We report a cohort study of fatal upper GI hemorrhage and/or perforation in relation to use of nonsteroidal anti-inflammatory drugs (NSAIDs) among the one million residents of Saskatchewan Canada in 1983. All hospitalized cases of GI hemorrhage and/or perforation with a fatal outcome were identified using the records linkage system of the Saskatchewan Department of Health. Discharge summaries and autopsy records were reviewed to select the cases of upper GI hemorrhage or upper GI perforation and to exclude cases in which known risk factors were present. The 134,060 residents who filled one or more prescriptions for an NSAID in 1983 were identified and individually linked to their hospital records by patient identification number. The age- and gender-specific incidence of fatal upper GI hemorrhage and/or perforation in the absence of risk factors in users was compared to that in nonusers, controlling for recent history of upper GI disease. Fatal upper GI hemorrhage or perforation in temporal association with NSAIDs is extremely rare in persons younger than 75 years of age. No temporally-related cases occurred in male NSAID users age 75 and older, but NSAID usage in this group was limited. Among women age 75 and older, the rate in users was higher than in nonusers, with the highest rate being in female NSAID users age 75 and older with a recent history of upper GI disease. Total mortality among women age 75 and older was slightly lower among users than among nonusers. Physicians who prescribe NSAIDs to patients age 75 and older should be aware of the potential risks, particularly in those with predisposing factors such as a history of upper GI disease.
This article documents the impact of the introduction of selective NSAIDs on overall prescription patterns of NSAIDs and associated gastroprotective agents (GPAs), and on the rate of nonfatal digestive perforations and haemorrhages.
A retrospective, closed cohort study was conducted using the Quebec Health Insurance Board databases, for a 3-year period overlapping the introduction of selective NSAIDs. All adult subjects who were continuously registered with the Public Prescription Drug Program (PPDP) between 1 January 1999 and 31 December 2001 (n = 2 052 231) were included. Prescriptions for NSAIDs (selective [celecoxib, rofecoxib and meloxicam] and nonselective), concomitant use of GPAs and nonfatal digestive perforations or haemorrhages diagnosed in hospital were compiled. Data were analysed on an annual basis according to age, sex and patient risk of gastrointestinal (GI) complications.
The listing of selective NSAIDs in the PPDP formulary was followed by a 28.2% increase in the prevalence of NSAID use from 19.5% in 1999 to 25% in 2001. The proportion of long-term users also evolved rapidly with a 135% increase over 3 years. From 1999 to 2001, there was a 75.9% increase in the rate of nonfatal digestive perforations and haemorrhages in the presence of NSAIDs.
The introduction of selective NSAIDs stimulated NSAID use and coincided with an increased incidence of nonfatal digestive perforations and haemorrhages in the presence of NSAIDs. Selective NSAIDs should be prescribed with caution to persons at risk for GI complications.
Comment In: Drug Saf. 2007;30(1):89-90; author reply 90-117194174
OBJECTIVES: To investigate the effect of hydrocortisone treatment on survival without bronchopulmonary dysplasia (BPD) and to study whether serum cortisol concentrations predict the response. STUDY DESIGN: We performed a randomized, placebo-controlled trial on infants with gestation