title: Adherence to changing from brand-name to generic atorvastatin in newly treated patients: a retrospective cohort study using health insurance claims.
abstract: BACKGROUND
  Effect of statin therapy has been reported to be associated with patient's adherence. Atorvastatin was available in Japan as a brand-name product beginning in 2000. The first atorvastatin generics were introduced in Japan in November 2011. The objective of this study was to analyze whether changing from a brand-name atorvastatin to a generic product would affect patient adherence.
  
  
  METHODS
  We conducted a retrospective cohort study that included adult patients who received newly prescribed brand-name atorvastatin between June 1, 2011 and May 31, 2012, using a health insurance claims database in Japan. Patients were classified by the presence or absence of changing to a generic during the 6 months from December 1, 2011 to May 31, 2012 (the index period). The first prescription date for the generic or brand product during the index period was defined as the index date. Adherence to therapy was assessed by the proportion of days covered (PDC) and persistence of treatment by time to discontinuation.
  
  
  RESULTS
  There were 135 patients changing to generic atorvastatin and 147 continuing with the brand-name product. There was no significant difference in decrease of PDC from pre- to post-index date between the changed cohort and continued cohort (-8.6% vs -10.3%, respectively; P = 0.443). After adjusting for baseline covariates, including adherence in pre-index date, no statistically significant differences were observed in the adjusted odds of adherence between the cohorts (adjusted odds ratio = 0.83, 95% confidence interval (CI) = 0.46-1.53). There was also no significant difference in persistence between two cohorts in the 180-day after post-index date. After analysis of a Cox proportional hazard regression model controlling for baseline covariates, including adherence in pre-index date, no statistically significant differences were observed for the hazard of non-persistence between the cohorts (adjusted hazard ratio = 0.96, 95% CI = 0.60-1.53).
  
  
  CONCLUSIONS
  Changing from a brand-name atorvastatin to generic product did not affect adherence for patients newly treated with atorvastatin.
authors.affiliation: Department of Pharmaceutical Sciences, International University of Health and Welfare, Otawara, Tochigi Japan.
authors.forename: Yasunari
authors.initials: Y
authors.lastname: Mano
authors.affiliation: Department of Pharmaceutical Sciences, International University of Health and Welfare, Otawara, Tochigi Japan.
authors.forename: Shota
authors.initials: S
authors.lastname: Fukushima
authors.affiliation: Department of Pharmaceutical Sciences, International University of Health and Welfare, Otawara, Tochigi Japan.
authors.forename: Hisayuki
authors.initials: H
authors.lastname: Kuroda
authors.affiliation: Department of Pharmaceutical Sciences, International University of Health and Welfare, Otawara, Tochigi Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Ohshima
authors.affiliation: Department of Pharmaceutical Sciences, International University of Health and Welfare, Otawara, Tochigi Japan.
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Kato
authors.affiliation: Department of Pharmaceutical Sciences, International University of Health and Welfare, Otawara, Tochigi Japan.
authors.forename: Kaori
authors.initials: K
authors.lastname: Ohuchi
authors.affiliation: Department of Pharmaceutical Sciences, International University of Health and Welfare, Otawara, Tochigi Japan.
authors.forename: Kayoko
authors.initials: K
authors.lastname: Maezawa
authors.affiliation: Department of Pharmaceutical Sciences, International University of Health and Welfare, Otawara, Tochigi Japan.
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Momose
authors.affiliation: Department of Pharmaceutical Sciences, International University of Health and Welfare, Otawara, Tochigi Japan.
authors.forename: Shunya
authors.initials: S
authors.lastname: Ikeda
authors.affiliation: Department of Pharmaceutical Sciences, International University of Health and Welfare, Otawara, Tochigi Japan.
authors.forename: Mariko
authors.initials: M
authors.lastname: Asahi
keywords: Adherence; Atorvastatin; Claim database; Cohort study; Generic substitution; Persistence; Proportion of days covered
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