Population impact of regulatory activity restricting prescribing of COX-2 inhibitors: ecological study.

aimsTo 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).

methodsEcological time series study of prescribing, mortality and hospital admission trends in people aged > or = 55 years.

resultsWithdrawal 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.

conclusionsWithdrawal/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.