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Rosiglitazone use and post-discontinuation glycaemic control in two European countries, 2000–2010
  1. V Ehrenstein1,
  2. R K Hernandez2,3,
  3. S P Ulrichsen1,
  4. J Rungby4,
  5. T L Lash1,5,
  6. A H Riis1,
  7. L Li2,
  8. H T Sørensen1,
  9. S S Jick2
  1. 1Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark
  2. 2Boston Collaborative Drug Surveillance Program (BCDSP), Boston University School of Public Health, Lexington, Massachusetts, USA
  3. 3Center for Observational Research, Amgen, Inc, Thousand Oaks, California, USA
  4. 4Department of Biomedicine—Pharmacology, Aarhus University, Aarhus, Denmark
  5. 5Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA
  1. Correspondence to Dr V Ehrenstein; ve{at}dce.au.dk

Abstract

Objectives To evaluate the impact of risk minimisation policies on the use of rosiglitazone-containing products and on glycaemic control among patients in Denmark and the UK.

Design, setting and participants We used population-based data from the Aarhus University Prescription Database (AUPD) in northern Denmark and from the General Practice Research Database (GPRD) in the UK.

Main outcome measures We examined the use of rosiglitazone during its entire period of availability on the European market (2000–2010) and evaluated changes in the glycated haemoglobin (HbA1c) and fasting plasma glucose (FPG) levels among patients discontinuing this drug.

Results During 2000–2010, 2321 patients with records in AUPD used rosiglitazone in northern Denmark and 25 428 patients with records in GPRD used it in the UK. The proportion of rosiglitazone users among all users of oral hypoglycaemic agents peaked at 4% in AUPD and at 15% in GPRD in May 2007, the month of publication of a meta-analysis showing increased cardiovascular morbidity associated with rosiglitazone use. 12 months after discontinuation of rosiglitazone-containing products, the mean change in HbA1c was −0.16% (95% CI −3.4% to 3.1%) in northern Denmark and −0.17% (95% CI −0.21% to 0.13%) in the UK. The corresponding mean changes in FPG were 0.01 mmol/L (95% CI −7.3 to 7.3 mmol/L) and 0.03 mmol/L (95% CI −0.22 to 0.28 mmol/L).

Conclusions Publication of evidence concerning the potential cardiovascular risks of rosiglitazone was associated with an irreversible decline in the use of rosiglitazone-containing products in Denmark and the UK. The mean changes in HbA1c and FPG after drug discontinuation were slight.

  • diabetes mellitus
  • drug safety
  • glucose-lowering drugs
  • rosiglitazone
  • thiazolidinediones

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

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