title: Patient and physician factors influence decision-making in hypercholesterolemia: a questionnaire-based survey.
abstract: BACKGROUND
  Goal attainment of guideline-recommended low-density lipoprotein cholesterol (LDL-C) is suboptimal. Little is known about how patient factors influence physicians' treatment decision-making in hypercholesterolemia. We examined physicians' treatment recommendations in high-risk patients whose LDL-C remained uncontrolled despite statin monotherapy.
  
  
  METHODS
  Physicians completed a questionnaire prior to randomization into period I of a two-period randomized controlled trial evaluating LDL-C goal attainment in patients whose LDL-C remained ≥100 mg/dL after 5 weeks' treatment with atorvastatin 10 mg/day (NCT01154036). Physicians' treatment recommendations were surveyed for two hypothetical and one real scenario: (1) LDL-C presumed near goal (between 100-105 mg/dL), (2) LDL-C presumed far from goal (~120 mg/dL), and (3) observed baseline LDL-C of enrolled patients. Prognostic factors considered during decision-making were identified by regression analysis. Observed lipid outcomes at the end of period I (following 6 weeks' treatment with ezetimibe 10 mg plus atorvastatin 10 mg, atorvastatin 20 mg, or rosuvastatin 10 mg) were compared with estimated LDL-C outcomes for physicians' treatment recommendations after 6 weeks (based on individual patients' pre-randomization LDL-C and expected incremental change).
  
  
  RESULTS
  Questionnaires were completed for 1,534 patients. No change in therapy, or double atorvastatin dose, were frequently recommended, even when LDL-C was far from goal (6.5% and 52.2% of patients, respectively). Double atorvastatin dose was commonly recommended in all scenarios (43-52% of patients). More intensive LDL-C-lowering regimens were recommended infrequently e.g. double atorvastatin dose and add ezetimibe only <12% in all scenarios. Overall, cardiovascular risk factors and desire to achieve a more aggressive LDL-C goal were prominent factors in decision-making for treatment. Comparison of observed and estimated LDL-C levels showed that physicians tended to overestimate the effectiveness of their recommendations.
  
  
  CONCLUSIONS
  This study provides insight into physicians' perspectives on clinical management of hypercholesterolemia and highlights a gap in knowledge translation from guidelines to clinical practice. The need for lower LDL-C and cardiovascular risk were key drivers in clinical decision-making, but physicians' treatment choices were more conservative than guideline recommendations, potentially resulting in poorer LDL-C reduction. When compared with actual outcomes, projected LDL-C control was better if physicians used more comprehensive strategies rather than simply doubling the statin dose.
  
  
  BACKGROUND
  Clinicaltrials.gov: NCT01154036.
authors.affiliation: Endocrinology and Nutrition, Hôpital Laënnec, Nantes, 44035, France. michel.krempf@univ-nantes.fr.
authors.forename: Michel
authors.initials: M
authors.lastname: Krempf
authors.affiliation: Center for Heart and Vascular Care, University of North Carolina, Chapel Hill, NC, USA. ross_simpson@med.unc.edu.
authors.forename: Ross J
authors.initials: RJ
authors.lastname: Simpson
authors.affiliation: Merck & Co, Inc., Kenilworth, NJ, USA. dena_ramey@merck.com.
authors.forename: Dena Rosen
authors.initials: DR
authors.lastname: Ramey
authors.affiliation: Merck & Co, Inc., Kenilworth, NJ, USA. philippe_brudi@merck.com.
authors.forename: Philippe
authors.initials: P
authors.lastname: Brudi
authors.affiliation: MSD Inc., Brussels, Belgium. hilde_giezek@merck.com.
authors.forename: Hilde
authors.initials: H
authors.lastname: Giezek
authors.affiliation: Merck & Co, Inc., Kenilworth, NJ, USA. joanne_tomassini@merck.com.
authors.forename: Joanne E
authors.initials: JE
authors.lastname: Tomassini
authors.affiliation: Merck & Co, Inc., Kenilworth, NJ, USA. raymond_lee2@merck.com.
authors.forename: Raymond
authors.initials: R
authors.lastname: Lee
authors.affiliation: Point Medical, 21000, Dijon, France. michelfarnier@nerim.net.
authors.forename: Michel
authors.initials: M
authors.lastname: Farnier
mesh_terms: D000368:Aged; D000924:Anticholesteremic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D000069059:Atorvastatin / Q000008:administration & dosage / Q000627:therapeutic use; D008078:Cholesterol, LDL / Q000097:blood; D004359:Drug Therapy, Combination; D000069438:Ezetimibe / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010347:Patient Care Planning; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D000068718:Rosuvastatin Calcium / Q000008:administration & dosage / Q000627:therapeutic use; D011795:Surveys and Questionnaires
chemical_list: D000924:Anticholesteremic Agents; D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000068718:Rosuvastatin Calcium; D000069059:Atorvastatin; D000069438:Ezetimibe