title: Off-patent generic medicines vs. off-patent brand medicines for six reference drugs: a retrospective claims data study from five local healthcare units in the Lombardy Region of Italy.
abstract: The scientific documentation supporting the potential clinical and economic benefits of a growing use of off-patent generic drugs in clinical practice seems to be limited in Italy as yet.
  
  
  METHODS
  We compared differences in outcomes between off-patent generic drugs and off-patent brand drugs in real clinical practice. The outcomes were: persistence and compliance with therapy, mortality, and other health resources consumption (hospitalizations, specialist examinations, other drugs) and total costs. Retrospective analysis was carried out by using the administrative databases of five Local Healthcare Units (ASLs - Aziende Sanitarie Locali) in the Lombardy Region of Italy. Data from the five ASLs were aggregated through a meta-analysis, which produced an estimate indicator of the mean or percentage difference between the two groups (branded vs. generic) and their respective significance tests. The therapeutic areas and studied drugs were: diabetes: metformin - A10BA02; hypertension: amlodipine - C08CA01; dyslipidemia: simvastatin - C10AA01; psychiatry: sertraline - N06AB06; cardiology: propafenone - C01BC03; osteoporosis: alendronate - M05BA04.
  
  
  RESULTS
  The 5 Local Healthcare Units (ASL) represent a population of 3,847,004 inhabitants. The selected sample included 347,073 patients, or 9.02% of the total ASL population; 67% of the patients were treated with off-patent brand drugs. The average age was 68 years, with no difference between the two groups. After 34 months of observation, compliance and persistence were in favor to generic drugs in all therapeutic areas and statistically significant in the metformin, amlodipine, simvastatin, and sertraline groups. The clinical outcomes (hospitalizations, mortality, and other health costs) show no statistically significant differences between off-patent generic vs. off-patent brand medicines.
  
  
  CONCLUSIONS
  Off-patent generic drugs appear to be a therapy option of choice in Italy as well, based on clinical outcomes and economic consequences, both for the National Health Service and patients, considering that the price difference between brand and generic drugs is completely charged on patients.
authors.affiliation: Department of Drug Sciences, University of Pavia, Pavia, Italy ; S.A.V.E. Studi Analisi Valutazioni Economiche, Milan, Italy.
authors.forename: Giorgio L
authors.initials: GL
authors.lastname: Colombo
authors.affiliation: Division of Medicine and Surgery, Spedali Civili, Brescia, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Agabiti-Rosei
authors.affiliation: Division of Cardiology, San Raffaele University Hospital, Milan, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Margonato
authors.affiliation: Department of Neuroscience, A.O. Fatebenefratelli e Oftalmico, Milan, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Mencacci
authors.affiliation: Division of Rheumatology, IRCCS Policlinico S Matteo, University of Pavia, Pavia, Italy.
authors.forename: Carlo Maurizio
authors.initials: CM
authors.lastname: Montecucco
authors.affiliation: Unit of Diabetology, Ospedali Riuniti di Bergamo, Bergamo, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Trevisan
mesh_terms: D019386:Alendronate / Q000008:administration & dosage; D017311:Amlodipine / Q000008:administration & dosage; D016568:Drugs, Generic / Q000008:administration & dosage*; D006801:Humans; D007558:Italy; D008687:Metformin / Q000008:administration & dosage; D004366:Nonprescription Drugs; D011405:Propafenone / Q000008:administration & dosage; D012189:Retrospective Studies; D020280:Sertraline / Q000008:administration & dosage
chemical_list: D016568:Drugs, Generic; D004366:Nonprescription Drugs; D017311:Amlodipine; D011405:Propafenone; D008687:Metformin; D020280:Sertraline; D019386:Alendronate