome and Process Assessment, Health Care / Q000191:economics*; D010455:Peptides / Q000008:administration & dosage / Q000191:economics*; D000077205:Pioglitazone; D019057:Quality-Adjusted Life Years; D018570:Risk Assessment; D012307:Risk Factors; D045162:Thiazolidinediones / Q000008:administration & dosage / Q000191:economics*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D014688:Venoms / Q000008:administration & dosage / Q000191:economics*
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D000077270:Exenatide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D010455:Peptides; D000077205:Pioglitazone; D045162:Thiazolidinediones; D014688:Venoms; C517652:hemoglobin A1c protein, human