title: Are generic and brand-name statins clinically equivalent? Evidence from a real data-base.
abstract: BACKGROUND
  Use of generic drugs can help contain drug spending. However, there is concern among patients and physicians that generic drugs may be clinically inferior to brand-name ones. This study aimed to compare patients treated with generic and brand-name statins in terms of therapeutic interruption and cardiovascular (CV) outcomes.
  
  
  METHODS
  13,799 beneficiaries of the health care system of Lombardy, Italy, aged 40 years or older who were newly treated with generic or brand-name simvastatin during 2008, were followed until 2011 for the occurrence of two outcomes: 1) therapeutic discontinuation and 2) hospitalization for CV events. Hazard ratios (HR) associated with use of generic or brand-name at starting therapy (intention-to-treat analysis) and during follow-up (as-treated analysis) were estimated by fitting proportional hazard Cox models. A Monte-Carlo sensitivity analysis was performed to account for unmeasured confounders.
  
  
  RESULTS
  Patients who started on generic did not experience a different risk of discontinuation (HR: 0.98; 95% CI 0.94 to 1.02) nor of CV outcomes (HR: 0.98; 95% CI 0.79 to 1.22) from those starting on brand-name. Patients who spent >75% of time of follow-up with statin available on generics did not experience a different risk of discontinuation (HR: 0.94; 95% CI 0.87 to 1.01), nor of CV outcomes (HR: 1.06; 95% CI 0.83 to 1.34), compared with those who mainly or only used brand-name statin.
  
  
  CONCLUSIONS
  Our findings do not support the notion that in the real world clinical practice brand-name statins are superior to generics for keeping therapy and preventing CV outcomes.
authors.affiliation: Department of Statistics and Quantitative Methods, Division of Biostatistics, Epidemiology and Public Health, Laboratory of Healthcare Research and Pharmacoepidemiology, University of Milano-Bicocca, Milan, Italy. Electronic address: giovanni.corrao@unimib.it.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Corrao
authors.affiliation: Department of Statistics and Quantitative Methods, Division of Biostatistics, Epidemiology and Public Health, Laboratory of Healthcare Research and Pharmacoepidemiology, University of Milano-Bicocca, Milan, Italy; IRCSS Istituto Auxologico Italiano, Milan, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Soranna
authors.affiliation: Department of Statistics and Quantitative Methods, Division of Biostatistics, Epidemiology and Public Health, Laboratory of Healthcare Research and Pharmacoepidemiology, University of Milano-Bicocca, Milan, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Arfè
authors.affiliation: Department of Pharmacological and Biomolecular Sciences, Centre of Epidemiology and Preventive Pharmacology (SEFAP), University of Milano, Milan, Italy.
authors.forename: Manuela
authors.initials: M
authors.lastname: Casula
authors.affiliation: Department of Pharmacological and Biomolecular Sciences, Centre of Epidemiology and Preventive Pharmacology (SEFAP), University of Milano, Milan, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Tragni
authors.affiliation: Operative Unit of Territorial Health Services, Region Lombardia, Milan, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Merlino
authors.affiliation: IRCSS Istituto Auxologico Italiano, Milan, Italy; Department of Health Science, University of Milano-Bicocca, Milan, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Mancia
authors.affiliation: Department of Pharmacological and Biomolecular Sciences, Centre of Epidemiology and Preventive Pharmacology (SEFAP), University of Milano, Milan, Italy; IRCSS Multimedica, Sesto San Giovanni, Milan, Italy.
authors.forename: Alberico L
authors.initials: AL
authors.lastname: Catapano
mesh_terms: D000368:Aged; D002318:Cardiovascular Diseases / Q000188:drug therapy*; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000493:pharmacokinetics*; D008297:Male; D008875:Middle Aged; D019821:Simvastatin / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D019821:Simvastatin
keywords: Brand-name; Cardiovascular events; Databases; Discontinuation; Generic; Statins