title: Variation in the net benefit of aggressive cardiovascular risk factor control across the US population of patients with diabetes mellitus.
abstract: BACKGROUND
  Lowering low-density lipoprotein cholesterol (LDL-C) and blood pressure (BP) in patients with diabetes mellitus (DM) can significantly reduce the risk of cardiovascular disease (CVD). However, to our knowledge, previous studies have not assessed variability in both the benefit and harm from pursuing LDL-C and BP target levels.
  
  
  METHODS
  Our sample comprised individuals 30 to 75 years old with DM participating in the National Health and Nutrition Examination Survey III. We used Monte Carlo methods to simulate a treat-to-target strategy, in which patients underwent treatment intensification with the goal of achieving LDL-C and BP target levels of 100 mg/dL and 130/80 mm Hg, respectively. Patients received up to 5 titrations of statin therapy and 8 titrations of antihypertensive therapy. Treatment adverse effects and polypharmacy risks and burdens were incorporated using disutilities. Health outcomes were simulated using a Markov model.
  
  
  RESULTS
  Treating to targets resulted in gains of 1.50 (for LDL-C) and 1.35 (for BP) quality-adjusted life-years (QALYs) of lifetime treatment-related benefit, which declined to 1.42 and 1.16 QALYs after accounting for treatment-related harms. Most of the total benefit was limited to the first few steps of medication intensification or to tight control for a limited group of very high-risk patients. However, because of treatment-related disutility, intensifying beyond the first step (LDL-C) or third step (BP) resulted in either limited benefit or net harm for patients with below-average risk.
  
  
  CONCLUSIONS
  The benefits and harms from aggressive risk factor modification vary widely across the US population of individuals with DM, depending on a patient's underlying CVD risk, suggesting that a personalized approach could maximize a patient's net benefit from treatment.
authors.affiliation: RAND Health, RAND Corp, 1200 S Hayes St, Arlington, VA 22202, USA. jtimbie@rand.org
authors.forename: Justin W
authors.initials: JW
authors.lastname: Timbie
authors.forename: Rodney A
authors.initials: RA
authors.lastname: Hayward
authors.forename: Sandeep
authors.initials: S
authors.lastname: Vijan
mesh_terms: D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D002318:Cardiovascular Diseases / Q000453:epidemiology* / Q000209:etiology / Q000517:prevention & control; D008078:Cholesterol, LDL / Q000097:blood / Q000187:drug effects; D003920:Diabetes Mellitus / Q000097:blood / Q000188:drug therapy / Q000453:epidemiology*; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D015994:Incidence; D008875:Middle Aged; D011159:Population Surveillance / Q000379:methods*; D011788:Quality of Life; D012189:Retrospective Studies; D012307:Risk Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
chemical_list: D000959:Antihypertensive Agents; D008078:Cholesterol, LDL; D006442:Glycated Hemoglobin; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors