title: Population impact of regulatory activity restricting prescribing of COX-2 inhibitors: ecological study.
abstract: OBJECTIVE
  To investigate impacts of withdrawal and regulatory advice regarding cyclooxygenase-2 (COX-2) inhibitors on UK population rates of gastrointestinal haemorrhage and acute myocardial infarction (MI).
  
  
  METHODS
  Ecological time series study of prescribing, mortality and hospital admission trends in people aged > or = 55 years.
  
  
  RESULTS
  Withdrawal and regulatory advice limiting COX-2 inhibitor availability from 2004 were temporally associated with reversal of previously unfavourable trends in emergency MI admissions among people aged > or = 65 years. Annual admission rate trends changed from +4.6% to -3.1% (P < 0.001) among women and from +2.1% to -3.8% (P= 0.003) among men. Absolute changes in average annual trend in the number of individuals aged > or = 65 years admitted following MI were from +981 (1999-2004) to -819 (2004-2006) per year for women and from +713 to -995 for men. No change in trend was apparent among people aged 55-64 years, or in MI mortality trends. There was some suggestion of an unfavourable change in admission trends for gastrointestinal haemorrhage among 55-64-year-olds, although this appeared to occur prior to COX-2 inhibitor withdrawal/regulation by up to 2 years. These trends were not apparent in older people, or in gastrointestinal haemorrhage mortality rates.
  
  
  CONCLUSIONS
  Withdrawal/regulation of COX-2 inhibitors was temporally associated with a favourable reversal of population-level hospital admission trends in MI among people aged > or = 65 years. Unfavourable reversal of previous declines in gastrointestinal haemorrhage admissions probably occurred before changes in COX-2 inhibitor availability. Withdrawal/ regulation of COX-2 inhibitors did not appear to have any adverse impact on population health and may have been beneficial.
authors.affiliation: Department of Social Medicine, University of Bristol, Bristol, UK. ben.wheeler@bristol.ac.uk
authors.forename: Benedict W
authors.initials: BW
authors.lastname: Wheeler
authors.forename: Chris
authors.initials: C
authors.lastname: Metcalfe
authors.forename: David
authors.initials: D
authors.lastname: Gunnell
authors.forename: Peter
authors.initials: P
authors.lastname: Stephens
authors.forename: Richard M
authors.initials: RM
authors.lastname: Martin
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D052246:Cyclooxygenase 2 Inhibitors / Q000009:adverse effects*; D004363:Drug Utilization / Q000706:statistics & numerical data; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced* / Q000401:mortality; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000139:chemically induced* / Q000401:mortality; D018570:Risk Assessment; D012307:Risk Factors; D006113:United Kingdom
chemical_list: D052246:Cyclooxygenase 2 Inhibitors